Lenalidomide-based induction and maintenance in elderly newly diagnosed multiple myeloma patients: updated results of the EMN01 randomized trial

S. Bringhen, M. D'Agostino, L. Paris, S. Ballanti, N. Pescosta, S. Spada, S. Pezzatti, M. Grasso, D. Rota-Scalabrini, L. De Rosa, V. Pavone, G. Gazzera, S. Aquino, M. Poggiu, A. Santoro, M. Gentile, L. Baldini, M.T. Petrucci, P. Tosi, R. MarascaC. Cellini, A. Palumbo, P. Falco, R. Hájek, M. Boccadoro, A. Larocca

Research output: Contribution to journalArticlepeer-review

Abstract

n the EMN01 trial, the addition of an alkylator (melphalan or cyclophosphamide) to lenalidomide-steroid induction therapy was prospectively evaluated in transplant-ineligible patients with multiple myeloma. After induction, patients were randomly assigned to maintenance treatment with lenalidomide alone or with prednisone continuously. The analysis presented here (median follow-up of 71 months) is focused on maintenance treatment and on subgroup analyses defined according to the International Myeloma Working Group Frailty Score. Of the 654 evaluable patients, 217 were in the lenalidomide-dexamethasone arm, 217 in the melphalan-prednisone-lenalidomide arm and 220 in the cyclophosphamide-prednisone-lenalidomide arm. With regards to the Frailty Score, 284 (43%) patients were fit, 205 (31%) were intermediate-fit and 165 (25%) were frail. After induction, 402 patients were eligible for maintenance therapy (lenalidomide arm, n=204; lenalidomide-prednisone arm, n=198). After a median duration of maintenance of 22.0 months, progression-free survival from the start of maintenance was 22.2 months with lenalidomide-prednisone vs 18.6 months with lenalidomide (hazard ratio 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 (
Original languageEnglish
Pages (from-to)1937-1947
Number of pages11
JournalHaematologica
Volume105
Issue number7
DOIs
Publication statusPublished - 2020

Keywords

  • ONCOLOGIA
  • STUDIO CLINICO
  • RIS

Fingerprint Dive into the research topics of 'Lenalidomide-based induction and maintenance in elderly newly diagnosed multiple myeloma patients: updated results of the EMN01 randomized trial'. Together they form a unique fingerprint.

Cite this