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临床试验/NCT00854139
NCT00854139已完成1 期

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

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2001年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
10
试验地点
1
主要终点
Remission status of multiple myeloma

研究概览

简要总结

The primary objective is to cure multiple myeloma with less toxic allogeneic bone marrow transplantation while inducing renal allograft tolerance through mixed chimerism in patients with end stage renal failure and multiple myeloma

详细描述

The induction of transplantation tolerance involves the specific elimination of the immune response to the transplant but not to other antigens. In the realm of kidney transplantation, tolerance means that the recipient is unable to detect the donor transplant kidney as foreign, and therefore the recipient is unable to reject the kidney. Donor bone marrow engraftment leads to kidney graft tolerance in animal models. Renal failure is a major complication of multiple myeloma, a plasma cell malignancy for which the only known cure is allogeneic bone marrow transplantation. Standard bone marrow transplantation is associated with frequent toxicity in patients with multiple myeloma, and is generally no considered an option for those patients with end stage renal disease. Myeloma patients are excluded from conventional renal transplantation protocols because of their underlying malignancy. A less toxic bone marrow transplantation protocol, combined with renal transplantation, could provide an opportunity for cure of the myeloma and correction of ESRD in patients with this disease. In addition, successful marrow engraftment may be expected to lead to a state of tolerance. Successful implementation of tolerance would be a major benefit to transplant recipients. The significance of developing tolerance is that the patient would be spared the disabling complications of indefinite immunosuppression, which include infections, cataracts, osteoporosis, diabetes, atherosclerosis, hypertension, and malignancy

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

入选标准

  • HLA-matched or one of six HLA A, B, or DR antigen-mismatched related male or female donor 18-65 years of age.
  • ECOG performance status 0 or
  • Excellent health per conventional pre-donor history (medical and psychosocial evaluation).
  • Acceptable laboratory parameters (hematology in normal or near-normal range; liver function < 2 times the upper limit of normal and normal creatinine).
  • Compatible ABO blood group.
  • Negative donor lymphocyte crossmatch.
  • No positive testing for viral infection (HbsAg, HIV, HCV, HTLV-1).
  • Cardiac/Pulmonary evaluation within normal limits (CXR, EKG).
  • Donor ability to understand and provide informed consent.

排除标准

  • 未提供

研究组 & 干预措施

Bone marrow and renal transplant

Experimental

Cyclophosphamide, anti-thymocyte globulin, thymic irradiation conditioning and kidney transplant and bone marrow transplant from a related donor for patients with multiple myeloma and end stage renal disease with cyclosporine for graft versus host disease prophylaxis

干预措施: Cyclophosphamide, anti-thymocyte globulin (Drug)

Bone marrow and renal transplant

Experimental

Cyclophosphamide, anti-thymocyte globulin, thymic irradiation conditioning and kidney transplant and bone marrow transplant from a related donor for patients with multiple myeloma and end stage renal disease with cyclosporine for graft versus host disease prophylaxis

干预措施: Kidney transplant (Procedure)

Bone marrow and renal transplant

Experimental

Cyclophosphamide, anti-thymocyte globulin, thymic irradiation conditioning and kidney transplant and bone marrow transplant from a related donor for patients with multiple myeloma and end stage renal disease with cyclosporine for graft versus host disease prophylaxis

干预措施: Thymic irradiation (Radiation)

Bone marrow and renal transplant

Experimental

Cyclophosphamide, anti-thymocyte globulin, thymic irradiation conditioning and kidney transplant and bone marrow transplant from a related donor for patients with multiple myeloma and end stage renal disease with cyclosporine for graft versus host disease prophylaxis

干预措施: Bone marrow transplant from a related donor (Procedure)

结局指标

主要结局

Remission status of multiple myeloma

时间窗: 3 years

Renal allograft acceptance and ability to discontinue immunosuppressive therapy

时间窗: 3 years

次要结局

  • Graft versus host disease (GVHD)(3 years)
  • Opportunistic infections(3 years)
  • T cell recovery and immune reconstitution(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Spitzer

MD

Massachusetts General Hospital

研究点 (1)

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