Carfilzomib, cyclophosphamide, and dexamethasone in patients with newly diagnosed multiple myeloma

A multicenter, phase 2 study

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 & 1 others Antonio Palumbo

Research output: Contribution to journalArticle

83 Citations (Scopus)

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 5 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 languageEnglish
Pages (from-to)63-69
Number of pages7
JournalBlood
Volume124
Issue number1
DOIs
Publication statusPublished - Jul 3 2014

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Multiple Myeloma
Cyclophosphamide
Dexamethasone
Patient treatment
Proteasome Inhibitors
Stem cells
Toxicity
Labels
Safety
Stem Cell Transplantation
Peripheral Nervous System Diseases
Neutropenia
Disease-Free Survival
Anemia
Survival Rate
Maintenance
carfilzomib
Therapeutics

ASJC Scopus subject areas

  • Hematology
  • Biochemistry
  • Cell Biology
  • Immunology
  • Medicine(all)

Cite this

Bringhen, S., Petrucci, M. T., Larocca, A., Conticello, C., Rossi, D., Magarotto, V., ... Palumbo, A. (2014). Carfilzomib, cyclophosphamide, and dexamethasone in patients with newly diagnosed multiple myeloma: A multicenter, phase 2 study. Blood, 124(1), 63-69. https://doi.org/10.1182/blood-2014-03-563759

Carfilzomib, cyclophosphamide, and dexamethasone in patients with newly diagnosed multiple myeloma : A multicenter, phase 2 study. / Bringhen, Sara; Petrucci, Maria Teresa; Larocca, Alessandra; Conticello, Concetta; Rossi, Davide; Magarotto, Valeria; Musto, Pellegrino; Boccadifuoco, Luana; Offidani, Massimo; Omedé, Paola; Gentilini, Fabiana; Ciccone, Giovannino; Benevolo, Giulia; Genuardi, Mariella; Montefusco, Vittorio; Oliva, Stefania; Caravita, Tommaso; Tacchetti, Paola; Boccadoro, Mario; Sonneveld, Pieter; Palumbo, Antonio.

In: Blood, Vol. 124, No. 1, 03.07.2014, p. 63-69.

Research output: Contribution to journalArticle

Bringhen, S, Petrucci, MT, Larocca, A, Conticello, C, Rossi, D, Magarotto, V, Musto, P, Boccadifuoco, L, Offidani, M, Omedé, P, Gentilini, F, Ciccone, G, Benevolo, G, Genuardi, M, Montefusco, V, Oliva, S, Caravita, T, Tacchetti, P, Boccadoro, M, Sonneveld, P & Palumbo, A 2014, 'Carfilzomib, cyclophosphamide, and dexamethasone in patients with newly diagnosed multiple myeloma: A multicenter, phase 2 study', Blood, vol. 124, no. 1, pp. 63-69. https://doi.org/10.1182/blood-2014-03-563759
Bringhen, Sara ; Petrucci, Maria Teresa ; Larocca, Alessandra ; Conticello, Concetta ; Rossi, Davide ; Magarotto, Valeria ; Musto, Pellegrino ; Boccadifuoco, Luana ; Offidani, Massimo ; Omedé, Paola ; Gentilini, Fabiana ; Ciccone, Giovannino ; Benevolo, Giulia ; Genuardi, Mariella ; Montefusco, Vittorio ; Oliva, Stefania ; Caravita, Tommaso ; Tacchetti, Paola ; Boccadoro, Mario ; Sonneveld, Pieter ; Palumbo, Antonio. / Carfilzomib, cyclophosphamide, and dexamethasone in patients with newly diagnosed multiple myeloma : A multicenter, phase 2 study. In: Blood. 2014 ; Vol. 124, No. 1. pp. 63-69.
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AU - Conticello, Concetta

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AU - Magarotto, Valeria

AU - Musto, Pellegrino

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AU - Offidani, Massimo

AU - Omedé, Paola

AU - Gentilini, Fabiana

AU - Ciccone, Giovannino

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AU - Montefusco, Vittorio

AU - Oliva, Stefania

AU - Caravita, Tommaso

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