title: Triplet vs doublet lenalidomide-containing regimens for the treatment of elderly patients with newly diagnosed multiple myeloma.
abstract: 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.
authors.affiliation: Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino, Torino, Italy;
authors.forename: Valeria
authors.initials: V
authors.lastname: Magarotto
authors.affiliation: Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino, Torino, Italy;
authors.forename: Sara
authors.initials: S
authors.lastname: Bringhen
authors.affiliation: Clinica di Ematologia, AOU Ospedali Riuniti di Ancona, Ancona, Italy;
authors.forename: Massimo
authors.initials: M
authors.lastname: Offidani
authors.affiliation: Struttura Complessa (SC) Ematologia, Dipartimento di Ematologia ed Oncologia, AOU Città della Salute e della Scienza di Torino, San Giovanni Battista, Torino, Italy;
authors.forename: Giulia
authors.initials: G
authors.lastname: Benevolo
authors.affiliation: Azienda Ospedaliera-Universitaria di Udine, Dipartimento Scienze Mediche, Sperimentali e Cliniche, Università di Udine, Udine, Italy;
authors.forename: Francesca
authors.initials: F
authors.lastname: Patriarca
authors.affiliation: Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino, Torino, Italy;
authors.forename: Roberto
authors.initials: R
authors.lastname: Mina
authors.affiliation: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Casa Sollievo della Sofferenza, Unità di Ematologia, San Giovanni Rotondo, Italy;
authors.forename: Antonietta Pia
authors.initials: AP
authors.lastname: Falcone
authors.affiliation: Division of Hematology, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont and Maggiore Hospital, Novara, Italy;
authors.forename: Lorenzo
authors.initials: L
authors.lastname: De Paoli
authors.affiliation: Unità Operativa (UO) Ematologia e Trapianto Cellule Staminali Emopoietiche, IRCCS, Centro di Riferimento Oncologico della Basilicata, Rionero in Vulture, Italy;
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Pietrantuono
authors.affiliation: Clinica di Ematologia, AOU Ospedali Riuniti di Ancona, Ancona, Italy;
authors.forename: Silvia
authors.initials: S
authors.lastname: Gentili
authors.affiliation: Unità Operativa Complessa Ematologia Azienda Ospedaliera Universitaria G. Martino, Messina, Italy;
authors.forename: Caterina
authors.initials: C
authors.lastname: Musolino
authors.affiliation: UO Di Ematologia e Centro Trapianti Midollo Osseo (CTMO), Azienda Ospedaliero-Universitaria di Parma, Parma, Italy; Myeloma Unit, Dipartimento di Medicina Clinica e Sperimentale, Università degli Studi di Parma, Parma, Italy;
authors.forename: Nicola
authors.initials: N
authors.lastname: Giuliani
authors.affiliation: Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino, Torino, Italy;
authors.forename: Annalisa
authors.initials: A
authors.lastname: Bernardini
authors.affiliation: Divisione di Ematologia, Azienda Policlinico-Ospedale Vittorio Emanuele, Università di Catania, Catania, Italy;
authors.forename: Concetta
authors.initials: C
authors.lastname: Conticello
authors.affiliation: Dipartimento di Ematologia, Medicina Trasfusionale e Biotecnologie, UO Ematologia Clinica, Ospedale Civile Spirito Santo, Pescara, Italy;
authors.forename: Stefano
authors.initials: S
authors.lastname: Pulini
authors.affiliation: 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;
authors.forename: Giovannino
authors.initials: G
authors.lastname: Ciccone
authors.affiliation: Fourth Department of Medicine-Hematology, Charles University Hospital Hradec Kralove, Hradec Kralove, Czech Republic;
authors.forename: Vladimír
authors.initials: V
authors.lastname: Maisnar
authors.affiliation: Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino, Torino, Italy;
authors.forename: Marina
authors.initials: M
authors.lastname: Ruggeri
authors.affiliation: Department of Medicine, Hematology and Clinical Immunology, Padua School of Medicine, Padua, Italy;
authors.forename: Renato
authors.initials: R
authors.lastname: Zambello
authors.affiliation: Divisione di Medicina Interna ed Ematologia, AOU San Luigi Gonzaga, Orbassano, Italy;
authors.forename: Tommasina
authors.initials: T
authors.lastname: Guglielmelli
authors.affiliation: Emat/CTMO Ospedale R. Binaghi Cagliari, Cagliari, Italy;
authors.forename: Antonio
authors.initials: A
authors.lastname: Ledda
authors.affiliation: Azienda Ospedaliera S. Maria di Terni, SC Oncoematologia, Terni, Italy;
authors.forename: Anna Marina
authors.initials: AM
authors.lastname: Liberati
authors.affiliation: Division of Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy; and.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Montefusco
authors.affiliation: Department of Haematooncology, University Hospital Ostrava and University of Ostrava, Ostrava, Czech Republic.
authors.forename: Roman
authors.initials: R
authors.lastname: Hajek
authors.affiliation: Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino, Torino, Italy;
authors.forename: Mario
authors.initials: M
authors.lastname: Boccadoro
authors.affiliation: Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino, Torino, Italy;
authors.forename: Antonio
authors.identifier: http://orcid.org/0000-0002-1763-6609
authors.initials: A
authors.lastname: Palumbo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003710:Demography; D018572:Disease-Free Survival; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000175:diagnosis* / Q000188:drug therapy*; D013792:Thalidomide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D000077269:Lenalidomide