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

被引：6

作者：

De Novellis, Danilo ^{[1
,2
]}

Derudas, Daniele ^{[3
]}

Vincelli, Donatella ^{[4
]}

Fontana, Raffaele ^{[1
]}

Della Pepa, Roberta ^{[5
]}

Palmieri, Salvatore ^{[6
]}

Accardi, Fabrizio ^{[7
]}

Rotondo, Francesco ^{[8
]}

Morelli, Emanuela ^{[9
]}

Gigliotta, Emilia ^{[10
]}

Roccotelli, Daniela ^{[11
,12
,13
]}

Marano, Luana ^{[14
]}

Barone, Maria Lucia ^{[15
]}

Cetani, Giusy ^{[16
]}

Esposito, Daniela ^{[17
]}

Lazzaro, Antonio ^{[18
,19
]}

Delle Cave, Giuseppe ^{[20
]}

Serio, Bianca ^{[1
]}

Morini, Denise ^{[1
]}

Porrazzo, Marika ^{[7
]}

Urciuoli, Eleonora ^{[14
]}

Masucci, Chiara ^{[14
]}

Fanelli, Fulvia ^{[14
]}

Rizzo, Michela ^{[1
]}

Arcamone, Manuela ^{[9
]}

Trastulli, Fabio ^{[6
]}

Rocco, Stefano ^{[6
]}

Leone, Aldo ^{[5
]}

Bianco, Rosario ^{[16
]}

Salvatore, Flavia ^{[8
]}

Idato, Aurora ^{[4
]}

Sicari, Maria ^{[4
]}

Tosi, Patrizia ^{[8
]}

Rascato, Maria Gabriella ^{[17
]}

Di Perna, Maria ^{[15
]}

Falcone, Antonietta Pia ^{[11
,12
,13
]}

Morello, Lucia ^{[18
,19
]}

Carlisi, Melania ^{[10
]}

Svanera, Gino ^{[20
]}

Annunziata, Mario ^{[17
]}

Frigeri, Ferdinando ^{[16
]}

Califano, Catello ^{[15
]}

Carella, Angelo Michele ^{[11
,12
,13
]}

Marcacci, Gianpaolo ^{[9
]}

Pane, Fabrizio ^{[5
]}

Risitano, Antonio Maria ^{[14
]}

Giudice, Valentina ^{[1
,2
]}

Botta, Ciro ^{[10
]}

Selleri, Carmine ^{[1
,2
]}

机构：

[1] Univ Hosp San Giovanni di Dio & Ruggi dAragona, Hematol & Transplant Ctr, Salerno, Italy

[2] Univ Salerno, Scuola Med Salernitana, Dept Med Surg & Dent, Baronissi, Italy

[3] Osped Oncol Riferimento Reg A Businco, SC Ematol & CTMO, Cagliari, Italy

[4] Azienda Osped Bianchi Melacrino Morelli, Div Hematol, Reggio Di Calabria, Italy

[5] Univ Hosp Federico II, Dept Clin Med & Surg, Hematol, Naples, Italy

[6] Hosp Antonio Cardarelli, Hematol, Naples, Italy

[7] Azienda Osped Osped Riuniti Villa Sofia Cervello, UOC Oncoematol, Palermo, Italy

[8] Infermi Hosp Rimini, Hematol Unit, Dermatol Unit, Rimini, Italy

[9] Fdn G Pascale, Ist Nazl Tumori, Hematol & Transplant Ctr, IRRCS, Naples, Italy

[10] Univ Palermo, Dipartimento Promoz Salute Maternoinfantile Med In, Palermo, Italy

[11] IRCCS S Giovanni Rotondo, Div Hematol, San Giovanni Rotondo, Italy

[12] IRCCS S Giovanni Rotondo, Stem Cell Unit, San Giovanni Rotondo, Italy

[13] Div Hematol, San Giovanni Rotondo, Italy

[14] Hosp San Giuseppe Moscati, Hematol, Avellino, Italy

[15] Hosp Andrea Tortora, Hematol, Pagani, Italy

[16] Hosp St Anna & San Sebastiano, Hematol, Caserta, Italy

[17] Hosp San Giuseppe Moscati, Hematol, Aversa, Italy

[18] Azienda Usl Piacenza, UO Ematol, Piacenza, Italy

[19] Azienda Usl Piacenza, Ctr Trapianti Midollo Osseo, Dipartimento Oncoematol, Piacenza, Italy

[20] Hosp San Giuliano, Hematol, Giugliano, Italy

来源：

EUROPEAN JOURNAL OF HAEMATOLOGY | 2025年 / 114卷 / 01期

关键词：

isatuximab; multiple myeloma; proteasome inhibitors; real life; CONSENSUS;

D O I：

10.1111/ejh.14314

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：105 / 114

页数：10

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