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
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT02773030 Recruiting May 16, 2016 September 23, 2022

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: Multiple Myeloma
Intervention/treatment: Drug: CC-220
Drug: Dexamethasone
Drug: Daratumumab
Drug: Bortezomib
Drug: Carfilzomib
Phase: 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
Study Type: Interventional
Estimated Enrollment : 449 participants
Allocation : Randomized
Intervention Model : Parallel Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: October 2016
Estimated Primary Completion Date: May 2026
Estimated Study Completion Date: February 2028

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
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

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
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
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

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
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

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

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
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

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

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
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

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

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
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

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

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
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

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
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

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

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
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

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

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
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

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

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
outcome measures
Primary Outcome Measures: 1. 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)
2. 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
3. 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: 1. 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
2. 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
3. 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)
4. 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)
5. 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
6. 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
7. 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 ]
8. Pharmacokinetics - Maximum plasma concentration of drug (Cmax) [ Time Frame: Approximately 1 year ]
9. Pharmacokinetics - Time to maximum plasma concentration of drug (Tmax) [ Time Frame: Approximately 1 year ]
10. 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
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
Contacts

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
United States, Arizona Mayo Clinic Scottsdale
United States, Arkansas University of Arkansas for Medical Sciences Little Rock
United States, Georgia Winship Cancer Institute of Emory University Atlanta
United States, Georgia Winship Cancer Institute of Emory University Atlanta
United States, Illinois Robert H Lurie Comprehensive Cancer Center NW Univ Chicago
United States, Kansas University of Kansas Cancer Center Fairway
United States, Maryland University of Maryland School of Med Baltimore
United States, Maryland University of Maryland School of Med Baltimore
United States, Massachusetts Beth Israel Deaconess Medical Center Boston
United States, Massachusetts Beth Israel Deaconess Medical Center Boston
United States, Massachusetts Massachusetts General Hospital Boston
United States, Massachusetts Massachusetts General Hospital Boston
United States, Massachusetts Dana-Farber/Mass General Brigham Cancer Care, Inc Boston
United States, Massachusetts Dana-Farber/Mass General Brigham Cancer Care, Inc Boston
United States, Michigan University of Michigan Comprehensive Cancer Center Ann Arbor
United States, Michigan Karmanos Cancer Institute Detroit
United States, New Jersey Hackensack University Medical Center Hackensack
United States, New York NYU Winthrop Hospital Mineola
United States, New York New York University School of Medicine New York
United States, New York Icahn School of Medicine at Mount Sinai Medical Center New York
United States, New York New York Presbyterian Hospital Weil Cornell Medical College New York
United States, New York New York Presbyterian Hospital Weil Cornell Medical College New York
United States, New York University of Rochester Cancer Center Rochester
United States, North Carolina Levine Cancer Institute Charlotte
United States, Ohio Cleveland Clinic Foundation Cleveland
United States, Ohio The Ohio State University Comprehensive Cancer Center Columbus
United States, Ohio The Ohio State University Comprehensive Cancer Center Columbus
United States, Pennsylvania University of Pennsylvania Philadelphia
United States, South Carolina Prisma Health Cancer Institute Greenville
United States, Texas University of Texas Southwestern Medical Center Dallas
United States, Utah Huntsman Cancer Institute at the University of Utah Salt Lake City
Canada, Alberta Local Institution - 904 Calgary
Canada, Alberta Tom Baker Cancer Centre Calgary
Canada, British Columbia Vancouver General Hospital Vancouver
Canada, Nova Scotia Local Institution - 902 Halifax
Canada, Nova Scotia Queen Elizabeth II Health Sciences Centre Halifax
Canada, Quebec McGill University Health Center - Royal Victoria Hospital Montreal
France CHRU Hopital Claude Huriez Lile Cedax
France CHU Bordeaux Pessac
France Centre Hospitalier Lyon Sud Pierre Benite cedex
France CHU La Miletrie Poitiers Cedex
Germany Medizinische Kinik und Poliklinik I Dresden
Germany Universitaetsklinikum Duesseldorf Dusseldorf
Germany Universitaetsklinik Hamburg - Eppendorf Hamburg
Germany Universitaetsklinikum Heidelberg Heidelberg
Germany UKT Universitaetsklinikum Tuebingen Tuebingen
Germany Universitaets-klinikum Wuerzburg Wuerzburg
Israel Local Institution - 0905 Jerusalem
Italy I.R.C.C.S. Policlinico San Matteo - Universita di Pavia Pavia
Italy Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova Reggio Emilia
Italy Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma - Centro di Ematologia Rome
Italy Osp. S.Giovanni Battista Le Molinette Torino
Japan Aomori Prefectural Central Hospital Aomori
Japan Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital Hiroshima City
Japan Tokai University Hospital Isehara City, Kanagawa
Japan Kameda Medical Center Kamogawa
Japan University Hospital, Kyoto Prefectural University of Medicine Kyoto-city
Japan Matsuyama Red Cross Hospital Matsuyama
Japan Japanese Red Cross Nagasaki Genbaku Hospital Nagasaki-shi
Japan Aichi Cancer Center Nagoya
Japan Local Institution - 801 Nagoya
Japan Nagoya City University Hospital Nagoya
Japan Ogaki Municipal Hospital Ogaki
Japan Local Institution - 804 Osaka
Japan Osaka City University Hospital Osaka
Japan Tohoku University Hospital Sendai
Japan Local Institution - 806 Shinagawa-ku, Tokyo
Japan NTT Medical Center Tokyo Shinagawa-ku, Tokyo
Japan Shizuoka Cancer Center Sunto-gun
Japan Local Institution - 807 Toyohashi
Japan Toyohashi Municipal Hospital Toyohashi
Netherlands VU University Medical Center Amsterdam
Netherlands Maastricht University Medical Center Maastrich
Netherlands Erasmus Medical Center Rotterdam
Netherlands University Medical Center Utrecht Utrecht
Spain Hospital Universitari Germans Trias i Pujol Can Ruti Badalona (Barcelona)
Spain Local Institution - 404 Badalona (Barcelona)
Spain Hospital Val d'Hebron Barcelona
Spain Local Institution - 401 Barcelona
Spain Instituto Catalan de Oncologia-Hospital Duran i Reynals Barcelona
Spain Local Institution - 405 Barcelona
Spain Hospital Gregorio Maranon Madrid
Spain Hospital Universitario Ramon y Cajal Madrid
Spain Clinica Universidad de Navarra Pamplona
Spain Local Institution - 402 Pamplona
Spain Hospital Universitario Dr. Pesset Valencia
United Kingdom University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham
United Kingdom Local Institution - 202 Leeds
United Kingdom Saint James University Hospital Leeds
United Kingdom Genesis Care Oxford
United Kingdom The Institut of Cancer Research Sutton
United Kingdom The Royal Marsden NHS Foundation Trust Sutton
Sponsors and Collaborators
Celgene
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Celgene
ClinicalTrials.gov Identifier : NCT02773030     
Other Study ID Numbers : CC-220-MM-001, U1111-1182-9200, 2016-000860-40
First Posted : May 16, 2016
Last Update Posted : September 23, 2022
Last Verified : September 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 :
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