| 1 |
NCT03217812 |
Recruiting |
A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region) |
|
- Drug: Velcade
- Drug: Melphalan
- Drug: Prednisone
- Drug: Daratumumab
|
Interventional
|
Phase 3 |
- Janssen Research & Development, LLC
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Very Good Partial Response (VGPR) or Better Rate at 6 Month After Last Participant First Dose
- Very Good Partial Response (VGPR) or Better Rate at 3 Years After Last Participant First Dose
- Progression-Free Survival (PFS)
- (and 14 more...)
|
210 |
All |
18 Years and older (Adult, Older Adult) |
NCT03217812 |
CR108340
54767414MMY3011 |
|
November 23, 2017 |
January 17, 2020 |
October 31, 2022 |
July 14, 2017 |
January 10, 2019 |
|
- Beijing Chaoyang Hospital
Beijing, China - Peking Union Medical College Hospital
Beijing, China - Peking University First Hospital
Beijing, China - (and 36 more...)
|
|
| 2 |
NCT03757221 |
Not yet recruiting |
Ixazomib -Daratumumab Without Dexamethasone (IDara) in Elderly Relapse Refractory Multiple Myeloma |
|
- Combination Product: Ixazomib and Daratumumab
|
Interventional
|
Phase 2 |
- University Hospital, Caen
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Very Good Partial Response (VGPR) + Complete Response (CR) Rate using the IMWG response criteria
|
70 |
All |
65 Years and older (Older Adult) |
NCT03757221 |
18-070 |
IDARA |
January 1, 2019 |
December 31, 2024 |
December 31, 2025 |
November 28, 2018 |
November 28, 2018 |
|
|
|
| 3 |
NCT03641456 |
Not yet recruiting |
VRD as Induction Followed by IR Maintenance in Patients With Newly Diagnosed High Risk Multiple Myeloma |
- Myeloma
- Newly Diagnosed
- High Risk
|
- Drug: bortezomib
- Drug: Lenalidomide
- Drug: Dexamethasone
- Drug: Ixazomib
|
Interventional
|
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Very good partial response or better by International Myeloma Working Group criteria
- progression free survival
- overall survival
- (and 3 more...)
|
50 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT03641456 |
MM-2018 |
|
January 10, 2019 |
September 30, 2020 |
September 30, 2022 |
August 22, 2018 |
January 21, 2019 |
|
- Sun Yat-sen University Cancer Center
GuangZhou, Guangdong, China
|
|
| 4 |
NCT02248428 |
Recruiting |
Clarithromycin Plus CTd Regimen for Patients With Newly Diagnosed Multiple Myeloma |
|
- Drug: Clarithromycin
- Drug: Thalidomide
- Drug: Cyclophosphamide
- Drug: Dexamethasone
|
Interventional
|
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With Very Good Partial Remission (VGPR) or Better
- Median Progression Free Survival (PFS) in months
- 2 Year Overall Survival (OS) Rate
- Number of participants with adverse events
|
130 |
All |
18 Years and older (Adult, Older Adult) |
NCT02248428 |
NAB20140324 |
CTd |
April 2012 |
September 2019 |
September 2020 |
September 25, 2014 |
September 6, 2017 |
|
- Jinling Hospital
Nanjing, Jiangsu, China
|
|
| 5 |
NCT03792620 |
Recruiting |
Daratumumab Intensified Treatment to Eligible MM New Patients CTD-Dara Induction, Follow by Dara Consolidation |
|
- Combination Product: Cyclo Thal Dex Daratumumab
|
Interventional
|
Phase 3 |
- Grupo de Estudos Multicentricos em Onco-Hematologia
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of response rate better than very good partial response after ASCT
- Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v 4.0
- Incidence of Overall response rate
- (and 12 more...)
|
20 |
All |
18 Years to 120 Years (Adult, Older Adult) |
NCT03792620 |
U1111-1219-9010
CAAE |
MAXDARA |
November 20, 2018 |
May 2020 |
April 2022 |
January 3, 2019 |
January 3, 2019 |
|
- CEHON - Centro de Hematologia e Oncologia da Bahia
Salvador, Bahia, Brazil
|
|
| 6 |
NCT03439293 |
Recruiting |
A Study of Ixazomib+Daratumumab+Dexamethasone (IDd) in Relapsed and/or Refractory Multiple Myeloma (RRMM) |
|
- Drug: Ixazomib
- Drug: Daratumumab
- Drug: Dexamethasone
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With Very Good Partial Response (VGPR) or Better
- Progression-free Survival (PFS)
- Time to Progression (TTP)
- (and 4 more...)
|
60 |
All |
18 Years and older (Adult, Older Adult) |
NCT03439293 |
C16047
U1111-1202-6022
2017-003977-32 |
|
June 8, 2018 |
December 2, 2019 |
December 31, 2023 |
February 20, 2018 |
September 7, 2018 |
|
- Pacific Cancer Medical Center
Anaheim, California, United States - Colorado Blood Cancer Institute
Denver, Colorado, United States - SCRI - Florida Cancer Specialists - Panhandle
Tallahassee, Florida, United States - (and 25 more...)
|
|
| 7 |
NCT01794520 |
Recruiting |
Study Evaluating ABT-199 in Subjects With Relapsed or Refractory Multiple Myeloma |
|
- Drug: Dexamethasone
- Drug: ABT-199
|
Interventional
|
Phase 1
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determination of peak concentration (Cmax) of ABT-199
- Calculation of objective response rate
- Determine dose and schedule of ABT-199
- (and 10 more...)
|
166 |
All |
18 Years and older (Adult, Older Adult) |
NCT01794520 |
M13-367
2012-000589-38 |
|
October 10, 2012 |
May 29, 2021 |
May 29, 2021 |
February 20, 2013 |
February 15, 2019 |
|
- Mayo Clinic - Scottsdale /ID# 75808
Scottsdale, Arizona, United States - University of Arkansas for Medical Sciences /ID# 170002
Little Rock, Arkansas, United States - Yale University /ID# 203704
New Haven, Connecticut, United States - (and 29 more...)
|
|
| 8 |
NCT03713294 |
Recruiting |
Dexamethasone, Elotuzumab, and Pomalidomide in Treating Patients With Refractory Multiple Myeloma |
- Refractory Plasma Cell Myeloma
|
- Drug: Dexamethasone
- Biological: Elotuzumab
- Drug: Pomalidomide
|
Interventional
|
Phase 2 |
- Mayo Clinic
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall response rate (ORR) defined as a partial response, very good partial response, complete response (CR) or stringent CR (sCR)
- Percentage of patients achieving complete response (CR)
- Progression-free survival (PFS)
- (and 2 more...)
|
41 |
All |
18 Years and older (Adult, Older Adult) |
NCT03713294 |
MC1884
NCI-2018-02140
P30CA015083 |
|
December 19, 2018 |
October 8, 2023 |
October 8, 2023 |
October 19, 2018 |
January 3, 2019 |
|
- Mayo Clinic in Florida
Jacksonville, Florida, United States
|
|
| 9 |
NCT03748953 |
Not yet recruiting |
A Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Participants With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation (SCT) |
|
- Drug: Ixazomib
- Drug: Ixazomib Placebo
|
Interventional
|
Phase 3 |
- Millennium Pharmaceuticals, Inc.
- Takeda
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Progression-Free Survival (PFS)
- Overall Survival (OS)
- Percentage of Participants who Achieve or Maintain Best Response Before PD or up to Subsequent Therapy
- (and 18 more...)
|
105 |
All |
18 Years and older (Adult, Older Adult) |
NCT03748953 |
C16021CSC
2014-001394-13 |
|
February 28, 2019 |
September 1, 2024 |
September 1, 2026 |
November 21, 2018 |
January 24, 2019 |
|
|
|
| 10 |
NCT03275285 |
Recruiting |
Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients |
|
- Drug: isatuximab SAR650984
- Drug: carfilzomib
- Drug: dexamethasone
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Progression Free Survival (PFS)
- Overall Response Rate (ORR)
- Rate of VGPR or better
- (and 11 more...)
|
300 |
All |
18 Years and older (Adult, Older Adult) |
NCT03275285 |
EFC15246
2017-001940-37
U1111-1195-5957 |
IKEMA |
October 25, 2017 |
October 2023 |
October 2023 |
September 7, 2017 |
December 13, 2018 |
|
- Investigational Site Number 8400002
San Francisco, California, United States - Investigational Site Number 8400003
Spartanburg, South Carolina, United States - Investigational Site Number 0360005
Blacktown, Australia - (and 67 more...)
|
|
| 11 |
NCT03393273 |
Not yet recruiting |
Elotuzumab in Patients With Multiple Myeloma Before and After Peripheral Stem Cell Autologous Graft |
|
|
Interventional
|
Phase 2 |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximal response rate Assesment of the International Myeloma Working Group uniform response criteria
- survival and progression-free survival
- evaluation of the answer to the treatment to improve or maintain the response
- (and 4 more...)
|
35 |
All |
66 Years and older (Older Adult) |
NCT03393273 |
P170103
2017-001446-10 |
IFM2016-03 |
May 2018 |
May 2023 |
May 2023 |
January 8, 2018 |
May 15, 2018 |
|
|
|
| 12 |
NCT02899052 |
Recruiting |
Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (MM) |
|
- Drug: Carfilzomib
- Drug: Venetoclax
- Drug: Dexamethasone
|
Interventional
|
Phase 2 |
- AbbVie
- Genentech, Inc.
- Onyx Therapeutics, Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Adverse events
- Objective Response Rate (ORR) of VenKd in participants with RRMM as well as those with t(11;14)-positive RRMM.
- Very Good Partial Response (VGPR) or better response rate of VenKd in participants with relapsed or refractory MM (RRMM) as well as those with t(11;14)-positive RRMM
- (and 15 more...)
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT02899052 |
M15-538 |
|
January 19, 2017 |
March 27, 2020 |
October 16, 2022 |
September 14, 2016 |
October 31, 2018 |
|
- University of Alabama /ID# 151405
Birmingham, Alabama, United States - University of Arkansas for Medical Sciences /ID# 151399
Little Rock, Arkansas, United States - Emory University Hospital /ID# 161710
Atlanta, Georgia, United States - (and 9 more...)
|
|
| 13 |
NCT03319667 |
Recruiting |
Clinical Benefit of SAR650984, Bortezomib, Lenalidomide and Dexamethasone Combination in NDMM Patients Not Eligible for Transplant |
|
- Drug: Isatuximab SAR650984
- Drug: Bortezomib
- Drug: Lenalidomide
- (and 4 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Progression free survival (PFS)
- Very good partial response (VGPR) or better rate
- Minimal residual disease (MRD) negativity rate
- (and 16 more...)
|
440 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT03319667 |
EFC12522
2017-002238-21
U1111-1194-2121 |
IMROZ |
December 7, 2017 |
December 2022 |
January 2025 |
October 24, 2017 |
January 31, 2019 |
|
- Investigational Site Number 8400006
Fort Myers, Florida, United States - Investigational Site Number 8400004
Saint Petersburg, Florida, United States - Investigational Site Number 8400007
Kansas City, Missouri, United States - (and 105 more...)
|
|
| 14 |
NCT03292263 |
Recruiting |
ASCT With Nivolumab in Patients With Multiple Myeloma |
|
- Drug: Melphalan
- Drug: Nivolumab
- Procedure: Autologous Stem Cell Transplantation
|
Interventional
|
Phase 1
Phase 2 |
- St. Petersburg State Pavlov Medical University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall response
- Progression free survival (PFS)
- Overall Survival (OS)
- Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03
|
30 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT03292263 |
11/17-n |
|
April 24, 2017 |
April 2019 |
April 2021 |
September 25, 2017 |
September 25, 2017 |
|
- Boris V Afanasyev, MD, Prof.
