TY - JOUR
T1 - Lenalidomide-based induction and maintenance in elderly newly diagnosed multiple myeloma patients
T2 - updated results of the EMN01 randomized trial
AU - Bringhen, Sara
AU - D'Agostino, Mattia
AU - Paris, Laura
AU - Ballanti, Stelvio
AU - Pescosta, Norbert
AU - Spada, Stefano
AU - Pezzatti, Sara
AU - Grasso, Mariella
AU - Rota-Scalabrini, Delia
AU - De Rosa, Luca
AU - Pavone, Vincenzo
AU - Gazzera, Giulia
AU - Aquino, Sara
AU - Poggiu, Marco
AU - Santoro, Armando
AU - Gentile, Massimo
AU - Baldini, Luca
AU - Petrucci, Maria Teresa
AU - Tosi, Patrizia
AU - Marasca, Roberto
AU - Cellini, Claudia
AU - Palumbo, Antonio
AU - Falco, Patrizia
AU - Hájek, Roman
AU - Boccadoro, Mario
AU - Larocca, Alessandra
N1 - Copyright © 2019, Ferrata Storti Foundation.
PY - 2019/10/3
Y1 - 2019/10/3
N2 - In the EMN01 trial, the addition of an alkylator (melphalan or cyclophosphamide) to lenalidomide-steroid induction has been prospectively evaluated in transplant-ineligible multiple myeloma patients. After induction, patients were randomly assigned to maintenance treatment with lenalidomide alone or with prednisone continuously. This analysis (median follow-up of 71 months) focused on maintenance treatment and on subgroup analyses according to the International Myeloma Working Group Frailty Score. 217 patients in lenalidomide-dexamethasone, 217 in melphalan-prednisone-lenalidomide and 220 in cyclophosphamide-prednisone-lenalidomide arms were evaluable. 284 (43%) patients were fit, 205 (31%) intermediate-fit and 165 (25%) frail. After induction, 402 patients were eligible for maintenance, (lenalidomide arm: 204; lenalidomide-prednisone: 198). After a median duration of maintenance of 22.0 months, progression-free survival from start of maintenance was 22.2 months with lenalidomide-prednisone vs 18.6 months with lenalidomide (HR 0.85,p=0.14), with no differences across frailty subgroups. The most frequent grade ≥3 toxicity was neutropenia (10% of lenalidomide-prednisone and 21% of lenalidomide patients; p=0.001). Grade ≥3 non-hematologic adverse events were rare (
AB - In the EMN01 trial, the addition of an alkylator (melphalan or cyclophosphamide) to lenalidomide-steroid induction has been prospectively evaluated in transplant-ineligible multiple myeloma patients. After induction, patients were randomly assigned to maintenance treatment with lenalidomide alone or with prednisone continuously. This analysis (median follow-up of 71 months) focused on maintenance treatment and on subgroup analyses according to the International Myeloma Working Group Frailty Score. 217 patients in lenalidomide-dexamethasone, 217 in melphalan-prednisone-lenalidomide and 220 in cyclophosphamide-prednisone-lenalidomide arms were evaluable. 284 (43%) patients were fit, 205 (31%) intermediate-fit and 165 (25%) frail. After induction, 402 patients were eligible for maintenance, (lenalidomide arm: 204; lenalidomide-prednisone: 198). After a median duration of maintenance of 22.0 months, progression-free survival from start of maintenance was 22.2 months with lenalidomide-prednisone vs 18.6 months with lenalidomide (HR 0.85,p=0.14), with no differences across frailty subgroups. The most frequent grade ≥3 toxicity was neutropenia (10% of lenalidomide-prednisone and 21% of lenalidomide patients; p=0.001). Grade ≥3 non-hematologic adverse events were rare (
U2 - 10.3324/haematol.2019.226407
DO - 10.3324/haematol.2019.226407
M3 - Article
SN - 0390-6078
JO - Haematologica
JF - Haematologica
ER -