A Study to Determine Dose, Safety, Tolerability, Drug Levels, and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Participants With Multiple Myeloma

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02773030

Recruitment Status : Recruiting

First Posted : May 16, 2016

Last Update Posted : May 11, 2022

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Sponsor:

Information provided by (Responsible Party):

Celgene

Study Description

Brief Summary:

This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 in combination with DEX for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma	Drug: CC-220 Drug: Dexamethasone Drug: Daratumumab Drug: Bortezomib Drug: Carfilzomib	Phase 1 Phase 2

Detailed Description:

Subjects assigned to CC-220 monotherapy, who develop progressive disease (PD) will have the option to receive DEX in addition to CC-220 after consultation with the Medical Monitor. The dose of CC-220 will not be higher than the dose of CC-220 used in combination with dexamethasone in Cohort B that has been determined to be safe. Progressive disease must be confirmed in accordance with international myeloma working group (IMWG) criteria.

The starting dose of DEX will be 40 mg for subjects who are ≤75 years of age and 20 mg for subjects who are >75 years of age, given once weekly. This treatment will continue until PD, unacceptable toxicity or the subject withdraws consent.

For Cohorts A and B, the starting dose level of CC-220, dose level 1, is 0.3 mg. A dose level -1, of 0.15 mg, may also be evaluated if the starting dose level of 0.3 mg for 21 days of a 28-day cycle is not tolerated. For Cohorts E and F, the starting dose level of CC-220, dose level 1, is one dose level below the maximum dose for Cohort B that has been determined to be safe by the dose escalation committee (DEC) at the start of enrollment for both cohorts. For Cohort E in addition to CC-220 and DEX, daratumumab will be administered intravenously (IV) at a 16mg/kg dose. For Cohort F in addition to CC-220 and DEX, bortezomib will be administered subcutaneous (SC) at a 1.3mg/m2 dose.

All subjects with a minimal response (MR) or better who discontinue study treatment in Part 1 or Part 2 of the study for a reason other than PD or withdrawal of consent from the study will be followed for response assessment every 28 days (every 21 days for Cohort F) until PD.

The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

The initiation of Part 2 will begin when the RP2D is established in Part 1 in either Cohort A or Cohort B. Either cohort may begin once the RP2D is determined for each cohort independently during Part 1. All expansion decisions will be determined by the DEC after review of all safety, PK, biomarker and preliminary efficacy data, as applicable. During Part 2, the Independent Expert Reviewer will review safety data and any other data deemed relevant so that subject safety is ensured.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	532 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase 1b/2a Multicenter, Open-label, Dose-escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CC-220 as Monotherapy and in Combination With Other Treatments in Subjects With Multiple Myeloma
Actual Study Start Date :	October 14, 2016
Estimated Primary Completion Date :	April 30, 2026
Estimated Study Completion Date :	February 2, 2028

