Carfilzomib, cyclophosphamide, and dexamethasone in patients with newly diagnosed multiple myeloma: a multicenter, phase 2 study
Menée sur 58 patients atteints d'un myélome multiple après 65 ans, cet essai de phase II évalue l'efficacité et la toxicité d'un traitement comprenant carfilzomib (un inhibiteur du protéasome), cyclophosphamide et dexaméthasone
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) aged ≥65 years or who were ineligible for autologous stem cell transplantation. Patients (N=58) received CCyd for up to nine 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 PFS and OS rates were 76% and 87%, respectively. The most frequent grade 3–5 toxicities were neutropenia (20%), anemia (11%), and cardiopulmonary adverse events (7%). Peripheral neuropathy was limited to grade 1–2 (9%). Fourteen percent of patients discontinued treatment owing to adverse events, and 21% of patients required carfilzomib dose reductions. This is the first study of carfilzomib in combination with an alkylating agent in elderly patients with NDMM; results showed high complete response rates and a good safety profile. This study was registered at clinicaltrials.gov, identifier: NCT01346787.
Blood 2014