Refractory Multiple Myeloma Clinical Trial
Official title:
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
In this study donor bone marrow transplantation is divided into a two step process to try to significantly reduce the side effects of the procedure yet still provide patients with multiple myeloma the benefits of this procedure
PRIMARY OBJECTIVES:
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 (PFS).
OUTLINE:
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
day 0.
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
0-27.
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.
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