Phase III Study of Single Autologous Stem Cell Transplantation Followed by Maintenance Therapy as Front-line Treatment for Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- response rate: CR/nCR/VGPR
研究概览
简要总结
The clinical trial is to evaluate the efficacy of single autologous hematopoietic stem cell transplantation with standard conditioning of melphalan 200 mg/m2 followed by thalidomide maintenance in patients with newly-diagnosed myeloma after receiving 4-6 cycles of induction chemotherapy consisting of vincristin,adriamycin and dexamethasone (VAD) or thalidomide/dexamethasone between 18 to 65 years.
详细描述
This is an open label clinical trial to evaluate the efficacy of single autologous hematopoietic stem cell transplantation in newly diagnosed multiple myeloma patients. All patients will receive 4-6 cycles of induction therapy which includes VAD chemotherapy (vincristin, adriamycin and dexamethasone) or thalidomide/dexamethasone. After peripheral hematopoietic stem cell mobilization and apheresis, patients will receive a standard conditioning with melphalan 200mg/m2 followed by thalidomide maintenance therapy at 100-200mg orally daily starting from D+60 till disease progression or untolerable toxicity.
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 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
结局指标
主要结局
response rate: CR/nCR/VGPR
时间窗: 6 months after auto-PBSCT
次要结局
- toxicity(3 years)
- progression free survival(3 years)
- overall survival(3 years)
研究者
Jiong HU
Head, Blood and Marrow Transplantation Center, Rui Jin Hospital
Shanghai Jiao Tong University School of Medicine