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
Study Details
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 |
|---|---|---|
| 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
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 Names:
|
| 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 Names:
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 Names:
|
| 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 Names:
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 Names:
|
| 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 Names:
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 Names:
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 Names:
|
| 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 Names:
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 Names:
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 Names:
|
| 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 Names:
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 Names:
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 Names:
|
| 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 Names:
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 Names:
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 Names:
|
| 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 Names:
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 Names:
|
| 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 Names:
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 Names:
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 Names:
|
| 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 Names:
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 Names:
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 Names:
|
| 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 Names:
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 Names:
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 Names:
|
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Establish maximum tolerated doses (MTDs) of CC-220 as monotherapy and in combination with other treatment [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 [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 [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) [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) [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) [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) [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) [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 [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]) [Approximately 1 year]
- Pharmacokinetics - Maximum plasma concentration of drug (Cmax) [Approximately 1 year]
- Pharmacokinetics - Time to maximum plasma concentration of drug (Tmax) [Approximately 1 year]
- Very good partial response or better rate (VGPR) [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
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Scottsdale | Arizona | United States | 85259 |
| 2 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 3 | Winship Cancer Institute of Emory University | Atlanta | Georgia | United States | 30322 |
| 4 | Winship Cancer Institute of Emory University | Atlanta | Georgia | United States | 30322 |
| 5 | Robert H Lurie Comprehensive Cancer Center NW Univ | Chicago | Illinois | United States | 60611 |
| 6 | University of Kansas Cancer Center | Fairway | Kansas | United States | 66205 |
| 7 | University of Maryland School of Med | Baltimore | Maryland | United States | 21201 |
| 8 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02115 |
| 9 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02115 |
| 10 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02117 |
| 11 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02117 |
| 12 | Dana-Farber/Mass General Brigham Cancer Care, Inc | Boston | Massachusetts | United States | 02215 |
| 13 | Dana-Farber/Mass General Brigham Cancer Care, Inc | Boston | Massachusetts | United States | 02215 |
| 14 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109 |
| 15 | Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 16 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 17 | NYU Winthrop Hospital | Mineola | New York | United States | 11501 |
| 18 | New York University School of Medicine | New York | New York | United States | 10016 |
| 19 | Icahn School of Medicine at Mount Sinai Medical Center | New York | New York | United States | 10029 |
| 20 | New York Presbyterian Hospital Weil Cornell Medical College | New York | New York | United States | 10065 |
| 21 | University of Rochester Cancer Center | Rochester | New York | United States | 14642 |
| 22 | Levine Cancer Institute | Charlotte | North Carolina | United States | 28204 |
| 23 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 24 | The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
