The Optimal Timing of a Second Autologous Peripheral Blood Stem Cell Transplantation in Patients (<61 Years) With Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- Overall survival (from randomistion) of the 2 groups at 5 years
研究概览
简要总结
Autologous peripheral blood stem cell (PBSC) transplantation is now considered standard therapy in patients (< 65 ans) with multiple myeloma. The Intergroupe Francophone du Myelome conducted a randomised trial of the treatment of multiple myeloma with high dose chemotherapy followed by either one or two successive autologous stem cell transplantation. The probabilities of event-free-survival and overall survival were doubled with a double transplant. The benefits were greatest among patients who had not had a very good partial response to the first transplant.
The aim of this multicenter randomised trial in previously untreated patients with multiple myelome (stage II, III DS)is to assess the optimal timing of a second autologous stem-cell transplant.After a first-line therapy with thalidomide-dexamethasone followed by a PBSC collection, patients are randomly assigned to receive two autologous PBSC transplants (arm A)or one autologous PBSC transplant followed by a consolidation therapy with thalidomide-dexamethasone (arm B). Patients included in the arm B will receive a second transplant in case of disease progression on consolidation therapy, or in case of relapse in responders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 61 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients less than 61 years of age
- •Durie Salmon stage II or III
- •written and informed consent
排除标准
- •Prior treatment for myeloma
- •ECOG performance score of 4
- •Positive HIV test
- •Chronic respiratory disease (DLco < 60%)
- •Systolic ejection fraction < 50%
- •Pregnant or nursing women
结局指标
主要结局
Overall survival (from randomistion) of the 2 groups at 5 years
次要结局
- Event-free-survival
