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A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03412565
Recruitment Status : Active, not recruiting
First Posted : January 26, 2018
Results First Posted : January 12, 2022
Last Update Posted : June 21, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Daratumumab Drug: Bortezomib Drug: Lenalidomide Drug: Dexamethasone Drug: Melphalan Drug: Prednisone Drug: Carfilzomib Phase 2

Detailed Description:
The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin. Safety will be measured by adverse events, laboratory test results, electrocardiogram (ECGs), vital sign measurements, physical examination findings, SC injection-site assessments, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status score. Study will consist of 3 phases (screening, treatment and follow-up) and duration of study is approximately 3 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens
Actual Study Start Date : April 26, 2018
Actual Primary Completion Date : August 12, 2020
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Daratumumab

Arm Intervention/treatment
Experimental: Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)
Participants will receive daratumumab 1800 milligram (mg) by subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligram per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.
Drug: Daratumumab
Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.

Drug: Bortezomib
Bortezomib will be administered as 1.3 mg/m^2 SC injection in Cycles 1 to 4 in D-VRd cohort and in Cycles 1 to 9 in D-VMP cohort.

Drug: Lenalidomide
Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd cohort and in all Cycles until documented progression of disease, unacceptable toxicity, or end of study in D-Rd cohort.

Drug: Dexamethasone
Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd and D-Kd cohort.

Experimental: D + Bortezomib + Melphalan + Prednisone (D-VMP)
Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 then on Days 1 and 22 in Cycles 2 to 9 and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.
Drug: Daratumumab
Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.

Drug: Bortezomib
Bortezomib will be administered as 1.3 mg/m^2 SC injection in Cycles 1 to 4 in D-VRd cohort and in Cycles 1 to 9 in D-VMP cohort.

Drug: Melphalan
Melphalan will be administered as 9 mg/m^2 orally in Cycles 1 to 9.

Drug: Prednisone
Prednisone will be administered as 60 mg/m^2 orally in cycles 1 to 9.

Experimental: Daratumumab + Lenalidomide + Dexamethasone (D-Rd)
Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or end of study.
Drug: Daratumumab
Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.

Drug: Lenalidomide
Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd cohort and in all Cycles until documented progression of disease, unacceptable toxicity, or end of study in D-Rd cohort.

Drug: Dexamethasone
Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd and D-Kd cohort.

Experimental: Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days) then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; Carfilzomib 20 mg/m^2 intravenously (IV) on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or IV weekly for Cycles 1-9 then on Days 1, 8, 15 of each cycle for Cycles 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study.
Drug: Daratumumab
Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.

Drug: Dexamethasone
Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd and D-Kd cohort.

Drug: Carfilzomib
Carfilzomib will be administered as 20 mg/m^2 IV on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Kd cohort.




Primary Outcome Measures :
  1. D-VMP, D-Rd, and D-Kd Cohorts: Overall Response Rate (ORR) [ Time Frame: Up to 2 years 3 months ]
    ORR was defined as the percentage of participants who achieved partial response (PR) or better according to international myeloma working group (IMWG) criteria. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 milligrams (mg) per 24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.

  2. D-VRd Cohort: Percentage of Participants With Very Good Partial Response (VGPR) or Better Response [ Time Frame: Up to 2 years and 3 months ]
    VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response [sCR]) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein level <100 mg/24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and <5% PCs in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry.


Secondary Outcome Measures :
  1. Maximum Observed Serum Concentration (Cmax) of Daratumumab [ Time Frame: D-VRd: Day 4 of Cycles 1 and 4 and post treatment at Week 8; D-VMP: Day 4 of Cycles 1 and 2 and post treatment at Week 8; D-Rd and D-Kd: Day 4 of Cycles 1 and 3 and post treatment at Week 8 ]
    Cmax was defined as maximum serum concentration observed following daratumumab administration. Each cycle for: D-VRd cohort is of 21 days, D-VMP cohort is of 42 days and D-Rd and D-Kd cohorts is of 28 days. Each cohort have a treatment period of 84 days.

  2. Percentage of Participants With Infusion-Related Reactions (IRRs) [ Time Frame: Up to 2 years and 3 months ]
    Percentage of Participants with IRRs were reported. The administration-related systemic reactions are referred to as IRRs.

