A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Celgene
- 入组人数
- 939
- 试验地点
- 518
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).
详细描述
This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM). Approximately 200 patients randomized in stage 1 to one of three iberdomide dose levels of 1, 1.3, or 1.6 mg in combination with daratumumab and dexamethasone (Treatment Arms A1, A2, or A3), or to the DVd comparator arm (Treatment Arm B).
In Stage 2 of the study, approximately 664 additional subjects will be randomized 1:1 between 2 treatment arms:
- Approximately 332 subjects will be randomized to receive Treatment Arm A (IberDd)
- Approximately 332 subjects will be randomized to receive Treatment Arm B (DVd)
Participants in both treatment arms will continue to receive treatment until confirmed progressive disease (PD), unacceptable toxicity or withdrawal of consent. To ensure accuracy and completeness of the primary endpoint assessment of progression-free survival (PFS), participants who permanently discontinue study treatment for any reason, other than confirmed PD or withdrawal of consent, will continue to be followed for disease assessment.
The study will be conducted in compliance with International Council for Harmonisation (ICH) and Good Clinical Practices (GCPs).
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
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
- •Documented diagnosis of multiple myeloma (MM) and measurable disease.
- •Received 1 to 2 prior lines of anti-myeloma therapy.
- •Must have documented disease progression during or after their last anti-myeloma regimen.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
排除标准
- •Any condition that confounds the ability to interpret data from the study.
- •Has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis.
- •Known central nervous system involvement with MM.
- •Prior therapy with iberdomide.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Daratumumab in combination with Iberdomide and dexamethasone - Dose 3
干预措施: Iberdomide (Drug)
Daratumumab in combination with Iberdomide and dexamethasone - Dose 2
干预措施: Dexamethasone (Drug)
Daratumumab in combination with Iberdomide and dexamethasone - Dose 3
干预措施: Dexamethasone (Drug)
Daratumumab in combination with Iberdomide and dexamethasone - Dose 1
Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.
干预措施: Dexamethasone (Drug)
Daratumumab in combination with Iberdomide and dexamethasone - Dose 1
Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.
干预措施: Iberdomide (Drug)
Daratumumab in combination with Iberdomide and dexamethasone - Dose 1
Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.
干预措施: Daratumumab (Drug)
Daratumumab in combination with Iberdomide and dexamethasone - Dose 2
干预措施: Daratumumab (Drug)
Daratumumab in combination with Iberdomide and dexamethasone - Dose 2
干预措施: Iberdomide (Drug)
Daratumumab in combination with Iberdomide and dexamethasone - Dose 3
干预措施: Daratumumab (Drug)
Daratumumab in combination with dexamethasone and bortezomib
Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone
干预措施: Bortezomib (Drug)
Daratumumab in combination with dexamethasone and bortezomib
Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone
干预措施: Dexamethasone (Drug)
Daratumumab in combination with dexamethasone and bortezomib
Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone
干预措施: Daratumumab (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Up to approximately 5 years
To compare the efficacy of iberdomide (also known as BMS-986382), daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM) in terms of progression free survival (PFS).
Minimal Residual Disease (MRD) negative Complete Response (CR) at any time
时间窗: Up to approximately 5 years
To compare the efficacy of iberdomide (also known as BMS-986382), daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM) in terms of minimal residual disease (MRD) negative complete response (CR) at any time.
次要结局
- Overall Survival (OS)(Up to approximately 5 years)
- Sustainability of Minimal Residual Disease (MRD) negativity(Up to approximately 5 years)
- Overall Response Rate (ORR)(Up to approximately 5 years)
- Time to response (TTR)(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)
- Maximum plasma concentration (Cmax)(Up to approximately 1 year)
- Progression-free Survival 2 (PFS2)(Up to approximately 5 years)
- Safety(Up to approximately 5 years)
- European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)(Up to approximately 5 years)
- European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)(Up to approximately 5 years)
- Recommended iberdomide dose for Stage 2(Up to approximately 1 year)
- Area under the plasma concentration-time curve from time zero to tau (AUC(TAU))(Up to approximately 1 year)
- Time to maximum plasma concentration (Tmax)(Up to approximately 1 year)