TY - JOUR
T1 - 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)
AU - Cavo, Michele
AU - Beksac, Meral
AU - Dimopoulos, Meletios A
AU - Pantani, Lucia
AU - Gay, Francesca
AU - Hájek, Roman
AU - Testoni, Nicoletta
AU - Mellqvist, Ulf-Henrik
AU - Patriarca, Francesca
AU - Montefusco, Vittorio
AU - Galli, Monica
AU - Johnsen, Hans Erik
AU - Ludwig, Heinz
AU - Zweegman, Sonja
AU - Wester, Ruth
AU - Wu, Ka Lung
AU - Driessen, Christoph
AU - Troia, Rossella
AU - Cornelisse, Petra
AU - van der Holt, Bronno
AU - Palumbo, Antonio
AU - Sonneveld, Pieter
PY - 2016
Y1 - 2016
N2 - 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
AB - 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
M3 - Article
SN - 0006-4971
VL - 128
SP - 673
JO - Blood
JF - Blood
IS - 22
ER -