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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Celgene
- 入组人数
- 62
- 试验地点
- 40
- 主要终点
- Number of participants with Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the preliminary safety and determine the RP2D of mezigdomide in combination with elranatamab in participants with relapsed and refractory multiple myeloma (RRMM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Adherence to contraception requirements.
排除标准
- •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.
研究组 & 干预措施
Phase 1
干预措施: Dexamethasone (Drug)
Phase 2
干预措施: Dexamethasone (Drug)
Phase 1
干预措施: Mezigdomide (Drug)
Phase 1
干预措施: Elranatamab (Drug)
Phase 2
干预措施: Mezigdomide (Drug)
Phase 2
干预措施: Elranatamab (Drug)
结局指标
主要结局
Number of participants with Adverse Events (AEs)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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 deaths
时间窗: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
Recommended Phase 2 Dose (RP2D)
时间窗: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
次要结局
- International Myeloma Working Group (IMWG) Uniform Response Criteria: Overall Response Rate (ORR)(From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years))
- IMWG Uniform Response Criteria: Complete Response Rate (CRR)(From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years))
- IMWG Uniform Response Criteria: Very Good Partial Response Rate (VGPRR)(From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years))
- IMWG Uniform Response Criteria: Time to Response (TTR)(From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years))
- IMWG Uniform Response Criteria: Duration of Response (DOR)(From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years))
- IMWG Uniform Response Criteria: Progression-free Survival (PFS)(From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years))
- IMWG Uniform Response Criteria: Overall Survival (OS)(From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years))
- Number of participants who achieve minimal residual disease (MRD) negativity(From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years))