Carfilzomib, cyclophosphamide, and dexamethasone in patients with newly diagnosed multiple myeloma: a multicenter, phase 2 study

S Bringhen, MT Petrucci, A Larocca, C Conticello, D Rossi, V Magarotto, P Musto, L Boccadifuoco, M Offidani, P Omede, F Gentilini, G Ciccone, G Benevolo, M Genuardi, V Montefusco, S Oliva, T Caravita, P Tacchetti, M Boccadoro, Pieter SonneveldA Palumbo

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Abstract

This multicenter, open-label phase 2 trial determined the safety and efficacy of carfilzomib, a novel and irreversible proteasome inhibitor, in combination with cyclophosphamide and dexamethasone (CCyd) in patients with newly diagnosed multiple myeloma (NDMM) >= 65 years of age or who were ineligible for autologous stem cell transplantation. Patients (N = 58) received CCyd for up to 9 28-day cycles, followed by maintenance with carfilzomib until progression or intolerance. After a median of 9 CCyd induction cycles (range 1-9), 95% of patients achieved at least a partial response, 71% achieved at least a very good partial response, 49% achieved at least a near complete response, and 20% achieved stringent complete response. After a median follow-up of 18 months, the 2-year progression-free survival and overall survival rates were 76% and 87%, respectively. The most frequent grade 3 to 5 toxicities were neutropenia (20%), anemia (11%), and cardiopulmonary adverse events (7%). Peripheral neuropathy was limited to grades 1 and 2 (9%). Fourteen percent of patients discontinued treatment because of adverse events, and 21% of patients required carfilzomib dose reductions. In summary, results showed high complete response rates and a good safety profile. This trial was registered at clinicaltrials.gov as #NCT01346787.
Original languageUndefined/Unknown
Pages (from-to)63-69
Number of pages7
JournalBlood
Volume124
Issue number1
DOIs
Publication statusPublished - 2014

Research programs

  • EMC MM-02-41-03

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