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Lenalidomide-based induction and maintenance in elderly newly diagnosed multiple myeloma patients: updated results of the EMN01 randomized trial
Sara Bringhen, Mattia D'Agostino, Laura Paris, Stelvio Ballanti, Norbert Pescosta, Stefano Spada, Sara Pezzatti, Mariella Grasso, Delia Rota-Scalabrini, Luca De Rosa, Vincenzo Pavone, Giulia Gazzera, Sara Aquino, Marco Poggiu, Armando Santoro, Massimo Gentile, Luca Baldini, Maria Teresa Petrucci, Patrizia Tosi, Roberto Marasca, Claudia Cellini, Antonio Palumbo, Patrizia Falco, Roman Hájek, Mario Boccadoro, Alessandra Larocca
Haematologica October 2019 : haematol.2019.226407; doi:10.3324/haematol.2019.226407
Sara Bringhen
Division of Hematology, University of Torino,AOU Città della Salute e della Scienza di Torino;
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Mattia D'Agostino
Division of Hematology, University of Torino,AOU Città della Salute e della Scienza di Torino;
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Laura Paris
Hematology and Bone Marrow Transplant Unit, ASST Papa Giovanni XXIII, Bergamo, Italy;
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Stelvio Ballanti
Ematologia e Immunologia Clinica, O. S. Maria della Misericordia, S. Andrea delle Fratte, Perugia;
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Norbert Pescosta
Reparto Ematologia e Centro TMO, Ospedale Centrale, Bolzano, Italy;
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Stefano Spada
Division of Hematology, University of Torino,AOU Città della Salute e della Scienza di Torino;
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Sara Pezzatti
Divisione di Ematologia, Ospedale S. Gerardo, Monza, Italy;
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Mariella Grasso
Azienda Ospedaliera S.Croce-Carle, Cuneo, Italy;
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Delia Rota-Scalabrini
Medical Oncology, Candiolo Cancer Institute FPO IRCCS, Candiolo, Italy;
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Luca De Rosa
Hematology and Stem Cell Transplantation Unit, Az. Osp. S. Camillo-Forlanini, Rome, Italy;
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Vincenzo Pavone
UOC Ematologia e trapianto, Az. Osp. C. Panico, Tricase (Lecce), Italy;
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Giulia Gazzera
Division of Hematology, University of Torino,AOU Città della Salute e della Scienza di Torino;
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Sara Aquino
Ematologia, IRCCS Osp. Policlinico S. Martino, Genova, Italy;
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Marco Poggiu
Division of Hematology, University of Torino,AOU Città della Salute e della Scienza di Torino;
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Armando Santoro
Istituto Clinico Humanitas, Humanitas University, Rozzano-Milano, Italy;
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Massimo Gentile
UOC Ematologia AO Cosenza, Cosenza, Italy;
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Luca Baldini
Ematologia, Univ. degli Studi di Milano, Fond. IRCCS Ca' Granda,Osp. Maggiore Policlinico, Milano;
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Maria Teresa Petrucci
Hematology, Azienda Policlinico Umberto I, Roma, Italy;
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Patrizia Tosi
UO Ematologia, Ospedale di Rimini, AUSL della Romagna, Rimini, Italy;
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Roberto Marasca
Hematology, Dpt. of Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena,IT;
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Claudia Cellini
U.O. Ematologia, Ospedale Santa Maria delle Croci, Ravenna, Italy;
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Antonio Palumbo
Division of Hematology, University of Torino,AOU Città della Salute e della Scienza di Torino;
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Patrizia Falco
SSD Ematologia, ASLTO4, Ospedali di Chivasso Cirié Ivrea, Italy;
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Roman Hájek
Dpt. of Haematooncology, Univ. Hospital Ostrava / Faculty of Medicine, University of Ostrava, CZ
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Mario Boccadoro
Division of Hematology, University of Torino,AOU Città della Salute e della Scienza di Torino;
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Alessandra Larocca
Division of Hematology, University of Torino,AOU Città della Salute e della Scienza di Torino;
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Author Affiliations

