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Feasibility, Tolerability and Efficacy of Carfilzomib in Combination with Lenalidomide and Dexamethasone in Relapsed Refractory Myeloma Patients: A Retrospective Real-Life Survey of the Sicilian Myeloma Network

Background: The ASPIRE (NCT01080391) phase 3 trial showed the efficacy of carfilzomib, lenalidomide and dexamethasone (KRd) triplet for relapse and refractory multiple myeloma (RRMM). However, little is known about safety and efficacy of KRd outside a clinical trial context. Methods: Herein we repor...

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Autores principales: Conticello, Concetta, Romano, Alessandra, Del Fabro, Vittorio, Martino, Enrica Antonia, Calafiore, Valeria, Sapienza, Giuseppe, Leotta, Valerio, Parisi, Marina Silvia, Markovic, Uros, Garibaldi, Bruno, Leotta, Salvatore, Cotzia, Emilia, Innao, Vanessa, Mannina, Donato, Neri, Santo, Musso, Maurizio, Scalone, Renato, Cangialosi, Clotilde, Acquaviva, Francesco, Cardinale, Giovanni, Merenda, Anxur, Maugeri, Cinzia, Uccello, Giuseppina, Poidomani, Massimo, Longo, Giuseppe, Carlisi, Melania, Tibullo, Daniele, Di Raimondo, Francesco
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6617295/
https://www.ncbi.nlm.nih.gov/pubmed/31248142
http://dx.doi.org/10.3390/jcm8060877
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author Conticello, Concetta
Romano, Alessandra
Del Fabro, Vittorio
Martino, Enrica Antonia
Calafiore, Valeria
Sapienza, Giuseppe
Leotta, Valerio
Parisi, Marina Silvia
Markovic, Uros
Garibaldi, Bruno
Leotta, Salvatore
Cotzia, Emilia
Innao, Vanessa
Mannina, Donato
Neri, Santo
Musso, Maurizio
Scalone, Renato
Cangialosi, Clotilde
Acquaviva, Francesco
Cardinale, Giovanni
Merenda, Anxur
Maugeri, Cinzia
Uccello, Giuseppina
Poidomani, Massimo
Longo, Giuseppe
Carlisi, Melania
Tibullo, Daniele
Di Raimondo, Francesco
author_facet Conticello, Concetta
Romano, Alessandra
Del Fabro, Vittorio
Martino, Enrica Antonia
Calafiore, Valeria
Sapienza, Giuseppe
Leotta, Valerio
Parisi, Marina Silvia
Markovic, Uros
Garibaldi, Bruno
Leotta, Salvatore
Cotzia, Emilia
Innao, Vanessa
Mannina, Donato
Neri, Santo
Musso, Maurizio
Scalone, Renato
Cangialosi, Clotilde
Acquaviva, Francesco
Cardinale, Giovanni
Merenda, Anxur
Maugeri, Cinzia
Uccello, Giuseppina
Poidomani, Massimo
Longo, Giuseppe
Carlisi, Melania
Tibullo, Daniele
Di Raimondo, Francesco
author_sort Conticello, Concetta
collection PubMed
description Background: The ASPIRE (NCT01080391) phase 3 trial showed the efficacy of carfilzomib, lenalidomide and dexamethasone (KRd) triplet for relapse and refractory multiple myeloma (RRMM). However, little is known about safety and efficacy of KRd outside a clinical trial context. Methods: Herein we report real life results of KRd given to 130 RRMM patients from 12 Sicilian Centers. Results: Median age was 62 years; patients had received a median of two previous lines of treatment (range 1–10) and 52% were refractory to previous treatment. Median number of KRd cycles was 12 (2–29), with a mean duration of treatment of 12 months; 21 patients had received at least 18 cycles. Overall response rate was 61%, including 18% complete response. Median PFS was 22.9 months, median OS was not reached. Creatinine clearance >30 mL/min, quality of the best achieved response and standard Fluorescence In Situ Hybridization (FISH) risk were independent predictors of favorable outcome. Patients who received the full-dosage of carfilzomib in the first two cycles had a better outcome. Conclusions: KRd was effective and well tolerated and in a considerable proportion of patients, therapy continued beyond the 18th cycle. The finding of a better outcome in patients with the higher cumulative dose of carfilzomib in the first two cycle encourages to maintain the maximum tolerated dose.
