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
- 1 期
- 状态
- 终止
- 发起方
- Celgene
- 入组人数
- 4
- 试验地点
- 11
- 主要终点
- Number of participants with AEs leading to discontinuation
研究概览
简要总结
The purpose of this study is 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.
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
- •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.
排除标准
- •Must not have previously received alnuctamab or mezigdomide.
- •Note: Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm B2
干预措施: Alnuctamab (Drug)
Arm C1
干预措施: Dexamethasone (Drug)
Arm B2
干预措施: Mezigdomide (Drug)
Arm B2
干预措施: Dexamethasone (Drug)
Arm C1
干预措施: Alnuctamab (Drug)
Arm C1
干预措施: Mezigdomide (Drug)
Arm C2
干预措施: Alnuctamab (Drug)
Arm B1
干预措施: Alnuctamab (Drug)
Part A
干预措施: Alnuctamab (Drug)
Part A
干预措施: Mezigdomide (Drug)
Part A
干预措施: Dexamethasone (Drug)
Arm B1
干预措施: Mezigdomide (Drug)
Arm B1
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Number of participants with AEs leading to discontinuation
时间窗: 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
时间窗: 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 adverse events (AEs)
时间窗: 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)
时间窗: 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 Dose-limiting toxicities (DLTs)
时间窗: 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)
Overall Response Rate (ORR)
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 (Up to approximately 5 years)
Phase 2 only
次要结局
- 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 (Up to approximately 5 years))
- 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 (Up to approximately 5 years))
- 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 (Up to approximately 5 years))
- 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 (Up to approximately 5 years))
- 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 (Up to approximately 5 years))
- 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 (Up to approximately 5 years))
- ORR(From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years))