NCT00185614

Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Wen-Kai Weng · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 g/m2 and filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue \[ie, autologous hematopoietic cells transplant (auto-HCT)\]. Post-infusion support includes filgrastim 5 µg/kg/day, 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) 6.25 mg/kg and mycophenolate mofetil (MMF) 15 mg/kg. The HLA-matched donor begins filgrastim injections 16 µg/kg/day on day -4 continuing to Day 0, with apheresis collections on Day -1 and Day 0, to a target of \> 5 x 10e6 CD34 cells/kg. 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.

Conditions

• Blood Cancer
• Multiple Myeloma

Interventions

Type	Name	Description
PROCEDURE	Autologous hematopoietic cell transplant (Auto-HCT)	The target cell dose is 2.6 x 10e6 CD34+ cells/kg
PROCEDURE	Allogeneic hematopoietic cell transplant (Allo-HCT)	The target cell dose is 5 x 10e6 CD34 cells/kg
DRUG	Cyclophosphamide	Cyclophosphamide administered intravenously (IV) at 4 mg /m² mobilize peripheral blood progenitor cells (PBPC) for autologous re-infusion
DRUG	Filgrastim	* Filgrastim 10 µg/kg/day to mobilize peripheral blood progenitor cells (PBPC) for autologous re-infusion (Auto-HCT) * Filgrastim 5 µg/kg/day starting 6 days after melphalan (Day 4 after Auto-HCT) * Filgrastim 16 µg/kg/day to mobilize donor peripheral blood progenitor cells (PBPC) for allogeneic transplant (Allo-HCT)
DRUG	Melphalan	Melphalan 200 mg/m2 (high-dose) intravenously as conditioning for Auto-HCT
RADIATION	Total body irradiation (TBI)	200 centigray (cGy) total body irradiation delivered on Day 0
PROCEDURE	Cyclosporine (CSP)	Cyclosporine administered twice-daily by mouth at a dose of 6.25 mg/kg from Day -3 through Day 56
DRUG	Mycophenolate Mofetil (MMF)	Mycophenolate mofetil will begin at 15 mg/kg twice-daily by mouth from Day 0 to Day 27

Timeline

• Start date: 2000-08-01
• Primary completion: 2009-04-01
• Completion: 2010-04-01
• First posted: 2005-09-16
• Last updated: 2018-01-18
• Results posted: 2018-01-18

Locations

1 site across 1 country: United States