NCT06232707撤回3 期
A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) - ALUMMINATE RRMM
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Celgene
- 试验地点
- 170
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm B: Standard of Care Regimens
Active Comparator
干预措施: Carfilzomib (Drug)
Arm B: Standard of Care Regimens
Active Comparator
干预措施: Dexamethasone (Drug)
Arm B: Standard of Care Regimens
Active Comparator
干预措施: Pomalidomide (Drug)
Arm B: Standard of Care Regimens
Active Comparator
干预措施: Daratumumab (Drug)
Arm B: Standard of Care Regimens
Active Comparator
干预措施: Elotuzumab (Drug)
Arm A: Alnuctamab
Experimental
干预措施: Alnuctamab (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Up to 5 years
次要结局
- Time to response (TTR)(Up to 5 years)
- Time to progression (TTP)(Up to 5 years)
- Minimal residual disease (MRD) negativity rate(Up to 5 years)
- Overall Survival (OS)(Up to 5 years)
- Incidence of serious adverse events (SAEs)(Up to 5 years)
- Complete response (CR) or better(Up to 5 years)
- Overall response (OR)(Up to 5 years)
- Very good partial response (VGPR) or better(Up to 5 years)
- Progression-free survival 2 (PFS2)(Up to 5 years)
- Change from baseline in subscale scores of European organization for research and treatment of cancer - quality of life core 30 (EORTC QLQ-C30)(Up to 5 years)
- Duration of response (DOR)(Up to 5 years)
- Restricted mean DOR (RMDOR)(Up to 5 years)
- Time to next treatment (TTNT)(Up to 5 years)
- Incidence of adverse events (AEs)(Up to 5 years)
- Change from baseline in subscale scores of European quality of life multiple myeloma module (EORTC QLQ-MY20)(Up to 5 years)
研究者
研究点 (170)
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