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
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 (CSP)/mycophenolate 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
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
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
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The current study will be regarded as potentially efficacious if the observed 3-year PFS rate among all patients treated exceeds 30%. The Kaplan-Meier (KM) estimate of PFS will be used.
From the date of transplant until the time of progression, relapse, death, or the date the patient was last known to be in remission, up to 3 years
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|University of Colorado||Denver, Colorado 80217|
|City of Hope||Duarte, California 91010|