Saint Petersburg, Russian Federation
|
|
| 15 |
NCT03490344 |
Recruiting |
Short Course Daratumumab in Patients With Multiple Myeloma |
|
- Drug: Daratumumab
- Drug: Lenalidomide
|
Interventional
|
Phase 2 |
- Memorial Sloan Kettering Cancer Center
- Janssen Scientific Affairs, LLC
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of MRD negativity by the completion of 6 months of daratumumab therapy
|
25 |
All |
18 Years and older (Adult, Older Adult) |
NCT03490344 |
18-048 |
|
May 3, 2018 |
October 2020 |
October 2020 |
April 6, 2018 |
January 4, 2019 |
|
- Memoral Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States - Memoral Sloan Kettering Monmouth
Middletown, New Jersey, United States - Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States - (and 4 more...)
|
|
| 16 |
NCT02765854 |
Recruiting |
Ixazomib and Dexamethasone Versus Ixazomib, Dexamethasone and Lenalidomide, Randomized With NFKB2 Rearrangement |
- Recurrent Plasma Cell Myeloma
- Refractory Plasma Cell Myeloma
|
- Drug: Dexamethasone
- Drug: Ixazomib
- Drug: Lenalidomide
|
Interventional
|
Phase 2 |
- Emory University
- Millennium Pharmaceuticals, Inc.
- Multiple Myeloma Research Consortium
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Response rate of very good partial response (VGPR) or better
- Overall response rate (CR + VGPR + partial response [PR]), stable disease or progression
- CR, stringent CR, and VGPR rate
- (and 7 more...)
|
90 |
All |
18 Years and older (Adult, Older Adult) |
NCT02765854 |
IRB00077815
NCI-2016-00043
MMRC060 |
|
September 1, 2016 |
September 2019 |
September 2020 |
May 9, 2016 |
September 3, 2018 |
|
- Grady Memorial Hospital
Atlanta, Georgia, United States - Emory University/Winship Cancer Institute
Atlanta, Georgia, United States - University of Michigan/Rogel Cancer Center
Ann Arbor, Michigan, United States - Washington University/Siteman Cancer Center
Saint Louis, Missouri, United States
|
|
| 17 |
NCT01864018 |
Recruiting |
Ixazomib Citrate, Cyclophosphamide, and Dexamethasone in Treating Patients With Previously Untreated Symptomatic Multiple Myeloma or Light Chain Amyloidosis |
- Amyloidosis
- Plasma Cell Myeloma
|
- Drug: Cyclophosphamide
- Drug: Dexamethasone
- Drug: Ixazomib Citrate
- (and 4 more...)
|
Interventional
|
Phase 1
Phase 2 |
- Mayo Clinic
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose of ixazomib with cyclophosphamide and dexamethasone (Phase I)
- Rate of complete response or very good partial response (Phase II)
- Incidence of adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
- (and 2 more...)
|
51 |
All |
18 Years and older (Adult, Older Adult) |
NCT01864018 |
MC1382
NCI-2013-01042
X16009
P30CA015083 |
|
August 20, 2013 |
October 22, 2020 |
October 22, 2020 |
May 29, 2013 |
July 9, 2018 |
|
- Mayo Clinic in Arizona
Scottsdale, Arizona, United States - Mayo Clinic
Rochester, Minnesota, United States
|
|
| 18 |
NCT03525678 |
Recruiting |
A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Subjects With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody |
|
- Drug: GSK2857916 frozen
- Drug: GSK2857916 lyophilized
- Other: NEI-VFQ-25 Questionnaire
- (and 3 more...)
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall response rate (ORR)
- Clinical benefit rate (CBR)
- Duration of response (DoR)
- (and 22 more...)
|
155 |
All |
18 Years and older (Adult, Older Adult) |
NCT03525678 |
205678 |
|
June 18, 2018 |
June 30, 2019 |
June 30, 2020 |
May 16, 2018 |
October 12, 2018 |
|
- GSK Investigational Site
Atlanta, Georgia, United States - GSK Investigational Site
Atlanta, Georgia, United States - GSK Investigational Site
Chicago, Illinois, United States - (and 49 more...)
|
|
| 19 |
NCT03287804 |
Recruiting |
APRIL CAR T Cells (AUTO2) Targeting BCMA and TACI for the Treatment of Multiple Myeloma |
|
|
Interventional
|
Phase 1
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase I - Safety (Frequency and severity of adverse events and serious AEs) and confirmation of phase II dose and schedule
- Phase II - Anti-myeloma response as per International Myeloma Working Group (IMWG) consensus recommendations
- Feasibility of generating AUTO2: Number of patients who cells achieve successful AUTO2 manufacture as a proportion of the number of patients undergoing leukapheresis
- clinical benefit (stringent complete response + complete response + very good partial response + partial response + minor response [sCR+CR+VGPR+PR+MR]) rate following AUTO2. Response criteria per IMWG consensus recommendations
|
80 |
All |
18 Years and older (Adult, Older Adult) |
NCT03287804 |
AUTO2-MM1
2016-003893-42 |
APRIL |
May 5, 2017 |
October 2020 |
October 2020 |
September 19, 2017 |
July 10, 2018 |
|
- VU University Medical Centre Amsterdam
Amsterdam, Netherlands - University College London Hospitals NHS Foundation Trust
London, United Kingdom - The Christie NHS Foundation Trust
Manchester, United Kingdom - Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
|
|
| 20 |
NCT03589222 |
Recruiting |
SELIBORDARA: Selinexor, Bortezomib and Daratumumab in Multiple Myeloma |
- Refractory Multiple Myeloma
|
- Drug: Selinexor
- Drug: Daratumumab
- Drug: Bortezomib
- Drug: Dexamethasone
|
Interventional
|
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of responses type to treatment
- Incidence of Treatment-Emergent Adverse Events
|
62 |
All |
18 Years and older (Adult, Older Adult) |
NCT03589222 |
GEM- SELIBORDARA |
|
July 15, 2018 |
June 2019 |
June 2022 |
July 17, 2018 |
July 27, 2018 |
|
- Hospital Germans Trials i Pujol
Badalona, Spain - Hospital Clinic de Barcelona
Barcelona, Spain - Hospital ICO de Girona
Girona, Spain - (and 12 more...)
|
|
| 21 |
NCT01090089 |
Recruiting |
Combination of Lenalidomide and Dexamethasone in Treatment of Multiple Myeloma |
|
- Drug: Lenalidomide, Dexamethasone
- Drug: Lenalidomide, Dexamethasone, PBSCT
|
Interventional
|
Phase 3 |
- Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
- ClinAssess GmbH
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-free survival (PFS)
- Overall survival (OS)
- • Response (complete response [CR], stringent complete response [sCR], very good partial response [VGPR], partial response [PR] and overall response [CR (incl. sCR)+ VGPR + PR]) according to IMWG criteria
|
348 |
All |
60 Years to 75 Years (Adult, Older Adult) |
NCT01090089 |
DSMM XIII |
DSM XIII |
March 1, 2010 |
December 2019 |
January 2020 |
March 19, 2010 |
September 8, 2017 |
|
- Universitätsklinikum Münster
Muenster, North Rhein Westfallen, Germany - Universitätsklinikum Aachen
Aachen, Germany - Agirov Klinik
Berg, Germany - (and 28 more...)
|
|
| 22 |
NCT03608501 |
Not yet recruiting |
A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation |
|
- Drug: Ixazomib
- Drug: Thalidomide
- Drug: Dexamethasone
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- ORR During Induction
- Progression-free Survival (PFS)
- ORR During Maintenance
- (and 2 more...)
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT03608501 |
C16041
U1111-1214-1078 |
IDEALL |
May 30, 2019 |
June 30, 2021 |
May 31, 2023 |
August 1, 2018 |
September 6, 2018 |
|
|
|
| 23 |
NCT02389517 |
Recruiting |
Lenalidomide With or Without Ixazomib Citrate and Dexamethasone in Treating Patients With Residual Multiple Myeloma After Donor Stem Cell Transplant |
- Plasma Cell Myeloma
- Residual Disease
|
- Drug: Ixazomib Citrate
- Drug: Lenalidomide
- Drug: Dexamethasone
|
Interventional
|
Phase 2 |
- University of Chicago
- National Cancer Institute (NCI)
- Multiple Myeloma Research Foundation
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of MRD between the two arms, as measured by flow cytometry and sequencing
- Overall response rate defined as an improvement from very good partial response (VGPR) to near complete response (nCR) or better than nCR including conversion from complete response (CR) to MRD negative disease according to IMWG criteria
- Overall response defined as an improvement from VGPR to nCR or better than nCR including conversion from CR to MRD negative disease according to IMWG criteria
- (and 5 more...)
|
86 |
All |
18 Years and older (Adult, Older Adult) |
NCT02389517 |
IRB14-0899
NCI-2015-00138
X16047
14-0899
P30CA014599 |
|
March 2, 2015 |
March 2, 2020 |
March 2, 2022 |
March 17, 2015 |
October 15, 2018 |
|
- University of Chicago
Chicago, Illinois, United States
|
|
| 24 |
NCT03762291 |
Not yet recruiting |
Multiple Myeloma Trial of Orally Administered Salmonella Based Survivin Vaccine |
|
- Biological: CVD908ssb-TXSVN
|
Interventional
|
Phase 1 |
- Baylor College of Medicine
- The Methodist Hospital System
- Texas Children's Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of patients with dose limiting toxicity (DLT) by CTCAE 4.X.
- Overall response rate according to the modified International Myeloma Working Group (IMWG) Uniform Response criteria.
|
24 |
All |
18 Years and older (Adult, Older Adult) |
NCT03762291 |
H-42712 MAPSS |
MAPSS |
January 1, 2019 |
January 1, 2022 |
November 1, 2026 |
December 3, 2018 |
December 3, 2018 |
|
|
|
| 25 |
NCT03274219 |
Recruiting |
Study of bb21217 in Multiple Myeloma |
|
|
Interventional
|
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of adverse events (AEs), DLTs, and changes in laboratory results
- Disease-specific response criteria
|
50 |
All |
18 Years and older (Adult, Older Adult) |
NCT03274219 |
CRB-402 |
|
August 16, 2017 |
June 2020 |
June 2020 |
September 6, 2017 |
February 4, 2019 |
|
- UCSF Medical Center at Parnassus
San Francisco, California, United States - H. Lee Moffitt Cancer Center
Tampa, Florida, United States - Winship Cancer Insitute, Emory University
Atlanta, Georgia, United States - (and 7 more...)
|
|
| 26 |
NCT01415882 |
Recruiting |
Ixazomib in Treating Patients With Relapsed Multiple Myeloma That Is Not Refractory to Bortezomib |
- Recurrent Plasma Cell Myeloma
- Refractory Plasma Cell Myeloma
|
- Drug: Cyclophosphamide
- Drug: Dexamethasone
- Drug: Ixazomib Citrate
- Other: Laboratory Biomarker Analysis
|
Interventional
|
Phase 2 |
- Mayo Clinic
- National Cancer Institute (NCI)
- Janssen Scientific Affairs, LLC
|
Other / NIH / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of confirmed responses with ixazomib citrate alone (Arm A only-closed to accrual as of addendum 5), ixazomib citrate with dexamethasone (Arms B + C), or ixazomib citrate with dexamethasone and cyclophosphamide (Arm D)
- Confirmed response rate with the addition of dexamethasone (Arm A only)
- Event-free survival
- (and 2 more...)
|
144 |
All |
18 Years and older (Adult, Older Adult) |
NCT01415882 |
MC1181
NCI-2011-02303
11-001516 00
Mod11-001516-50
P30CA015083 |
|
February 4, 2016 |
April 1, 2019 |
April 1, 2019 |
August 12, 2011 |
January 21, 2019 |
|
- Mayo Clinic in Arizona
Scottsdale, Arizona, United States - Mayo Clinic in Florida
Jacksonville, Florida, United States - Mayo Clinic
Rochester, Minnesota, United States
|
|
| 27 |
NCT02909036 |
Recruiting |
Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant. |
- Multiple Myeloma
- Amyloidosis
|
- Device: Melphalan
- Drug: Pegfilgrastim
- Procedure: Autologous Hematopoietic Progenitor Cell Transplant
|
Interventional
|
Phase 1 |
- Memorial Sloan Kettering Cancer Center
- Spectrum Pharmaceuticals, Inc
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Response Rate (ORR)
|
26 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT02909036 |
16-875 |
|
September 2016 |
September 2019 |
September 2019 |
September 21, 2016 |
September 18, 2018 |
|
- Memorial Sloan Kettering Cancer Center
New York, New York, United States
|
|
| 28 |
NCT03104270 |
Recruiting |
Combination Study for High Risk Multiple Myeloma Patients |
|
- Drug: Elotuzumab
- Drug: Pomalidomide
- Drug: Carfilzomib
- Drug: Dexamethasone
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
- Efficacy
- PFS
- (and 2 more...)
