jRCT2063220071招募中不适用
A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in Participants with Newly Diagnosed Multiple Myeloma who are Transplant Eligible (EMN28-CARTITUDE-6)
European Myeloma Network (EMN)0 个研究点目标入组 50 人开始时间: 2024年8月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participants with documented NDMM according to IMWG diagnostic criteria, for whom high-dose therapy and ASCT are part of the intended initial treatment plan.
- •Measurable disease, as assessed by central laboratory, at screening as defined by any of the following:
- •a. Serum monoclonal paraprotein (M-protein) level >=1.0 g/dL or urine M-protein level >=200 mg/24 hours; or
- •b. Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) >=10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.
- •ECOG performance status of grade 0 or 1
- •Clinical laboratory values within prespecified range.
排除标准
- •Prior treatment with CAR-T therapy directed at any target.
- •Any prior BCMA target therapy.
- •Any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids
- •Received a strong cytochrome P450 (CYP)3A4 inducer within 5 half-lives prior to randomization
- •Received or plans to receive any live, attenuated vaccine (except for COVID-19 vaccines) within 4 weeks prior to randomization.
- •Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM
- •Stroke or seizure within 6 months of signing Informed Consent Form (ICF)
结局指标
主要结局
-
The dual primary endpoints are PFS and sustained MRD-negative CR.
次要结局
- Overall response Rate
- CR or better status
- Overall MRD-negative CR(any time after the date of randomization before initiation of subsequent antimyeloma therapy)
- Time to subsequent antimyeloma therapy(from the date of randomization to the start of subsequent antimyeloma therapy)
- PFS2(from the date of randomization to the date of event)
- OS(from the date of randomization to the date of death)
研究者
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