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

Blood (2014-05-24)
Sara Bringhen, Maria Teresa Petrucci, Alessandra Larocca, Concetta Conticello, Davide Rossi, Valeria Magarotto, Pellegrino Musto, Luana Boccadifuoco, Massimo Offidani, Paola Omedé, Fabiana Gentilini, Giovannino Ciccone, Giulia Benevolo, Mariella Genuardi, Vittorio Montefusco, Stefania Oliva, Tommaso Caravita, Paola Tacchetti, Mario Boccadoro, Pieter Sonneveld, Antonio Palumbo
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.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Dexamethasone, powder, BioReagent, suitable for cell culture, ≥97%
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Dexamethasone, meets USP testing specifications
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Dexamethasone, VETRANAL®, analytical standard
Dexamethasone for system suitability, European Pharmacopoeia (EP) Reference Standard
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Dexamethasone, tested according to Ph. Eur.
Dexamethasone for peak identification, European Pharmacopoeia (EP) Reference Standard