NCT06615479招募中3 期
A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company215 个研究点 分布在 14 个国家目标入组 440 人开始时间: 2025年3月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 440
- 试验地点
- 215
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of arlo-cel (BMS-986393) versus standard regimens in adult participants with Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma.
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
- •Participants must have relapsed or refractory multiple myeloma (RRMM).
- •Participants must have received at least 1 but no greater than 3 prior multiple myeloma (MM) regimens which may include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody and have prior exposure to lenalidomide.
- •Participants must have a documented diagnosis of MM as per International Myeloma Working Group Criteria.
- •Participants must have measurable disease during screening.
- •Participants must have adequate organ function.
- •Participants must have an Eastern Cooperative Oncology group performance status 0 or 1.
排除标准
- •Participants must not have known active or history of central nervous system (CNS) involvement of Multiple Myeloma (MM).
- •Participants must not have solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease.
- •Participants must not need urgent treatment due to rapidly progressing MM.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Arm B
Active Comparator
干预措施: Carfilzomib (Drug)
Arm A
Experimental
干预措施: BMS-986393 (Drug)
Arm A
Experimental
干预措施: Fludarabine (Drug)
Arm A
Experimental
干预措施: Daratumumab (Drug)
Arm A
Experimental
干预措施: Pomalidomide (Drug)
Arm B
Active Comparator
干预措施: Daratumumab (Drug)
Arm B
Active Comparator
干预措施: Dexamethasone (Drug)
Arm A
Experimental
干预措施: Dexamethasone (Drug)
Arm A
Experimental
干预措施: Cyclophosphamide (Drug)
Arm A
Experimental
干预措施: Carfilzomib (Drug)
Arm B
Active Comparator
干预措施: Pomalidomide (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Up to 5 years after the last participant is randomized
Minimal residual disease (MRD)-negativity in complete response (CR)
时间窗: Up to 1 year after the last participant is randomized
次要结局
- Time of maximum observed plasma concentration (Tmax) of transgene level(Up to 5 years after the last participant is randomized)
- Overall survival (OS)(Up to 5 years after the last participant is randomized)
- Minimal residual disease (MRD)-negative status(Up to 5 years after the last participant is randomized)
- Complete response rate (CRR)(Up to 5 years after the last participant is randomized)
- Time to response (TTR)(Up to 5 years after the last participant is randomized)
- Duration of response (DOR)(Up to 5 years after the last participant is randomized)
- Maximum observed concentration (Cmax) of transgene level(Up to 5 years after the last participant is randomized)
- Area under the concentration-time curve (AUC) of transgene level(Up to 5 years after the last participant is randomized)
- Changes from baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 items (QLQ-C30) primary domains(Up to 5 years after the last participant is randomized)
- Changes from baseline in EORTC Quality of Life Multiple Myeloma Module- 20 items (QLQ-MY20) primary domains(Up to 5 years after the last participant is randomized)
- Time to meaningful improvement in EORTC QLQ-C30 global health status/QoL.(Up to 5 years after the last participant is randomized)
- Overall response rate (ORR)(Up to 5 years after the last participant is randomized)
- Overall survival (OS)(Up to 5 years after the last participant is randomized)
- Overall response rate (ORR)(Up to 5 years after the last participant is randomized)
- Minimal residual disease (MRD)-negative status(Up to 5 years after the last participant is randomized)
- Complete response rate (CRR)(Up to 5 years after the last participant is randomized)
- Time to response (TTR)(Up to 5 years after the last participant is randomized)
- Duration of response (DOR)(Up to 5 years after the last participant is randomized)
- Maximum observed concentration (Cmax) of transgene level(Up to 5 years after the last participant is randomized)
- Time of maximum observed plasma concentration (Tmax) of transgene level(Up to 5 years after the last participant is randomized)
- Area under the concentration-time curve (AUC) of transgene level(Up to 5 years after the last participant is randomized)
- Changes from baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 items (QLQ-C30) primary domains(Up to 5 years after the last participant is randomized)
- Changes from baseline in EORTC Quality of Life Multiple Myeloma Module- 20 items (QLQ-MY20) primary domains(Up to 5 years after the last participant is randomized)
- Time to meaningful improvement in EORTC QLQ-C30 global health status/QoL.(Up to 5 years after the last participant is randomized)
研究者
研究点 (215)
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