2024-515279-37-00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 (QUINTESSENTIAL-2)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 189
- 试验地点
- 63
- 主要终点
- Progression free survival (PFS): The average time participants are alive without their MM getting worse after starting the study.
研究概览
简要总结
To see if arlo-cel works better than standard treatments (Daratumumab with Pomalidomide and Dexamethasone (DPd) or Carfilzomib with Dexamethasone (Kd)) by comparing two main effectiveness measures.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Have RRMM, have received 1-3 prior lines of therapy (LOT) for MM, and with proof that the disease got worse during or after the last treatment and have prior exposure to LEN.
- •Have measurable signs of MM as per the study criteria.
- •Be at least 18 years old and have adequate organ function and performance status as per study criteria.
排除标准
- •Known or history of central nervous system involvement with MM.
- •Solitary plasmacytomas or non-secretory MM and no other measurable signs of MM.
- •Need for urgent treatment due to rapidly progressing MM.
结局指标
主要结局
Progression free survival (PFS): The average time participants are alive without their MM getting worse after starting the study.
Progression free survival (PFS): The average time participants are alive without their MM getting worse after starting the study.
Minimal residual disease (MRD)-negative, complete response (CR): No signs of MM can be found in the participant’s body.
Minimal residual disease (MRD)-negative, complete response (CR): No signs of MM can be found in the participant’s body.
次要结局
- Overall survival (OS): The average time participants are alive after starting the study.
- Overall response rate (ORR): How many participants show a positive response to treatment.
研究者
Celgene Corporation
Scientific
Celgene Corp.
研究点 (63)
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