High‐dose therapy and autologous blood stem cell transplantation in multiple myeloma: Preliminary results of a randomized trial involving 167 patients

Since 1986, we have treated young patients with aggressive multiple myeloma (MM) by high‐dose chemotherapy (HDC) and total body irradiation (TBI) followed with autologous blood stem cell transplantation (ABSCT). To evaluate this strategy: 1) We conducted a phase II trial that included 63 patients. Within a median follow‐up of five years after transplantation, overall survival was 60% and median event‐free survival was four years, and 2) In the early 1990s, we initiated a prospective trial where, after collection of chemotherapy‐mobilized ABSC, patients under 55 years of age with newly diagnosed MM were randomly assigned either to HDC and TBI supported with ABSCT (high‐dose therapy [HDT] arm) or to a conventional vincristine, melphalan, cyclophosphamide and prednisone (VMCP) regimen (VMCP arm). In the latter, HDT with ABSCT was performed as a rescue therapy, in case of primary resistance to VMCP or at relapse in responders.