An Open-label, Dose-escalation and Multi-center Study to Evaluate the Safety, Pharmacokinetics and Efficacy of SAR650984 (Isatuximab) in Patients With Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 55
- 试验地点
- 18
- 主要终点
- Part B: Overall Response Rate (ORR)
研究概览
简要总结
Primary Objective:
- Part A: To evaluate the safety of SAR650984 (isatuximab) in patients with relapsed/refractory multiple myeloma (RRMM).
- Part B: To evaluate the activity of SAR650984 (isatuximab) as assessed by overall response rate (ORR) in RRMM patients previously treated with daratumumab.
Secondary Objectives:
- Part A:
- To determine the pharmacokinetics (PK) of SAR650984 (isatuximab) in patients with RRMM.
- Part B:
- To evaluate the safety of SAR650984 (isatuximab).
- To evaluate the efficacy of SAR650984 (isatuximab) as assessed by duration of response (DOR), clinical benefit rate (CBR) and progression free survival (PFS).
- To assess the pharmacokinetics (PK) of SAR650984 (isatuximab) and daratumumab at baseline.
- To evaluate the immunogenicity of SAR650984 (isatuximab).
详细描述
Study duration for an individual patient will include a screening period for inclusion of up to 3 weeks, the treatment period and, a follow up period. Treatment with SAR650984 (isatuximab) may continue until disease progression, unacceptable adverse event, or other reason for discontinuation.
After study treatment discontinuation, an end of treatment visit will be done at 30 days to assess safety and PK, and at 30 and 60 days for anti-drug antibody (ADA). If the ADA is positive at Day 60, ADA will be repeated every 30 days until ADA is negative.
Patients with partial remission or better who discontinue treatment for reasons other than progression of disease will be followed monthly until progression or initiation of subsequent therapy, the final analysis cutoff date, whichever comes first.
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
Isatuximab (escalating dose) on Days 1, 8, 15, and 22, then Days 1 and 15 in 28-day cycles up to disease progression
干预措施: Isatuximab (Drug)
结局指标
主要结局
Part B: Overall Response Rate (ORR)
时间窗: 4 months
Part A: Number of patients with adverse events (AEs) and changes in laboratory tests and vital signs according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 4.03 grade scaling
时间窗: Up to 30 days following the last administration of study treatment or up to 12 months for ongoing related AE, ongoing serious AE and new related AE
Part A: Dose Limiting Toxicities (DLTs)
时间窗: Up to 4 weeks
次要结局
- Part B: Number of patients with AEs and changes in laboratory tests and vital signs according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 4.03 grade scaling(Up to 30 days following the last administration of study treatment or up to 12 months for ongoing related AE, ongoing serious AE and new related AE)
- Part B: Progression Free Survival (PFS)(Up to 12 months from the last patient in)
- Part B: Levels of isatuximab antibodies(Up to 12 months from the last patient in)
- Part B: Duration of Response (DOR)(Up to 12 months from the last patient in)
- Part B: Clinical Benefit Rate (CBR)(Up to 12 months from the last patient in)
- Assessment of PK parameters: partial area under the serum concentration time curve (AUC)(1 week after first treatment)
- Assessment of PK parameters: maximum observed concentration (Cmax)(1 week after first treatment)