An Open-Label Phase 1/2 Study of VELCADE for Injection in Subjects With Light-Chain (AL)-Amyloidosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Subjects With Treatment Emergent Adverse Events Leading to Treatment Termination
研究概览
简要总结
This is a phase 1/2 open-label, dose-escalation study investigating single-agent therapy with VELCADE in patients with previously treated systemic AL-amyloidosis who require further treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Male or Female 18 y/o and older
- •Female patients must be practicing an effective method of birth control
- •Biopsy-proven AL-amyloidosis
- •Must have been previously treated (failed at least 1 previous treatment) and in the opinion of the physician, patient requires further treatment
排除标准
- •Hypersensitivity to boron or mannitol
- •Prior treatment with VELCADE
- •Patient requires other concomitant chemotherapy, radiotherapy or ancillary therapy considered investigational
- •Uncontrolled infection
研究组 & 干预措施
1
VELCADE
干预措施: VELCADE (Drug)
结局指标
主要结局
Subjects With Treatment Emergent Adverse Events Leading to Treatment Termination
时间窗: from first study-related procedure to 30 days after last dose of study medication
Treatment emergent adverse events observed during outcome measure time frame leading to treatment termination
Maximum Tolerated Dose
时间窗: 5 weeks in once weekly (QW) dose cohorts and 3 weeks in twice weekly (BIW) dose cohorts
Maximum Tolerated Dose (MTD) was defined as the highest dose level that has 0/1 out of 6 patients experiences Dose Limited Toxicity (DLT). MTD is defined separately for QW and BIQ dose cohorts. DLT was defined as adverse events occurring during Cycle 1 and: (1) related to VELCADE, (2) Grade 4 thrombocytopenia or neutropenia, (3) Grade 3 or higher nonhematologic toxicity.
Subjects With Treatment Emergent Adverse Events
时间窗: from first study-related procedure to 30 days after last dose of study medication
Treatment emergent adverse events observed during outcome measure time frame
Subjects With Serious Treatment Emergent Adverse Events
时间窗: from first study-related procedure to 30 days after last dose of study medication
Serious treatment emergent adverse events observed during outcome measure time frame
Subjects Grade 3/4/5 Treatment Emergent Adverse Events
时间窗: from first study-related procedure to 30 days after last dose of study medication
Grade 3/4/5 treatment emergent adverse events observed during outcome measure time frame. Grade is determined according to Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0.
次要结局
- Best Confirmed Hematologic Responders(from first dose of study medication to end of study visit)