Carfilzomib, cyclophosphamide, and dexamethasone in patients with newly diagnosed multiple myeloma: a multicenter, phase 2 study
| Autor: | Pieter Sonneveld, Concetta Conticello, Massimo Offidani, Valeria Magarotto, Stefania Oliva, Fabiana Gentilini, Sara Bringhen, Luana Boccadifuoco, Mario Boccadoro, Vittorio Montefusco, Pellegrino Musto, Giulia Benevolo, Davide Rossi, Maria Teresa Petrucci, Alessandra Larocca, Paola Omedè, Paola Tacchetti, Tommaso Caravita, Giovannino Ciccone, Antonio Palumbo, Mariella Genuardi |
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| Přispěvatelé: | Hematology, 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 |
| Rok vydání: | 2014 |
| Předmět: |
Male
medicine.medical_specialty Cyclophosphamide Immunology Phases of clinical research Kaplan-Meier Estimate Neutropenia Biochemistry Gastroenterology Dexamethasone Disease-Free Survival chemistry.chemical_compound Autologous stem-cell transplantation MULTIPLE MYELOMA Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Adverse effect Multiple myeloma Aged Very Good Partial Response carfilzomib business.industry Cell Biology Hematology medicine.disease Carfilzomib Surgery Treatment Outcome chemistry Female business Oligopeptides medicine.drug |
| Zdroj: | Blood, 124(1), 63-69. American Society of Hematology |
| ISSN: | 0006-4971 |
| Popis: | 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. © 2014 by The American Society of Hematology. |
| Databáze: | OpenAIRE |
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