Clinical Efficacy of Isatuximab Plus Carfilzomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients
- Authors: 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.; Lucia, ; 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.; Gabriella, ; Di , ; Perna, M.; Falcone, A.; Pia, ; Morello, L.; Carlisi, M.; Svanera, G.; Annunziata, M.; Frigeri, F.; Califano, C.; Carella, A.; Michele, ; Marcacci, G.; Pane, F.; Risitano, A.; Maria, ; Giudice, V.; Botta, C.; Selleri, C.
- Publication year: 2025
- Type: Articolo in rivista
- Key words: isatuximab; multiple myeloma; proteasome inhibitors; real life;
- OA Link: http://hdl.handle.net/10447/659375
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.