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)
A Phase 1/2, Multicenter, Open-label, Study to Determine the Recommended Dose and Regimen, and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
Sponsor: Celgene
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Recommended Dose
Time frame: Up to approximately 3 years
Recommended regimen as measured by dose-limiting toxicities
Time frame: Up to approximately 3 years
Number of participants with Adverse Events (AEs)
Time frame: From first participant first visit until 28 days after the last subject discontinues study treatment, up to 5 years
Overall response rate (ORR)
Time frame: Up to approximately 5 years
Secondary Endpoints
Time-to-response (TTR)
Duration of response (DOR)
Complete Response (CR) rate
Eligibility Criteria
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
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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