Autologous Followed By Non-Myeloablative Allogeneic Transplant For Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 15
- 主要终点
- Treatment-related mortality
研究概览
简要总结
RATIONALE: Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect).
PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant followed by donor peripheral stem cell transplant works in treating patients with multiple myeloma.
详细描述
OBJECTIVES:
- Determine whether autologous peripheral blood stem cell transplantation (PBSCT) followed by non-myeloablative allogeneic PBSCT is associated with no more than 20% treatment-related mortality rates at 6 months in patients with multiple myeloma.
- Determine the response rate of patients treated with this regimen.
- Determine the percent donor chimerism in patients treated with this regimen.
- Determine the rate of graft-vs-host disease in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the disease-free and overall survival of patients treated with this regimen.
- Determine whether abnormal cytogenetics at presentation correlate with poor response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive cyclophosphamide IV over 1-2 hours on day 1 and filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until peripheral blood stem cell (PBSC) collection is complete.
Approximately 2-4 weeks after PBSC collection, patients receive melphalan IV over 15-30 minutes on day -2. Patients then undergo autologous PBSC transplantation (PBSCT) on day 0. Patients receive G-CSF SC beginning on day 5 and continuing until blood counts recover.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 64 Years（Child, 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
Autologous + Allogeneic Transplant
autologous PB stem cell transplant followed by non-myeloablative allogeneic transplant fr multiple myeloma
干预措施: filgrastim (Biological)
Autologous + Allogeneic Transplant
autologous PB stem cell transplant followed by non-myeloablative allogeneic transplant fr multiple myeloma
干预措施: CD34+ cells (Biological)
Autologous + Allogeneic Transplant
autologous PB stem cell transplant followed by non-myeloablative allogeneic transplant fr multiple myeloma
干预措施: cyclophosphamide (Drug)
Autologous + Allogeneic Transplant
autologous PB stem cell transplant followed by non-myeloablative allogeneic transplant fr multiple myeloma
干预措施: fludarabine phosphate (Drug)
Autologous + Allogeneic Transplant
autologous PB stem cell transplant followed by non-myeloablative allogeneic transplant fr multiple myeloma
干预措施: melphalan (Drug)
Autologous + Allogeneic Transplant
autologous PB stem cell transplant followed by non-myeloablative allogeneic transplant fr multiple myeloma
干预措施: methotrexate (Drug)
Autologous + Allogeneic Transplant
autologous PB stem cell transplant followed by non-myeloablative allogeneic transplant fr multiple myeloma
干预措施: tacrolimus (Drug)
结局指标
主要结局
Treatment-related mortality
时间窗: 6 months
次要结局
- Respone Rate(2-4 wks prior, and 3,6 mon then q 3 mon for 3 yrs, post allo transpl, then q 6 mon for max 15 yrs from study entry)
- GVHD Incidence(post allo transpl, & pre & post DLI)
- Survival(2 years)
- Correlation of cytogenetics and response(6, 12 mon then q 1 yr for 3 yrs post allo transpl)
- Treatment Completion Rate(post treatment)
- Chimerism Rate(1,2,3,4, & 6 mon post allo transpl, & 100 d post DLI)