A Multicenter Phase 1-DEC (Dose Expansion Cohort) Open-label Study of Iberdomide (CC-220) in Combination With Elotuzumab and Dexamethasone for Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Iberdomide dose limiting toxicity
研究概览
简要总结
This is a single-arm, open-label study evaluating the safety, tolerability and efficacy of Iberdomide (CC-220) in combination with Elotuzumab and Dexamethasone in patients with RRMM. The researchers hypothesize that the combination of Iberdomide and Elotuzumab will synergize to promote myeloma cell death, resulting in an overall response rate of at least 53%, with an acceptable safety profile. Patients will be enrolled in a 3+3 dose escalation cohort to evaluate the safety of this combination and to establish the MTD (maximum tolerated dose). The MTD will be the dose for the patients enrolled in dose expansion cohort. A total maximum of 37 patients will be recruited: maximum 18 patients will be recruited in the dose escalation phase, followed by an additional 19 patients in the dose expansion cohort for a total of 25 patients treated at the MTD.
详细描述
Part 1 is an open-label, sequential allocation, dose-finding evaluation of the sequential administration of Iberdomide in combination with Elotuzumab and Dexamethasone at their approved doses for patients with relapsed/refractory multiple myeloma. This phase will follow a standard 3+3 design. During this phase, the maximum tolerated dose of Iberdomide in combination with Elotuzumab and Dexamethasone will be determined and recommended for the dose expansion cohort.
Part 2 of this study is an open-label, single-arm dose expansion cohort that will enroll additional patients at the recommended maximum tolerated dose of Iberdomide as determined in Part 1. Researchers will continue to verify the safety and tolerability of this combination and examine the anti-myeloma activity of the regimen. In addition to measuring overall response rate, duration of response, and survival data, researchers will explore the effect of this combination on the biology of multiple myeloma and the immune system in order to gain insight into patterns of response that may help predict patient population most-likely to benefit from this treatment in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
Iberdomide, Elotuzumab and Dexamethasone
Dose-Finding: Patients will be enrolled in a 3+3 dose escalation cohort. Dose-Expansion: additionally enrolled patients at the recommended maximum tolerated dose of Iberdomide as was determined in Part 1 (Dose-Finding Phase).
干预措施: Iberdomide (Drug)
Iberdomide, Elotuzumab and Dexamethasone
Dose-Finding: Patients will be enrolled in a 3+3 dose escalation cohort. Dose-Expansion: additionally enrolled patients at the recommended maximum tolerated dose of Iberdomide as was determined in Part 1 (Dose-Finding Phase).
干预措施: Elotuzumab (Drug)
Iberdomide, Elotuzumab and Dexamethasone
Dose-Finding: Patients will be enrolled in a 3+3 dose escalation cohort. Dose-Expansion: additionally enrolled patients at the recommended maximum tolerated dose of Iberdomide as was determined in Part 1 (Dose-Finding Phase).
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Iberdomide dose limiting toxicity
时间窗: 28 days
The dose limiting toxicity (DLT) rate at the Maximum Tolerated Dose, defined as the proportion of patients in the safety population of the study that experience at least 1 DLT within the first cycle of Iberdomide (CC-220) in combination with Elotuzumab and Dexamethasone treated at the maximum tolerated dose (MTD).
次要结局
- Progression-free survival (PFS)(up to 3 months)
- Number of adverse events (AE)(up to 3 months)
- Best Overall Response Rate (BOR)(up to 3 months)
- Overall Response Rate (ORR)(up to 3 months)
- Clinical Benefit Rate(up to 3 months)
- Duration of Response (DOR)(up to 3 months)
- Overall Survival (OS)(up to 3 months)
- Disease Control Rate(up to 3 months)
研究者
Cesar Rodriguez Valdes
Associate Professor of Medicine
Icahn School of Medicine at Mount Sinai
