Lenalidomide-dexamethasone improved outcome in newly diagnosed elderly multiple myeloma patients. We randomly assigned 662 patients who were age ≥65 years or transplantation-ineligible to receive induction with melphalan-prednisone-lenalidomide (MPR) or cyclophosphamide-prednisone-lenalidomide (CPR) or lenalidomide plus low-dose dexamethasone (Rd). The primary end point was progression-free survival (PFS) in triplet (MPR and CPR) vs doublet (Rd) lenalidomide-containing regimens. After a median follow-up of 39 months, the median PFS was 22 months for the triplet combinations and 21 months for the doublet (P = .284). The median overall survival (OS) was not reached in either arms, and the 4-year OS was 67% for the triplet and 58% for the doublet arms (P = .709). By considering the 3 treatment arms separately, no difference in outcome was detected among MPR, CPR, and Rd. The most common grade ≥3 toxicity was neutropenia: 64% in MPR, 29% in CPR, and 25% in Rd patients (P < .0001). Grade ≥3 nonhematologic toxicities were similar among arms and were mainly infections (6.5% to 11%), constitutional (3.5% to 9.5%), and cardiac (4.5% to 6%), with no difference among the arms. In conclusion, in the overall population, the alkylator-containing triplets MPR and CPR were not superior to the alkylator-free doublet Rd, which was associated with lower toxicity. This study was registered at www.clinicaltrials.gov as #NCT01093196.

4th Department of Medicine Hematology Charles University Hospital Hradec Kralove Hradec Kralove Czech Republic;

Azienda Ospedaliera S Maria di Terni SC Oncoematologia Terni Italy;

Azienda Ospedaliera Universitaria di Udine Dipartimento Scienze Mediche Sperimentali e Cliniche Università di Udine Udine Italy;

Clinica di Ematologia AOU Ospedali Riuniti di Ancona Ancona Italy;

Department of Haematooncology University Hospital Ostrava and University of Ostrava Ostrava Czech Republic

Department of Medicine Hematology and Clinical Immunology Padua School of Medicine Padua Italy;

Dipartimento di Ematologia Medicina Trasfusionale e Biotecnologie UO Ematologia Clinica Ospedale Civile Spirito Santo Pescara Italy;

Division of Hematology Department of Translational Medicine Amedeo Avogadro University of Eastern Piedmont and Maggiore Hospital Novara Italy;

Division of Hematology Fondazione IRCCS Istituto Nazionale dei Tumori Milano Italy; and

Divisione di Ematologia Azienda Policlinico Ospedale Vittorio Emanuele Università di Catania Catania Italy;

Divisione di Medicina Interna ed Ematologia AOU San Luigi Gonzaga Orbassano Italy;

Emat CTMO Ospedale R Binaghi Cagliari Cagliari Italy;

Istituto di Ricovero e Cura a Carattere Scientifico Casa Sollievo della Sofferenza Unità di Ematologia San Giovanni Rotondo Italy;

Myeloma Unit Division of Hematology University of Torino Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino Torino Italy;

Struttura Complessa Ematologia Dipartimento di Ematologia ed Oncologia AOU Città della Salute e della Scienza di Torino San Giovanni Battista Torino Italy;

Unit of Clinical Epidemiology AOU Città della Salute e della Scienza di Torino and Centro di Riferimento per l'Epidemiologia e la Prevenzione Oncologica in Piemonte Torino Italy;

Unità Operativa Complessa Ematologia Azienda Ospedaliera Universitaria G Martino Messina Italy;

Unità Operativa Ematologia e Trapianto Cellule Staminali Emopoietiche IRCCS Centro di Riferimento Oncologico della Basilicata Rionero in Vulture Italy;

UO Di Ematologia e Centro Trapianti Midollo Osseo Azienda Ospedaliero Universitaria di Parma Parma Italy; Myeloma Unit Dipartimento di Medicina Clinica e Sperimentale Università degli Studi di Parma Parma Italy;

Erratum v

Blood. 2018 Mar 29;131(13):1495. doi: 10.1182/blood-2018-02-832048. PubMed

Citace poskytuje Crossref.org

Epidemiology, genetics and treatment of multiple myeloma and precursor diseases

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

First-line therapy with either bortezomib-melphalan-prednisone or lenalidomide-dexamethasone followed by lenalidomide for transplant-ineligible multiple myeloma patients: a pooled analysis of two randomized trials

Outcome of paraosseous extra-medullary disease in newly diagnosed multiple myeloma patients treated with new drugs

Lenalidomide Maintenance with or without Prednisone in Newly Diagnosed Myeloma Patients: A Pooled Analysis

Maintenance Treatment and Survival in Patients With Myeloma: A Systematic Review and Network Meta-analysis

Zobrazit více v PubMed

ClinicalTrials.gov
NCT01093196