Multiple Myeloma Clinical Trial
Official title:
Combined HLA-matched Bone Marrow and Kidney Transplantation for Multiple Myeloma With Renal Failure
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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