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.

Study hypothesis: Combined renal transplantation with bone marrow transplantation from the same donor, using nonmyeloablative, relatively non-toxic conditioning, can cure the underlying malignancy while allowing acceptance of a donor renal allograft without chronic immunosuppression.

Condition	Treatment or Intervention	Phase
Kidney Failure, Chronic Multiple Myeloma	Procedure: Combined bone marrow and kidney transplant	Phase I

Further Study Details: 

Primary Outcomes: Remission status of multiple myeloma; renal allograft acceptance and ability to discontinue immunosuppressive therapy
Secondary Outcomes: Graft vs. host disease (GVHD); opportunistic infections; T cell recovery and immune reconstitution
Expected Total Enrollment:  10

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.

Hypothesis: combined renal transplantation with bone marrow transplantation from the same donor, using nonmyeloablative, relatively non-toxic conditioning, can cure the underlying malignancy while allowing acceptance of a donor renal allograft without chronic immunosuppression.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

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, or high-dose radiation therapy with autologous stem cell transplantation)
• On dialysis or have a creatinine clearance > 20 ml/min
• HLA-matched or one of six HLA antigen-mismatched related donor

Exclusion Criteria

• Compromised pulmonary, cardiac, or liver function
• Active infection

Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114-2696,  United States; Recruiting

Study chairs or principal investigators

Megan Sykes, MD,  Principal Investigator,  Massachussets General Hospital   

Study ID Numbers:  ITN008ST; NKDO1; DAIT NKDO1
Record last reviewed:  January 2005
Last Updated:  March 9, 2005
Record first received:  June 9, 2003
ClinicalTrials.gov Identifier:  NCT00062621
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08