Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00185614
Status:
COMPLETED
Last Update Posted:
2018-01-18
First Post:
2005-09-12
Brief Title:
Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma
Sponsor:
Wen-Kai Weng
Organization:
Stanford University
Study Overview
Official Title:
Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2018-01
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:
Mixed chimerism transplantation is an approach to allogeneic transplants that attempts to decrease regimen-related toxicity by using non-myeloablative preparatory regimens establish mixed chimerism using low dose total body irradiation along with immunosuppression using cyclosporine and mycophenolate mofetil suppress graft-vs-host and host-vs-graft reactions to allow a mixed chimeric state to be established encourage tolerance and prevent graft-vs-host disease GvHD during the mixed chimerism period and use donor lymphocyte infusions to convert the patient to a full chimera while developing a graft-vs-tumor effect
Detailed Description:
Participants are mobilized with cyclophosphamide 4 gm2 and filgrastim 10 µgkgday for peripheral blood progenitor cell PBPC collection by apheresis Transplant conditioning is high-dose melphalan 200 mgm2 followed by PBPC infusion as melphalan rescue ie autologous hematopoietic cells transplant auto-HCT Post-infusion support includes filgrastim 5 µgkgday starting 6 days following melphalan Participants with stable or responsive disease at 4 weeks eligible to continue on to the planned allogenic HCT allo-HCT For allo-HCT a sibling donor that is fully matched for human leukocyte antigen HLA-matched is identified Participants receive a single dose of total body irradiation TBI 200 centigray cGy as well as immunosuppression with cyclosporine CSP 625 mgkg and mycophenolate mofetil MMF 15 mgkg The HLA-matched donor begins filgrastim injections 16 µgkgday on day -4 continuing to Day 0 with apheresis collections on Day -1 and Day 0 to a target of 5 x 10e6 CD34 cellskg Allo-HCT is infused to participant on Day 0 with premedication hydrocortisone 100 mg IV and diphenhydramine 50 mg IV CSP will be tapered beginning Day 56 with a goal of discontinuing CSP on Day 180 adjusted as needed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| BMT109 | OTHER | OnCore | None |
| 75190 | OTHER | None | None |