High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Number of Participants With Pulmonary Toxicity
研究概览
简要总结
This study uses a sequence of high-dose chemotherapy drugs and a stem cell transplant to treat multiple myeloma. The study is being performed to evaluate the efficacy and side effects of treatment. Specifically, the study is designed to reduce the risk of interstitial pneumonitis.
详细描述
Analysis of 196 previously treated patients demonstrated a median event-free survival (EFS) of 36 months with a median overall survival of more than 6 years. The main toxicity of this therapy is related to carmustine-induced pneumonitis or interstitial pneumonitis (IP). This complication is related to the dose of carmustine. Institutional experience in myeloma patients using this dose of carmustine indicates an incidence of IP of34%.
There have been recent studies evaluating the role of tandem autologous transplants for patients with multiple myeloma. These trials were based upon the hypothesis that performing tandem high-dose therapy regimens would lead to increased tumor cell kill, decreased tumor burden and an improvement in overall survival. Our results with high-dose sequential therapy including the dose-intense carmustine/melphalan transplant demonstrates similar median EFS and overall survival (OS) when compared with the results of tandem transplant approaches.The proposed trial will continue to use a high-dose sequential transplant approach, however, we will use a reduced dose of carmustine which we expect to be associated with a lower incidence of IP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
High-Dose Sequential Therapy
Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
干预措施: Cyclophosphamide (Drug)
High-Dose Sequential Therapy
Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
干预措施: Etoposide (Drug)
High-Dose Sequential Therapy
Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
干预措施: Melphalan (Drug)
High-Dose Sequential Therapy
Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
干预措施: Carmustine (Drug)
High-Dose Sequential Therapy
Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
干预措施: Filgrastim (Drug)
结局指标
主要结局
Number of Participants With Pulmonary Toxicity
时间窗: 2 years
Pulmonary toxicity was assessed as the incidence of interstitial pneumonitis.
次要结局
- Overall Participant Survival (OS)(5 years)
- Number of Participants That Relapse After Autologous Transplantation(5 years)
研究者
Sally Arai
Assistant Professor of Medicine
Stanford University
