NCT00315757已完成2 期
A Phase 2, Multi-Center, Open-Label, Randomized Study of Mapatumumab (TRM-1 [HGS1012], a Fully Human Monoclonal Antibody to TRAIL-R1) in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 20
- 主要终点
- To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone
研究概览
简要总结
The purpose of this study is to evaluate the efficacy (disease response) and safety of mapatumumab in combination with bortezomib and bortezomib alone in subjects with relapsed or refractory multiple myeloma (MM).
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
- •Diagnosed with multiple myeloma that is refractory or has relapsed after treatment
- •Measurable serum and/or urine M-protein
- •Failed 1 or 2 prior therapies for multiple myeloma
- •18 years of age or older
排除标准
- •Received more than 2 prior therapies for multiple myeloma.
- •Previous cancer therapies (chemotherapy, biologic therapy, radiation therapy or immunosuppressants) within the last 3 weeks
- •Received monoclonal antibodies within the last 3 weeks (chimeric or murine) or 8 weeks (human or humanized)
- •Received investigational (not yet approved by a regulatory authority) agent to treat multiple myeloma within the last 4 weeks
- •Subjects who received a stem cell transplant using cells from themselves in the past 16 weeks
- •Subjects who received a stem cell transplant using cells from another individual
- •Previously treated with bortezomib or mapatumumab
- •Known HIV, hepatitis-B, hepatitis-C, or hepatitis A infection
- •Infection requiring antibiotics or hospitalization within the last 2 weeks
- •Major surgery within the last 4 weeks
- •Diagnosis with POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes)
- •History of other cancers within the past 5 years
- •Pregnant or breast-feeding women
研究组 & 干预措施
A
Active Comparator
Bortezomib
干预措施: Bortezomib (Drug)
B-10
Experimental
Bortezomib and Mapatumumab 10 mg/kg
干预措施: Mapatumumab (Biological)
B-10
Experimental
Bortezomib and Mapatumumab 10 mg/kg
干预措施: Bortezomib (Drug)
B-20
Experimental
Bortezomib and Mapatumumab 20 mg/kg
干预措施: Mapatumumab (Biological)
B-20
Experimental
Bortezomib and Mapatumumab 20 mg/kg
干预措施: Bortezomib (Drug)
结局指标
主要结局
To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone
时间窗: 17 cycles (up to a year)
次要结局
- To evaluate the safety, including the frequency and severity of adverse events and laboratory abnormalities, of mapatumumab in combination with bortezomib and bortezomib alone throughout the study period(17 cycles (up to a year))
研究者
研究点 (20)
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