  1. Sara Bringhen1,*,
  2. Mattia D'Agostino1,
  3. Laura Paris2,
  4. Stelvio Ballanti3,
  5. Norbert Pescosta4,
  6. Stefano Spada1,
  7. Sara Pezzatti5,
  8. Mariella Grasso6,
  9. Delia Rota-Scalabrini7,
  10. Luca De Rosa8,
  11. Vincenzo Pavone9,
  12. Giulia Gazzera1,
  13. Sara Aquino10,
  14. Marco Poggiu1,
  15. Armando Santoro11,
  16. Massimo Gentile12,
  17. Luca Baldini13,
  18. Maria Teresa Petrucci14,
  19. Patrizia Tosi15,
  20. Roberto Marasca16,
  21. Claudia Cellini17,
  22. Antonio Palumbo1,
  23. Patrizia Falco18,
  24. Roman Hájek19,
  25. Mario Boccadoro1 and
  26. Alessandra Larocca1
  1. 1 Division of Hematology, University of Torino,AOU Città della Salute e della Scienza di Torino;
  2. 2 Hematology and Bone Marrow Transplant Unit, ASST Papa Giovanni XXIII, Bergamo, Italy;
  3. 3 Ematologia e Immunologia Clinica, O. S. Maria della Misericordia, S. Andrea delle Fratte, Perugia;
  4. 4 Reparto Ematologia e Centro TMO, Ospedale Centrale, Bolzano, Italy;
  5. 5 Divisione di Ematologia, Ospedale S. Gerardo, Monza, Italy;
  6. 6 Azienda Ospedaliera S.Croce-Carle, Cuneo, Italy;
  7. 7 Medical Oncology, Candiolo Cancer Institute FPO IRCCS, Candiolo, Italy;
  8. 8 Hematology and Stem Cell Transplantation Unit, Az. Osp. S. Camillo-Forlanini, Rome, Italy;
  9. 9 UOC Ematologia e trapianto, Az. Osp. C. Panico, Tricase (Lecce), Italy;
  10. 10 Ematologia, IRCCS Osp. Policlinico S. Martino, Genova, Italy;
  11. 11 Istituto Clinico Humanitas, Humanitas University, Rozzano-Milano, Italy;
  12. 12 UOC Ematologia AO Cosenza, Cosenza, Italy;
  13. 13 Ematologia, Univ. degli Studi di Milano, Fond. IRCCS Ca' Granda,Osp. Maggiore Policlinico, Milano;
  14. 14 Hematology, Azienda Policlinico Umberto I, Roma, Italy;
  15. 15 UO Ematologia, Ospedale di Rimini, AUSL della Romagna, Rimini, Italy;
  16. 16 Hematology, Dpt. of Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena,IT;
  17. 17 U.O. Ematologia, Ospedale Santa Maria delle Croci, Ravenna, Italy;
  18. 18 SSD Ematologia, ASLTO4, Ospedali di Chivasso Cirié Ivrea, Italy;
  19. 19 Dpt. of Haematooncology, Univ. Hospital Ostrava / Faculty of Medicine, University of Ostrava, CZ
  1. ↵* Corresponding author; email: sarabringhen{at}yahoo.com
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Abstract

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 (<15%). In fit patients, melphalan-prednisone-lenalidomide significantly prolonged progression-free survival compared to cyclophosphamide-prednisone-lenalidomide (HR 0.72,p=0.05) and lenalidomide-dexamethasone (HR 0.72, p=0.04). Likewise, a trend towards a better overall survival was noted for melphalan-prednisone-lenalidomide and cyclophosphamide-prednisone-lenalidomide, as compared to lenalidomide-dexamethasone. No differences were observed in intermediate-fit and frail patients. This analysis showed positive outcomes of maintenance with lenalidomide-based regimens, with a good safety profile. For the first time, we showed that fit patients benefit from a triplet full-dose regimen, while intermediate-fit and frail patients from gentler regimens. ClinicalTrials.gov registration number: NCT01093196.

  • Received May 20, 2019.
  • Accepted September 26, 2019.
  • Copyright © 2019, Ferrata Storti Foundation
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Keywords

multiple myeloma
elderly patients
lenalidomide based induction
lenalidomide based maintenance
newly diagnosed

Vol 104 Issue 12

Haematologica: 104 (12)
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Lenalidomide-based induction and maintenance in elderly newly diagnosed multiple myeloma patients: updated results of the EMN01 randomized trial
Sara Bringhen, Mattia D'Agostino, Laura Paris, Stelvio Ballanti, Norbert Pescosta, Stefano Spada, Sara Pezzatti, Mariella Grasso, Delia Rota-Scalabrini, Luca De Rosa, Vincenzo Pavone, Giulia Gazzera, Sara Aquino, Marco Poggiu, Armando Santoro, Massimo Gentile, Luca Baldini, Maria Teresa Petrucci, Patrizia Tosi, Roberto Marasca, Claudia Cellini, Antonio Palumbo, Patrizia Falco, Roman Hájek, Mario Boccadoro, Alessandra Larocca
Haematologica Oct 2019, haematol.2019.226407; DOI: 10.3324/haematol.2019.226407

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Sara Bringhen, Mattia D'Agostino, Laura Paris, Stelvio Ballanti, Norbert Pescosta, Stefano Spada, Sara Pezzatti, Mariella Grasso, Delia Rota-Scalabrini, Luca De Rosa, Vincenzo Pavone, Giulia Gazzera, Sara Aquino, Marco Poggiu, Armando Santoro, Massimo Gentile, Luca Baldini, Maria Teresa Petrucci, Patrizia Tosi, Roberto Marasca, Claudia Cellini, Antonio Palumbo, Patrizia Falco, Roman Hájek, Mario Boccadoro, Alessandra Larocca
Haematologica Oct 2019, haematol.2019.226407; DOI: 10.3324/haematol.2019.226407
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Original Article

  • Thrombin generation in cardiovascular disease and mortality - results from the Gutenberg Health Study
  • Fractures and survival in multiple myeloma: results from a population-based study
  • Functional plasminogen activator inhibitor 1 is retained on the activated platelet membrane following platelet activation
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