Phase 2/3 Randomized, Open-Label Clinical Trial of Tanespimycin (KOS-953) Plus Bortezomib Comparing Three Doses of Tanespimycin in Patients With Relapsed-Refractory Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
This is a phase 2/3, open label trial for patients with relapsed-refractory multiple myeloma. Study agent is tanespimycin (KOS-953), at three different dose levels in combination with a fixed dose of bortezomib.
详细描述
Phase 2/3 combination study comparing bortezomib plus one of three doses of tanespimycin in patients with relapsed-refractory multiple myeloma after failure of at least three prior anti-cancer therapy regimens. Prior therapy must include bortezomib and lenalidomide. Primary objective is to assess the dose-response relationship of objective response rate (ORR) using EBMT/IBMTR criteria of any three dose levels of tanespimycin (KOS-953) in combination with bortezomib after four treatment cycles.
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
- •Histologic evidence of multiple myeloma
- •Have had at least three prior treatment regimens for multiple myeloma that included both bortezomib and lenalidomide
- •No prior treatment with a heat shock 90 inhibitor or an investigational proteasome inhibitor
- •No known infections of HAV, HBV, HCV, or HIV
- •No chemotherapy, radiation therapy, or immune therapy for three weeks prior to enrollment.
排除标准
- 未提供
研究组 & 干预措施
tanespimycin and bortezomib
A patient will receive a standard dose of bortezomib followed by a high dose of tanespimycin.
干预措施: tanespimycin (Drug)
tanespimycin and bortezomib
A patient will receive a standard dose of bortezomib followed by a high dose of tanespimycin.
干预措施: Bortezomib (Drug)
bortezomib and tanespimycin
A patient will receive a standard dose of bortezomib followed by a mid dose of tanespimycin.
干预措施: tanespimycin (Drug)
bortezomib and tanespimycin
A patient will receive a standard dose of bortezomib followed by a mid dose of tanespimycin.
干预措施: Bortezomib (Drug)
bortezomib tanespimycin
A patient will receive a standard dose of bortezomib followed by a low dose of tanespimycin.
干预措施: tanespimycin (Drug)
bortezomib tanespimycin
A patient will receive a standard dose of bortezomib followed by a low dose of tanespimycin.
干预措施: Bortezomib (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: approximately 3 months
次要结局
- Response rate between treatment arms and time-to-event endpoints.(Up to 24 months)