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spelling pubmed-66172952019-07-18 Feasibility, Tolerability and Efficacy of Carfilzomib in Combination with Lenalidomide and Dexamethasone in Relapsed Refractory Myeloma Patients: A Retrospective Real-Life Survey of the Sicilian Myeloma Network Conticello, Concetta Romano, Alessandra Del Fabro, Vittorio Martino, Enrica Antonia Calafiore, Valeria Sapienza, Giuseppe Leotta, Valerio Parisi, Marina Silvia Markovic, Uros Garibaldi, Bruno Leotta, Salvatore Cotzia, Emilia Innao, Vanessa Mannina, Donato Neri, Santo Musso, Maurizio Scalone, Renato Cangialosi, Clotilde Acquaviva, Francesco Cardinale, Giovanni Merenda, Anxur Maugeri, Cinzia Uccello, Giuseppina Poidomani, Massimo Longo, Giuseppe Carlisi, Melania Tibullo, Daniele Di Raimondo, Francesco J Clin Med Article Background: The ASPIRE (NCT01080391) phase 3 trial showed the efficacy of carfilzomib, lenalidomide and dexamethasone (KRd) triplet for relapse and refractory multiple myeloma (RRMM). However, little is known about safety and efficacy of KRd outside a clinical trial context. Methods: Herein we report real life results of KRd given to 130 RRMM patients from 12 Sicilian Centers. Results: Median age was 62 years; patients had received a median of two previous lines of treatment (range 1–10) and 52% were refractory to previous treatment. Median number of KRd cycles was 12 (2–29), with a mean duration of treatment of 12 months; 21 patients had received at least 18 cycles. Overall response rate was 61%, including 18% complete response. Median PFS was 22.9 months, median OS was not reached. Creatinine clearance >30 mL/min, quality of the best achieved response and standard Fluorescence In Situ Hybridization (FISH) risk were independent predictors of favorable outcome. Patients who received the full-dosage of carfilzomib in the first two cycles had a better outcome. Conclusions: KRd was effective and well tolerated and in a considerable proportion of patients, therapy continued beyond the 18th cycle. The finding of a better outcome in patients with the higher cumulative dose of carfilzomib in the first two cycle encourages to maintain the maximum tolerated dose. MDPI 2019-06-19 /pmc/articles/PMC6617295/ /pubmed/31248142 http://dx.doi.org/10.3390/jcm8060877 Text en © 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Conticello, Concetta
Romano, Alessandra
Del Fabro, Vittorio
Martino, Enrica Antonia
Calafiore, Valeria
Sapienza, Giuseppe
Leotta, Valerio
Parisi, Marina Silvia
Markovic, Uros
Garibaldi, Bruno
Leotta, Salvatore
Cotzia, Emilia
Innao, Vanessa
Mannina, Donato
Neri, Santo
Musso, Maurizio
Scalone, Renato
Cangialosi, Clotilde
Acquaviva, Francesco
Cardinale, Giovanni
Merenda, Anxur
Maugeri, Cinzia
Uccello, Giuseppina
Poidomani, Massimo
Longo, Giuseppe
Carlisi, Melania
Tibullo, Daniele
Di Raimondo, Francesco
Feasibility, Tolerability and Efficacy of Carfilzomib in Combination with Lenalidomide and Dexamethasone in Relapsed Refractory Myeloma Patients: A Retrospective Real-Life Survey of the Sicilian Myeloma Network
title Feasibility, Tolerability and Efficacy of Carfilzomib in Combination with Lenalidomide and Dexamethasone in Relapsed Refractory Myeloma Patients: A Retrospective Real-Life Survey of the Sicilian Myeloma Network
title_full Feasibility, Tolerability and Efficacy of Carfilzomib in Combination with Lenalidomide and Dexamethasone in Relapsed Refractory Myeloma Patients: A Retrospective Real-Life Survey of the Sicilian Myeloma Network
title_fullStr Feasibility, Tolerability and Efficacy of Carfilzomib in Combination with Lenalidomide and Dexamethasone in Relapsed Refractory Myeloma Patients: A Retrospective Real-Life Survey of the Sicilian Myeloma Network
title_full_unstemmed Feasibility, Tolerability and Efficacy of Carfilzomib in Combination with Lenalidomide and Dexamethasone in Relapsed Refractory Myeloma Patients: A Retrospective Real-Life Survey of the Sicilian Myeloma Network
title_short Feasibility, Tolerability and Efficacy of Carfilzomib in Combination with Lenalidomide and Dexamethasone in Relapsed Refractory Myeloma Patients: A Retrospective Real-Life Survey of the Sicilian Myeloma Network
title_sort feasibility, tolerability and efficacy of carfilzomib in combination with lenalidomide and dexamethasone in relapsed refractory myeloma patients: a retrospective real-life survey of the sicilian myeloma network
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6617295/
https://www.ncbi.nlm.nih.gov/pubmed/31248142
http://dx.doi.org/10.3390/jcm8060877
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