|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborators: |
Immune Tolerance Network Massachusetts General Hospital |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00062621 |
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 I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Combined HLA-Matched Bone Marrow and Kidney Transplantation for Multiple Myeloma With Renal Failure |
| Enrollment: | 5 |
| Study Start Date: | June 2003 |
| Study Completion Date: | December 2006 |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Bone marrow and liver transplantation occurring at the same time
|
Procedure: Combined bone marrow and kidney transplant
Combined marrow and kidney transplant
|
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:
Exclusion Criteria:
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
| Study ID Numbers: | DAIT ITN008ST, NKDO1, DAIT NKDO1 |
| Study First Received: | June 9, 2003 |
| Last Updated: | May 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00062621 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Renal Insufficiency Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Hematologic Diseases Blood Protein Disorders Kidney Failure, Chronic Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Neoplasms Hemorrhagic Disorders Urologic Diseases Renal Insufficiency, Chronic Cardiovascular Diseases Kidney Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell Kidney Failure |