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| Descriptive Information Fields | |||||||||
| Brief Title † | Combined Bone Marrow and Kidney Transplant for Multiple Myeloma With Kidney Failure | ||||||||
| Official Title † | Combined HLA-Matched Bone Marrow and Kidney Transplantation for Multiple Myeloma With Renal Failure | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase I | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | 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 ] |
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| Secondary Outcome Measure † | 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 ] |
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| Condition † | Kidney Failure, Chronic Multiple Myeloma |
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| Intervention † | Procedure: Combined bone marrow and kidney transplant | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | Click here for the Immune Tolerance Network Web site  |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 5 | ||||||||
| Start Date † | June 2003 | ||||||||
| Completion Date | December 2006 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00062621 | ||||||||
| Organization ID | ITN008ST | ||||||||
| Secondary IDs †† | NKDO1, DAIT NKDO1 | ||||||||
| Study Sponsor † | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Collaborators †† | Immune Tolerance Network Massachusetts General Hospital |
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| Investigators † |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Verification Date | November 2007 | ||||||||
| First Received Date † | June 9, 2003 | ||||||||
| Last Updated Date | May 8, 2008 | ||||||||
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