Lenalidomide maintenance with or without prednisone in newly diagnosed myeloma patients: A pooled analysis

Francesca Bonello, Stefano Pulini, Stelvio Ballanti, Massimo Gentile, Stefano Spada, Ombretta Annibali, Paola Omedé, Sonia Ronconi, Clotilde Cangialosi, Luigi Podda, Angelo Palmas, Alessandra Malfitano, Giulia Rivoli, Angelo Belotti, Fabrizio Ciambelli, Iolanda Donatella Vincelli, Anna Maria Cafro, Vanessa Innao, Antonio Palumbo, Pieter SonneveldAndrew Spencer, Roman Hájek, Mario Boccadoro, Francesca Gay

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Article number1735
Issue number11
Publication statusPublished - Nov 2019


  • Lenalidomide
  • Maintenance
  • Multiple myeloma
  • Newly diagnosed
  • Prednisone

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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