: Isatuximab, a novel anti-CD38 monoclonal antibody, is approved in combination with carfilzomib and dexamethasone (Isa-Kd) in relapsed/refractory multiple myeloma (RRMM) patients. Because of its recent introduction, real-world efficacy and safety are poorly reported. In this Italian multicenter real-life observational retrospective study, efficacy and safety of the Isa-Kd regimen were evaluated in a cohort of 103 RRMM patients. Overall response rate (ORR) was 85%, with stringent (sCR) or complete response (CR) in 18% of cases and very good partial response (VGPR) in 39%. Median PFS and OS were not reached within the study period, while 1-year PFS and OS were 72% and 77%, respectively. Hematological toxicities were observed in 42% of subjects, and cardiac toxicities occurred in 24% of cases. Moreover, we conducted a subanalysis on patients (N = 69) treated with Isa-Kd after one prior line of therapy, showing an ORR of 88%, with sCR + CR in 20% of subjects, VGPR in 46%, and PR in 22% of patients. In this group, median PFS and OS were not reached, while 1-year PFS and OS were 92% and 95%, respectively. In conclusions, our study confirmed Isa-Kd as an effective treatment option for RRMM with a manageable safety profile even in real-life settings.

Clinical Efficacy of Isatuximab Plus Carfilzomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients / De , ; Novellis, D.; Derudas, D.; Vincelli, D.; Fontana, R.; Della , ; Pepa, R.; Palmieri, S.; Accardi, F.; Rotondo, F.; Morelli, E.; Gigliotta, E.; Roccotelli, D.; Marano, L.; Barone, M. L.; Cetani, G.; Esposito, D.; Lazzaro, A.; Delle , ; Cave, G.; Serio, B.; Morini, D.; Porrazzo, M.; Urciuoli, E.; Masucci, C.; Fanelli, F.; Rizzo, M.; Arcamone, M.; Trastulli, F.; Rocco, S.; Leone, A.; Bianco, R.; Salvatore, F.; Idato, A.; Sicari, M.; Tosi, P.; Rascato, M. G.; Di , ; Perna, M.; Falcone, A. P.; Morello, L.; Carlisi, M.; Svanera, G.; Annunziata, M.; Frigeri, F.; Califano, C.; Carella, A. M.; Marcacci, G.; Pane, F.; Risitano, A. M.; Giudice, V.; Botta, C.; Selleri, C.. - In: EUROPEAN JOURNAL OF HAEMATOLOGY. - ISSN 0902-4441. - 114:1(2025), pp. 105-114. [10.1111/ejh.14314]

Clinical Efficacy of Isatuximab Plus Carfilzomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients

Serio B.;Morini D.;Urciuoli E.;Masucci C.;Fanelli F.;Arcamone M.;Trastulli F.;Rocco S.;Leone A.;Salvatore F.;Rascato M. G.;Califano C.;Pane F.;Risitano A. M.;Selleri C.
2025

Abstract

: Isatuximab, a novel anti-CD38 monoclonal antibody, is approved in combination with carfilzomib and dexamethasone (Isa-Kd) in relapsed/refractory multiple myeloma (RRMM) patients. Because of its recent introduction, real-world efficacy and safety are poorly reported. In this Italian multicenter real-life observational retrospective study, efficacy and safety of the Isa-Kd regimen were evaluated in a cohort of 103 RRMM patients. Overall response rate (ORR) was 85%, with stringent (sCR) or complete response (CR) in 18% of cases and very good partial response (VGPR) in 39%. Median PFS and OS were not reached within the study period, while 1-year PFS and OS were 72% and 77%, respectively. Hematological toxicities were observed in 42% of subjects, and cardiac toxicities occurred in 24% of cases. Moreover, we conducted a subanalysis on patients (N = 69) treated with Isa-Kd after one prior line of therapy, showing an ORR of 88%, with sCR + CR in 20% of subjects, VGPR in 46%, and PR in 22% of patients. In this group, median PFS and OS were not reached, while 1-year PFS and OS were 92% and 95%, respectively. In conclusions, our study confirmed Isa-Kd as an effective treatment option for RRMM with a manageable safety profile even in real-life settings.
2025
Clinical Efficacy of Isatuximab Plus Carfilzomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients / De , ; Novellis, D.; Derudas, D.; Vincelli, D.; Fontana, R.; Della , ; Pepa, R.; Palmieri, S.; Accardi, F.; Rotondo, F.; Morelli, E.; Gigliotta, E.; Roccotelli, D.; Marano, L.; Barone, M. L.; Cetani, G.; Esposito, D.; Lazzaro, A.; Delle , ; Cave, G.; Serio, B.; Morini, D.; Porrazzo, M.; Urciuoli, E.; Masucci, C.; Fanelli, F.; Rizzo, M.; Arcamone, M.; Trastulli, F.; Rocco, S.; Leone, A.; Bianco, R.; Salvatore, F.; Idato, A.; Sicari, M.; Tosi, P.; Rascato, M. G.; Di , ; Perna, M.; Falcone, A. P.; Morello, L.; Carlisi, M.; Svanera, G.; Annunziata, M.; Frigeri, F.; Califano, C.; Carella, A. M.; Marcacci, G.; Pane, F.; Risitano, A. M.; Giudice, V.; Botta, C.; Selleri, C.. - In: EUROPEAN JOURNAL OF HAEMATOLOGY. - ISSN 0902-4441. - 114:1(2025), pp. 105-114. [10.1111/ejh.14314]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11588/994189
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