NCT05827016进行中（未招募）3 期
A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)
Bristol-Myers Squibb479 个研究点 分布在 6 个国家目标入组 1,230 人开始时间: 2023年6月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,230
- 试验地点
- 479
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).
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
- •Confirmed diagnosis of symptomatic multiple myeloma (MM).
- •Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or
- •Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) [eg, bortezomib thalidomide and dexamethasone (VTd), lenalidomide, bortezomib and dexamethasone (RVd)] with or without a CD38 monoclonal antibody, daratumumab + bortezomib/thalidomide/dexamethasone [D-VTd] and daratumumab + bortezomib/ lenalidomide/dexamethasone [D-VRd]), or VCd / daratumumab + bortezomib/cyclophosphamide/dexamethasone [D-VCd], and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted.
- •Participants within 12 months (single transplant) or 15 months (tandem transplant) from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation, according to International Myeloma Working Group (IMWG 2016) criteria.
排除标准
- •Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy.
- •Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma.
- •Known central nervous system/meningeal involvement of MM.
- •Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Arm A1: Iberdomide Dose 1
Experimental
干预措施: Iberdomide (Drug)
Arm A2: Iberdomide Dose 2
Experimental
干预措施: Iberdomide (Drug)
Arm A3: Iberdomide Dose 3
Experimental
干预措施: Iberdomide (Drug)
Arm B: Lenalidomide
Active Comparator
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Up to 6 years
次要结局
- Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (± 3) months of maintenance treatment(Up to 6 years)
- Area under the iberdomide plasma concentration-time curve from time zero to tau(Up to 1 year)
- Area under the iberdomide plasma concentration-time curve within a dosing interval AUC (TAU)(Up to 1 year)
- Maximum iberdomide concentration (Cmax)(Up to 1 year)
- Achieving MRD negativity in participants with CR or better at any time after the date of randomization(Up to 6 years)
- Overall Survival(Up to 12 years)
- Time to maximum iberdomide plasma concentration (Tmax)(Up to 1 year)
- Recommended iberdomide dose for Stage 2(Up to 1 year)
- Number of participants with adverse events (AEs)(Up to 6 years)
- Progression-free survival on next line of treatment (PFS2)(Up to 6 years)
- Conversion from MRD positive to MRD negative in participants with CR or better(Up to 6 years)
- Achievement of CR or better and maintaining MRD-negative status in 2 bone marrow aspirate assessments that are a minimum of 1 year apart, without any examination showing MRD positive status in between assessments(Up to 6 years)
- Time to progression (TTP)(Up to 6 years)
- Time to next treatment (TTNT)(Up to 6 years)
- Best response achieved prior to progressive disease (PD)(Up to 6 years)
- Patient-reported health-related quality of life (HRQoL) outcomes and multiple myeloma-related symptoms as measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life C30 questionnaire (QLQ-C30)(Up to 6 years)
- Patient-reported HRQoL outcomes and multiple myeloma-related symptoms as measured by the EORTC Quality of Life Multiple Myeloma Module (QLQ-MY20)(Up to 6 years)
研究者
研究点 (479)
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