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Multiple myeloma

MedlinePlus related topics: Multiple Myeloma

Genetic and Rare Diseases Information Center resources: Multiple Myeloma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cohort A: CC-220 Monotherapy - Part 1 Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle Other Name: Iberdomide
Experimental: Cohort B: CC-220 in combination with Dexamethasone (DEX) - Part 1 Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. For subjects ≤ 75 years old, oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, DEX will be administered at 20 mg on Days 1, 8,15, and 22 of each 28-day cycle. Subjects who surpass the age of 75 years while on treatment may be switched to the 20 mg QD dosage based on the investigator's best judgment.	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle Other Name: Iberdomide Drug: Dexamethasone Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle Other Name: Decadron
Experimental: Cohort D: CC-220 in combination with Dexamethasone - Part 2 Oral CC-220 at Recommended Phase 2 dose (RP2D) from Day 1-21 of each 28-day cycle Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle Other Name: Iberdomide Drug: Dexamethasone Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle Other Name: Decadron
Experimental: Cohort E: CC-220 with DEX and daratumumab (DARA) - Part 1 Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. Oral DEX for subjects ≤ 75 years old at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle. Intravenous DARA at dose 16mg/kg on Days 1, 8, 15, and 22 at cycle 1-2, Days 1, 15 at cycle 3-6, and Day 1 at cycle ≥7 of each 28-day cycle. Once the MTD and/or RP2D is determined in Cohort E (CC-220Dd), subjects will be enrolled at this dose level using SC DARA. Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. Oral DEX for subjects ≤ 75 years old at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle. Subcutaneous DARA at dose 1800 mg over 3 to 5 minutes on Days 1, 8, 15, and 22 at cycle 1-2, Days 1, 15 at cycle 3-6, and Day 1 at cycle ≥7 of each 28-day cycle.	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle Other Name: Iberdomide Drug: Dexamethasone Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle Other Name: Decadron Drug: Daratumumab Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle Other Name: Darzalex
Experimental: Cohort F: CC-220 with DEX and bortezomib - Part 1 Oral CC-220 at dose specified by cohort dose level from Day 1-14 of each 21-day cycle. Oral DEX for subjects ≤ 75 years old at 40 mg on Days 1, 8, and 15 of each 21-day cycle. For subjects >75 years old, oral DEX at 20 mg on Days 1, 8, and 15 of each 21-day cycle. Subcutaneous BTZ at dose 1.3 mg/m^2 on Days 1, 4, 8 and 11 at cycle 1-8, and Days 1, 8 at cycle ≥9 of each 21-day cycle.	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle Other Name: Iberdomide Drug: Dexamethasone Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle Other Name: Decadron Drug: Bortezomib Bortezomib 1.3 mg/m^2 on Days 1, 4, 8 and 11 at cycle 1-8, and Days 1, 8 at cycle ≥9 of each 21-day cycle Other Name: Velcade
Experimental: Cohort G1: CC-220 in combination with CFZ and DEX - Part 1 Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle Intravenous (IV) CFZ (Carfilzomib)administered at a starting dose of 20 mg/m2 on C1D1; and at a dose specified by cohort dose level thereafter on days 1, 8, 15 of each 28-day cycle Oral DEX (Dexamethasone) on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects ≤ 75 years old, the DEX dose will be 40 mg. For subjects > 75 years old, the DEX dose will be 20 mg	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle Other Name: Iberdomide Drug: Dexamethasone Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle Other Name: Decadron Drug: Carfilzomib Intravenous (IV) CFZ administered at a starting dose of 20 mg/m2 on C1D1 and C1D2; and at a dose level specified by cohort dose level thereafter Days 1, 2, 8, 9, 15, 16 of each 28-day cycle Other Name: Kyprolis
Experimental: Cohort G2 - CC-220 in combination with CFZ and DEX - Part 1 Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle Intravenous (IV) CFZ administered at a starting dose of 20 mg/m2 on C1D1; and at a dose level specified by cohort dose level thereafter Days 1, 2, 8, 9, 15, 16 of each 28-day cycle Oral DEX on Days 1, 2, 8, 9, 15, 16, 22, 23 of each 28-day cycle. The DEX dose will be 20 mg	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle Other Name: Iberdomide Drug: Dexamethasone Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle Other Name: Decadron Drug: Carfilzomib Intravenous (IV) CFZ administered at a starting dose of 20 mg/m2 on C1D1 and C1D2; and at a dose level specified by cohort dose level thereafter Days 1, 2, 8, 9, 15, 16 of each 28-day cycle Other Name: Kyprolis
Experimental: Cohort I: CC-220 in combination with DEX in post BCMA RRMM - Part 2 Oral CC-220 at Recommended Phase 2 dose (RP2D) from Day 1-21 of each 28-day cycle Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle.	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle Other Name: Iberdomide Drug: Dexamethasone Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle Other Name: Decadron
Experimental: Cohort J1: CC-220 in combination with DEX and BTZ in NDMM - Part 2 Oral CC-220 at Recommended Phase 2 Dose from Day 1-14 of each 21-day cycle (Cycle 1 to 8) and from Day 1-21 of each 28-day cycle (Cycle 9 and above). Oral DEX at Cycles 1 to 8, 20 mg (≤ 75 years old) or 10 mg (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of each 21-day cycle and Cycles ≥ 9, 40 mg (≤ 75 years old) or 20 mg (> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle. Subcutaneous BTZ at dose 1.3 mg/m2 on Days 1, 4, 8 and 11 at Cycle 1-8 of each 21-day cycle.	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle Other Name: Iberdomide Drug: Dexamethasone Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle Other Name: Decadron Drug: Bortezomib Bortezomib 1.3 mg/m^2 on Days 1, 4, 8 and 11 at cycle 1-8, and Days 1, 8 at cycle ≥9 of each 21-day cycle Other Name: Velcade
Experimental: Cohort J2: CC-220 in combination with DEX and BTZ in NDMM - Part 2 Oral CC-220 at Recommended Phase 2 Dose from Day 1-14 of each 21-day cycle. Oral DEX at 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) for Cycles 1 to 6 on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. Subcutaneous BTZ at dose 1.3 mg/m2 on Days 1, 4, 8 and 11 at Cycle 1-6 of each 21-day cycle.	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle Other Name: Iberdomide Drug: Dexamethasone Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle Other Name: Decadron Drug: Bortezomib Bortezomib 1.3 mg/m^2 on Days 1, 4, 8 and 11 at cycle 1-8, and Days 1, 8 at cycle ≥9 of each 21-day cycle Other Name: Velcade
Experimental: Cohort K: CC-220 with DEX and DARA in NDMM and not autologous stem cell transplant eligible Part 2	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle Other Name: Iberdomide Drug: Dexamethasone Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle Other Name: Decadron Drug: Daratumumab Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle Other Name: Darzalex
Experimental: Cohort C: CC-220 Monotherapy in RRMM Part 2	Drug: CC-220 CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle Other Name: Iberdomide

