2024-514417-34-00招募中3 期
A Phase 3 Randomized, Open-label, Multicenter Study Assessing the Clinical Benefit of Isatuximab (SAR650984) in Combination with Bortezomib (Velcade®), Lenalidomide and Dexamethasone versus Bortezomib, Lenalidomide and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
Sanofi-Aventis Recherche & Developpement47 个研究点 分布在 11 个国家目标入组 308 人开始时间: 2024年9月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 308
- 试验地点
- 47
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
To demonstrate the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone in the prolongation of progression free survival (PFS) as compared to bortezomib, lenalidomide, and dexamethasone, in participants with newly diagnosed multiple myeloma (NDMM) not eligible for transplant.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Multiple myeloma (International Myeloma Working Group [IMWG] criteria).
- •Newly diagnosed multiple myeloma not eligible for transplant due to age (≥ 65 years) or participants < 65 years with comorbidities impacting possibility of transplant.
- •Evidence of measurable disease.
- •Written informed consent
排除标准
- •Age <18 years.
- •Prior treatment for multiple myeloma.
- •Any other prior or ongoing disease/health conditions incompatible with the study objectives.
- •Organ function values not met.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) >
- •Hypersensitivity to the study medications.
- •Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods.
- •Male participants who disagree to follow the study contraceptive counseling.
结局指标
主要结局
Progression free survival (PFS)
Progression free survival (PFS)
次要结局
- Complete response (CR)
- Minimal residual disease (MRD) negativity rate for participants with CR
- Very good partial response (VGPR) or better rate
- Overall survival (OS)
- Overall response rate (ORR)
- Time to progression (TTP)
- Duration of response (DOR)
- Time to first response (TT1R)
- Time to best response (TTBR)
- PFS on next line of therapy (PFS2)
- PFS in MRD negative participants
- Sustained MRD negativity ≥12 months rate
- Adverse Events
- Assessment of PK parameter: Ctrough
- Immunogenicity
- Participants reported outcome (PRO): QLQ-C30
- PRO: QLQ-MY20
- PRO: EQ-5D-5L
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Recherche & Developpement
研究点 (47)
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