NCT06045806进行中（未招募）3 期
A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9)
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
- Celgene
- 入组人数
- 79
- 试验地点
- 101
- 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 efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).
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
- •Participants aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT), without subsequent consolidation or maintenance. EXCEPTION: Participant received ≤ 7 days of lenalidomide (LEN) maintenance therapy and the investigator documents that there is no impact to the overall benefit/risk assessment due to the temporary interruption of LEN.
- •Participant must have received 4 to 6 cycles of induction therapy, which must contain at a minimum an immunomodulatory drugs (IMiD) and a proteasome inhibitor (PI) (with or without anti-CD38 monoclonal antibody) and must have had a single ASCT 80 to 120 days prior to consent. Note: Participant must not have confirmed progression since commencing induction.
- •Participant must have documented response of PR or VGPR at time of consent.
- •Participant must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (participants with ECOG 2 due to pain because of underlying myeloma-associated bone lesions are eligible per investigator's discretion).
- •Participant must have recovered to ≤ Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.
排除标准
- •Participant with known central nervous system involvement with myeloma.
- •Participant has non-secretory MM.
- •Participant has systemic and uncontrolled fungal, bacterial, viral, or other infection.
- •Participant has history of primary immunodeficiency.
- •Participant has previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or B-cell maturation antigen targeted therapy.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Arm A
Experimental
干预措施: idecabtagene vicleucel (Biological)
Arm A
Experimental
干预措施: Lenalidomide (Drug)
Arm A
Experimental
干预措施: Fludarabine (Drug)
Arm A
Experimental
干预措施: Cyclophosphamide (Drug)
Arm B
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 approximately 50 months after the first participant is randomized
PFS as assessed by Independent Review Committee (IRC)
次要结局
- Overall Survival (OS)(Up to approximately 60 months after the last participant is randomized)
- Percentage of Participants with Sustained Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months(From randomization up to 60 months from randomization)
- Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR)(From randomization up to 15 months from randomization)
- Event-Free Survival (EFS)(Up to approximately 60 months after the last participant is randomized)
- Duration of Response (DOR)(Up to approximately 60 months after the last participant is randomized)
- Percentage of Participants with Complete Response (CR)(Up to approximately 60 months after the last participant is randomized)
- Time to Progression (TTP)(Up to approximately 60 months after the last participant is randomized)
- Progression post-next line of treatment (PFS2)(Up to approximately 60 months after the last participant is randomized)
- Time to Next Treatment (TTNT)(Up to approximately 60 months after the last participant is randomized)
- Number of Participants Experiencing Adverse Events (AEs)(Up to approximately 60 months after the last participant is randomized)
- Number of Participants Experiencing Adverse Events of Special Interest (AESI)(Up to approximately 60 months after the last participant is randomized)
- Maximum Observed Plasma Concentration (Cmax)(Up to approximately 60 months after the last participant is randomized)
- Time of Maximum Observed Plasma Concentration (Tmax)(Up to approximately 60 months after the last participant is randomized)
- Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0- 28D])(Up to 28 days post infusion)
- Time of Last Measurable Observed Plasma Concentration (Tlast)(Up to approximately 60 months after the last participant is randomized)
- Time-to-Definitive Deterioration(Up to approximately 50 months after the first participant is randomized)
- Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales(Up to approximately 50 months after the first participant is randomized)
- Mean Change from Baseline in EORTC QLQ-MY20 Selected Subscales(Up to approximately 50 months after the first participant is randomized)
研究者
研究点 (101)
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