  3. D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With VGPR or Better Response [ Time Frame: Up to 2 years and 3 months ]
    VGPR or better rate was defined as the percentage of participants who achieved VGPR or CR (including sCR) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and <5% PCs in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry.

  4. D-VRd Cohort: Overall Response Rate (ORR) [ Time Frame: Up to 2 years and 3 months ]
    ORR was defined as the percentage of participants who achieved a PR or better, IMWG criteria, during the study or during follow up. IMWG criteria for PR >= 50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.

  5. Percentage of Participants With CR or Better Response [ Time Frame: Up to 2 years and 3 months ]
    CR or better rate was defined as the percentage of participants with a CR or better response (that is, CR and sCR) as per IMWG criteria. CR: as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (<) 5 percent plasma cells in bone marrow; sCR: CR plus normal FLC ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.

  6. D-VMP, D-Rd and D-Kd Cohorts: Duration of Response (DOR) [ Time Frame: Up to 2 years and 3 months ]
    DOR was defined as the time from the date of initial documented response (PR or better response) to the date of first documented evidence of progressive disease (PD) or death due to PD. PD is defined as an increase of 25% from the lowest response value in one of the following: serum and urine M-component (absolute increase must be >=0.5 gram per deciliter [g/dL] and >=200 mg/24 hours respectively); only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dL); definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.

  7. Percentage of Participants With Anti-Daratumumab Antibodies [ Time Frame: Up to 10 months ]
    Percentage of participants with antibodies to daratumumab were reported.

  8. Percentage of Participants With Anti-rHuPH20 Antibodies [ Time Frame: Up to 10 months ]
    Percentage of participants with antibodies to rHuPH20 were reported.

  9. D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With Minimal Residual Disease (MRD) Negative Rate [ Time Frame: Up to 2 years and 3 months ]
    MRD negativity rate was defined as the percentage of participants who were considered MRD negative after MRD testing at any timepoint after the first dose by bone marrow aspirate. MRD negativity rate was assessed by next-generation sequencing at a threshold of <10^5.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria
  • Measurable, secretory disease as defined by any of the following:

    1. Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or
    2. Urine M-protein level >= 200 milligram per 24 hours (mg/24 hours); or
    3. Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal FLC ratio
  • Meets one of the sets of the following criteria:

    1. For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma
    2. For Daratumumab + lenalidomide + dexamethasone (D-Rd) and Daratumumab + Carfilzomib + Dexamethasone (D-Kd) regimen: relapsed or refractory disease
    3. D-Kd cohort: Participants must have received only 1 prior line of therapy for MM which included at least 2 consecutive cycles of lenalidomide therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2
  • During the study, during dose interruptions, and for 3 months after receiving the last dose of any component of the study treatment, a female participant must agree not to donate eggs (ova, oocytes) and male participants of reproductive potential must not donate semen or sperm during the study, during dose interruptions, or for 3 months after the last dose of any study drug

Exclusion Criteria:

  • History of malignancy (other than MM) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years
  • Exhibits clinical signs of meningeal involvement of MM
  • Either of the following: a) Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (<) 50 percentage (%) of predicted normal b) Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification c) For D-Kd cohort: Known infiltrative pulmonary disease or known pulmonary hypertension
  • Any of the following: a) Known to be seropositive for human immunodeficiency virus; b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [Anti-HBc] and/or antibodies to hepatitis B surface antigen [Anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are polymerase chain reaction (PCR) positive will be excluded
  • Known to be seropositive for hepatitis C (Anti-HCV antibody positive or HCV-RNA quantitation positive) except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy
  • For D-Kd cohort only: Transthoracic echocardiogram showing left ventricular ejection fraction (LVEF) <40%; uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic >99 mmHg despite optimal treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412565


