LCI-HEM-MYE-CRD-004 (MMRC-073 CARJAK): Phase I/II Study of Carfilzomib, Ruxolitinib, and Low Dose Dexamethasone for Carfilzomib-Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
The primary objective of Phase I is to establish the maximum tolerated dose (MTD) of ruxolitinib in combination with carfilzomib and dexamethasone. The primary objective of phase II is to evaluate progression-free survival (PFS) at 4 months in multiple myeloma subjects who receive the combination treatment carfilzomib, dexamethasone, and ruxolitinib.
详细描述
This is an open-label, Phase I/II study of carfilzomib, ruxolitinib, and low-dose dexamethasone for carfilzomib-refractory multiple myeloma. Phase I is designed to evaluate overall maximum tolerated dose (MTD) of ruxolitinib in combination with carfilzomib and dexamethasone in the following cohorts: Cohort 1) 5mg ruxolitinib, Cohort 2) 10mg ruxolitinib, Cohort 3) 15mg ruxolitinib. Phase II is designed to evaluate 4-month progression-free survival (PFS) in the following cohorts: Cohort A) non-responders to Phase I regimen, Cohort B) responders to Phase I regimen. Up to 18 evaluable subjects will be enrolled in Phase I over approximately 12 months. An additional 30 evaluable subjects will be enrolled in Phase II over 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（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
Phase I
Cohort 1) 5mg ruxolitinib, Cohort 2) 10mg ruxolitinib, Cohort 3) 15mg ruxolitinib
干预措施: Carfilzomib (Drug)
Phase I
Cohort 1) 5mg ruxolitinib, Cohort 2) 10mg ruxolitinib, Cohort 3) 15mg ruxolitinib
干预措施: Ruxolitinib (Drug)
Phase I
Cohort 1) 5mg ruxolitinib, Cohort 2) 10mg ruxolitinib, Cohort 3) 15mg ruxolitinib
干预措施: Dexamethasone (Drug)
Phase II
Cohort A) non-responders to Phase I regimen, Cohort B) responders to Phase I regimen
干预措施: Carfilzomib (Drug)
Phase II
Cohort A) non-responders to Phase I regimen, Cohort B) responders to Phase I regimen
干预措施: Ruxolitinib (Drug)
Phase II
Cohort A) non-responders to Phase I regimen, Cohort B) responders to Phase I regimen
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: 28 days
DLTs will be determined for each subject as a binary variable indicating whether or not the subject experienced a DLT during Cycle 1
次要结局
- Clinical Benefit Rate(Approximately 180 days after treatment start (disease assessment occurred after every 28-day cycle))
- Duration of Response(approx. 5 years)
- Disease Control Rate(Approximately 180 days after treatment start (disease assessment occurred after every 28-day cycle))
- Progression-free Survival (PFS)(approx. 5 years)
- Time to Best Response(Approximately 180 days after treatment start (disease assessment occurred after every 28-day cycle))
- Objective Response Rate (ORR)(Approximately 180 days after treatment start (disease assessment occurred after every 28-day cycle))
- Overall Survival(approx. 5 years)
- Time to Progression(approx. 5 years)