NCT00193544已完成2 期
Phase II Trial of Arsenic Trioxide and Thalidomide 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
- 主要终点
- Overall response rate
研究概览
简要总结
In this trial, we plan to evaluate further the role of arsenic trioxide in the treatment of patients with refractory multiple myeloma. Arsenic trioxide will be used in combination with thalidomide. Although both drugs have a similar mechanism of action, it is likely that the mechanisms may be additive or synergistic. Since neither drug produces much myelosuppression, this combination regimen should be tolerable in patients with compromised marrow function due to involvement with myeloma and/or previous cytotoxic chemotherapy
详细描述
Upon determination of eligibility, patients will be receive:
- Arsenic Trioxide + Thalidomide
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:
- •Confirmed diagnosis of multiple Myeloma
- •Received at least one previous chemotherapy regimen at most 3 previous
- •Thalidomide with or without dexamethasone without chemotherapy will not factor in to total number of regimens.
- •Age at least 18 years years
- •Able to perform activities of daily living with minimal assistance
- •Life expectancy more than 3 months
- •Adequate bone marrow, liver and kidney function
- •Must give written informed consent in order to participate.
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Women pregnant or lactating.
- •Pre-existing moderate neuropathy
- •Patients with significant underlying cardiac dysfunction
- •Uncontrolled hypercalcemia
- •Active serious infections not controlled by antibiotics
- •History of grand mal seizures (other than infantile febrile seizures)
- •Receiving other medications that prolong the QT interval.
- •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
Overall response rate
次要结局
- Time to progression
- Overall survival
- Overall toxicity
研究者
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