Locations
Hide Hide 64 study locations
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United States, Connecticut
Cancer Center of Central Connecticut - Southington
Southington, Connecticut, United States, 06489-3237
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
UF Health Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
United States, Michigan
Karmonos Cancer Institute
Detroit, Michigan, United States, 48201
Providence Cancer Center
Southfield, Michigan, United States, 48075
United States, Montana
Billings Clinic
Billings, Montana, United States, 59101
United States, Nebraska
Nebraska Hematology and Oncology
Lincoln, Nebraska, United States, 68506
Southeast Nebraska Cancer Center
Lincoln, Nebraska, United States, 68510
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
United States, New Mexico
San Juan Oncology Associates
Farmington, New Mexico, United States, 87401
United States, New York
NYU Winthrop
Mineola, New York, United States, 11501
Mt. Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
United States, South Dakota
Avera Medical Group - Oncology & Hematology
Sioux Falls, South Dakota, United States, 57105
United States, Utah
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84121
United States, Virginia
University of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic
Charlottesville, Virginia, United States, 22903
Brazil
Liga Norte Riograndense Contra O Cancer
Natal, Brazil, 59062-000
Centro de Pesquisa do Instituto do Câncer- Hospital São Vicente de Paulo
Passo Fundo, Brazil, 99010-090
Instituto Nacional do Cancer - INCA
Rio de Janeiro, Brazil, 20230-130
Universidade Federal de Sao Paulo
Sao Paulo, Brazil, 04037-002
Hospital do Servidor Publico Estadual - IAMSPE
Sao Paulo, Brazil
Clinica Sao Germano
São Paulo, Brazil, 01455-010
Czechia
Fakultni nemocnice Brno
Brno, Czechia, 625 00
Fakultni nemocnice Hradec Kralove
Hradec Kralove, Czechia, 500 05
Fakultni nemocnice Ostrava
Ostrava, Czechia, 70852
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
Praha 2, Czechia, 128 08
France
CHU de Nantes hôtel-Dieu
Nantes Cedex 1, France, 44093
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac cedex, France, 33604
Centre hospitalier Lyon-Sud
Pierre-Bénite, France, 69495
CHU Bretonneau
Tours Cedex 9, France, 37044
CHU Nancy Brabois
Vandoeuvre Les Nancy, France, 54511
Germany
Klinikum Chemnitz gGmbH
Chemnitz, Germany, 09113
Universitaetsklinikum Hamburg Eppendorf
Hamburg, Germany, 20246
Asklepios Klinik Altona
Hamburg, Germany, 22763
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69120
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
Tübingen, Germany, 72076
Israel
Rambam Medical Center
Haifa, Israel, 31096
Carmel Medical Center
Haifa, Israel, 3436212
Hadassah Medical Center
Jerusalem, Israel, 9112001
Galilee Medical Center
Nahariya, Israel, 22100
Sheba Medical Center
Ramat Gan, Israel, 52621
Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel, 64239
Japan
Kanazawa University Hospital
Kanazawa, Japan, 920-8641
Matsuyama Red Cross Hospital
Matsuyama, Japan, 790-8524
Nagoya City University Hospital
Nagoya, Japan, 467-8602
Japanese Red Cross Medical Center
Shibuya, Japan, 150-8935
Spain
Inst. Cat. D'Oncologia-Badalona
Badalona, Spain, 08916
Hosp. Clinic I Provincial de Barcelona
Barcelona, Spain, 08036
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona, Spain, 08908
Hosp. Univ. Vall D Hebron
Barcelona, Spain, 8035
Hosp. Gral. Univ. Gregorio Marañon
Madrid, Spain, 28007
Clinica Univ. de Navarra
Madrid, Spain, 28027
Hosp. Univ. Ramon Y Cajal
Madrid, Spain, 28034
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Hosp. Son Llatzer
Mallorca, Spain, 07198
Clinica Univ. de Navarra
Pamplona, Spain, 31008
Hosp. Clinico Univ. de Salamanca
Salamanca, Spain, 37007
Hosp. Univ. Dr. Peset
Valencia, Spain, 46017
United Kingdom
Heart of England NHS Foundation Trust
Birmingham, United Kingdom, B9 5SS
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
Kent and Canterbury Hospital
Canterbury, United Kingdom, CT1 3NG
Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Royal Stoke University Hospital
Stoke on Trent, United Kingdom, ST4 6QG
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:
Study Protocol  [PDF] September 30, 2020
Statistical Analysis Plan  [PDF] September 8, 2020

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03412565    
Other Study ID Numbers: CR108435
2017-004203-41 ( EudraCT Number )
54767414MMY2040 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: January 26, 2018    Key Record Dates
Results First Posted: January 12, 2022
Last Update Posted: June 21, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Prednisone
Lenalidomide
Bortezomib
Melphalan
Daratumumab
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal