Combined Bone Marrow and Kidney Transplant for Multiple Myeloma With Kidney Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Combined HLA-matched Bone Marrow and Kidney Transplantation for Multiple Myeloma With Renal Failure

Conditions
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Kidney Failure, Chronic, Multiple Myeloma

Intervention / Treatment
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* Procedure: Combined bone marrow and kidney transplant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Combined bone marrow and kidney transplant|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission status of multiple myeloma |  | Throughout study | 
| Renal allograft acceptance and ability to discontinue immunosuppressive therapy |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft vs. host disease (GVHD) |  | Throughout study | 
| Opportunistic infections |  | Throughouto study | 
| T-cell recovery and immune reconstitution |  | Throughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESRD, Immune tolerance, Graft vs host disease, Kidney Failure, Kidney diseases, End Stage Renal Disease, Multiple Myeloma, Bone Marrow Transplant, Kidney Transplant, Renal Transplant, Tolerance, Chimerism