| 25 | The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
| 26 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 27 | Prisma Health Cancer Institute | Greenville | South Carolina | United States | 29605 |
| 28 | University of Texas Southwestern Medical Center | Dallas | Texas | United States | 75390 |
| 29 | Huntsman Cancer Institute at the University of Utah | Salt Lake City | Utah | United States | 84112-5550 |
| 30 | Local Institution - 904 | Calgary | Alberta | Canada | T2N 4N2 |
| 31 | Tom Baker Cancer Centre | Calgary | Alberta | Canada | T2N 4N2 |
| 32 | Vancouver General Hospital | Vancouver | British Columbia | Canada | V5Z 1M9 |
| 33 | Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | Canada | B3H 1V7 |
| 34 | McGill University Health Center - Royal Victoria Hospital | Montreal | Quebec | Canada | H4A 3J1 |
| 35 | CHRU Hopital Claude Huriez | Lile Cedax | France | 59037 | |
| 36 | CHU Bordeaux | Pessac | France | 33604 | |
| 37 | Centre Hospitalier Lyon Sud | Pierre Benite cedex | France | 69495 | |
| 38 | CHU La Miletrie | Poitiers Cedex | France | 86021 | |
| 39 | Medizinische Kinik und Poliklinik I | Dresden | Germany | 01307 | |
| 40 | Universitaetsklinikum Duesseldorf | Dusseldorf | Germany | 40225 | |
| 41 | Universitaetsklinik Hamburg - Eppendorf | Hamburg | Germany | 20246 | |
| 42 | Universitaetsklinikum Heidelberg | Heidelberg | Germany | 69120 | |
| 43 | UKT Universitaetsklinikum Tuebingen | Tuebingen | Germany | 72076 | |
| 44 | Universitaets-klinikum Wuerzburg | Wuerzburg | Germany | 97080 | |
| 45 | Local Institution - 0905 | Jerusalem | Israel | 91031 | |
| 46 | I.R.C.C.S. Policlinico San Matteo - Universita di Pavia | Pavia | Italy | 27100 | |
| 47 | Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova | Reggio Emilia | Italy | 42100 | |
| 48 | Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma - Centro di Ematologia | Rome | Italy | 00161 | |
| 49 | Osp. S.Giovanni Battista Le Molinette | Torino | Italy | 10126 | |
| 50 | Aomori Prefectural Central Hospital | Aomori | Japan | 030-8553 | |
| 51 | Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital | Hiroshima City | Japan | 730-8619 | |
| 52 | Tokai University Hospital | Isehara City, Kanagawa | Japan | 259-1193 | |
| 53 | Kameda Medical Center | Kamogawa | Japan | 296-8602 | |
| 54 | University Hospital, Kyoto Prefectural University of Medicine | Kyoto-city | Japan | 602-8566 | |
| 55 | Matsuyama Red Cross Hospital | Matsuyama | Japan | 790-8524 | |
| 56 | Japanese Red Cross Nagasaki Genbaku Hospital | Nagasaki-shi | Japan | 8528511 | |
| 57 | Aichi Cancer Center | Nagoya | Japan | 464-8681 | |
| 58 | Nagoya City University Hospital | Nagoya | Japan | 467-8602 | |
| 59 | Ogaki Municipal Hospital | Ogaki | Japan | 503-8502 | |
| 60 | Osaka City University Hospital | Osaka | Japan | 545-8586 | |
| 61 | Tohoku University Hospital | Sendai | Japan | 980-8574 | |
| 62 | Local Institution - 806 | Shinagawa-ku, Tokyo | Japan | 141-8625 | |
| 63 | NTT Medical Center Tokyo | Shinagawa-ku, Tokyo | Japan | 141-8625 | |
| 64 | Shizuoka Cancer Center | Sunto-gun | Japan | 411-8777 | |
| 65 | Local Institution - 807 | Toyohashi | Japan | 441-8570 | |
| 66 | Toyohashi Municipal Hospital | Toyohashi | Japan | 441-8570 | |
| 67 | VU University Medical Center | Amsterdam | Netherlands | 1081 HV | |
| 68 | Maastricht University Medical Center | Maastrich | Netherlands | 6202 AZ | |
| 69 | Erasmus Medical Center | Rotterdam | Netherlands | 3075 EA | |
| 70 | University Medical Center Utrecht | Utrecht | Netherlands | 3584 CX | |
| 71 | Hospital Universitari Germans Trias i Pujol Can Ruti | Badalona (Barcelona) | Spain | 08916 | |
| 72 | Hospital Val d'Hebron | Barcelona | Spain | 08035 | |
| 73 | Local Institution - 401 | Barcelona | Spain | 08035 | |
| 74 | Instituto Catalan de Oncologia-Hospital Duran i Reynals | Barcelona | Spain | 08908 | |
| 75 | Local Institution - 405 | Barcelona | Spain | 08908 | |
| 76 | Hospital Gregorio Maranon | Madrid | Spain | 28007 | |
| 77 | Hospital Universitario Ramon y Cajal | Madrid | Spain | 28034 | |
| 78 | Clinica Universidad de Navarra | Pamplona | Spain | 31008 | |
| 79 | Hospital Universitario Dr. Pesset | Valencia | Spain | 46017 | |
| 80 | University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital | Birmingham | United Kingdom | B15 2TH | |
| 81 | Local Institution - 202 | Leeds | United Kingdom | LS9 7TF | |
| 82 | Saint James University Hospital | Leeds | United Kingdom | LS9 7TF | |
| 83 | Genesis Care | Oxford | United Kingdom | OX4 6LB | |
| 84 | The Institut of Cancer Research | Sutton | United Kingdom | SM2 5NG | |
| 85 | The Royal Marsden NHS Foundation Trust | Sutton | United Kingdom | SM2 5PT |
Sponsors and Collaborators
- Celgene
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- FDA Safety Alerts and Recalls
- Investigator Inquiry Form
Publications
None provided.- CC-220-MM-001
- U1111-1182-9200
- 2016-000860-40