NCT00193557已完成2 期
Phase I Trial of Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- objective response rate
研究概览
简要总结
This phase I study will evaluate the feasibility and toxicity of weekly bortezomib in the treatment of relapsed or refractory multiple Myeloma and determine whether a twice-weekly schedule of bortezomib is effective in producing responses in patients with stable disease or progression after weekly bortezomib
详细描述
Upon determination of eligibility, patients will be receive:
- Bortezomib
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
- •To be included in this study, you must meet the following criteria:
- •Multiple Myeloma
- •Received no more than 2 previous treatment regimens for multiple Myeloma
- •ECOG performance status 0, 1, or 2
- •Serum creatinine < 2.0mg/dL
- •calculated or measured creatinine clearance > 30ml/minute
- •Measurable or evaluable disease
- •Provide written informed consent prior to receiving protocol therapy.
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Moderate or severe peripheral neuropathy
- •Other serious medical conditions
- •Other active malignancies
- •history of treatment for other invasive cancers
- •Women who are pregnant or lactating
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
结局指标
主要结局
objective response rate
次要结局
- overall survival
- Safety
- progression-free survival
研究者
研究点 (4)
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