Date:12/6/2010

ologous stem cell transplant followed by non-myeloablative allogeneic stem cell transplant (auto-allo). The BMT CTN is funded by the National Heart, Lung, and Blood Institute and the National Cancer Institute of the National Institutes of Health and has the objective of conducting phase II and III clinical trials in transplantation in the United States. This large, multicenter phase III clinical trial (BMT CTM 0102) assigned 710 patients from 43 institutions to one of two treatment arms. Patients without a matched sibling stem cell donor were enrolled in the auto-auto arm, in which a tandem autologous stem cell transplant was performed using a chemotherapy conditioning regimen of melphalan 200 mg/m2. Patients in this arm were further randomized to receive maintenance therapy of thalidomide and dexamethasone, which are active anti-myeloma drugs, or observation for one year. Patients with a matched sibling stem cell donor were enrolled in the experimental arm, referred to as the auto-allo arm, in which patients underwent an autologous stem cell transplant using a chemotherapy conditioning regimen of melphalan 200 mg/m2 followed by an allogeneic stem cell transplant using a total body irradiation (2 Gy) conditioning regimen. All patients in the study received cyclosporine and mycophenolate mofetil for prevention of graft-versus-host disease. This is a common complication of bone marrow transplantation in which the transplanted donor cells attack the cells in the recipient's body. The primary endpoint of the study was three-year progression-free survival.

The study demonstrated that after three years of follow-up, progression-free survival was 46 percent for the standard auto-auto arm compared with 43 percent for the experimental auto-allo arm, demonstrating that the experimental auto-allo approach was not significantly better than the standard auto-auto approach. Overall survival was 80 percent and 77 percent for the auto-auto and auto-allo arms, respectively.
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Contact: Lindsey Love llove@hematology.org 540-538-9326 American Society of Hematology Source:Eurekalert

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