Melphalan vs Busulfan+ Cyclophosphamide+ Etoposide Conditioning Regimen for Multiple Myeloma Undergoing Autologous Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Melphalan and BUCY+VP-16 myeloablative conditioning regimens in multiple myeloma undergoing autologous hematopoietic stem cell transplantation.
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
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple Myeloma patients
- •Achieving at least VGPR after chemotherapy, then mobilizing and collecting of peripheral blood stem cells
排除标准
- •Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- •Patients with any conditions not suitable for the trial (investigators' decision
研究组 & 干预措施
BUCY+VP-16
For MM patients undergoing auto-HSCT，BUCY+VP-16 conditioning regimen was BU 3.2 mg/kg/day on days -8 and -6；CY 60 mg/kg/day on days -5 and -4; VP-16 10mg/kg/day on days -3 and -2.
干预措施: Cyclophosphamide (CY) (Drug)
BUCY+VP-16
For MM patients undergoing auto-HSCT，BUCY+VP-16 conditioning regimen was BU 3.2 mg/kg/day on days -8 and -6；CY 60 mg/kg/day on days -5 and -4; VP-16 10mg/kg/day on days -3 and -2.
干预措施: Busulfan (BU) (Drug)
BUCY+VP-16
For MM patients undergoing auto-HSCT，BUCY+VP-16 conditioning regimen was BU 3.2 mg/kg/day on days -8 and -6；CY 60 mg/kg/day on days -5 and -4; VP-16 10mg/kg/day on days -3 and -2.
干预措施: Etoposide (VP-16) (Drug)
Melphalan
For MM patients undergoing auto-HSCT，Melphalan conditioning regimen was Melphalan 200mg/m2 on day -2.
干预措施: Melphalan (Drug)
结局指标
主要结局
OS
时间窗: 3 year
overall survival (OS)
次要结局
- TRM(3 year)
- DFS(3 year)
- relapse rate relapse rate(3 year)
研究者
Qifa Liu
Professor
Nanfang Hospital, Southern Medical University