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT03104270 |
CA204-187 |
|
March 13, 2017 |
February 2020 |
May 2020 |
April 7, 2017 |
January 8, 2019 |
|
- California Cancer Associates for Research & Excellence (cCARE)
Encinitas, California, United States - Robert A. Moss, MD, FACP, Inc
Fountain Valley, California, United States - Pacific Cancer Care
Monterey, California, United States - (and 3 more...)
|
|
| 29 |
NCT03202628 |
Recruiting |
Ixazomib Citrate, Pomalidomide, Dexamethasone, and Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Multiple Myeloma |
- Recurrent Plasma Cell Myeloma
- Refractory Plasma Cell Myeloma
|
- Procedure: Autologous Hematopoietic Stem Cell Transplantation
- Drug: Dexamethasone
- Drug: Ixazomib Citrate
- (and 2 more...)
|
Interventional
|
Phase 2 |
- Mayo Clinic
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-free survival at 18 months (PFS18) defined as the proportion of patients alive and free from disease progression at 18 months from study entry
- Greater than or equal to (>=) very good partial response (VGPR) rate
- Incidence of adverse events graded according to the National Cancer Institute (NC) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4
- (and 2 more...)
|
25 |
All |
18 Years and older (Adult, Older Adult) |
NCT03202628 |
MC168A
NCI-2017-01145
P30CA015083 |
|
July 24, 2017 |
July 24, 2022 |
July 24, 2022 |
June 28, 2017 |
August 14, 2018 |
|
- Mayo Clinic
Rochester, Minnesota, United States
|
|
| 30 |
NCT03508765 |
Recruiting |
Neurocognitive and Neuroimaging Outcomes in Older Patients With Multiple Myeloma Treated With Autologous Stem Cell Transplantation |
|
- Diagnostic Test: Structural Image
- Diagnostic Test: Functional Image
- Behavioral: Digit Span subtest
- (and 8 more...)
|
Interventional
|
Not Applicable |
- Memorial Sloan Kettering Cancer Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Changes in neurocognitive functions in older participants with Multiple Myeloma following high-dose (HD) chemotherapy and autologous stem cell transplantation (ASCT) assessed by initial and follow-up neurocognitive evaluation
- Changes in regional brain volume and functional connectivity when baseline and follow-up MRIs are compared.
|
18 |
All |
60 Years to 75 Years (Adult, Older Adult) |
NCT03508765 |
18-154 |
|
March 27, 2018 |
March 2020 |
March 2020 |
April 26, 2018 |
January 4, 2019 |
|
- Memorial Sloan Kettering Cancer Center
New York, New York, United States
|
|
| 31 |
NCT03288974 |
Recruiting |
Post Marketing Surveillance on Safety Evaluation of POMALYST® (Pomalidomide) Treatment of Multiple Myeloma in Korea |
|
- Drug: POMALYST® (Pomalidomide)
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Adverse events
- Overall response rate
|
600 |
All |
19 Years and older (Adult, Older Adult) |
NCT03288974 |
NIPMS-POM-KR-001
U1111-1201-1712 |
Pomalyst PMS |
December 28, 2017 |
June 8, 2023 |
June 8, 2023 |
September 20, 2017 |
May 21, 2018 |
|
- Korea University Ansan Hospital
Ansan, Korea, Republic of - Hallym University Sacred Heart Hospital
Anyang, Korea, Republic of - Soonchunhyang University Hospital
Bucheon, Korea, Republic of - (and 26 more...)
|
|
| 32 |
NCT02998047 |
Recruiting |
A Phase I Study of Lintuzumab-Ac225 in Patients With Refractory Multiple Myeloma |
- Refractory Multiple Myeloma
|
|
Interventional
|
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated dose of Lintuzumab-AC225
- Adverse events- Treatment Emergent
- Response rates (objective response rate, complete response rate, stringent complete response rate, very good partial response rate and partial response rate)
- (and 2 more...)
|
12 |
All |
18 Years and older (Adult, Older Adult) |
NCT02998047 |
Lin-AC225-MM01 |
|
December 2016 |
December 2019 |
January 2020 |
December 20, 2016 |
December 18, 2018 |
|
- UCLA
Los Angeles, California, United States - University Of Kansas Medical Center
Kansas City, Kansas, United States - Baylor Scott and White Research Institute, Charles A. Sammons Cancer Center
Dallas, Texas, United States
|
|
| 33 |
NCT02199665 |
Recruiting |
Selinexor, Carfilzomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma |
- Refractory Multiple Myeloma
|
- Drug: selinexor
- Drug: carfilzomib
- Drug: dexamethasone
|
Interventional
|
Phase 1 |
- University of Chicago
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated Dose (MTD) of selinexor, carfilzomib, and dexamethasone
- Incidence of toxicities related to the combination of selinexor and carfilzomib assessed using NCI CTCAE version 4.0
- Efficacy as measured by stable disease or better (including MR, partial response, very good partial response, complete response and stringent complete response) according to IMWG criteria
- Incidence of toxicities assessed using NCI CTCAE version 4.0
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT02199665 |
IRB14-0033
NCI-2014-01199
P30CA014599 |
SINE |
June 12, 2014 |
April 2019 |
April 2019 |
July 24, 2014 |
April 11, 2018 |
|
- Mayo Clinic (AZ)
Scottsdale, Arizona, United States - University of Chicago
Chicago, Illinois, United States - University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States - (and 2 more...)
|
|
| 34 |
NCT03379584 |
Recruiting |
A Safety Study of SGN-CD48A in Patients With Multiple Myeloma |
|
|
Interventional
|
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Type, incidence, severity, seriousness, and relatedness of adverse events
- Incidence of laboratory abnormalities
- Incidence of dose limiting toxicity
- (and 8 more...)
|
85 |
All |
18 Years and older (Adult, Older Adult) |
NCT03379584 |
SGN48A-001 |
|
February 20, 2018 |
August 2020 |
December 2021 |
December 20, 2017 |
February 4, 2019 |
|
- University of California at San Francisco
San Francisco, California, United States - Yale Cancer Center
New Haven, Connecticut, United States - H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States - (and 3 more...)
|
|
| 35 |
NCT02547662 |
Recruiting |
Pomalidomide, Ixazomib Citrate, and Dexamethasone in Treating Patients With Previously Treated Multiple Myeloma or Plasma Cell Leukemia |
- Plasma Cell Leukemia
- Plasma Cell Myeloma
- Plasmacytoma
|
- Drug: Dexamethasone
- Drug: Ixazomib Citrate
- Other: Laboratory Biomarker Analysis
- Drug: Pomalidomide
|
Interventional
|
Phase 2 |
- Mayo Clinic
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Confirmed response rate
- Biochemical response, defined as a response by serum M-protein, urine M-protein, or serum free light chain (FLC) assay parameters
- Extramedullary response, defined as a response by extramedullary plasmacytoma or plasma cell count parameters
- (and 2 more...)
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT02547662 |
MC1487
NCI-2015-01481
P30CA015083 |
|
December 24, 2015 |
December 15, 2020 |
December 15, 2020 |
September 11, 2015 |
August 14, 2018 |
|
- Mayo Clinic
Rochester, Minnesota, United States - Sarah Cannon Cancer Center
Nashville, Tennessee, United States
|
|
| 36 |
NCT03605056 |
Not yet recruiting |
Phase 2 Trial of Chidamide-Lenalidomide-Dexamethasone(CRD) Regimen in R/R MM |
|
- Drug: chidamide
- Drug: lenalidomide
- Drug: dexamethasone
|
Interventional
|
Phase 2 |
- Peng Liu
- Chipscreen Biosciences, Ltd.
- Shanghai Zhongshan Hospital
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Response Rate
- Number of participants with treatment-related adverse events
- Overall Survival Rate
|
25 |
All |
18 Years and older (Adult, Older Adult) |
NCT03605056 |
SHZS-MM001 |
|
July 31, 2018 |
July 31, 2020 |
July 31, 2022 |
July 30, 2018 |
July 30, 2018 |
|
- 180 Fenglin Road
Shanghai, Shanghai, China
|
|
| 37 |
NCT03687125 |
Recruiting |
Tinostamustine Conditioning and Autologous Stem Cell |
- Multiple Myeloma in Relapse
- Multiple Myeloma Progression
- Multiple Myeloma With Failed Remission
|
- Drug: Treatment with TINOSTAMUSTINE
|
Interventional
|
Phase 1
Phase 2 |
|
Industry |
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determine objective response rate (ORR) based on the IMWG Response Criteria
- During the Phase 1 portion, determine dose limiting toxicities (DLT) according to CTCAE 4.03
- Objective response rate (ORR) for patients treated at the recommended phase 2 dose
- (and 6 more...)
|
71 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT03687125 |
EDO-S101-1004
2018-001907-35 |
TITANIUM1 |
September 19, 2018 |
June 30, 2022 |
March 7, 2023 |
September 27, 2018 |
January 16, 2019 |
|
- University of Alabama
Birmingham, Alabama, United States - University of Kansas Medical Center Kansas City
Kansas City, Kansas, United States - Memorial Sloan Kettering Cancer Centre
New York, New York, United States - (and 9 more...)
|
|
| 38 |
NCT03770260 |
Not yet recruiting |
Ixazomib and Pevonedistat in Treating Patients With Multiple Myeloma That Has Come Back or Does Not Respond to Treatment |
- Recurrent Plasma Cell Myeloma
- Refractory Plasma Cell Myeloma
|
- Drug: Ixazomib Citrate
- Drug: Pevonedistat
|
Interventional
|
Phase 1 |
- National Cancer Institute (NCI)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of adverse events
- Maximum tolerated dose of pevonedistat and ixazomib citrate
- Overall response rates
- (and 3 more...)
|
54 |
All |
18 Years and older (Adult, Older Adult) |
NCT03770260 |
NCI-2018-03121
10249
UM1CA186691 |
|
June 7, 2019 |
September 30, 2021 |
September 30, 2021 |
December 10, 2018 |
February 15, 2019 |
|
|
|
| 39 |
NCT02294357 |
Recruiting |
Weekly 70 mg/m2 Carfilzomib for Multiple Myeloma Patients Refractory to 27 mg/m2 Carfilzomib |
|
- Drug: Carfilzomib
- Drug: Dexamethasone
- Drug: Prednisone
- (and 3 more...)
