Combined HLA-matched Bone Marrow and Kidney Transplantation for Multiple Myeloma With Renal Failure
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Remission status of multiple myeloma
研究概览
简要总结
The purpose of this study is to determine whether a combined bone marrow and kidney transplant will be effective in treating stage II or greater multiple myeloma and associated kidney failure. This study will determine whether transplant rejection and the need for immunosuppressive drugs are decreased with this combined transplant approach.
详细描述
In very limited human testing, a combined kidney and bone marrow transplant appears to be safe and effective in treating multiple myeloma and associated kidney failure. This study will evaluate this approach in 10 patients with kidney failure due to or in association with stage II or greater multiple myeloma. Treatment prior to transplant will include cyclophosphamide, ATGAM (a lymphocyte-specific immunosuppressant), local radiation to the thymus, and cyclosporine (an immunosuppressive drug).
An infusion of donor bone marrow and a kidney graft from a closely matched, related donor will be transplanted simultaneously. An additional infusion of donor white blood cells may be administered between day 45 and 74 after transplant in an effort to eliminate any remaining cancer cells. Patients will remain on cyclosporine for a defined period of time. The cyclosporine doses will be slowly decreased and stopped if graft rejection and graft-versus-host disease do not occur.
Each participant will be involved in the study for 3 years; this includes the intervention phase (time from initial screening at approximately 7 days before transplant through 100 days after the transplant) and continued follow-up visits for at least 2 years following the transplant.
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
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End-stage renal disease (ESRD) due to or in association with stage II or greater multiple myeloma
- •Participants in whom the development of ESRD is not due to the underlying myeloma will be included if they have evidence of active myeloma despite past treatment with standard therapies (e.g., prednisone, melphalan, high-dose radiation therapy with autologous stem cell transplantation)
- •On dialysis or have a creatinine clearance greater than 20 ml/min
- •HLA-matched or one of six HLA antigen-mismatched related donor
排除标准
- •Compromised pulmonary, cardiac, or liver function
- •Active infection
结局指标
主要结局
Remission status of multiple myeloma
时间窗: Throughout study
Renal allograft acceptance and ability to discontinue immunosuppressive therapy
时间窗: Throughout study
次要结局
- Graft vs. host disease (GVHD)(Throughout study)
- Opportunistic infections(Throughouto study)
- T-cell recovery and immune reconstitution(Throughout study)
