A Phase II Trial of Romidepsin and Bortezomib for Multiple Myeloma Patients With Relapsed or Refractory Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Celgene
- 入组人数
- 32
- 试验地点
- 12
- 主要终点
- Count of Participant Best Overall Response As Assessed by the Investigator
研究概览
简要总结
This is a phase II, open-label, multicenter, dual-strata study designed to evaluate the efficacy and safety of IV romidepsin given in combination with IV bortezomib for multiple myeloma (MM) patients with refractory or relapsed disease. Patients will be enrolled into one of two strata, bortezomib-resistant or bortezomib non-resistant.
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
Romidepsin + Bortezomib
Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
干预措施: Bortezomib (Drug)
Romidepsin + Bortezomib
Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
干预措施: Romidepsin (Drug)
结局指标
主要结局
Count of Participant Best Overall Response As Assessed by the Investigator
时间窗: up to 8 months
Complete Response: disappearance of monoclonal protein from blood and urine, and disappearance of soft tissue plasmacytomas, \<5% plasmas cells in marrow and no increase of lytic bone lesions. Very Good Partial Response: disappearance of plasmacytomas, no increase of lytic bone lesions, serum and urine M-protein not detectable by immunofixation, other. Partial Response: \>=50% decrease in serum monoclonal protein, and in soft tissue plasmacytomas, no increase of lytic bone lesions, other. Minimal Response (MR): ≥ 25% to ≤ 49% decrease in serum monoclonal protein, and in size of plasmacytomas, no increase of lytic bone lesions, other. Stable Disease: Less than MR, but not PD Progressive Disease(PD):\>25% increase in serum monoclonal paraprotein, or \>25% plasma cells in marrow, or \>25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia.
次要结局
- Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞)(Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion)
- Total Clearance (CL)(Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion)
- Participants With Treatment-emergent Adverse Events (TEAEs)(up to 9 months)
- Time to Maximum Observed Concentration (Tmax)(Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion)
- Kaplan Meier Estimate for Time to Progression Assessed by the Investigator(up to month 8)
- Maximum Observed Concentration (Cmax)(Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion)
- Total Volume of Distribution (Vz)(Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion)
- Kaplan Meier Estimates for Progression-free Survival Assessed by the Investigator(up to month 8)
- Terminal Half-life (t1/2)(Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion)
- Kaplan Meier Estimate for Time to Response Assessed by the Investigator(up to month 8)
- Kaplan Meier Estimate for Duration of Response Assessed by the Investigator(up to month 8)
- Kaplan Meier Estimates for Overall Survival(up to month 8)