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall response rate (ORR)
- Clinical Benefit Rate (CBR)
- Number of patients undergoing adverse events
- (and 5 more...)
|
45 |
All |
18 Years and older (Adult, Older Adult) |
NCT02294357 |
IST-CAR-2014-100701 (20159897) |
|
December 2014 |
November 2018 |
December 2018 |
November 19, 2014 |
October 5, 2018 |
|
- California Cancer Associates for Research & Excellence (cCARE)
Encinitas, California, United States - Wellness Oncology and Hematology
West Hills, California, United States - James R Berenson, MD, Inc.
West Hollywood, California, United States - (and 4 more...)
|
|
| 40 |
NCT03829020 |
Not yet recruiting
New |
Metformin and Nelfinavir in Treating Patients With Relapsed and/or Refractory Multiple Myeloma |
- Recurrent Plasma Cell Myeloma
- Refractory Plasma Cell Myeloma
|
- Drug: Bortezomib
- Drug: Metformin Hydrochloride
- Drug: Nelfinavir Mesylate
|
Interventional
|
Phase 1 |
- Mayo Clinic
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose of the combination of metformin and nelfinavir
- Incidence of adverse events
- Hematologic response rate
|
36 |
All |
18 Years and older (Adult, Older Adult) |
NCT03829020 |
MC1811
NCI-2019-00466
P30CA015083 |
|
March 1, 2019 |
August 21, 2021 |
August 21, 2021 |
February 4, 2019 |
February 4, 2019 |
|
- Mayo Clinic
Rochester, Minnesota, United States
|
|
| 41 |
NCT02633059 |
Recruiting |
Idasanutlin, Ixazomib Citrate, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma |
- Loss of Chromosome 17p
- Recurrent Plasma Cell Myeloma
|
- Drug: Dexamethasone
- Drug: Idasanutlin
- Drug: Ixazomib Citrate
- (and 2 more...)
|
Interventional
|
Phase 1
Phase 2 |
- Mayo Clinic
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Adverse events profile graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Phase I)
- Incidence of toxicity graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Phase I)
- Maximum tolerated dose (MTD) of ixazomib citrate and idasanutlin in combination with dexamethasone (Phase I)
- (and 6 more...)
|
53 |
All |
18 Years and older (Adult, Older Adult) |
NCT02633059 |
MC1582
NCI-2015-02155
NP29909
X16066
MMRC-061
P30CA015083 |
|
December 30, 2015 |
May 13, 2021 |
May 13, 2021 |
December 17, 2015 |
July 12, 2018 |
|
- City of Hope Comprehensive Cancer Center
Duarte, California, United States - Mayo Clinic in Florida
Jacksonville, Florida, United States - Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States - (and 5 more...)
|
|
| 42 |
NCT03194867 |
Recruiting |
Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients |
|
- Drug: Isatuximab SAR650984
- Drug: Cemiplimab REGN2810
|
Interventional
|
Phase 1
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Dose Limiting Toxicities (DLTs)
- Adverse events (AEs) and changes in laboratory tests and vital signs
- Overall Response Rate (ORR)
- (and 9 more...)
|
105 |
All |
18 Years and older (Adult, Older Adult) |
NCT03194867 |
TCD14906
2017-001431-39
U1111-1189-4706 |
|
February 21, 2018 |
May 2023 |
May 2023 |
June 21, 2017 |
January 16, 2019 |
|
- Investigational Site Number 8400001
Denver, Colorado, United States - Investigational Site Number 8400003
Kansas City, Kansas, United States - Investigational Site Number 8400002
New York, New York, United States - (and 30 more...)
|
|
| 43 |
NCT03314181 |
Recruiting |
A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Subjects With Relapsed or Refractory Multiple Myeloma |
|
- Drug: Dexamethasone
- Drug: Daratumumab
- Drug: Venetoclax
- Drug: Bortezomib
|
Interventional
|
Phase 2 |
- AbbVie
- Janssen Research & Development, LLC
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Part 1: Objective Response Rate (ORR)
- Part 1: Number of Participants with Dose Limiting Toxicities (DLT)
- Part 2: Number of Participants with Dose Limiting Toxicities (DLT)
- (and 12 more...)
|
90 |
All |
18 Years and older (Adult, Older Adult) |
NCT03314181 |
M15-654
2017-002099-26 |
|
March 12, 2018 |
November 4, 2020 |
March 22, 2023 |
October 19, 2017 |
February 11, 2019 |
|
- Univ of Colorado Cancer Center /ID# 167331
Aurora, Colorado, United States - H. Lee Moffitt Cancer Center /ID# 169614
Tampa, Florida, United States - Emory University Hospital /ID# 165427
Atlanta, Georgia, United States - (and 28 more...)
|
|
| 44 |
NCT02332850 |
Recruiting |
SAR650984 in Combination With Carfilzomib for Treatment of Relapsed or Refractory Multiple Myeloma |
|
- Drug: SAR650984
- Drug: Carfilzomib
|
Interventional
|
Phase 1 |
- University of California, San Francisco
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Adverse Events
- Maximum Tolerated Dose
- Immunogenicity of SAR650984
- (and 9 more...)
|
42 |
All |
up to 18 Years (Child, Adult) |
NCT02332850 |
139511 |
|
December 2014 |
December 2018 |
December 2019 |
January 7, 2015 |
September 18, 2017 |
|
- UCSF, 400 Parnassus Ave
San Francisco, California, United States
|
|
| 45 |
NCT03768960 |
Not yet recruiting |
A Study of DARZALEX (Daratumumab) In Indian Participants With Relapsed and Refractory Multiple Myeloma, Whose Prior Therapy Included a Proteasome Inhibitor and an Immunomodulatory Agent |
|
|
Interventional
|
Phase 4 |
- Johnson & Johnson Private Limited
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of Treatment Emergent Adverse Events (TEAE)
- Overall Response Rate (ORR)
- Percentage of Participants with Very Good Partial Response (VGPR) or better
- (and 4 more...)
|
150 |
All |
18 Years and older (Adult, Older Adult) |
NCT03768960 |
CR108556
54767414MMY4008 |
|
March 15, 2019 |
October 31, 2020 |
April 5, 2021 |
December 7, 2018 |
January 11, 2019 |
|
|
|
| 46 |
NCT03756896 |
Recruiting |
Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With High-Risk Multiple Myeloma |
|
- Drug: Carfilzomib
- Drug: Dexamethasone
- Drug: Pomalidomide
|
Interventional
|
Phase 2 |
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- ≥ Complete response (CR) rates
- Progression-free survival (PFS)
- Best response on-study
- (and 4 more...)
|
34 |
All |
18 Years and older (Adult, Older Adult) |
NCT03756896 |
IRB00097882
NCI-2017-02052
Winship4101-17 |
|
January 25, 2019 |
January 30, 2021 |
November 30, 2021 |
November 28, 2018 |
February 12, 2019 |
|
- Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
|
|
| 47 |
NCT02188368 |
Recruiting |
Pomalidomide for Lenalidomide for Relapsed or Refractory Multiple Myeloma Patients |
|
- Drug: POM
- Drug: Steroids
- Drug: PLD
- (and 5 more...)
|
Interventional
|
Phase 2 |
- Oncotherapeutics
- Celgene Corporation
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated Dose (MTD)
- Number of subjects with adverse events
- Overall Response Rate
- (and 6 more...)
|
45 |
All |
18 Years and older (Adult, Older Adult) |
NCT02188368 |
PO-CL-MM-PI-003854 |
|
August 2014 |
December 2018 |
December 2018 |
July 11, 2014 |
October 5, 2018 |
|
- California Cancer Associates for Research & Excellence (cCARE)
Encinitas, California, United States - Compassionate Care Research Group
Fountain Valley, California, United States - Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, United States - (and 9 more...)
|
|
| 48 |
NCT01729091 |
Recruiting |
Umbilical Cord Blood-Derived Natural Killer Cells, Elotuzumab, Lenalidomide, and High Dose Melphalan, Followed by Stem Cell Transplant in Treating Patients With Multiple Myeloma |
- Plasma Cell Leukemia
- Plasma Cell Myeloma
|
- Procedure: Autologous Hematopoietic Stem Cell Transplantation
- Biological: Elotuzumab
- Other: Laboratory Biomarker Analysis
- (and 4 more...)
|
Interventional
|
Phase 2 |
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose of umbilical cord blood (UCB)-derived natural killer (NK) cells defined as the highest dose for which the probability of toxicity is closest to 20%
- Percent of patients achieving very good partial response (VGPR) + complete response (CR)
- Minimal residual disease (MRD) rate
- (and 3 more...)
|
60 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01729091 |
2011-0379
NCI-2014-01096
NCI-2014-00541
RV-MM-PI-0691
P30CA016672 |
|
June 10, 2013 |
June 28, 2019 |
June 28, 2019 |
November 20, 2012 |
November 7, 2018 |
|
- M D Anderson Cancer Center
Houston, Texas, United States
|
|
| 49 |
NCT03173092 |
Recruiting |
An Effectiveness and Safety Study of Ixazomib in Combination With Lenalidomide and Dexamethasone (IRD) in Participants With Multiple Myeloma (MM) Previously Receiving a Bortezomib-based Induction Regimen (US MM-6) |
|
- Drug: Ixazomib
- Drug: Lenalidomide
- Drug: Dexamethasone
|
Interventional
|
Phase 4 |
- Millennium Pharmaceuticals, Inc.
- Takeda
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression Free Survival (PFS)
- Percentage of Participants with Partial Response (PR), Very Good Partial Response (VGPR) and Complete Response (CR)
- Duration of Response
- (and 3 more...)
|
160 |
All |
18 Years and older (Adult, Older Adult) |
NCT03173092 |
C16038
U1111-1192-7696 |
|
September 20, 2017 |
November 30, 2023 |
November 30, 2023 |
June 1, 2017 |
February 6, 2019 |
|
- Arizona Oncology Associates, P.C.
Tucson, Arizona, United States - CARTI Cancer Center
Little Rock, Arkansas, United States - Pacific Cancer Medical Center
Anaheim, California, United States - (and 25 more...)
|
|
| 50 |
NCT03168438 |
Recruiting |
NY-ESO-1ᶜ²⁵⁹T Alone and in Combination With Pembrolizumab for Multiple Myeloma |
|
- Genetic: NY-ESO-1ᶜ²⁵⁹T cells
- Drug: NY-ESO-1ᶜ²⁵⁹T in combination with pembrolizumab
|
Interventional
|
Phase 2 |
- GlaxoSmithKline
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of subjects with Treatment Limiting Toxicities (TLT), adverse events (AE), including serious adverse events (SAE).
