NCT00186238已完成2 期
High Dose Sequential Therapy and Autologous Stem Cell Rescue for Multiple Myeloma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Toxicity and efficacy of sequentially administered high dose chemotherapy and autologous hematopoietic cell transplantation
研究概览
简要总结
To assess the role of autologous hematopoietic cell rescue in the treatment of multiple myeloma.
详细描述
To assess the toxicity and efficacy of sequentially administered high dose cyclophosphamide and VP-16 followed by total body irradiation or BCNU and high dose mephalan and autologous stem cell rescue in the treatment of 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •received cytoreduction prior to transplant
- •adequate organ function
排除标准
- •previous transplant
- •smoldering MM or benign monoclonal gammopathy
结局指标
主要结局
Toxicity and efficacy of sequentially administered high dose chemotherapy and autologous hematopoietic cell transplantation
时间窗: Patients will have a daily CBC with platelet count, and chemistries until engraftment, then as indicated clinically. Chest x-rays will be done weekly until engraftment, then as indicated clinically. Patients will be restaged for abnormal proteins (SPIE)
次要结局
未报告次要终点
研究者
研究点 (2)
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