A Randomized, Open-Label, Controlled Phase 3 Study of Comparing Daratumumab, Lenalidomide and Dexamethasone Induction Followed by Linvoseltamab Versus Continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 33
- 主要终点
- Minimal Residual Disease (MRD)
研究概览
简要总结
This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible).
The main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.
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 must have confirmed diagnosis of symptomatic MM per IMWG criteria.
- •Participants must not be considered a candidate for high-dose chemotherapy (HDT) and ASCT, as described in the protocol.
- •Participants must have measurable disease as defined in the protocol.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
- •Participants must have clinical laboratory values within a prespecified range.
排除标准
- •International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone.
- •Participants who defer transplant due to personal preference.
- •Participants with non-secretory MM, active plasma cell leukemia, known light-chain (AL) amyloidosis in the presence of a concurrent diagnosis of myeloma, any other form of amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome.
- •Any prior therapy for monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), or MM, with the exception of:
- •focal radiation and/or
- •a short course of corticosteroids as defined in the protocol.
- •Participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against MM
- •Participants who have known central nervous system (CNS) or meningeal involvement with MM or known or suspected progressive multifocal leukoencephalopathy (PML), a history of a neurocognitive condition or CNS movement disorder, OR a history of seizure, transient ischemic attack (TIA), stroke or seizure within 12 months prior to study C1D
- •Participants who have uncontrolled intercurrent illness.
- •Known contraindications to the use of daratumumab or lenalidomide per local prescribing information.
- •History of allogeneic hematopoietic stem cell transplantation or solid organ transplant at any time.
- •NOTE Other protocol defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Experimental Arm DRd+ linvolsetamab
干预措施: Daratumumab (Drug)
Experimental Arm DRd+ linvolsetamab
干预措施: Lenalidomide (Drug)
Experimental Arm DRd+ linvolsetamab
干预措施: Dexamethasone (Drug)
Control arm DRd
干预措施: Daratumumab (Drug)
Control arm DRd
干预措施: Lenalidomide (Drug)
Control arm DRd
干预措施: Dexamethasone (Drug)
Experimental Arm DRd+ linvolsetamab
干预措施: Linvoseltamab (Drug)
结局指标
主要结局
Minimal Residual Disease (MRD)
时间窗: up to 11 years
Minimal Residual Disease (MRD) negative Complete Remission (CR) status at 10\^-5 per International Myeloma Working Group (IMWG) criteria
MRD negative CR status by BICR
时间窗: up to 11 years
MRD negative CR status at 10\^-5 as determined by the Blinded Independent Central Review (BICR)
Progression Free Survival (PFS) per IMWG criteria
时间窗: up to 11 years
defined as the time from the date of randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, where disease progression is determined per IMWG criteria.
PFS as determined by BICR
时间窗: up to 11 years
defined as the time from the date of randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, where disease progression is determined per by BICR.
次要结局
- Overall Survival (OS)(up to 11 years)
- OR of Very Good Partial Response (VGPR)(up to 11 years)
- OR of Partial Response (PR)(up to 11 years)
- Objective Response (OR) of Complete Response (CR)(up to 11 years)
- Sustained MRD(up to 11 years)
- Duration of response (DOR) of stringent (s)CR(up to 11 years)
- Duration of response (DOR) of CR(up to 11 years)
- Duration of response (DOR) of VGPR(up to 11 years)
- Duration of response (DOR) of PR(up to 11 years)
- Time to response ≥CR(up to 11 years)
- Time to response ≥VGPR(up to 11 years)
- Time to response ≥PR(up to 11 years)
- Disease progression(up to 11 years)
- Incidence of TEAEs(up to 11 years)
- Severity of TEAEs(up to 11 years)
- Serious Adverse Events(up to 11 years)
- Concentrations of linvoseltamab(up to 11 years)
- Incidence antidrug antibodies(up to 11 years)
- Titer of ADA(up to 11 years)
- EORTC QLQ-C30 Global Health Status / Quality of Life(up to 11 years)
- EORTC QLQ-C30 Physical Functioning (PF)(up to 11 years)
- EORTC QLQ-C30 Role Functioning (RF)(up to 11 years)
- EORTC QLQ-C30 Pain(up to 11 years)
- EORTC QLQ-C30 Fatigue(up to 11 years)
- EQ-5D-5L VAS(up to 11 years)