Intensification therapy with autologous stem cell transplantation versus bortezomib-melphalan-prednisone for newly diagnosed multiple myeloma patients: A multicenter, phase III study of the european myeloma network (EMN02/HO95 MM trial)

The prospective, multicenter, phase III EMN02/HO95 MM trial was designed to randomly compare (R1) (1:1 ratio; stratification by ISS) four 42-day cycles of standard dose bortezomib-melphalan-prednisone (VMP) vs either a single or two sequential courses of melphalan 200 mg/m2 followed by autologous stem cell transplantation (ASCT), as intensification therapy for newly diagnosed multiple myeloma (MM) patients. A second randomization (R2) to consolidation therapy with bortezomib-lenalidomide-dexamethasone vs no consolidation was performed after intensification, to be followed by lenalidomide maintenance until progression or toxicity in both arms. A primary study end point was progression-free survival (PFS) from R1. From February 2011 to April 2014, 1510 patients aged