Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma

PHASE2CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

August 31, 2000

Primary Completion Date

April 30, 2009

Study Completion Date

April 30, 2010

Conditions
Blood CancerMultiple Myeloma
Interventions
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

Trial Locations (1)

94305

Stanford University School of Medicine, Stanford

All Listed Sponsors
lead

Wen-Kai Weng

OTHER

NCT00185614 - Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma | Biotech Hunter | Biotech Hunter