Intensification Therapy with Bortezomib-Melphalan-Prednisone Versus Autologous Stem Cell Transplantation for Newly Diagnosed Multiple Myeloma: An Intergroup, Multicenter, Phase III Study of the European Myeloma Network (EMN02/HO95 MM Trial)

Michele Cavo, Meral Beksac, Meletios A Dimopoulos, Lucia Pantani, Francesca Gay, Roman Hájek, Nicoletta Testoni, Ulf-Henrik Mellqvist, Francesca Patriarca, Vittorio Montefusco, Monica Galli, Hans Erik Johnsen, Heinz Ludwig, Sonja Zweegman, Ruth Wester, Ka Lung Wu, Christoph Driessen, Rossella Troia, Petra Cornelisse, Bronno van der HoltAntonio Palumbo, Pieter Sonneveld

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BackgroundThe role of upfront autologous stem cell transplantation (ASCT) for younger patients with newly diagnosed (ND) multiple myeloma (MM) has been questioned in the novel agent era.MethodsA prospective, multicenter, phase III study was designed to compare (first randomization, R1) (1:1 ratio; stratification according to ISS stage) four 42-day cycles of bortezomib-melphalan-prednisone (VMP) given at the same dosing schedule reported in the VISTA study (NEJM 2008; 359:906-17) vs either a single course or two sequential courses of melphalan at 200 mg/m2 (HDM) followed by single or double ASCT, respectively, as intensification therapy after three to four 21-day cycles of induction therapy with bortezomib-cyclophosphamide-dexamethasone and subsequent collection of peripheral blood stem cells. 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.ResultsFrom February 2011 to April 2014, 1510 patients aged
Original languageEnglish
Pages (from-to)673
Number of pages1
Issue number22
Publication statusPublished - 2016

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