A Phase I Study of Bortezomib During Maintenance Phase After High Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib after an autologous peripheral blood stem cell transplant may stop the growth of any cancer cells that remain after transplant.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib in treating patients with multiple myeloma who have undergone an autologous peripheral blood stem cell transplant.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of bortezomib during maintenance phase after high-dose melphalan and autologous peripheral blood stem cell transplantation in patients with multiple myeloma.
- Determine the safety and tolerability of bortezomib in these patients.
Secondary
- Determine the overall response rate, complete response rate, and response duration in patients treated with bortezomib at the MTD.
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
Bortezomib
Bortezomib is administered as a 5 second IV bolus on days 1, 4, 8,11 or 1,8 and 15 of a 21-35 days cycle (Depending on the Dosing schedule). The dosage will be calculated based on actual weight of the patient unless the actual weight is greater than 40% above the ideal body weight. In this instance the dosage will be based on the adjusted ideal body weight. The Adjusted IBW (kg) = IBW + 0.25 x (actual body weight - IBW). The dosage will be adjusted based on the safety and toxicity profile, until a MTD is determined.
干预措施: bortezomib (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: At course 8
Maximum tolerated dose
时间窗: At course 8
次要结局
- Complete response rate by SWOG criteria(At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment)
- Overall response rate by Southwest Oncology Group (SWOG) criteria(At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment)
- Response duration by SWOG criteria(At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment)
研究者
Muneer Abidi
Principal Investigator
Barbara Ann Karmanos Cancer Institute