A Randomized Study of 4 vs. 8 Cycles of Velcade-based Regimen With Autologous Stem Cell Transplantation in Newly-diagnosed Myeloma Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
The is a randomized control study for newly-diagnosed myeloma patients 18-65 year old. All patients will receive 4 cycles of velcade and Dexamethasone as front-line therapy. Then patients will be randomized into standard group which will receive a single autologous hematopoietic stem cell transplantation with standard conditioning of melphalan 200mg/m2 and the study group which will receive single autologous hematopoietic stem cell transplantation with conditioning of melphalan 200mg/m2 + velcade followed by 3 more cycles of velcade alone as consolidation.
详细描述
The is a randomized control study for newly-diagnosed myeloma patients 18-65 year old. Newly-diagnosed myeloma patient enrolled will receive 4 cycles of velcade and Dexamethasone as front-line induction therapy. All patients finished the induction therapy will be randomized into standard group and the study group. All patients will mobilized by cyclophosphamide with G-CSF to collect a target of 2x106 CD34+/kg and then undergo autologous stem cell transplantation. For standard group, patients will receive single auto-SCT with standard conditioning of melphalan 200mg/m2. The patients in the study group will receive single auto-SCT with conditioning of melphalan 200mg/m2 added with 4 dose of velcade at 1.0mg/m2 during the transplantation procedure and then followed by 3 more cycles of velcade alone as consolidation.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman between age 18-65 with newly diagnosed Multiple Myeloma for whom stem cell transplantation is considered appropriate
- •Measurable serum and/or urinary paraprotein
- •European Cooperative Oncology Group performance status 0-3
- •Serum bilirubin < 1.5x the upper limit of normal (ULN) Serum alanine transaminase (ALT)/aspartate transaminase values < 2.5 x ULN
- •Subjects (or their legally acceptable representatives) must signed an informed consent document indicating that they understanding the purpose of and procedures required for the study and are willing to participate in the study
排除标准
- •Woman of child bearing potential
- •Non-secretory MM
- •Serum creatinine > 400 Micromol/l after initial resuscitation patients with previous Grade 2-4 peripheral neuropathy
- •Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug)
- •Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, uncontrolled angina, clinically significant pericardial disease, or III-IV heart failure
研究组 & 干预措施
vel 8 - ASCT
8 cycles of velcade with ASCT
干预措施: velcade (Drug)
vel4 - ASCT
4 cycles of velcade with ASCT
干预措施: velcade (Drug)
结局指标
主要结局
Response rate
时间窗: 60 days and 2 years after the treatment
次要结局
- Overall survival(2 years)
- Progression-free survival(2 years)
- Quality of life(2 year)
研究者
Jiong HU
Head, Blood and Marrow Transplantation Center, Rui Jin Hospital
Shanghai Jiao Tong University School of Medicine