Outcome Measures

Primary Outcome Measures :

Establish maximum tolerated doses (MTDs) of CC-220 as monotherapy and in combination with other treatment [ Time Frame: Approximately 1 year ]
Establish the maximum tolerated doses (MTDs) of CC-220 monotherapy, in combination with DEX, and in combination with DEX and daratumumab (CC-220Dd), in combination with DEX and bortezomib (CC-220Vd), and in combination with DEX and carfilzomib (CC-220Kd)
Establish Recommended Phase 2 doses (RP2Ds) of CC-220 as monotherapy and in combination with other treatment [ Time Frame: Approximately 1 year ]
RP2D is defined as the dose selected for phase 2 based on safety, pharmacokinetics and biomarker data from phase 1 of the study
Overall response rate (ORR) of CC-220 in combination with Dexamethasone (DEX) in Cohort D [ Time Frame: Approximately 3 years ]
Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Kumar, 2011) in CC-220 in combination with DEX

Secondary Outcome Measures :

Adverse Events (AEs) [ Time Frame: Approximately 3 years ]
Type, frequency, seriousness and severity of adverse events (AEs) (and AEs of special interest) and relationship of AEs to investigational product
Overall response rate (ORR) [ Time Frame: Approximately 3 years ]
Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Kumar, 2016) for subjects who achieved partial response (PR) or better
Time to Response (TTR) [ Time Frame: Approximately 3 years ]
Is defined as the time from the first date of dosing of IP to the first date of documented response (partial response [PR] or greater)
Duration of Response (DOR) [ Time Frame: Approximately 3 years ]
Is defined as Time from the first documentation of response (PR or greater) to the first documentation of Progressive disease (PD)
Progression-free Survival (PFS) [ Time Frame: Approximately 3 years ]
Time from the first dose of investigational product (IP) to the first documentation of PD or death from any cause, whichever occurs first
Overall Survival (OS) in Part 2 relapsed and refractory multiple myeloma (RRMM) cohorts [ Time Frame: Approximately 3 years ]
Time from first dose of IP to death due to any cause
Pharmacokinetics - Area under the plasma concentration-time curve from time zero to tau, where tau is the dosing interval (AUC[TAU]) [ Time Frame: Approximately 1 year ]
Pharmacokinetics - Maximum plasma concentration of drug (Cmax) [ Time Frame: Approximately 1 year ]
Pharmacokinetics - Time to maximum plasma concentration of drug (Tmax) [ Time Frame: Approximately 1 year ]
Very good partial response or better rate (VGPR) [ Time Frame: Approximately 4 years ]
Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Kumar, 2016) for subjects who achieved VGPR or better

