A Prospective Phase II Study to Assess Immunophenotypic Remission After 3-drug Induction Followed by Randomized Stem Cell Mobilization, Autologous Stem Cell Transplantation (ASCT) and Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 12
- 主要终点
- Immunophenotypic response
研究概览
简要总结
The purpose of this study is to determinate the efficacy and safety of the 3-drug induction treatment (RVD; lenalidomide plus bortezomib plus dexamethasone)followed by randomized autologous stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance. Primary endpoint is the immunophenotypic remission rate.During the randomized mobilization phase two active comparator arms Cyclophosphamide (CY)2g/m2 + Granulocyte-colony stimulating factor(G-CSF) vrs G-CSF will be compared regarding efficacy, costs and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •symptomatic, previously untreated International Stating System (ISS) 1-3 myeloma
- •measurable disease
- •WHO perf status 0-3
- •eligible for ASCT
排除标准
- •previously treated
- •peripheral neuropathy gr >/= 2
- •significant hepatic dysfunction
- •severe cardiac dysfunction
- •severe renal failure if not in dialysis
研究组 & 干预措施
B
Filgrastim
干预措施: Filgrastim (Drug)
A
Cyclophosphamide plus filgrastim
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Immunophenotypic response
时间窗: Change from the start of induction treatment at 3 months, change from the start of induction at 6 months, at 9 months, at 12 months, at 16 months, at 20 months, at 24 moths
Response will be measured by International Myeloma Working Group (IMWG) guidelines, and if the response is stringent CR and immunophenotypic remission, those patients will be followed also by allele-spesific oligonucleotide-polymerase chain reaction assay (ASO-PCR) to find out molecular remission rate.
次要结局
- Progression free survival(From date of inclusion until the date of first documented progression or date of death from any cause whatever come first assessed up to last patient 2 years on maintenance)