NCT00327249已完成1 期
A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) for Patients With Previously Treated Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 4
- 主要终点
- Determine the maximally tolerated dose of imexon in multiple myeloma patients
研究概览
简要总结
AMP-007 is a Phase 1/2 study for the treatment of advanced, previously treated multiple myeloma. The first phase of the study is designed to determine a safe dose of imexon that can be given to patients with advanced, previously-treated multiple myeloma. The Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether imexon can improve the outcome for patients with multiple myeloma
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
- •Advanced myeloma, with measurable disease as defined in the protocol.
- •Prior treatment, at least 2 prior regimens are required. This may include prior treatment with investigational products.
- •Able to perform the activities of daily living.
- •Off prior therapy for at least 2-4 weeks depending on the drug.
- •Blood counts and blood chemistries in or near normal range.
- •If female, neither pregnant nor nursing.
- •Willing to use contraceptives to prevent pregnancy.
- •No other serious illnesses.
- •No other active malignancy.
- •No serious infections.
- •No current other drug therapy for the myeloma except for steroid therapy under certain circumstances. Biphosphonate therapy is permitted.
- •Prior radiation is permitted.
排除标准
- •Use of corticosteroids for amyloid disorders, or high dose chronic steroids.
结局指标
主要结局
Determine the maximally tolerated dose of imexon in multiple myeloma patients
evaluate the toxicity of imexon
Preliminarily evaluate efficacy in terms of response and progression free survival.
次要结局
- Evaluate biomarker responses.
研究者
研究点 (4)
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