NCT05552976进行中（未招募）3 期
A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480/BMS-986348), Carfilzomib, and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-2
Bristol-Myers Squibb423 个研究点 分布在 3 个国家目标入组 525 人开始时间: 2023年1月10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
- 进行中（未招募）
- 发起方
- 入组人数
- 525
- 试验地点
- 423
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
The purpose of the study is to compare Mezigdomide (CC-92480/BMS-986348) with carfilzomib and dexamethasone (MeziKD) against carfilzomib and dexamethasone (Kd) in the treatment of RRMM: SUCCESSOR-2.
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
盲法说明
This is an open-label study; however, any review of aggregate study data by the Sponsor will be performed in a blinded manner.
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
- •- Participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following:.
- •i) Myeloma-protein (M-protein) ≥ 0.5 grams/deciliter (g/dL) by serum protein electrophoresis (sPEP), or.
- •ii) M-protein ≥ 200 milligrams (mg)/24-hour urine collection by urine protein electrophoresis (uPEP) or,.
- •iii) For participants without measurable disease in sPEP or uPEP: serum free light chain levels > 100 mg/liter (L) (10 mg/dL) involved light chain and an abnormal κ/λ free light chain ratio.
- •Participant has received at least one prior line of anti-myeloma therapy. Note: One line can contain several phases (e.g., induction, [with or without] hematopoietic stem cell transplant, (with or without) consolidation, and/or [with or without] maintenance therapy).
- •Participant must have received prior treatment with lenalidomide and at least 2 cycles of an anti-CD38 monoclonal antibody (mAb) (participants who were intolerant of an anti-CD38 mAb and received < 2 cycles are still eligible).
- •Participant achieved minimal response or better to at least 1 prior anti-myeloma therapy.
- •Participant must have documented disease progression during or after their last antimyeloma regimen.
排除标准
- •Participant who has had prior treatment with mezigdomide or carfilzomib.
- •Participant has previously received allogeneic stem cell transplant at any time or received autologous stem cell transplant within 12 weeks of initiating study treatment.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Kd (Carfilzomib + Dexamethasone)
Active Comparator
干预措施: Carfilzomib (Drug)
MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)
Experimental
干预措施: Mezigdomide (Drug)
MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)
Experimental
干预措施: Carfilzomib (Drug)
MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)
Experimental
干预措施: Dexamethasone (Drug)
Kd (Carfilzomib + Dexamethasone)
Active Comparator
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Up to approximately 5 years
次要结局
- Rate Of Very Good Partial Response (VGPR) Or Better (VGPRR)(Up to approximately 5 years)
- Time To Response (TTR)(Up to approximately 5 years)
- Progression-free Survival 2 (PFS-2)(Up to approximately 5 years)
- Number Of Participants With Adverse Events (AEs)(Up to approximately 5 years)
- Change From Baseline in the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)(Up to approximately 5 years)
- Recommended Mezigdomide Dose(Up to 12 months)
- Plasma concentrations of Mezigdomide in Combination with Carfilzomib and Dexamethasone(Up to 176 days)
- Overall Survival (OS)(Up to approximately 5 years)
- Overall Response (OR)(Up to approximately 5 years)
- Complete Response (CR) Or Better (CRR)(Up to approximately 5 years)
- Duration Of Response (DOR)(Up to approximately 5 years)
- Time To Progression (TTP)(Up to approximately 5 years)
- Time To Next Treatment (TTNT)(Up to approximately 5 years)
- Minimal Residual Disease (MRD) Negativity Rate(Up to approximately 5 years)
- Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)(Up to approximately 5 years)
研究者
研究点 (423)
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