A Study to Evaluate Alnuctamab in Combination With Mezigdomide in Participants With Relapsed and/or Refractory Multiple Myeloma
A Phase 1b/2a, Multicenter, Open-label Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Alnuctamab in Combination With Mezigdomide in Participants With Relapsed and/or Refractory Multiple Myeloma
Sponsor: Celgene
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number of participants with adverse events (AEs)
Time frame: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Number of participants with serious AEs (SAEs)
Time frame: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Number of participants with AEs leading to discontinuation
Time frame: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Number of deaths
Time frame: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)
Secondary Endpoints
Complete Response Rate (CRR)
Very Good Partial Response Rate (VGPRR)
Progression-free Survival (PFS)
Eligibility Criteria
Inclusion Criteria: Participant has a history of RRMM, and must: * Part A: Have previously received ≥ 3 prior lines of anti-myeloma therapy. * Part B and Part C: Have received 1 to 3 prior lines of anti-myeloma therapy. Exclusion Criteria: • Must not have previously received alnuctamab or mezigdomide. Note: 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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