Bevacizumab as Treatment for Patients With Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 主要终点
- Percentage of Participants With a Complete Response or a Partial Response
研究概览
简要总结
This study evaluated the efficacy and safety of Avastin (bevacizumab, 5 mg/kg intravenously every 2 weeks) in patients with multiple myeloma, relapsed/refractory after at least 2 lines of prior therapy.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, 19-75 years of age
- •Multiple myeloma.
- •Progressive disease after at least 2 lines of prior therapy.
排除标准
- •Non-secretory myeloma.
- •History of malignancy, other than squamous cell cancer, basal cell cancer, or cancer in situ of the cervix within the last 5 years.
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start.
- •Clinically significant cardiac disease.
研究组 & 干预措施
Bevacizumab 5 mg/kg
Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Percentage of Participants With a Complete Response or a Partial Response
时间窗: Baseline to the end of the study (up to 1 year)
A complete response was defined as the disappearance of the original monoclonal protein from the blood and urine on at least 2 determinations 6 weeks apart; \< 5% plasma cells in the bone marrow on at least 2 determinations 6 weeks apart; if a skeletal survey is available, no increase in the size or number of lytic bone lesions; and the disappearance of soft tissue plasmacytomas for at least 6 weeks. A partial response was defined as a ≥ 50% reduction of monoclonal protein in the blood on at least 2 determinations 6 weeks apart; if present, reduction in 24-hour urinary light chain excretion by either ≥ 90% or to \< 200 mg for at least 2 determinations 6 weeks apart; ≥ 50% reduction in the size of tissue plasmacytomas for at least 6 weeks; and if a skeletal survey is available, no increase in the size or number of lytic bone lesions.
次要结局
- Progression-free Survival(Baseline to the end of the study (up to 1 year))
- Overall Survival(Baseline to the end of the study (up to 1 year))