Combined Bone Marrow and Kidney Transplant for Multiple Myeloma With Kidney Failure
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Failure, Chronic Multiple Myeloma |
Procedure: Combined bone marrow and kidney transplant |
Phase 1 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 5 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00062621 History of Changes |
| Other Study ID Numbers: | DAIT ITN008ST, NKDO1, DAIT NKDO1 |
| Study First Received: | June 9, 2003 |
| Last Updated: | February 1, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
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 ESRD |
Additional relevant MeSH terms:
|
Kidney Failure, Chronic Multiple Myeloma Neoplasms, Plasma Cell Renal Insufficiency Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases Neoplasms by Histologic Type Neoplasms Hemostatic Disorders |
Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013