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

Relapsed and/or Refractory Multiple Myeloma

All phases: Type, frequency, seriousness, and severity of all aAEs;. To be assessed continuously for all participants until 80 days after the last dose of alnuctamab or 28 days after the last dose of mezigdomide, whichever is later., Phase 1b: Establish RP2D and dosing schedule of mezigdomide in combination with alnuctamab for Phase 2a expansion. To be assessed at end of Phase 1., Phase 2a: Overall response rate. To be assessed every cycle for all participants starting at Cycle 2 Day 1 until end of treatment. Participants in efficacy follow-up may be assessed every 8 weeks until dprogression, withdrawal of consent, death, or initiation of new systemic anticancer therapies.

All phases: Other myeloma response measures such as very good partial or better rate and complete response rate; time-to-response (the time it takes for a myeloma response after treatment) and duration of response. These will be assessed for all participants starting at Cycle 2 Day 1. Other measures include progression-free survival (the amount of time after starting treatment that the cancer does not worsen) and overall survival, both of which will be assessed continuously, Phase 1b: overall response rate. To be assessed every cycle for all participants starting at Cycle 2 Day 1 until end of treatment. Participants in efficacy follow-up may be assessed every 8 weeks until dprogression, withdrawal of consent, death, or initiation of new systemic anticancer therapies.

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