Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003954
Status:
COMPLETED
Last Update Posted:
2020-02-06
First Post:
1999-11-01
Brief Title:
Melphalan and Stem Cell Transplant Before Total-Body Irradiation and Donor Stem Cell Transplant in Treating Patients With Stage I-III Multiple Myeloma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Allogeneic Stem Cell Transplantation For Multiple Myeloma A Two Step Approach To Reduce Toxicity Involving High Dose Melphalan and Autologous Stem Cell Transplant Followed By PBSC Allografting After Low Dose TBI
Status:
COMPLETED
Status Verified Date:
2019-05
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:
In this study donor bone marrow transplantation is divided into a two step process to try to significantly reduce the side effects of the procedure yet still provide patients with multiple myeloma the benefits of this procedure
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate engraftment of human leukocyte antigen HLA identical peripheral blood stem cell PBSC allografts given after conditioning with total-body irradiation TBI 200 cGy and post-grafting immunosuppression with cyclosporine CSPmycophenolate mofetil MMF in myeloma patients initially cytoreduced with high-dose melphalan
II To evaluate non-relapse mortality at day 100 post allografting III To evaluate the efficacy of this allografting strategy in terms of long-term progression free survival PFS
OUTLINE
CONDITIONING REGIMEN Patients receive high-dose melphalan intravenously IV over 15-20 minutes on day -2
TRANSPLANTATION Patients undergo autologous bone marrow or PBSC transplantation PBSCT on day 0
NON-MYELOABLATIVE CONDITIONING REGIMEN Beginning 40-120 days after autologous transplant patients undergo TBI on day 0
TRANSPLANTATION Patients undergo donor PBSCT on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine IV twice daily BID on days -1 and 0 and orally PO BID on days 1-80 with taper based on evaluation of disease response and graft-versus-host disease GVHD Patients also receive mycophenolate mofetil PO BID on days 0-27
POST-TRANSPLANTATION DONOR LYMPHOCYTE INFUSION DLI Beginning 4 weeks after immunosuppression patients achieving persistent or progressive disease may undergo DLI over 30 minutes every 4 weeks for up to 3 treatments
After completion of study treatment patients are followed up for 3 years
I To evaluate engraftment of human leukocyte antigen HLA identical peripheral blood stem cell PBSC allografts given after conditioning with total-body irradiation TBI 200 cGy and post-grafting immunosuppression with cyclosporine CSPmycophenolate mofetil MMF in myeloma patients initially cytoreduced with high-dose melphalan
II To evaluate non-relapse mortality at day 100 post allografting III To evaluate the efficacy of this allografting strategy in terms of long-term progression free survival PFS
OUTLINE
CONDITIONING REGIMEN Patients receive high-dose melphalan intravenously IV over 15-20 minutes on day -2
TRANSPLANTATION Patients undergo autologous bone marrow or PBSC transplantation PBSCT on day 0
NON-MYELOABLATIVE CONDITIONING REGIMEN Beginning 40-120 days after autologous transplant patients undergo TBI on day 0
TRANSPLANTATION Patients undergo donor PBSCT on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine IV twice daily BID on days -1 and 0 and orally PO BID on days 1-80 with taper based on evaluation of disease response and graft-versus-host disease GVHD Patients also receive mycophenolate mofetil PO BID on days 0-27
POST-TRANSPLANTATION DONOR LYMPHOCYTE INFUSION DLI Beginning 4 weeks after immunosuppression patients achieving persistent or progressive disease may undergo DLI over 30 minutes every 4 weeks for up to 3 treatments
After completion of study treatment patients are followed up for 3 years
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 |
|---|---|---|---|
| P01CA078902 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchP01CA078902 |
| NCI-2012-00670 | REGISTRY | None | None |