- Proportion of subjects with a positive response : Partial Response (PR), Very Good Partial response (VGPR), Complete Response (CR) or stringent CR (sCR)
- Interval between the date of T-cell infusion and first documented evidence of positive response (PR, VGPR, CR, sCR)
- (and 2 more...)
|
24 |
All |
18 Years and older (Adult, Older Adult) |
NCT03168438 |
208470
ADP-0011-008
KEYNOTE-487 |
|
August 18, 2017 |
April 19, 2021 |
April 19, 2021 |
May 30, 2017 |
October 4, 2018 |
|
- GSK Investigational Site
Duarte, California, United States - GSK Investigational Site
Tampa, Florida, United States - GSK Investigational Site
Baltimore, Maryland, United States
|
|
| 51 |
NCT03221634 |
Not yet recruiting |
Efficacy and Safety Study of Pembrolizumab (MK-3475) in Combination With Daratumumab in Participants With Relapsed Refractory Multiple Myeloma (MK-3475-668/KEYNOTE-668) |
|
- Biological: Pembrolizumab
- Biological: Daratumumab
|
Interventional
|
Phase 2 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective Response Rate (ORR)
- Disease Control Rate (DCR)
- Duration of Response (DOR)
- (and 2 more...)
|
57 |
All |
18 Years and older (Adult, Older Adult) |
NCT03221634 |
3475-668
2017-001001-32 |
|
August 1, 2017 |
March 20, 2019 |
June 10, 2021 |
July 18, 2017 |
July 18, 2017 |
|
- Mayo Clinic Jacksonville ( Site 0003)
Jacksonville, Florida, United States - Emory University School of Medicine ( Site 0002)
Atlanta, Georgia, United States - Karmanos Cancer Institute ( Site 0001)
Bloomfield Hills, Michigan, United States - (and 22 more...)
|
|
| 52 |
NCT03143049 |
Recruiting |
Pomalidomide-Cyclophosphamide-Dexamethasone (PCD) Versus Pomalidomide-Dexamethasone (PD) in Relapse or Refractory Myeloma |
|
|
Interventional
|
Phase 3 |
- National University Hospital, Singapore
- Celgene
- International Myeloma Foundation
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression free survival (PFS)
- Overall response rate (ORR)
- Overall survival (OS)
- (and 2 more...)
|
120 |
All |
21 Years to 99 Years (Adult, Older Adult) |
NCT03143049 |
AMN003 |
|
September 13, 2017 |
June 1, 2018 |
June 1, 2022 |
May 8, 2017 |
November 6, 2017 |
|
- Queen Mary Hospital
Hong Kong, Hong Kong - Japan, Japan
- South Korea, Korea, Republic of
- (and 2 more...)
|
|
| 53 |
NCT03841565 |
Not yet recruiting
New |
Daratumumab and Dexamethasone With Pomalidomide or Carfilzomib in Treating Patients With Relapsed Multiple Myeloma |
- Neoplastic Plasma Cells 30 Percent or More of Bone Marrow Nucleated Cells
- Recurrent Plasma Cell Myeloma
|
- Drug: Carfilzomib
- Biological: Daratumumab
- Drug: Dexamethasone
- Drug: Pomalidomide
|
Interventional
|
Phase 2 |
- Academic and Community Cancer Research United
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Best overall response rate (ORR) to the initial therapy prior to the crossover
- Overall survival (OS) in each arm
- Progression-free survival (PFS) in each arm
- (and 2 more...)
|
80 |
All |
18 Years and older (Adult, Older Adult) |
NCT03841565 |
ACCRU-MY-1601
NCI-2019-00386
P30CA015083 |
|
March 31, 2019 |
March 31, 2024 |
March 31, 2024 |
February 15, 2019 |
February 15, 2019 |
|
- Illinois CancerCare-Peoria
Peoria, Illinois, United States - Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States - Mayo Clinic
Rochester, Minnesota, United States - (and 3 more...)
|
|
| 54 |
NCT03672318 |
Recruiting |
Study of ATLCAR.CD138 Cells for Relapsed/Refractory Multiple Myeloma |
- Multiple Myeloma
- Immune System Diseases
|
|
Interventional
|
Phase 1 |
- UNC Lineberger Comprehensive Cancer Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of participants with dose limiting toxicities as a measure of maximum tolerated dose of CAR138 T cells
- Survival of CAR138 T cells in vivo as assessed by PCR and flow cytometry
- Overall survival after infusion of CAR138 T cells
- (and 2 more...)
|
33 |
All |
18 Years and older (Adult, Older Adult) |
NCT03672318 |
LCCC 1603-ATL |
|
January 31, 2019 |
November 2020 |
October 2032 |
September 14, 2018 |
January 4, 2019 |
|
- Lineberger Comprehensive Cancer Center at University of North Carolina
Chapel Hill, North Carolina, United States
|
|
| 55 |
NCT03143036 |
Recruiting |
Daratumumab, Thalidomide and Dexamethasone in Relapse and/or Refractory Myeloma |
- Relapse and / or Refractory Myeloma
|
- Drug: Daratumumab, thalidomide and dexamethasone
|
Interventional
|
Phase 2 |
- National University Hospital, Singapore
- Janssen, LP
- International Myeloma Foundation
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression free survival (PFS)
- Overall Response Rate (ORR)
- Overall survival (OS)
- (and 2 more...)
|
100 |
All |
21 Years to 99 Years (Adult, Older Adult) |
NCT03143036 |
AMN004 |
|
May 1, 2018 |
July 1, 2019 |
July 1, 2022 |
May 8, 2017 |
June 7, 2018 |
|
- Queen Mary Hospital
Hong Kong, Hong Kong - Samsung Medical Center
South Korea, Korea, Republic of - National University Hospital
Singapore, Singapore - (and 2 more...)
|
|
| 56 |
NCT02504359 |
Recruiting |
Combination Chemotherapy and Donor Stem Cell Transplant Followed by Ixazomib Citrate Maintenance Therapy in Treating Patients With Relapsed High-Risk Multiple Myeloma |
- Plasma Cell Leukemia
- Recurrent Plasma Cell Myeloma
|
- Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- Drug: Carmustine
- Drug: Cytarabine
- (and 7 more...)
|
Interventional
|
Phase 1 |
- OHSU Knight Cancer Institute
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of grade III-IV acute (or overlap) graft versus host disease (GvHD) and ixazomib related grade III-IV toxicity
- Transplant related mortality (TRM)
- Incidence of discontinuation of ixazomib maintenance therapy
- (and 5 more...)
|
24 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02504359 |
IRB00011097
NCI-2015-01065
HEM-14099-LM
P30CA069533 |
|
July 20, 2015 |
July 1, 2020 |
July 1, 2021 |
July 21, 2015 |
May 16, 2018 |
|
- Duke University Medical Center
Durham, North Carolina, United States - OHSU Knight Cancer Institute
Portland, Oregon, United States
|
|
| 57 |
NCT03256045 |
Recruiting |
Panobinostat, Carfilzomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma |
- Recurrent Plasma Cell Myeloma
- Refractory Plasma Cell Myeloma
|
- Drug: Carfilzomib
- Other: Chemosensitivity Assay
- Drug: Dexamethasone
- (and 2 more...)
|
Interventional
|
Phase 2 |
- University of Washington
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Partial response (PR) rate
- Very good partial response (VGPR) rate
- Complete Response (CR) rate
- (and 7 more...)
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT03256045 |
9757
NCI-2017-00453
P30CA015704 |
|
February 8, 2018 |
May 16, 2021 |
May 16, 2024 |
August 21, 2017 |
November 12, 2018 |
|
- Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
|
| 58 |
NCT03601078 |
Recruiting |
An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma |
|
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall response rate (ORR)- Cohort 1
- Complete response (CR) rate - Cohort 2a , b and c
- Complete response (CR) rate - Cohort 1
- (and 18 more...)
|
181 |
All |
18 Years and older (Adult, Older Adult) |
NCT03601078 |
BB2121-MM-002
U1111-1216-4209
2018-000264-28 |
KarMMa-2 |
December 13, 2018 |
March 12, 2025 |
March 12, 2025 |
July 26, 2018 |
February 8, 2019 |
|
- John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States - Levine Cancer Institute
Charlotte, North Carolina, United States - Sarah Cannon Research Inst
Nashville, Tennessee, United States - Clinica Universitaria de Navarra
Pamplona, Spain
|
|
| 59 |
NCT03277105 |
Recruiting |
A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma |
|
- Drug: Dara SC
- Drug: Dara IV
|
Interventional
|
Phase 3 |
- Janssen Research & Development, LLC
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Response Rate (ORR)
- Maximum Trough Concentration (Ctrough) of Daratumumab
- Percentage of participants With Infusion-Related Reactions (IRR)
- (and 8 more...)
|
480 |
All |
18 Years and older (Adult, Older Adult) |
NCT03277105 |
CR108342
2017-000206-38
54767414MMY3012 |
|
October 27, 2017 |
November 5, 2019 |
October 8, 2020 |
September 8, 2017 |
February 8, 2019 |
|
- Dana-Farber Cancer Institute
Boston, Massachusetts, United States - Washington University
Saint Louis, Missouri, United States - Memorial Sloan Kettering Cancer Center
New York, New York, United States - (and 162 more...)
|
|
| 60 |
NCT02976493 |
Recruiting |
Elotuzumab Safety Surveillance In Japanese Patients With Relapse Or Refractory Multiple Myeloma |
|
|
Observational
|
|
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Incidence of all adverse events(AE) to elotuzumab in real-world practice in Japan
- Incidence of immune-related (IR) adverse events to elotuzumab in real-world practice in Japan
- Number of patients who achieve a Stringent complete response (sCR) as measured by International Myeloma Working Group (IMWG) criteria
- (and 5 more...)
|
330 |
All |
Child, Adult, Older Adult |
NCT02976493 |
CA204-179 |
|
September 28, 2016 |
August 19, 2019 |
August 19, 2019 |
November 29, 2016 |
December 13, 2017 |
|
- Local Institution
Shinjuku-ku, Tokyo, Japan
|
|
| 61 |
NCT02654990 |
Recruiting |
Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma |
|
- Drug: panobinostat capsules
- Drug: bortezomib injection
- Drug: dexamethasone tablets
|
Interventional
|
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall response rate (ORR) up to 8 cycles
- ORR throughout study
- individual immunophenotypic complete response (CR) rate
- (and 14 more...)
|
240 |
All |
18 Years and older (Adult, Older Adult) |
NCT02654990 |
CLBH589D2222 |
PANORAMA_3 |
April 27, 2016 |
June 10, 2019 |
December 15, 2022 |
January 13, 2016 |
February 15, 2019 |
|
- Highlands Oncology Group
Fayetteville, Arkansas, United States - Los Angeles Hematology/Oncology Medical Group Wilson Terr
Los Angeles, California, United States - Poudre Valley Hospital SC
Fort Collins, Colorado, United States - (and 90 more...)
|
|
| 62 |
NCT03539744 |
Recruiting |
A Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma |
|
- Drug: Pomalidomide
- Drug: Dexamethasone
- Drug: Venetoclax
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-Free Survival (PFS)
- Very Good Partial Response or Better Response Rate (VGPR)
- Overall Response Rate (ORR)
- (and 11 more...)
|
244 |
All |
18 Years and older (Adult, Older Adult) |
NCT03539744 |
M13-494 |
CANOVA |
October 22, 2018 |
January 12, 2021 |
January 27, 2022 |
May 28, 2018 |
February 12, 2019 |
|
- VA Central California Health C /ID# 200047
Fresno, California, United States - University of California, Los Angeles /ID# 171524
Los Angeles, California, United States - Mayo Clinic /ID# 200075
Jacksonville, Florida, United States - (and 87 more...)
|
|
| 63 |
NCT03548207 |
Recruiting |
A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma |
|
|
Interventional
|
Phase 1
Phase 2 |
- Janssen Research & Development, LLC
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase 1b: Number of Participants with Adverse Events
- Phase 1b: Number of Participants with Adverse Events by Severity
- Phase 2: Overall Response Rate (ORR)
- (and 21 more...)
|
84 |
All |
18 Years and older (Adult, Older Adult) |
NCT03548207 |
CR108480
2018-000121-32
68284528MMY2001 |
|
June 29, 2018 |
September 14, 2021 |
September 14, 2021 |
June 7, 2018 |
February 1, 2019 |
|
- Mayo Clinic Cancer Center-Scottsdale
Phoenix, Arizona, United States - City of Hope
Duarte, California, United States - University of California, San Francisco
San Francisco, California, United States - (and 20 more...)
