A Phase 1/2, Multi-center, Open-label, Dose-escalation Study of Elotuzumab(Humanized Anti-CS1 Monoclonal IgG1 Antibody) and Bortezomib in Subjects With Multiple Myeloma Following One to Three Prior Therapies.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Abbott
- 入组人数
- 28
- 试验地点
- 8
- 主要终点
- Identify the maximum tolerated dose of elotuzumab in combination with bortezomib (phase 1).
研究概览
简要总结
This Phase 1/2, multi-center, open-label, multiple-dose, dose escalation study will evaluate the combination of elotuzumab and bortezomib in subjects with MM following 1 to 3 prior therapies. For the Phase 1 portion, elotuzumab will be administered by intravenous (IV) infusion at up to 4 dose levels ranging from 2.5 mg/kg to 20.0 mg/kg within 30 minutes following the administration of bortezomib at 1.3 mg/m^2 IV bolus. Bortezomib will be given in 21 day cycles (twice weekly for 2 weeks on Days 1, 4, 8, and 11 followed by a 10-day rest period). Elotuzumab will be administered as a separate infusion within 30 minutes following bortezomib administration on the same days as the first and last dose of each bortezomib cycle (i.e., Days 1 and 11).
详细描述
The phase 2 portion of this study was not initiated because a decision was made to conduct a phase 2 randomized clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
Cohort 1
2.5 mg/kg
干预措施: Elotuzumab (HuLuc63) (Drug)
Cohort 2
5.0 mg/kg
干预措施: Elotuzumab (HuLuc63) (Drug)
Cohort 3
10.0 mg/kg
干预措施: Elotuzumab (HuLuc63) (Drug)
Cohort 4
20.0 mg/kg
干预措施: Elotuzumab (HuLuc63) (Drug)
结局指标
主要结局
Identify the maximum tolerated dose of elotuzumab in combination with bortezomib (phase 1).
时间窗: First cycle of treatment.
The highest dose level of elotuzumab at which \<= 1 dose-limiting toxicity occurs in 6 subjects
Evaluate the efficacy of elotuzumab in combination with bortezomib (phase 2).
时间窗: Screening to the 30 day follow up visit.
Objective response rate (complete and partial response) according to European Group for Blood and Marrow Transplantation (EBMT) criteria
次要结局
- Evaluate the efficacy of elotuzumab in combination with bortezomib (phase 1).(Screening to the 30 day follow up visit.)
- Evaluate the immunogenicity of elotuzumab in combination with bortezomib (phase 1 and 2).(Screening to the 30 day follow up visit.)
- Evaluate the pharmacodynamics of elotuzumab in combination with bortezomib (phase 1 and 2).(Screening to the 30 day follow up visit.)
- Evaluate the pharmacokinetic parameters of elotuzumab in combination with bortezomib (phase 1 and 2)(Screening to the 30 day follow up visit.)
- Evaluate the safety of elotuzumab in combination with bortezomib (phase 1 and 2).(Screening to the 30 day follow up visit.)