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 lowdose 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 medianPFSwas22 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.

Triplet vs doublet lenalidomide-containing regimens for the treatment of elderly patients with newly diagnosed multiple myeloma / Magarotto, Valeria; Bringhen, Sara; Offidani, Massimo; Benevolo, Giulia; Patriarca, Francesca; Mina, Roberto; Falcone, Antonietta Pia; De Paoli, Lorenzo; Pietrantuono, Giuseppe; Gentili, Silvia; Musolino, Caterina; Giuliani, Nicola; Bernardini, Annalisa; Conticello, Concetta; Pulini, Stefano; Ciccone, Giovannino; Maisnar, Vladimír; Ruggeri, Marina; Zambello, Renato; Guglielmelli, Tommasina; Ledda, Antonio; Liberati, Anna Marina; Montefusco, Vittorio; Hajek, Roman; Boccadoro, Mario; Palumbo, Antonio. - In: BLOOD. - ISSN 0006-4971. - 127:9(2016), pp. 1102-1108. [10.1182/blood-2015-08-662627]

Triplet vs doublet lenalidomide-containing regimens for the treatment of elderly patients with newly diagnosed multiple myeloma

GIULIANI, Nicola;
2016-01-01

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 lowdose 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 medianPFSwas22 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.
2016
Triplet vs doublet lenalidomide-containing regimens for the treatment of elderly patients with newly diagnosed multiple myeloma / Magarotto, Valeria; Bringhen, Sara; Offidani, Massimo; Benevolo, Giulia; Patriarca, Francesca; Mina, Roberto; Falcone, Antonietta Pia; De Paoli, Lorenzo; Pietrantuono, Giuseppe; Gentili, Silvia; Musolino, Caterina; Giuliani, Nicola; Bernardini, Annalisa; Conticello, Concetta; Pulini, Stefano; Ciccone, Giovannino; Maisnar, Vladimír; Ruggeri, Marina; Zambello, Renato; Guglielmelli, Tommasina; Ledda, Antonio; Liberati, Anna Marina; Montefusco, Vittorio; Hajek, Roman; Boccadoro, Mario; Palumbo, Antonio. - In: BLOOD. - ISSN 0006-4971. - 127:9(2016), pp. 1102-1108. [10.1182/blood-2015-08-662627]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/2810784
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