A Phase 1 Dose Escalation Study of Bortezomib (Velcade®), Pegylated Liposomal Doxorubicin (Doxil®), and Vorinostat (Suberoylanilide Hydromaxic Acid, Saha, Zolinzatm) in Patients With Relapse/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Maximum tolerated dose of vorinostat
研究概览
简要总结
RATIONALE: Vorinostat and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of multiple myeloma by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving doxorubicin hydrochloride liposome together with vorinostat and bortezomib may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat and to see how well it works when given together with bortezomib and doxorubicin hydrochloride liposome in treating patients with relapsed or refractory multiple myeloma.
详细描述
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of vorinostat when added to the standard regimen of bortezomib and pegylated liposomal doxorubicin hydrochloride in patients with relapsed or refractory multiple myeloma.
- To identify the dose-limiting toxicities of this regimen in these patients.
Secondary
- To gain preliminary evidence of antitumor activity of this regimen in these patients.
- To assess the degree of proteasome inhibition achieved with this regimen in these patients.
- To evaluate the accumulation of acetylated alpha-tubulin after treatment with vorinostat.
- To evaluate overall survival, time to progression, and progression-free survival of patients treated with this regimen.
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
Non-Randomized Open Label Single Arm
Phase 1 dose escalation trial of vorinostat in combination with bortezomib and pegylated liposomal doxorubicin hydrochloride.
干预措施: bortezomib (Drug)
Non-Randomized Open Label Single Arm
Phase 1 dose escalation trial of vorinostat in combination with bortezomib and pegylated liposomal doxorubicin hydrochloride.
干预措施: pegylated liposomal doxorubicin hydrochloride (Drug)
Non-Randomized Open Label Single Arm
Phase 1 dose escalation trial of vorinostat in combination with bortezomib and pegylated liposomal doxorubicin hydrochloride.
干预措施: vorinostat (Drug)
结局指标
主要结局
Maximum tolerated dose of vorinostat
时间窗: 4 years
次要结局
- Overall response rate(5 years)
- Duration of response(5 years)