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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT02773030 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 1/Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Celgene |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Bristol-Myers Squibb |
Principal Investigator Affiliation | Bristol-Myers Squibb |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Australia, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Spain, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Multiple Myeloma |
Study Website: | View Trial Website |
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.
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
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.
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
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.
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.
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
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
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.
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.
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.
Experimental: Cohort K: CC-220 with DEX and DARA in NDMM and not autologous stem cell transplant eligible
Part 2
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
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
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
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
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Mayo Clinic
Scottsdale, Arizona, 85259
Status
Withdrawn
Address
The University of Arizona Cancer Center
Tucson, Arizona, 85719
Status
Completed
Address
Local Institution - 107
Little Rock, Arkansas, 72205
Status
Recruiting
Address
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Status
Recruiting
Address
Robert H Lurie Comprehensive Cancer Center NW Univ
Chicago, Illinois, 60611
Status
Withdrawn
Address
Loyola University Medical Center LUMC - Cardinal Bernardin Cancer Center CBCC
Maywood, Illinois, 60153
Status
Recruiting
Address
The University of Kansas - Clinical Research Center
Fairway, Kansas, 66205
Status
Recruiting
Address
University of Maryland School of Med
Baltimore, Maryland, 21201
Status
Withdrawn
Address
Saint Agnes Hospital
Baltimore, Maryland, 21229
Status
Recruiting
Address
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Status
Recruiting
Address
Massachusetts General Hospital
Boston, Massachusetts, 02117
Status
Recruiting
Address
Dana-Farber/Mass General Brigham Cancer Care, Inc
Boston, Massachusetts, 02215
Status
Recruiting
Address
University Of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
Karmanos Cancer Institute
Detroit, Michigan, 48201
Status
Recruiting
Address
"Grand Island"- Oncology Hematology West, PC dba Nebraska Cancer Specialist
Grand Island, Nebraska, 68803
Status
Recruiting
Address
"Regional" - Oncology Hematology West, PC dba Nebraska Cancer Specialist
Grand Island, Nebraska, 68803
Status
Recruiting
Address
"Methodist"- Oncology Hematology West, PC dba Nebraska Cancer Specialist
Omaha, Nebraska, 68114
Status
Recruiting
Address
"Bergan"- Oncology Hematology West, PC dba Nebraska Cancer Specialist
Omaha, Nebraska, 68124
Status
Recruiting
Address
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Status
Recruiting
Address
"Papillion"- Oncology Hematology West, PC dba Nebraska Cancer Specialist
Papillion, Nebraska, 68046
Status
Recruiting
Address
Local Institution - 756
Cherry Hill, New Jersey, 08003
Status
Recruiting
Address
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Status
Withdrawn
Address
Mount Sinai Brooklyn
Brooklyn, New York, 11234
Status
Recruiting
Address
NYU Winthrop Hospital
Mineola, New York, 11501
Status
Withdrawn
Address
The Blavatnik Family- Chelsea Medical Center at Mount Sinai
New York, New York, 10011
Status
Recruiting
Address
New York University School Of Medicine
New York, New York, 10016
Status
Recruiting
Address
Icahn School of Medicine at Mount Sinai Medical Center
New York, New York, 10029
Status
Recruiting
Address
New York Presbyterian Hospital Weil Cornell Medical College
New York, New York, 10065
Status
Recruiting
Address
University of Rochester Cancer Center
Rochester, New York, 14642
Status
Recruiting
Address
Levine Cancer Institute
Charlotte, North Carolina, 28204
Status
Recruiting
Address
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Status
Recruiting
Address
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Status
Completed
Address
Local Institution - 116
Philadelphia, Pennsylvania, 19104
Status
Completed
Address
Local Institution - 123
Greenville, South Carolina, 29605
Status
Recruiting
Address
Baptist Cancer Center
Memphis, Tennessee, 38120
Status
Completed
Address
Local Institution - 118
Dallas, Texas, 75390
Status
Recruiting
Address
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112-5550
