multiple myeloma autologous stem cell transplantation (IFM99-04 trial) in high-risk de novo followed by a dose-reduced allograft (IFM99-03 trial) with tandem Prospective comparison of autologous stem cell transplantation

Abstract For patients with high-risk (beta-2 microglobulin > 3mg/L and chromosome 13 deletion at diagnosis) de novo multiple myeloma, the IFM group has initiated in 1999 two specific trials. In both protocols, induction regimen consisted of VAD followed by a first autologous stem cell transplantation (ASCT) prepared by melphalan 200 mg/m2. Patients with an HLA-sibling donor were subsequently treated with a dose-reduced allogeneic stem cell transplantation (IFM99-03 trial), while patients without an HLA-sibling donor were randomized to receive a second ASCT prepared by melphalan 220 mg/m2 dexamethasone +/- anti-IL6 monoclonal antibody (IFM99-04 protocol). 284 patients were prospectively treated and received at least one course of VAD, 65 in the IFM99-03 trial and 219 in the IFM99-04 trial. On an intent-to-treat basis, the overall survival (OS) and the event-free survival (EFS) did not differ significantly in both studies (median 35 and 25 months in the IFM99-03 trial versus 41 and 30 months in the IFM99-04 trial, respectively). With a median follow-up time of 24 months, the EFS of the 166 patients randomized in the tandem ASCT protocol was similar to the EFS of the 46 patients who received the whole IFM99-03 program, median 35 versus 31.7 months, with a trend for a better OS in patients treated with tandem ASCT, median 47.2 versus 35 months, p = .07. In patients with high-risk de novo MM, the combination of ASCT followed by dose-reduced allogeneic transplantation was not superior to a tandem dose-intensified melphalan-based ASCT.From bloodjournal.hematologylibrary.org by guest on June 5, 2013. For personal use only.