Combined Bone Marrow and Kidney Transplant for Multiple Myeloma With Kidney Failure
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.
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.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  Compromised pulmonary, cardiac, or liver function

 -  Active infection