2023-509859-13-00招募中3 期
A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib And Dexamethasone (MeziVd) Versus Pomalidomide, Bortezomib And Dexamethasone (PVd) In Subjects With Relapsed Or Refractory Multiple Myeloma (RRMM): Successor-1
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 333
- 试验地点
- 65
- 主要终点
- Progression free Survival (PFS)
研究概览
简要总结
To compare the progression-free survival (PFS) of mezigdomide, bortezomib and dexamethasone (MeziVd) to that of pomalidomide, bortezomib and dexamethasone (PVd) in subjects with relapsed or refractory multiple myeloma (RRMM)
研究设计
- 研究类型
- Interventional
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
- •Subject has documented diagnosis of MM and measurable disease, defined as: —M-protein ≥ 0.5 g/dL by serum protein electrophoresis (sPEP), or ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or —For subjects without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio
- •Subject has received 1 to 3 prior anti-myeloma lines of therapy
- •Subject must have received prior treatment with a lenalidomide containing regimen. For country-specific requirements, see APPENDIX I
- •Subject achieved a minimal response [MR] or better to at least 1 prior antimyeloma therapy
- •Subject must have documented disease progression during or after their last antimyeloma regimen
- •Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
排除标准
- •Subject has had prior treatment with mezigdomide or pomalidomide
- •Subject has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below: a. Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks or less are not excluded.
- •For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.
结局指标
主要结局
Progression free Survival (PFS)
Progression free Survival (PFS)
次要结局
- Time to Next Treatment (TTNT)
- Progression-free survival 2 (PFS-2)
- Recommended mezigdomide dose
- Pharmacokinetics
- Overall Survival (OS)
- Overall Response Rate (OR)
- Complete Response Rate (CR) or better
- Very Good Partial Response Rate (VGPR) or better
- Time to Response (TTR)
- Duration of Response (DOR)
- Time to Progression (TTP)
- Minimal residual disease (MRD) negativity
- Safety
- Health Related Quality of Life (HRQoL) Evaluation
研究者
GSM-CT
Scientific
Celgene Corp.
研究点 (65)
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