NCT00186407已完成2 期
High Dose Chemotherapy and Autologous Stem Cell Rescue for Primary Amyloidosis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis
研究概览
简要总结
To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis.
详细描述
To learn about the use of high dose chemotherapy followed by transplantation using peripheral blood stem cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary amyloidosis
- •Age < 75 years.
- •Patients must have their pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.
- •Patients who have undergone bone marrow transplantation previously will not be eligible.
- •Patients must have a Karnofsky performance status greater than 70%.
- •Patients must have a serum creatinine less than 2 mg/dl or creatinine clearance greater than 30 ml/min, bilirubin less than 2 mg/dl, transaminases less than two times normal, left ventricular ejection fraction >45% on echocardiography, cardiac index > 1.8 liters/min/m^2 and pulmonary function tests demonstrating FEV1 and DLCO > 60%.
- •Patients must be HIV negative.
- •Pregnant or lactating women will not be eligible to participate.
- •Patients must provide signed informed consent.
- •Patients with multiple myeloma and amyloid are eligible.
排除标准
- •prior blood or marrow transplant
结局指标
主要结局
To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis
次要结局
未报告次要终点
研究者
研究点 (2)
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