Eligibility Criteria

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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:

Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
Relapsed and refractory multiple myeloma (RRMM) participants must have documented disease progression on or within 60 days from the last dose of their last myeloma therapy
Newly diagnosed multiple myeloma (NDMM) participants must have documented diagnosis with previously untreated symptomatic multiple myeloma (MM)
Participants in Cohorts J1 and K are those for whom autologous stem cell transplantation is not planned for initial therapy or are not considered by the investigator as eligible for high-dose chemotherapy and autologous stem cell transplantation

Exclusion Criteria:

Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study
Nonsecretory multiple myeloma
Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

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): NCT02773030

Contacts

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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com	855-907-3286	Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.

Locations

Show 74 study locations

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United States, Arizona
Mayo Clinic	Recruiting
Scottsdale, Arizona, United States, 85259
United States, Arkansas
University of Arkansas for Medical Sciences	Recruiting
Little Rock, Arkansas, United States, 72205
United States, Georgia
Winship Cancer Institute of Emory University	Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Robert H Lurie Comprehensive Cancer Center NW Univ	Recruiting
Chicago, Illinois, United States, 60611
United States, Kansas
University of Kansas Cancer Center	Recruiting
Fairway, Kansas, United States, 66205
United States, Maryland
University of Maryland School of Med	Recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02117
Dana-Farber/Mass General Brigham Cancer Care, Inc	Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Comprehensive Cancer Center	Recruiting
Ann Arbor, Michigan, United States, 48109
Karmanos Cancer Institute	Recruiting
Detroit, Michigan, United States, 48201
United States, New Jersey
Hackensack University Medical Center	Recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
NYU Winthrop Hospital	Recruiting
Mineola, New York, United States, 11501
New York University School of Medicine	Recruiting
New York, New York, United States, 10016
Icahn School of Medicine at Mount Sinai Medical Center	Recruiting
New York, New York, United States, 10029
New York Presbyterian Hospital Weil Cornell Medical College	Recruiting
New York, New York, United States, 10065
University of Rochester Cancer Center	Recruiting
Rochester, New York, United States, 14642
United States, North Carolina
Levine Cancer Institute	Recruiting
Charlotte, North Carolina, United States, 28204
United States, Ohio
Cleveland Clinic Foundation	Recruiting
Cleveland, Ohio, United States, 44195
The Ohio State University Comprehensive Cancer Center	Recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Prisma Health Cancer Institute	Recruiting
Greenville, South Carolina, United States, 29605
United States, Texas
University of Texas Southwestern Medical Center	Recruiting
Dallas, Texas, United States, 75390
United States, Utah
Huntsman Cancer Institute at the University of Utah	Recruiting
Salt Lake City, Utah, United States, 84112-5550
Canada, Alberta
Tom Baker Cancer Centre	Recruiting
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
Vancouver General Hospital	Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre	Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Quebec
McGill University Health Center - Royal Victoria Hospital	Recruiting
Montreal, Quebec, Canada, H4A 3J1
France
CHRU Hopital Claude Huriez	Recruiting
Lile Cedax, France, 59037
CHU Bordeaux	Recruiting
Pessac, France, 33604
Centre Hospitalier Lyon Sud	Recruiting
Pierre Benite cedex, France, 69495
CHU La Miletrie	Recruiting
Poitiers Cedex, France, 86021
Germany
Medizinische Kinik und Poliklinik I	Recruiting
Dresden, Germany, 01307
