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Combined Bone Marrow and Kidney Transplant for Multiple Myeloma with Kidney Failure
This study is currently recruiting patients.
Sponsored by: | National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
Purpose
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.
Condition | Treatment or Intervention | Phase |
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Kidney Failure, Chronic Multiple Myeloma |
Procedure: Combined bone marrow and kidney transplant |
Phase I |
MedlinePlus related topics: Kidney Failure; Multiple Myeloma
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Combined HLA-matched Bone Marrow and Kidney Transplantation for Multiple Myeloma with Renal Failure
Expected Total Enrollment: 10
Study start: June 2003
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.
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria
Exclusion Criteria
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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