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临床试验/NCT00062621
NCT00062621已完成1 期

Combined HLA-matched Bone Marrow and Kidney Transplantation for Multiple Myeloma With Renal Failure

National Institute of Allergy and Infectious Diseases (NIAID)2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2003年6月1日最近更新:
适应症

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

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)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (2)

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