Phase 3 Randomized, Open-Label Clinical Trial of Tanespimycin (KOS-953) Plus Bortezomib Compared to Bortezomib Alone in Patients With Multiple Myeloma in First Relapse
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 19
- 主要终点
- Progression-free survival
研究概览
简要总结
This is a phase 3, open label trial for patients with multiple myeloma in first relapse. Trial will compare tanespimycin (KOS-953), in combination with a fixed dose of bortezomib versus bortezomib alone.
详细描述
Phase 3 combination study comparing tanespimycin (KOS-953) plus bortezomib to bortezomib alone in patients with multiple myeloma in first relapse after failure of previous anti-cancer therapy and/or bone marrow transplantation. Primary objective is to compare the progression-free survival (PFS) associated with the use of tanespimycin (KOS-953) in combination with bortezomib versus that associated with administration of bortezomib alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Good Performance Status
- •Documented evidence of multiple myeloma
- •Documented progression of disease after initial response to one line of therapy
- •Measurable disease (serum M-protein >.5g/dl or > 200 mg urinary M protein excretion)
排除标准
- •Prior treatment with a heat shock 90 inhibitor or an investigational proteasome inhibitor
- •Known active infections of HAV, HBV, HCV, or HIV
- •Administration of chemotherapy, radiation therapy, or immune therapy within 21 days prior to randomization.
- •Acute diffuse infiltrate pulmonary disease or pericardial dise
研究组 & 干预措施
Arm A
Tanespimycin + Bortezomib
干预措施: Tanespimycin (Drug)
Arm A
Tanespimycin + Bortezomib
干预措施: Bortezomib (Drug)
Arm B
Bortezomib
干预措施: Bortezomib (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 6-24 months
次要结局
- Overall survival in each arm of the study(Up to 24 months)