Combined Bone Marrow and Kidney Transplant for Multiple Myeloma With Kidney 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.
Kidney Failure, Chronic
Procedure: Combined bone marrow and kidney transplant
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Combined HLA-matched Bone Marrow and Kidney Transplantation for Multiple Myeloma With Renal Failure|
- Remission status of multiple myeloma [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Renal allograft acceptance and ability to discontinue immunosuppressive therapy [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Graft vs. host disease (GVHD) [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Opportunistic infections [ Time Frame: Throughouto study ] [ Designated as safety issue: Yes ]
- T-cell recovery and immune reconstitution [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2003|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062621
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114-2696|
|Principal Investigator:||Thomas Spitzer, MD||Massachussetts General Hospital|
|Principal Investigator:||A. Benedict Cosimi, MD||Massachussetts General Hospital|