|
|
| 64 |
NCT03068351 |
Recruiting |
Study of Bromodomain and Extra-Terminal Protein (BET) Inhibitor RO6870810 as Mono- and Combination Therapy in Advanced Multiple Myeloma |
|
- Drug: RO6870810
- Biological: daratumumab
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Dose-Limiting Toxicities (DLTs)
- Objective Response Rate (ORR)
- Progression Free Survival (PFS)
- (and 11 more...)
|
86 |
All |
18 Years and older (Adult, Older Adult) |
NCT03068351 |
NP39403
2016-003615-35 |
|
June 26, 2017 |
June 13, 2020 |
June 13, 2020 |
March 1, 2017 |
January 23, 2019 |
|
- City of Hope
Duarte, California, United States - Stanford Cancer Center
Stanford, California, United States - Mayo Clinic
Jacksonville, Florida, United States - (and 11 more...)
|
|
| 65 |
NCT03582033 |
Recruiting |
A Safety Study of SEA-BCMA in Patients With Multiple Myeloma |
|
|
Interventional
|
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of participants reporting one or more treatment-emergent adverse events (TEAEs)
- Number of participants with Grade 3 or higher adverse events (AEs)
- Number of participants reporting one or more serious adverse event (SAE)
- (and 11 more...)
|
65 |
All |
18 Years and older (Adult, Older Adult) |
NCT03582033 |
SGNBCMA-001 |
|
November 1, 2018 |
September 2021 |
June 2022 |
July 10, 2018 |
February 4, 2019 |
|
- University of Miami
Miami, Florida, United States - Washington University School of Medicine
Saint Louis, Missouri, United States
|
|
| 66 |
NCT03758417 |
Not yet recruiting |
A Study of LCAR-B38M CAR-T Cells, a Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Chinese Participants With Relapsed or Refractory Multiple Myeloma |
|
- Biological: LCAR-B38M CAR-T Cell
|
Interventional
|
Phase 2 |
- Nanjing Legend Biotech Co.
- Janssen Research & Development, LLC
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Response Rate (ORR)
- Number of Participants With Adverse Events
- Chimeric Antigen Receptor T (CAR-T) Positive Cell Concentration
- (and 18 more...)
|
60 |
All |
18 Years and older (Adult, Older Adult) |
NCT03758417 |
CR108494
68284528MMY2002 |
|
January 21, 2019 |
July 20, 2020 |
April 21, 2022 |
November 29, 2018 |
November 29, 2018 |
|
- Peking University Third Hospital
Beijing, Beijing, China - Fujian Medical University Union hospital
Fuzhou, Fujian, China - Jiangsu Province Hospital
Nanjing, Jiangsu, China - (and 5 more...)
|
|
| 67 |
NCT02519452 |
Recruiting |
A Study of Daratumumab With the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma |
|
- Drug: Daratumumab Subcutaneous (SC) Administration
- Drug: Recombinant Human Hyaluronidase [rHuPH20]) SC Administration
|
Interventional
|
Phase 1 |
- Janssen Research & Development, LLC
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Serum Trough Concentrations (Ctrough) of Daratumumab
- Part 1, 2 and 3: Number of Participants with Adverse Events (AEs) and Serious AEs
- Part 1, 2 and 3: Serum Concentration of Daratumumab and Recombinant Human Hyaluronidase (rHuPH20) (Plasma) Antibodies
- (and 4 more...)
|
108 |
All |
18 Years and older (Adult, Older Adult) |
NCT02519452 |
CR107838
2015-001210-94
54767414MMY1004 |
|
October 22, 2015 |
December 13, 2017 |
June 17, 2021 |
August 11, 2015 |
February 4, 2019 |
|
- Winship Cancer Institute Emory University
Atlanta, Georgia, United States - Mt. Sinai School of Medicine
New York, New York, United States - Levine Cancer Institute
Charlotte, North Carolina, United States - (and 12 more...)
|
|
| 68 |
NCT03143985 |
Recruiting |
TEW-7197 in Combination w/ Pomalidomide in Relapsed or Relapsed and Refractory Multiple Myeloma |
|
- Drug: TEW-7197
- Drug: Pomalidomide
|
Interventional
|
Phase 1 |
- Case Comprehensive Cancer Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine the maximum tolerated dose (MTD) or maximum tested dose level of TEW-7197 given in combination with POM for the treatment of relapsed or RRMM
- Overall response rate
- Progression-free survival (PFS)
- (and 4 more...)
|
18 |
All |
18 Years and older (Adult, Older Adult) |
NCT03143985 |
CASE1A17 |
|
July 21, 2017 |
March 2019 |
May 2019 |
May 8, 2017 |
February 6, 2019 |
|
- University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States - Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
|
|
| 69 |
NCT03652064 |
Recruiting |
A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy |
|
- Drug: Daratumumab
- Drug: Bortezomib
- Drug: Lenalidomide
- Drug: Dexamethasone
|
Interventional
|
Phase 3 |
- Janssen Research & Development, LLC
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants with Negative Minimal Residual Disease (MRD) Status
- Progression-Free Survival (PFS)
- MRD Negative Rate at 1 Year
- (and 14 more...)
|
360 |
All |
18 Years and older (Adult, Older Adult) |
NCT03652064 |
CR108529
2018-001545-13
54767414MMY3019 |
|
November 6, 2018 |
March 29, 2024 |
April 30, 2025 |
August 29, 2018 |
February 8, 2019 |
|
- Sharp Center for Research
San Diego, California, United States - Innovative Clinical Research, Inc.
Whittier, California, United States - Baptist MD Anderson
Jacksonville, Florida, United States - (and 122 more...)
|
|
| 70 |
NCT03234972 |
Recruiting |
A Study to Compare Daratumumab, Bortezomib, and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Chinese Participants With Relapsed or Refractory Multiple Myeloma |
|
- Drug: Daratumumab
- Drug: Velcade
- Drug: Dexamethasone
|
Interventional
|
Phase 3 |
- Janssen Research & Development, LLC
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-Free Survival (PFS)
- Time to Disease Progression (TTP)
- Overall Response Rate (ORR)
- (and 6 more...)
|
210 |
All |
18 Years and older (Adult, Older Adult) |
NCT03234972 |
CR104378
54767414MMY3009 |
|
November 30, 2017 |
September 16, 2020 |
August 31, 2022 |
August 1, 2017 |
December 13, 2018 |
|
- Beijing Chaoyang Hospital
Beijing, China - Peking Union Medical College Hospital
Beijing, China - Peking University First Hospital
Beijing, China - (and 27 more...)
|
|
| 71 |
NCT03170882 |
Recruiting |
An Efficacy Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma |
- Relapsed and/or Refractory Multiple Myeloma
|
- Drug: Ixazomib
- Drug: Pomalidomide
- Drug: Dexamethasone
|
Interventional
|
Phase 2
Phase 3 |
- Millennium Pharmaceuticals, Inc.
- Takeda
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression Free Survival (PFS)
- Overall Survival (OS)
- Percentage of Participants with Objective Response Rate (ORR - Partial Response [PR], Very Good Partial Response [VGPR] and Complete Response [CR])
- (and 9 more...)
|
300 |
All |
18 Years and older (Adult, Older Adult) |
NCT03170882 |
C16029
2016-004742-28
U1111-1188-2677
2017/1235
N-20170083
17/NW/0546 |
|
July 25, 2017 |
November 30, 2021 |
March 31, 2023 |
May 31, 2017 |
February 12, 2019 |
|
- Highlands Oncology Group
Fayetteville, Arkansas, United States - St Joseph Heritage Healthcare
Santa Rosa, California, United States - Lynn Cancer Institute
Boca Raton, Florida, United States - (and 121 more...)
|
|
| 72 |
NCT03440411 |
Recruiting |
Pom-dex Versus Pom-Cyclo-dex in MM Patients With Biochemical or Clinical Relapse, During Lena Maintenance Treatment |
|
- Drug: Pomalidomide
- Drug: Cyclophosphamide
- Drug: Dexamethasone
|
Interventional
|
Phase 3 |
- Fondazione Neoplasie Sangue Onlus
|
Other |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Survival (OS)
- Time to clinical progression
- Progression free-survival (PFS)
- (and 3 more...)
|
260 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT03440411 |
PO-CL-MM-PI-003887 |
PO-3887 |
February 18, 2016 |
February 18, 2021 |
February 18, 2023 |
February 21, 2018 |
February 21, 2018 |
|
- FO.NE.SA.Onlus
Torino, Italy
|
|
| 73 |
NCT03701321 |
Recruiting |
Daratumumab, Bortezomib, and Dexamethasone With or Without Venetoclax in Treating Patients With Relapsed or Refractory Multiple Myeloma |
- Recurrent Plasma Cell Myeloma
- Refractory Plasma Cell Myeloma
|
- Drug: Bortezomib
- Biological: Daratumumab
- Drug: Dexamethasone
- Drug: Venetoclax
|
Interventional
|
Phase 1
Phase 2 |
- National Cancer Institute (NCI)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose of venetoclax in combination with daratumumab, bortezomib and dexamethasone (Phase I)
- Minimal residual disease (MRD) negative status (Phase II)
- Overall survival (OS) (Phase II)
- (and 4 more...)
|
282 |
All |
18 Years and older (Adult, Older Adult) |
NCT03701321 |
NCI-2018-02131
EAA172
U10CA180820 |
|
January 25, 2019 |
October 31, 2023 |
October 31, 2023 |
October 10, 2018 |
February 11, 2019 |
|
- Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States
|
|
| 74 |
NCT02004275 |
Recruiting |
Pomalidomide and Dexamethasone With or Without Ixazomib in Treating Patients With Relapsed Multiple Myeloma |
- Multiple Myeloma in Relapse
|
- Drug: pomalidomide
- Drug: ixazomib
- Drug: dexamethasone
|
Interventional
|
Phase 1
Phase 2 |
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
- Celgene Corporation
- Millennium Pharmaceuticals, Inc.
|
Other / NIH / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated Dose (MTD) of pomalidomide and ixazomib, determined according to incidence of dose limiting toxicity (DLT) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
- Progression free survival (PFS) (Phase II)
- Incidence and type of dose limiting toxicities (DLTs), serious adverse events, and adverse events, graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
- (and 11 more...)
|
73 |
All |
18 Years and older (Adult, Older Adult) |
NCT02004275 |
A061202
NCI-2013-01702
U10CA031946 |
|
February 2014 |
March 2021 |
|
December 9, 2013 |
January 24, 2019 |
|
- Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States - Anchorage Radiation Therapy Center
Anchorage, Alaska, United States - Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States - (and 324 more...)
|
|
| 75 |
NCT03288493 |
Recruiting |
P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM) |
|
- Biological: P-BCMA-101 CAR-T cells
- Drug: Rimiducid
|
Interventional
|
Phase 1 |
- Poseida Therapeutics, Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose of P-BCMA-101 based on dose limiting toxicities
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- Anti-myeloma effect of P-BCMA-101(Response Rate)
- (and 7 more...)
