2023-507632-20-00招募中3 期
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
European Myeloma Network B.V.44 个研究点 分布在 9 个国家目标入组 440 人开始时间: 2024年5月1日最近更新:
适应症
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
- 44
- 主要终点
- PFS
研究概览
简要总结
To compare the efficacy of DVRd followed by cilta-cel and lenalidomide therapy versus DVRd followed by ASCT, DVRd consolidation, and lenalidomide therapy in terms of PFS and sustained MRD-negative CR
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
- 是
入选标准
- •18 years of age or older
- •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: 1) Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or 2) 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 as listed in 5.1.1, page 55 of the protocol.
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 halflives 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
PFS
PFS
Sustained MRD-negative CR, defined as MRD-negative CR for at a minimum 12 months duration, with MRD status determined by NGS with a sensitivity of at least 10-5
Sustained MRD-negative CR, defined as MRD-negative CR for at a minimum 12 months duration, with MRD status determined by NGS with a sensitivity of at least 10-5
次要结局
- OS
- Overall response (PR or better) status and CR or better status
- Overall MRD-negative CR with a sensitivity of at least 10-5
- Time to subsequent antimyeloma therapy
- PFS on next-line therapy (PFS2)
- Incidence, severity, and type of AEs, clinical laboratory results, and other safety parameters
- PK and pharmacodynamic markers by protein, DNA, or RNA analyses, including but not limited to, systemic inflammatory cytokine concentrations, markers of CAR-T cell expansion (proliferation) and persistence via monitoring of cilta-cel-positive cellular concentrations, and cilta-cel transgene levels
- Mean change from baseline in the EORTC-QLQ-C30, MySIm-Q, and EQ-5D-5L subscale scores and the PROCTCAE items
- Time to improvement or worsening of symptoms, functioning, and overall well-being
- Improvement or worsening in the EORTC-QLQ- C30 and MySIm-Q subscale scores using the PGIS to calculate the meaningful change threshold
- Presence of RCL
研究者
Pieter Sonneveld
Scientific
European Myeloma Network Stichting
研究点 (44)
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