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临床试验/NCT00207805
NCT00207805已完成3 期

The Optimal Timing of a Second Autologous Peripheral Blood Stem Cell Transplantation in Patients (<61 Years) With Multiple Myeloma

Centre National de Greffe de Moelle Osseuse2 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2003年5月1日最近更新:
适应症

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

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

研究者

发起方
Centre National de Greffe de Moelle Osseuse
申办方类型
Other Gov

研究点 (2)

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