A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
Purpose
The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.
Condition
- Multiple Myeloma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 For participants in Cohorts A, B, C, D, E, F, H, I, J, and K the following inclusions will also apply: - Documented diagnosis of multiple myeloma (MM) and measurable disease - Documented disease progression during or after their last antimyeloma regimen - Achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen
Exclusion Criteria
- Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant amyloidosis - Known central nervous system (CNS) involvement with myeloma - Received immunosuppressive medication within the last 14 days of initiating study treatment - Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment Other protocol-defined inclusion/exclusion criteria apply
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
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Experimental Cohort A: CC-92480 with bortezomib and dexamethasone |
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Experimental Cohort C: CC-92480 with carfilzomib and dexamethasone |
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Experimental Cohort H: CC-92480 with elotuzumab and dexamethasone |
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Experimental Cohort I: CC-92480 with isatuximab and dexamethasone |
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Experimental Cohort D: CC-92480 with bortezomib and dexamethasone |
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Experimental Cohort F: CC-92480 with carfilzomib and dexamethasone |
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Experimental Cohort J: CC-92480 with elotuzumab and dexamethasone |
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Experimental Cohort K: CC-92480 with isatuximab and dexamethasone |
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Experimental Cohort G: CC-92480 with bortezomib and dexamethasone |
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Experimental Subcohort B1: CC-92480 with daratumumab and dexamethasone |
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Experimental Subcohort B2: CC-92480 with daratumumab and dexamethasone |
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Experimental Subcohort B3: CC-92480 with daratumumab and dexamethasone |
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Experimental Subcohort E1: CC-92480 with daratumumab and dexamethasone |
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Experimental Subcohort E2: CC-92480 with daratumumab and dexamethasone |
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Experimental Subcohort E3: CC-92480 with daratumumab and dexamethasone |
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Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Contact:
Noopur Raje, Site 117
617-726-0711
Noopur Raje, Site 117
617-726-0711
More Details
- Status
- Recruiting
- Sponsor
- Celgene
Study Contact
BMS Study Connect Contact Center www.BMSStudyConnect.com855-907-3286
Clinical.Trials@bms.com