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
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
To determine the safety and tolerability of alnuctamab in combination with mezigdomide in participants with RRMM (primary - all phases). To determine the recommended Phase 2 dose (RP2D) and schedule of mezigdomide when administered in combination with alnuctamab in participants with RRMM (Phase 1b only). To evaluate the preliminary efficacy of alnuctamab in combination with mezigdomide in comparison to alnuctamab monotherapy in participants with RRMM (Phase 2a only).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 with history of RRMM treated with ≥ 3 prior lines of antimyeloma therapy (Part A) or 1 to 3 prior lines of anti-myeloma therapy (Parts B and C).
- •Measurable MM by central laboratory.
- •Eastern Cooperative Oncology Group performance status of 0 to
- •Adherence to contraception requirements.
排除标准
- •Prior treatment with mezigdomide or alnuctamab.
- •Other exclusion criteria can be found in the protocol.
结局指标
主要结局
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.
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 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.
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.
次要结局
- 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.
研究者
GSM-CT
Scientific
Celgene International II S.a.r.l.