Prospective, Observational, Multicenter Trial Evaluating Autologous Stem Cell Transplantation for Myeloma Patients Over the Age of 65
试验速览
- 阶段
- 不适用
- 入组人数
- 55
- 试验地点
- 3
- 主要终点
- Progression Free survival
研究概览
简要总结
Autologous stem cell transplantation remains the gold standard of treatment for newly diagnosed patients under the age of 65. Even though it is also regularly performed above the age of 65, there are very few data in this patient population. The investigators will capture safety and efficacy data in that setting.
详细描述
Newly diagnosed myeloma patients above the age of 65 years will be treated the following way: Bortezomib (Velcade®) based induction treatment (either Velcade Dexamethasone, Velcade Thalidomide Dexamethasone (VTD) or Velcade Cyclophosphamide Dexamethasone (VCD)). After the induction phase, for patients at least in partial remission, a collection of peripheral blood stem cells (PBSC) is done according to each center practice. High dose melphalan (140 mg/m2) followed by PBSC autologous transplantation is then performed. Three months post transplant, 2-3 cycles (similar to the initial induction phase) of consolidation are allowed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •newly diagnosed MM,
- •age over 65,
- •measurable disease
排除标准
- •Patients less than 65 and/or not proceeding to autologous PBSC transplantation
结局指标
主要结局
Progression Free survival
时间窗: 2 years
次要结局
- Overall Survival(2 years)
- Time To Progression(2 years)
- Response(after induction, 3 months post transplant, 2 months post consolidation)