Clinical Efficacy of Isatuximab Plus Carfilzomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients
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.
Authors
- Emilia Gigliotta (ORCID: https://orcid.org/0009-0007-2070-0652)
- Luana Marano (ORCID: https://orcid.org/0009-0000-1841-9887)
- Francesco Rotondo (ORCID: https://orcid.org/0000-0001-8599-7994)
- Angelo Michele Carella (ORCID: https://orcid.org/0000-0002-4967-4204)
- Cirino Botta (ORCID: https://orcid.org/0000-0002-1522-4504)
- Antonietta Falcone
- Fabio Trastulli (ORCID: https://orcid.org/0000-0001-6929-0729)
- Gino Svanera
- Patrizia Tosi (ORCID: https://orcid.org/0000-0002-5862-4196)
- Daniela Roccotelli (ORCID: https://orcid.org/0000-0003-1196-4510)
- Manuela Arcamone
- Rosario Bianco (ORCID: https://orcid.org/0000-0002-4470-4670)
- Carmine Selleri (ORCID: https://orcid.org/0000-0002-5861-8984)
- Giusy Cetani
- Mario Annunziata (ORCID: https://orcid.org/0000-0001-9993-947X)
- Michela Rizzo
- Marika Porrazzo (ORCID: https://orcid.org/0000-0001-6487-5971)
- Raffaele Fontana (ORCID: https://orcid.org/0009-0000-3990-120X)
- Eleonora Urciuoli
- Valentina Giudice (ORCID: https://orcid.org/0000-0002-7492-6848)
- Fabrizio Accardi (ORCID: https://orcid.org/0000-0002-7736-2822)
- Antonio M. Risitano (ORCID: https://orcid.org/0000-0002-4744-5109)
- Aldo Leone (ORCID: https://orcid.org/0000-0002-7148-7122)
- Giuseppe Delle Cave
- Roberta Della Pepa (ORCID: https://orcid.org/0000-0001-5641-231X)
- Fabrizio Pane (ORCID: https://orcid.org/0000-0003-2563-4125)
- Lucia Morello (ORCID: https://orcid.org/0000-0002-5860-5358)
- Antonio Lazzaro
- Daniela Espósito (ORCID: https://orcid.org/0000-0001-8993-2071)
- Maria Gabriella Rascato (ORCID: https://orcid.org/0000-0002-5132-1221)
- Maria Lucia Barone
- Salvatore Palmieri (ORCID: https://orcid.org/0000-0001-9634-4147)
- Emanuela Morelli (ORCID: https://orcid.org/0000-0001-8704-9330)
- Denise Morini (ORCID: https://orcid.org/0009-0005-4921-1081)
- Daniele Derudas (ORCID: https://orcid.org/0000-0002-0997-4157)
- Ferdinando Frigeri (ORCID: https://orcid.org/0000-0002-9818-3073)
- Melania Carlisi (ORCID: https://orcid.org/0000-0002-5641-2974)
- Chiara Masucci (ORCID: https://orcid.org/0000-0003-2374-3299)
- Catello Califano (ORCID: https://orcid.org/0000-0001-5633-4657)
- Maria Di Perna (ORCID: https://orcid.org/0000-0003-2977-0634)
- Bianca Serio (ORCID: https://orcid.org/0000-0001-6613-2370)
- Danilo De Novellis (ORCID: https://orcid.org/0000-0002-2590-0529)
- Fulvia Fanelli
- Aurora Idato
- Flavia Salvatore
- Gianpaolo Marcacci
- Stefano Rocco
- Donatella Vincelli
- Maria Sicari
Institutions
- University of Salerno (IT)
- Ospedale Antonio Cardarelli (IT)
- Azienda ospedaliera "Bianchi-Melacrino-Morelli" (IT)
- Ospedale Vincenzo Cervello (IT)
- Azienda Ospedaliera S.Giuseppe Moscati (IT)
- CTO Andrea Alesini (IT)
- Regione Puglia (IT)
- Federico II University Hospital (IT)
- Ospedale Infermi di Rimini (IT)
- Giuliani (Italy) (IT)
- Ospedali Riuniti San Giovanni di Dio e Ruggi d'Aragona (IT)
- Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" (IT)
- Ospedale Sant'Anna (IT)
- University of Palermo (IT)
Publication Details
- Journal
- European Journal Of Haematology
- Published
- 2024-10-06
- DOI
- https://doi.org/10.1111/ejh.14314
- Citations
- 8
- Primary Topic
- Multiple Myeloma Research and Treatments
- Type
- article
- Field-Weighted Citation Impact
- 3.64
Funders
- Università degli Studi di Salerno