: We conducted a pooled analysis of two phase III trials, RV-MM-EMN-441 and EMN01, to compare maintenance with lenalidomide-prednisone vs. lenalidomide in newly diagnosed transplant-eligible and -ineligible myeloma patients. Primary endpoints were progression-free survival, progression-free survival 2 and overall survival with both regimens. A secondary aim was to evaluate the impact of duration of maintenance on overall survival and on outcome after relapse. A total of 625 patients (lenalidomide-prednisone arm, n = 315; lenalidomide arm, n = 310) were analyzed. The median follow-up was 58 months. Median progression-free survival (25 vs. 19 months; p = 0.08), progression-free survival 2 (56 vs. 49 months; p = 0.9) and overall survival (73 months vs. NR; p = 0.08) were not significantly different between the two arms. Toxicity profiles of lenalidomide-prednisone and lenalidomide were similar, with the exception of neutropenia that was higher in the lenalidomide arm (grade ≥ 3: 9% vs. 19%, p < 0.001), without an increase in the rate of infections. Overall survival (median NR vs. 49 months, p < 0.001), progression-free survival from relapse (median 35 vs. 24 months, p = 0.004) and overall survival from relapse (median not reached vs. 41 months, p = 0.002) were significantly longer in patients continuing maintenance for ≥2 years. We showed that the addition of prednisone at 25 or 50 mg every other day (eod) to lenalidomide maintenance did not induce any significant advantage.

Department of Haematology Alfred Health Monash University Melbourne VIC 3004 Australia

Department of Haematooncology University Hospital Ostrava 70852 Ostrava Czech Republic

Department of Hematology Erasmus MC Cancer Institute 3015 GD Rotterdam The Netherlands

Department of Oncology and Hematology Niguarda Ca'Granda Hospital 20162 Milano Italy

Division of Hematology ASST Spedali Civili di Brescia 25123 Brescia Italy

Division of Hematology Department of Human Pathology and the Adult Developmental Faculty of Medicine Messina University 98122 Messina Italy

Divisione di Ematologia Grande Ospedale Metropolitano Bianchi Melacrino Morelli 89124 Reggio Calabria Italy

Divisione Ematologia UTMO Azienda Ospedaliera Villa Sofia Cervello 90146 Palermo Italy

Ematologia Azienda Ospedaliero Universitaria Sassari 07100 Sassari Italy

Ematologia con TMO Ospedale Santa Maria della Misericordia 06129 Perugia Italy

Ematologia Ospedale S Francesco 08100 Nuoro ATS Sardegna Italy

Faculty of Medicine University of Ostrava ‎70300 Ostrava Czech Republic

Haematology Clinic Department of Internal Medicine University of Genoa Policlinico San Martino IRCCS per l'Oncologia 16132 Genova Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS 47014 Meldola Italy

Myeloma Unit Division of Hematology University of Torino Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino via Genova 3 10126 Torino Italy

Sc Ematologia ASST Valle Olona 21052 Busto Arsizio Italy

U O Ematologia Clinica Dipartimento di Ematologia Ospedale Civile Spirito Santo 65124 Pescara Italy

Unit of Hematology Stem Cell Transplantation University Campus Bio Medico 00128 Rome Italy

UOC di Ematologia AO Cosenza 87100 Cosenza Italy

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