A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab 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 Mezigdomide in Combination With Elranatamab 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: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
Number of participants with Serious AEs
Time frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
Number of participants with AEs meeting protocol-defined DLT criteria
Time frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
Number of participants with AEs leading to discontinuation
Time frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
Secondary Endpoints
International Myeloma Working Group (IMWG) Uniform Response Criteria: Overall Response Rate (ORR)
IMWG Uniform Response Criteria: Complete Response Rate (CRR)
IMWG Uniform Response Criteria: Very Good Partial Response Rate (VGPRR)
Eligibility Criteria
Inclusion Criteria: * Age ≥18 with history of relapsed and refractory multiple myeloma (RRMM) treated with 2 to 4 prior lines of anti-myeloma therapy (Phase 1) or 1 to 3 prior lines of anti-myeloma therapy (Phase 2). * Measurable MM by local laboratory. * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1. * Adherence to contraception requirements. Exclusion Criteria: * Prior treatment with mezigdomide. * Prior treatment with T cell engaging or T cell engager (TCE). * Prior treatment with B cell-maturation antigen (BCMA)-targeting therapy, with the exception of participants who have received autologous BCMA-targeted CART-cell therapy\> 6 months from the start of study therapy * 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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