An Open-label, Multi-center Study to Evaluate the Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Assessment of PK: Ctrough
研究概览
简要总结
Primary Objective:
To evaluate the pharmacokinetics (PK) of isatuximab.
Secondary Objectives:
- To evaluate the safety and tolerability of isatuximab.
- To assess the preliminary antitumor effect of isatuximab.
- To evaluate the immunogenicity of isatuximab.
详细描述
The duration of the study for an individual patient will include a screening period of up to 21 days, a treatment period of repeated 28-day cycles, and a follow-up period. End of treatment visit will be done at 30 (±7) days after last treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Isatuximab
Administered intravenously every week in Cycle 1 (4 weeks) followed by every 2 weeks (Q2W) in subsequent cycles.
干预措施: Isatuximab SAR650984 (Drug)
结局指标
主要结局
Assessment of PK: Ctrough
时间窗: Up to approximately 40 weeks (Cycle 10)
To evaluate concentration observed just before investigational medicinal product (IMP) administration during repeated dosing (Ctrough)
Assessment of PK: Cmax
时间窗: Cycle 1, up to 168 hours after start of infusion
To evaluate the maximum observed concentration (Cmax)
Assessment of PK: tmax
时间窗: Cycle 1, up to 168 hours after start of infusion
To evaluate the time to reach Cmax (tmax)
Assessment of PK: AUC0-168h
时间窗: Cycle 1, up to 168 hours after start of infusion
To evaluate area under the plasma concentration versus time curve over the dosing interval (AUC0-168h)
Assessment of PK: Ceoi
时间窗: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1; Cycle duration is 28 days
To evaluate the concentration observed at the end of an IV infusion (Ceoi)
次要结局
- Adverse Events(Up to 30 days after the last IMP administration)
- Anti-Tumor Activity: Overall survival (OS)(Up to 12 months after last patient treated)
- Anti-Tumor Activity: Duration of response (DOR)(Up to 12 months after last patient treated)
- Anti-Tumor Activity: Time to progression (TTP)(Up to 12 months after last patient treated)
- Immunogenicity(Up to 13 months (10 cycles + 3 months) after last patient treated)
- Anti-tumor activity: Overall response (ORR)(Up to 12 months after last patient treated)
- Anti-Tumor Activity: Progression free survival (PFS)(Up to 12 months after last patient treated)