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT03288493 |
P-BCMA-101-001 |
|
September 20, 2017 |
December 31, 2018 |
June 30, 2021 |
September 20, 2017 |
November 14, 2018 |
|
- University of California San Diego
San Diego, California, United States - Colorado Blood Cancer Institute
Denver, Colorado, United States - Johns Hopkins University
Baltimore, Maryland, United States - (and 3 more...)
|
|
| 76 |
NCT01863550 |
Recruiting |
Bortezomib or Carfilzomib With Lenalidomide and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma |
|
- Drug: Bortezomib
- Drug: Carfilzomib
- Drug: Dexamethasone
- (and 3 more...)
|
Interventional
|
Phase 3 |
- ECOG-ACRIN Cancer Research Group
- National Cancer Institute (NCI)
- Eastern Cooperative Oncology Group
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall survival (OS) for the maintenance analysis
- Progression-free survival for the induction analysis
- Progression-free survival for the maintenance analysis
- (and 16 more...)
|
1080 |
All |
18 Years and older (Adult, Older Adult) |
NCT01863550 |
E1A11
NCI-2012-02608
ECOG-E1A11
s17-00040
U10CA180820
U10CA021115
U24CA196172 |
|
December 2, 2013 |
November 1, 2023 |
|
May 29, 2013 |
August 22, 2018 |
|
- Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States - Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States - Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States - (and 917 more...)
|
|
| 77 |
NCT03683277 |
Not yet recruiting |
IPD in RRMM Characterized With Genomic Abnormalities of Adverse Prognostic |
- Multiple Myeloma
- Relapsed and Refractory Multiple Myeloma
- Genetic Condition
|
- Drug: Ixazomib/Pomalidomide/Dexamethasone
|
Interventional
|
Phase 2 |
- Intergroupe Francophone du Myelome
- AXONAL
- Nantes University Hospital
- (and 2 more...)
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Time to disease progression (TTP) to IPD in RRMM with adverse Genomic Abnormalities
- Incidence of Serious Adverse Events and Averse Events (grade 3 and higher) as assessed by CTCAE version 4.0, dose reduction and discontinuation
- plasma concentrations of ixazomib after twice-weekly dosing in combination with Pomalidomide and Dexamethasone
- (and 8 more...)
|
70 |
All |
18 Years and older (Adult, Older Adult) |
NCT03683277 |
IFM 2014-01 |
IFM2014-01 |
October 1, 2018 |
October 1, 2023 |
October 1, 2023 |
September 25, 2018 |
September 25, 2018 |
|
|
|
| 78 |
NCT02946333 |
Recruiting |
A Study to Assess Disease Burden, in Terms of Health-related Quality of Life and Direct Healthcare Costs, in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Autologous Stem Cell Transplant (ASCT) in Spain |
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Health-related quality of life (HRQoL)
- EuroQoL 5-Dimension, 5-Level Questionnaire (EQ-5D-5L)
- Quality of Life Questionnaire (QLQ-C30)
- (and 8 more...)
|
450 |
All |
18 Years and older (Adult, Older Adult) |
NCT02946333 |
CEL-MIE-2016-01 |
QoLMMBuS |
November 25, 2016 |
October 10, 2020 |
October 30, 2025 |
October 27, 2016 |
July 12, 2018 |
|
- Hospital Punta de Europa
Algeciras, Andalusia, Spain - Hospital de Antequera
Antequera, Andalusia, Spain - Hospital Reina Sofía
Córdoba, Andalusia, Spain - (and 64 more...)
|
|
| 79 |
NCT03110822 |
Recruiting |
A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients |
|
- Drug: Ruxolitinib Oral Tablet [Jakafi]
- Drug: Lenalidomide 5Mg Oral Capsule
- Drug: Methyl Prednisolonate
|
Interventional
|
Phase 1 |
- Oncotherapeutics
- Incyte Corporation
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determination of maximum tolerated dose (MTD) of ruxolitinib in combination with steroids and lenalidomide [Tolerability].
- Efficacy will be measured by assessing overall response rate (ORR) and clinical benefit rate (CBR)
- Incidence of Treatment-Emergent Adverse Events [Safety]
- (and 4 more...)
|
49 |
All |
18 Years and older (Adult, Older Adult) |
NCT03110822 |
I-RUX-15-04 |
|
February 1, 2017 |
February 2020 |
May 2020 |
April 12, 2017 |
November 29, 2018 |
|
- Comprehensive Blood and Cancer Center
Bakersfield, California, United States - California Cancer Associates for Research & Excellence (cCARE)
Encinitas, California, United States - Robert A. Moss, M.D., F.A.C.P., Inc.
Fountain Valley, California, United States - (and 5 more...)
|
|
| 80 |
NCT03140943 |
Recruiting |
Carfilzomib Thalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma |
- Relapsed and/or Refractory Multiple Myeloma
|
- Drug: Carfilzomib, Thalidomide and Dexamethasone
|
Interventional
|
Phase 2 |
- National University Hospital, Singapore
- The Australasian Leukaemia & Lymphoma Group (ALLG)
- International Myeloma Foundation
- Celgene
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression free survival (PFS)
- Overall survival (OS)
- Overall Rate of Response (ORR)
- (and 4 more...)
|
100 |
All |
21 Years to 99 Years (Adult, Older Adult) |
NCT03140943 |
AMN002 |
|
September 13, 2017 |
June 1, 2019 |
June 1, 2022 |
May 4, 2017 |
November 6, 2017 |
|
- Queen Mary Hospital
Hong Kong, Hong Kong - South Korea, Korea, Republic of
- National University Hospital
Singapore, Singapore - National Taiwan University
Taipei, Taiwan
|
|
| 81 |
NCT03031730 |
Recruiting |
MDM2 Inhibitor AMG-232, Carfilzomib, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma |
- Hypercalcemia
- Plasmacytoma
- Recurrent Plasma Cell Myeloma
- Refractory Plasma Cell Myeloma
|
- Drug: Carfilzomib
- Drug: Dexamethasone
- Other: Laboratory Biomarker Analysis
- (and 3 more...)
|
Interventional
|
Phase 1 |
- National Cancer Institute (NCI)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety parameters assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
- Incidence of treatment-emergent adverse event (TEAE) assessed by NCI CTCAE version 5.0
- Change in laboratory test results (hematology and blood chemistry)
- (and 13 more...)
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT03031730 |
NCI-2017-00099
NCI10076
10076
UM1CA186688 |
|
October 27, 2017 |
March 31, 2019 |
March 31, 2019 |
January 26, 2017 |
February 12, 2019 |
|
- University of California Davis Comprehensive Cancer Center
Sacramento, California, United States - University of Colorado Hospital
Aurora, Colorado, United States - M D Anderson Cancer Center
Houston, Texas, United States
|
|
| 82 |
NCT03340883 |
Recruiting |
Safety and Tolerability of BION-1301 in Adults With Relapsed or Refractory Multiple Myeloma (MM) |
|
|
Interventional
|
Phase 1
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety (Phase 1)
- Recommended Phase 2 Dose (Phase 1)
- Biomarkers (Phase 1 and 2 )
- (and 5 more...)
|
41 |
All |
18 Years and older (Adult, Older Adult) |
NCT03340883 |
ADU-CL-16 |
|
November 15, 2017 |
December 2019 |
June 2020 |
November 14, 2017 |
August 29, 2018 |
|
- James R. Berenson, MD, Inc
West Hollywood, California, United States - Winship Cancer Institute/Emory University
Atlanta, Georgia, United States - Ohio State University Wexner Medical Center James Cancer Hospital
Columbus, Ohio, United States - (and 4 more...)
|
|
| 83 |
NCT02943473 |
Recruiting |
Study on the Effect of Ibrutinib on High Risk Smoldering Multiple Myeloma Patients |
- High Risk Smoldering Multiple Myeloma
|
|
Interventional
|
Phase 2 |
- Icahn School of Medicine at Mount Sinai
- Pharmacyclics LLC.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of patients without symptomatic myeloma
- Overall Response Rate
- Bone Density Changes
- (and 8 more...)
|
36 |
All |
18 Years and older (Adult, Older Adult) |
NCT02943473 |
GCO 16-1867 |
|
November 2016 |
December 2023 |
December 2023 |
October 24, 2016 |
March 23, 2018 |
|
- Icahn School of Medicine at Mount Sinai
New York, New York, United States
|
|
| 84 |
NCT03785184 |
Not yet recruiting |
A Study of Venetoclax Plus Lenalidomide and Dexamethasone for the Treatment of Newly Diagnosed t(11;14)-Positive Multiple Myeloma in Subjects Who Are Ineligible for High-Dose Therapy |
|
- Drug: venetoclax
- Drug: lenalidomide
- Drug: dexamethasone
|
Interventional
|
Phase 2 |
- AbbVie
- Genentech, Inc.
- Celgene Corporation
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participates Who Achieve CR
- Percent of Participants Who Achieve MRD Negativity
- Percent of Participants Who Achieve VGPR or Better
- (and 8 more...)
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT03785184 |
M16-104 |
|
March 29, 2019 |
April 3, 2024 |
September 26, 2027 |
December 24, 2018 |
December 24, 2018 |
|
- University of Alabama /ID# 208307
Birmingham, Alabama, United States - Marin Cancer Care /ID# 208476
Greenbrae, California, United States - Karmanos Cancer Institute /ID# 208805
Detroit, Michigan, United States - (and 16 more...)
|
|
| 85 |
NCT02506959 |
Recruiting |
Panobinostat, Gemcitabine Hydrochloride, Busulfan, and Melphalan Before Stem Cell Transplant in Treating Patients With Refractory or Relapsed Multiple Myeloma |
- Plasma Cell Leukemia
- Plasmacytoma
- Recurrent Plasma Cell Myeloma
- Refractory Plasma Cell Myeloma
|
- Procedure: Autologous Hematopoietic Stem Cell Transplantation
- Drug: Busulfan
- Drug: Gemcitabine Hydrochloride
- (and 5 more...)
|
Interventional
|
Phase 2 |
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression free survival (PFS)
- Complete response (CR) rate, assessed using the International Myeloma Working Group (IMWG) uniform response criteria
- Overall survival (OS)
- (and 6 more...)
|
80 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02506959 |
2014-0516
NCI-2015-01308
P30CA016672 |
|
September 14, 2015 |
September 14, 2019 |
September 14, 2019 |
July 23, 2015 |
October 30, 2018 |
|
- M D Anderson Cancer Center
Houston, Texas, United States
|
|
| 86 |
NCT03180736 |
Recruiting |
Comparison of Pomalidomide and Dexamethasone With or Without Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Previously Treated With Lenalidomide and a Proteasome InhibitorDaratumumab/Pomalidomide/Dexamethasone vs Pomalidomide/Dexamethasone |
|
- Drug: Daratumumab
- Drug: Pomalidomide
- Drug: Dexamethasone
|
Interventional
|
Phase 3 |
- European Myeloma Network
- Janssen Research & Development, LLC
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Comparison of Progression Free Survival between treatment arms
- Overall response rate
- VGPR or better rate
- (and 12 more...)
|
302 |
All |
18 Years and older (Adult, Older Adult) |
NCT03180736 |
EMN14/54767414MMY3013 |
EMN14 |
June 12, 2017 |
June 1, 2021 |
July 1, 2023 |
June 8, 2017 |
April 13, 2018 |
|
- Antwerpen
Antwerpen, Belgium - Brussel
Brussel, Belgium - UZ Gent
Gent, Belgium - (and 38 more...)
|
|
| 87 |
NCT03710603 |
Recruiting |
Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma |
|
- Drug: Daratumumab
- Drug: velcade
- Drug: Lenalidomide
- Drug: dexamethasone
|
Interventional
|
Phase 3 |
- European Myeloma Network
- Janssen Research & Development, LLC
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression Free Survival (PFS)
- Post-consolidation MRD negativity rate,
- Overall Response Rate (ORR)
- (and 11 more...)
|
690 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT03710603 |
EMN17/54767414MMY3014 |
Perseus |
December 14, 2018 |
May 2029 |
November 2029 |
October 18, 2018 |
January 17, 2019 |
|
- Alfred Hospital
Melbourne, Australia - University Hospital Leuven
Leuven, Belgium - University Hospital Ostrava
Ostrava, Czechia - (and 10 more...)