Universitaetsklinikum Duesseldorf	Recruiting
Dusseldorf, Germany, 40225
Universitaetsklinik Hamburg - Eppendorf	Recruiting
Hamburg, Germany, 20246
Universitaetsklinikum Heidelberg	Recruiting
Heidelberg, Germany, 69120
UKT Universitaetsklinikum Tuebingen	Recruiting
Tuebingen, Germany, 72076
Universitaets-klinikum Wuerzburg	Recruiting
Wuerzburg, Germany, 97080
Italy
I.R.C.C.S. Policlinico San Matteo - Universita di Pavia	Recruiting
Pavia, Italy, 27100
Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova	Recruiting
Reggio Emilia, Italy, 42100
Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma - Centro di Ematologia	Recruiting
Rome, Italy, 00161
Osp. S.Giovanni Battista Le Molinette	Recruiting
Torino, Italy, 10126
Japan
Aomori Prefectural Central Hospital	Recruiting
Aomori, Japan, 030-8553
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital	Recruiting
Hiroshima City, Japan, 730-8619
Tokai University Hospital	Recruiting
Isehara City, Kanagawa, Japan, 259-1193
Kameda Medical Center	Recruiting
Kamogawa, Japan, 296-8602
University Hospital, Kyoto Prefectural University of Medicine	Recruiting
Kyoto-city, Japan, 602-8566
Matsuyama Red Cross Hospital	Recruiting
Matsuyama, Japan, 790-8524
Japanese Red Cross Nagasaki Genbaku Hospital	Recruiting
Nagasaki-shi, Japan, 8528511
Aichi Cancer Center	Not yet recruiting
Nagoya, Japan, 464-8681
Nagoya City University Hospital	Recruiting
Nagoya, Japan, 467-8602
Ogaki Municipal Hospital	Recruiting
Ogaki, Japan, 503-8502
Osaka City University Hospital	Recruiting
Osaka, Japan, 545-8586
Tohoku University Hospital	Recruiting
Sendai, Japan, 980-8574
NTT Medical Center Tokyo	Recruiting
Shinagawa-ku, Tokyo, Japan, 141-8625
Shizuoka Cancer Center	Recruiting
Sunto-gun, Japan, 411-8777
Toyohashi Municipal Hospital	Recruiting
Toyohashi, Japan, 441-8570
Netherlands
VU University Medical Center	Recruiting
Amsterdam, Netherlands, 1081 HV
Maastricht University Medical Center	Recruiting
Maastrich, Netherlands, 6202 AZ
Erasmus Medical Center	Recruiting
Rotterdam, Netherlands, 3075 EA
University Medical Center Utrecht	Recruiting
Utrecht, Netherlands, 3584 CX
Spain
Hospital Universitari Germans Trias i Pujol Can Ruti	Recruiting
Badalona (Barcelona), Spain, 08916
Hospital Val d'Hebron	Recruiting
Barcelona, Spain, 08035
Local Institution - 401	Recruiting
Barcelona, Spain, 08035
Contact: Site 401
Instituto Catalan de Oncologia-Hospital Duran i Reynals	Recruiting
Barcelona, Spain, 08908
Hospital Gregorio Maranon	Recruiting
Madrid, Spain, 28007
Hospital Universitario Ramon y Cajal	Recruiting
Madrid, Spain, 28034
Clinica Universidad de Navarra	Recruiting
Pamplona, Spain, 31008
Hospital Universitario Dr. Pesset	Recruiting
Valencia, Spain, 46017
United Kingdom
University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital	Recruiting
Birmingham, United Kingdom, B15 2TH
Saint James University Hospital	Recruiting
Leeds, United Kingdom, LS9 7TF
Genesis Care	Recruiting
Oxford, United Kingdom, OX4 6LB
The Institut of Cancer Research	Completed
Sutton, United Kingdom, SM2 5NG
The Royal Marsden NHS Foundation Trust	Recruiting
Sutton, United Kingdom, SM2 5PT

Sponsors and Collaborators

Celgene

Investigators

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Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

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Responsible Party:	Celgene
ClinicalTrials.gov Identifier:	NCT02773030
Other Study ID Numbers:	CC-220-MM-001 U1111-1182-9200 ( Registry Identifier: WHO ) 2016-000860-40 ( EudraCT Number )
First Posted:	May 16, 2016 Key Record Dates
Last Update Posted:	May 11, 2022
Last Verified:	May 2022

Keywords provided by Celgene:


Multiple Myeloma Relapsed Refractory Pharmacokinetics Safety Efficacy CC-220	Relapsed and refractory multiple myeloma Dexamethasone Daratumumab Bortezomib Newly diagnosed multiple myeloma Newly diagnosed multiple myeloma transplant non-eligible

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 Bortezomib 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 Antineoplastic Agents

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