Status
Withdrawn
Address
Northwest Medical Specialties PLLC
Bonney Lake, Washington, 98391
Status
Withdrawn
Address
Northwest Medical Specialties PLLC
Federal Way, Washington, 98003
Status
Withdrawn
Address
Northwest Medical Specialties PLLC
Gig Harbor, Washington, 98332
Status
Withdrawn
Address
Northwest Medical Specialties PLLC
Puyallup, Washington, 98373
Status
Not yet recruiting
Address
University of Washington-Seattle Cancer Care Alliance
Seattle, Washington, 98109
Status
Recruiting
Address
Northwest Medical Specialties PLLC
Tacoma, Washington, 98405
Status
Withdrawn
Address
Local Institution - 853
Westmead, New South Wales, 2145
Status
Recruiting
Address
Local Institution - 854
Adelaide, South Australia, 5000
Status
Recruiting
Address
Local Institution - 852
Box Hill, Victoria, 3128
Status
Recruiting
Address
Local Institution - 904
Calgary, Alberta, T2N 4N2
Status
Recruiting
Address
Local Institution - 901
Vancouver, British Columbia, V5Z 1M9
Status
Recruiting
Address
Local Institution - 902
Halifax, Nova Scotia, B3H 1V7
Status
Recruiting
Address
Local Institution - 903
Montreal, Quebec, H4A 3J1
Status
Recruiting
Address
Local Institution - 704
Lile Cedax, , 59037
Status
Recruiting
Address
Local Institution - 701
Pessac, , 33604
Status
Recruiting
Address
Local Institution - 703
Pierre Benite cedex, , 69495
Status
Completed
Address
Local Institution - 702
Poitiers Cedex, , 86021
Status
Recruiting
Address
Local Institution - 605
Dresden, , 01307
Status
Recruiting
Address
Local Institution - 603
Dusseldorf, , 40225
Status
Recruiting
Address
Local Institution - 604
Hamburg, , 20246
Status
Recruiting
Address
Local Institution - 602
Heidelberg, , 69120
Status
Recruiting
Address
Local Institution - 601
Tuebingen, , 72076
Status
Recruiting
Address
Local Institution - 606
Wuerzburg, , 97080
Status
Recruiting
Address
Local Institution - 751
Jerusalem, Yerushalayim, 91031
Status
Withdrawn
Address
Local Institution - 753
Afula, , 1834111
Status
Withdrawn
Address
Local Institution - 752
Haifa, , 3109601
Status
Withdrawn
Address
Local Institution - 0905
Jerusalem, , 91031
Status
Withdrawn
Address
Local Institution - 757
Kfar Saba, , 44281
Status
Not yet recruiting
Address
Local Institution - 754
Tel Hashomer, , 52620
Status
Recruiting
Address
Local Institution - 755
Tel-Aviv, , 64239
Status
Recruiting
Address
Local Institution - 307
Meldola, , 47014
Status
Withdrawn
Address
Local Institution - 306
Napoli, , 80131
Status
Recruiting
Address
Local Institution - 305
Pavia, , 27100
Status
Recruiting
Address
Local Institution - 302
Reggio Emilia, , 42100
Status
Recruiting
Address
Local Institution - 303
Rome, , 00161
Status
Recruiting
Address
Local Institution - 301
Torino, , 10126
Status
Recruiting
Address
Local Institution - 808
Matsuyama, Ehime, 790-8524
Status
Recruiting
Address
Local Institution - 805
Aomori, , 030-8553
Status
Recruiting
Address
Local Institution - 813
Hiroshima City, , 730-8619
Status
Recruiting
Address
Local Institution - 812
Isehara City, Kanagawa, , 259-1193
Status
Recruiting
Address
Local Institution - 809
Kamogawa, , 296-8602
Status
Completed
Address
Local Institution - 802
Kyoto-city, , 602-8566
Status
Recruiting
Address
Local Institution - 811
Nagasaki-shi, , 8528511
Status
Recruiting
Address
Local Institution - 810
Nagoya, , 464-8681
Status
Recruiting
Address
Local Institution - 801
Nagoya, , 467-8602
Status
Recruiting
Address
Local Institution - 815
Ogaki, , 503-8502
Status
Recruiting
Address
Local Institution - 804
Osaka, , 545-8586
Status
Completed
Address
Local Institution - 803
Sendai, , 980-8574
Status
Recruiting
Address
Local Institution - 806
Shinagawa-ku, Tokyo, , 141-8625
Status
Recruiting
Address
Local Institution - 814
Sunto-gun, , 411-8777
Status
Recruiting
Address
Local Institution - 807
Toyohashi, , 441-8570
Status
Recruiting
Address
Local Institution - 503
Amsterdam, , 1081 HV
Status
Recruiting
Address
Local Institution - 504
Maastrich, , 6202 AZ
Status
Completed
Address
Local Institution - 501
Rotterdam, , 3075 EA
Status
Recruiting
Address
Local Institution - 502
Utrecht, , 3584 CX
Status
Recruiting
Address
Local Institution - 404
Badalona (Barcelona), , 08916
Status
Recruiting
Address
Local Institution - 401
Barcelona, , 08035
Status
Recruiting
Address
Local Institution - 405
Barcelona, , 08908
Status
Recruiting
Address
Local Institution - 408
Madrid, , 28007
Status
Recruiting
Address
Local Institution - 407
Madrid, , 28034
Status
Recruiting
Address
Local Institution - 402
Pamplona, , 31008
Status
Recruiting
Address
Local Institution - 406
Valencia, , 46017
Status
Completed
Address
Local Institution - 205
Birmingham, , B15 2TH
Status
Recruiting
Address
Local Institution - 202
Leeds, , LS9 7TF
Status
Recruiting
Address
Local Institution - 204
Oxford, , OX4 6LB
Status
Completed
Address
Local Institution - 201
Sutton, , SM2 5NG
Status
Recruiting
Address
Local Institution - 203
Sutton, , SM2 5PT