|
|
| 88 |
NCT03196947 |
Recruiting |
Safety and Pharmacokinetics of Rising Doses of APO010 in Relapsed/Refractory Multiple Myeloma Patients Selected by DRP |
- Relapsed/Refractory Multiple Myeloma
|
|
Interventional
|
Phase 1
Phase 2 |
- Oncology Venture
- Smerud Medical Research International AS
- Medical Prognosis Institute A/S
|
Industry / Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated Dosage
- Recommended Dosage
- Percentage (%) of patients with drug-related adverse events (adverse reactions)
- (and 8 more...)
|
35 |
All |
18 Years and older (Adult, Older Adult) |
NCT03196947 |
APO010/P1/002 |
SMR-3184 |
June 13, 2017 |
December 2019 |
January 2020 |
June 23, 2017 |
February 8, 2019 |
|
- University Hospital of Copenhagen
Copenhagen, Denmark
|
|
| 89 |
NCT03567616 |
Recruiting |
A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma |
|
- Drug: Venetoclax
- Drug: Pomalidomide
- Drug: Dexamethasone
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With Adverse Events
- Overall Response Rate (ORR)
- Progression-Free Survival (PFS)
- (and 8 more...)
|
60 |
All |
18 Years and older (Adult, Older Adult) |
NCT03567616 |
M16-085 |
|
November 9, 2018 |
August 20, 2020 |
January 22, 2021 |
June 25, 2018 |
February 8, 2019 |
|
- John B. Amos Cancer Center - C /ID# 202055
Columbus, Georgia, United States - University of Kansas Cancer Center /ID# 201292
Fairway, Kansas, United States - Dana-Farber Cancer Institute /ID# 201297
Boston, Massachusetts, United States - (and 15 more...)
|
|
| 90 |
NCT03030261 |
Recruiting |
Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma |
- Multiple Myeloma in Relapse
|
- Drug: Elotuzumab
- Drug: Pomalidomide
- Drug: Dexamethasone
- (and 2 more...)
|
Interventional
|
Phase 2 |
- Washington University School of Medicine
- Bristol-Myers Squibb
- Celgene
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Event-free survival (EFS) rate
- Overall response rate (ORR)
- Complete response rate (CRR)
- (and 5 more...)
|
40 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT03030261 |
201701084
CA204-225
PO-CL-MM-PI-008341 |
|
November 22, 2017 |
May 31, 2021 |
February 28, 2026 |
January 24, 2017 |
January 21, 2019 |
|
- Washington University School of Medicine
Saint Louis, Missouri, United States
|
|
| 91 |
NCT03477539 |
Recruiting |
Daratumumab in Treating Transplant-Eligible Participants With Multiple Myeloma |
- Minimal Residual Disease
- Plasma Cell Myeloma
|
- Procedure: Autologous Hematopoietic Stem Cell Transplantation
- Biological: Daratumumab
- Other: Laboratory Biomarker Analysis
- (and 2 more...)
|
Interventional
|
Phase 2 |
- Mayo Clinic
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of minimal residual disease (MRD) negative response after autologous stem cell transplantation (ASCT)
- The rate of MRD negative response after pre-stem cell transplant (SCT) consolidation with daratumumab
- Rate of MRD negative response after 1 year (12 courses) of daratumumab and lenalidomide maintenance
- (and 4 more...)
|
50 |
All |
18 Years to 64 Years (Adult) |
NCT03477539 |
MC1785
NCI-2018-00332
P30CA015083 |
|
April 9, 2018 |
April 1, 2019 |
April 1, 2019 |
March 26, 2018 |
April 10, 2018 |
|
- Mayo Clinic in Florida
Jacksonville, Florida, United States
|
|
| 92 |
NCT03544281 |
Recruiting |
To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM) |
|
- Drug: GSK2857916
- Drug: Lenalidomide
- Drug: Dexamethasone
- (and 2 more...)
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of subjects with AE's and serious adverse events (SAEs),Part 1
- Number of subjects with electrocardiogram (ECG) parameters of potential clinical importance (PCI), Part 1
- Number of subjects with abnormal hematology parameters, Part 1
- (and 69 more...)
|
90 |
All |
18 Years and older (Adult, Older Adult) |
NCT03544281 |
207497 |
|
September 20, 2018 |
June 29, 2020 |
November 28, 2022 |
June 1, 2018 |
October 12, 2018 |
|
- GSK Investigational Site
Birmingham, Alabama, United States
|
|
| 93 |
NCT03733717 |
Recruiting |
Evaluation of Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma |
|
- Drug: Isatuximab SAR650984
|
Interventional
|
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Assessment of PK: Cmax
- Assessment of PK: tmax
- Assessment of PK: AUC0-168h
- (and 9 more...)
|
20 |
All |
18 Years and older (Adult, Older Adult) |
NCT03733717 |
TED15085
U1111-1195-6028 |
|
October 22, 2018 |
September 30, 2020 |
May 2, 2022 |
November 7, 2018 |
November 7, 2018 |
|
- Tianjin Hematology Institution
Tianjin, China
|
|
| 94 |
NCT03720041 |
Not yet recruiting |
Myeloma XIV: Frailty-adjusted Therapy in Transplant Non-Eligible Patients With Newly Diagnosed Multiple Myeloma |
|
- Drug: R1: Ixazomib, Lenalidomide, Dexamethasone (IRD) induction therapy - reactive arm
- Drug: R1: Ixazomib, Lenalidomide, Dexamethasone (IRD) induction therapy - adaptive arm
- Drug: R2: Lenalidomide plus placebo maintenance
- Drug: R2: Lenalidomide + ixazomib maintenance
|
Interventional
|
Phase 3 |
- University of Leeds
- Cancer Research UK
- Takeda
- Celgene
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Randomisation 1: Number of participants with early treatment cessation
- Randomisation 2: Progression-free survival (PFS-R2)
- Progression-free survival (PFS-R1)
- (and 16 more...)
|
740 |
All |
18 Years and older (Adult, Older Adult) |
NCT03720041 |
MyelomaXIV |
FiTNEss |
January 2019 |
December 2024 |
December 2024 |
October 25, 2018 |
October 25, 2018 |
|
- Aberdeen Royal Infirmary
Aberdeen, United Kingdom - Nevill Hall Hospital
Abergavenny, United Kingdom - Bronglais General Hospital
Aberystwyth, United Kingdom - (and 109 more...)
|
|
| 95 |
NCT03287908 |
Recruiting |
A Phase 1 Study of AMG 701 in Subjects With Multiple Myeloma |
- Relapsed/Refractory Multiple Myeloma
|
|
Interventional
|
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Subject incidence of adverse events as a Measure of Safety
- Subject incidence of dose-limiting toxicities (DLTs) as a Measure of Safety
- Anti-tumor activity
- Pharmacokinetic parameter of AMG 701
|
115 |
All |
18 Years and older (Adult, Older Adult) |
NCT03287908 |
20170122
2017-001997-41 |
|
November 13, 2017 |
July 23, 2020 |
August 6, 2023 |
September 19, 2017 |
February 1, 2019 |
|
- Research Site
Phoenix, Arizona, United States - Research Site
Little Rock, Arkansas, United States - Research Site
Jacksonville, Florida, United States - (and 17 more...)
|
|
| 96 |
NCT03829371 |
Recruiting
New |
STUDY COMPARING TWO STANDARD TREATMENTS IN AUTOLOGOUS STEM CELL TRANSPLANTATION INELIGIBLE POPULATION AFFECTED BY MULTIPLE MYELOMA |
|
- Drug: Velcade
- Drug: Melphalan
- Drug: Prednisone
- (and 2 more...)
|
Interventional
|
Phase 4 |
- University of Turin, Italy
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-free survival (PFS)
- Overall response rate (ORR)
- Duration of response (DOR)
- (and 10 more...)
|
350 |
All |
65 Years and older (Older Adult) |
NCT03829371 |
Real MM |
|
January 3, 2019 |
January 3, 2023 |
January 3, 2023 |
February 4, 2019 |
February 11, 2019 |
|
- Dipartimento di Biotecnologie Molecolari e Scienze per la Salute
Torino, TO, Italy
|
|
| 97 |
NCT03512353 |
Recruiting |
A Study of Carfilzomib Plus Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma at US Community Oncology Centers |
- Relapsed or Refractory Multiple Myeloma
|
- Combination Product: Dexamethasone
- Combination Product: Carfilzomib
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of subjects completing
- Cumulative Dose
- Relative Dose Intensity
- (and 6 more...)
|
75 |
All |
18 Years and older (Adult, Older Adult) |
NCT03512353 |
20170596 |
|
July 5, 2018 |
January 15, 2024 |
January 15, 2024 |
April 30, 2018 |
January 17, 2019 |
|
- Research Site
Palm Springs, California, United States - Research Site
Riverside, California, United States - Research Site
Glenwood Springs, Colorado, United States - (and 27 more...)
|
|
| 98 |
NCT03301220 |
Recruiting |
A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma |
- Smoldering Multiple Myeloma
|
- Drug: Daratumumab SC: daratumumab + rHuPH20
|
Interventional
|
Phase 3 |
- Janssen Research & Development, LLC
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-free Survival (PFS)
- Time to Biochemical or Diagnostic (SLiM-CRAB) Progression
- Overall Response Rate (ORR)
- (and 15 more...)
|
360 |
All |
18 Years and older (Adult, Older Adult) |
NCT03301220 |
CR108172
54767414SMM3001
2016-001205-16 |
|
November 7, 2017 |
December 16, 2021 |
December 22, 2025 |
October 4, 2017 |
February 8, 2019 |
|
- Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, United States - UCLA
Santa Monica, California, United States - Innovative Clinical Research, Inc.
Whittier, California, United States - (and 183 more...)
|
|
| 99 |
NCT02586038 |
Recruiting |
STUDY THAT COMPARE 3 ARM: MLN9708 DEXAMETHASONE, MLN9708 CYCLOPHOSPHAMIDE AND DEXAMETHASONE, MLN9708 THALIDOMIDE AND DEXAMETHASONE FOLLOWED BY MAINTENANCE WITH MLN9708 IN NEWLY DIAGNOSED ELDERLY MULTIPLE MYELOMA PATIENTS |
|
- Drug: MLN9708
- Drug: Dexamethasone
- Drug: Cyclophosphamide
- Drug: Thalidomide
|
Interventional
|
Phase 2 |
- Silvio Aime
- University of Turin, Italy
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression Free Survival (PFS)
- Response rate
- Toxicity in terms of rate of hematologic and non-hematologic adverse events
- (and 4 more...)
|
183 |
All |
65 Years and older (Older Adult) |
NCT02586038 |
UNITO-EMN10 |
|
October 2015 |
October 2020 |
October 2023 |
October 26, 2015 |
February 19, 2018 |
|
- AO SS Antonio e Biagio e Cesare Arrigo di Alessandria
Alessandria, Italy
|
|
| 100 |
NCT03639610 |
Recruiting |
A PK Study of Melphalan During Treatment With Melflufen and Dex in RRMM Pat With Impaired Renal Function |
|
- Drug: Melflufen
- Drug: Dexamethasone
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pharmakokinetics tmax
- Pharmakokinetics Cmax
- Pharmakokinetics AUC0-t
- (and 9 more...)
|
25 |
All |
18 Years and older (Adult, Older Adult) |
NCT03639610 |
OP-107 |
|
August 6, 2018 |
August 2019 |
August 2019 |
August 21, 2018 |
December 20, 2018 |
|
- University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology
Brno, Czechia - University Hospital Hradec Kralove, 4th Internal Clinic of Hematology
Kralovice, Czechia - University Hospital Olomouc, Clinic of Hemato-Oncology
Olomouc, Czechia - (and 6 more...)
|
|
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