Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062621
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
2003-06-09
Brief Title:
Combined Bone Marrow and Kidney Transplant for Multiple Myeloma With Kidney Failure
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Combined HLA-matched Bone Marrow and Kidney Transplantation for Multiple Myeloma With Renal Failure
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DAIT NKDO1 | None | None | None |
| NKDO1 | None | None | None |