Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054353
Status:
COMPLETED
Last Update Posted:
2017-10-16
First Post:
2003-02-05
Brief Title:
Reduced-Intensity Conditioning Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Multiple Myeloma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Reduced-Intensity Allogeneic HSC Transplantation From HLA-Matched Related and Unrelated Donors for Patients With Multiple Myeloma - A Multi-Center Trial
Status:
COMPLETED
Status Verified Date:
2017-09
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:
This phase III trial studies the side effects of giving reduced-intensity conditioning followed by donor peripheral blood stem cell transplant PBSCT and how well it works in treating patients with multiple myeloma MM Giving low doses of chemotherapy such as fludarabine phosphate and melphalan and total-body irradiation TBI before a donor PBSCT helps stop the growth of cancer cells It may also stop the patients immune system from rejecting the donors stem cells The donated stem cells may replace the patients immune cells and help destroy any remaining cancer cells graft-versus-tumor effect Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving mycophenolate mofetil and cyclosporine after transplant may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the efficacy of this approach by determining the 1-year progression-free survival PFS and overall survival OS
II To evaluate day 100 non-relapse mortality
III To determine the incidences of grades II-IV acute graft-versus-host disease GVHD and chronic extensive GVHD
OUTLINE
PREPARATIVE REGIMEN Patients receive fludarabine phosphate intravenously IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2 Patients also undergo low-dose TBI on day 0
TRANSPLANTATION Patients undergo allogeneic PBSCT on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO twice daily BID on days -3 to 80 with taper to day 180 related donors or on days -3 to 100 with taper to day 180 unrelated donors Patients also receive mycophenolate mofetil PO BID on days 0-27 related donors or thrice daily TID on days 0-40 with taper to day 96 unrelated donors
After completion of study treatment patients are followed up at 3 6 12 18 and 24 months and then annually thereafter for 5 years
I To evaluate the efficacy of this approach by determining the 1-year progression-free survival PFS and overall survival OS
II To evaluate day 100 non-relapse mortality
III To determine the incidences of grades II-IV acute graft-versus-host disease GVHD and chronic extensive GVHD
OUTLINE
PREPARATIVE REGIMEN Patients receive fludarabine phosphate intravenously IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2 Patients also undergo low-dose TBI on day 0
TRANSPLANTATION Patients undergo allogeneic PBSCT on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO twice daily BID on days -3 to 80 with taper to day 180 related donors or on days -3 to 100 with taper to day 180 unrelated donors Patients also receive mycophenolate mofetil PO BID on days 0-27 related donors or thrice daily TID on days 0-40 with taper to day 96 unrelated donors
After completion of study treatment patients are followed up at 3 6 12 18 and 24 months and then annually thereafter for 5 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 |
|---|---|---|---|
| P30CA015704 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |
| NCI-2011-00386 | REGISTRY | None | None |
| 174300 | OTHER | None | None |