Isatuximab, pomalidomide, and dexamethasone as salvage therapy for patients with multiple myeloma: the Italian, multicenter, retrospective clinical experience with 270 cases outside of controlled clinical trials

Isatuximab, pomalidomide, and dexamethasone as salvage therapy for patients with multiple myeloma: the Italian, multicenter, retrospective clinical experience with cases outside of controlled clinical trialsThis real-world multicenter study aimed to evaluate the efficacy and tolerability of the isatuximab, pomalidomide, and dexamethasone (IsaPd) combination in relapsed/refractory multiple myeloma (RRMM).Our results confirm the safety and efficacy of IsaPd, in line with findings from the pivotal ICARIA-MM clinical trial. 1,2satuximab and daratumumab, both anti-CD38 antibodies, have demonstrated high response rates and improved survival in RRMM patients when used with agents like pomalidomide, lenalidomide, carfilzomib, and dexamethasone. [3][4]][5][6][7][8] The pivotal ICARIA-MM trial, demonstrated a significant improvement in progression-free survival (PFS) of IsaPd, compared to pomalidomide-dexamethasone (Pd) with a median PFS of 11.5 months versus 6.5 months in the control group. 1 Extended follow-up confirmed the outcome benefit, with a median overall survival (OS) of 24.6 months compared to 17.7 months in the control arm. 2 Our study analyzed 270 RRMM patients treated with IsaPd across 51 Italian centers between January 2021 and June 2024.This study was approved by the ethics committee at all participating hospitals.It adhered to the principles of the Declaration of Helsinki and Good Clinical Practice guidelines.All patients received prophylactic antibacterial, antiviral, and antithrombotic therapy.PFS, OS, and timeto-next treatment (TTNT) were evaluated as time-to-event endpoints.Safety and treatment responses were also assessed. 9,10At baseline, 13.7% of patients were in stage III according to the International Staging System (ISS), and 26.7% had refractory disease (Table 1).About 29.3% of patients showed a creatinine clearance (CrCl) <60 mL/min.Cytogenetic evaluations performed at IsaPd initiation classified 104 out of 147 evaluable cases as standard-risk and 43 as high-risk (Table 1).Furthermore, 23% of cases showed a gain/amplification of 1q21 (1q21+).About 64% had received two lines of therapy and most cases were refractory to lenalidomide; in addition, 51 patients had been exposed to daratumumab, with 98% refractory to this therapy.Twelve patients received IsaPd immediately after a daratumumab-containing regimen, while 39 patients received other schedules in between.Median time between IsaPd and daratumumab-containing regimen was ten months (range: 0.5-41 months).Compared to the ICARIA-MM trial, 1 our cohort had a lower incidence of renal impairment (29.3% vs. 39%), a higher

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Journal
Haematologica
Published
2024-11-28
DOI
https://doi.org/10.3324/haematol.2024.286658
Citations
3
Primary Topic
Multiple Myeloma Research and Treatments
Type
article
Field-Weighted Citation Impact
1.36
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article

Isatuximab, pomalidomide, and dexamethasone as salvage therapy for patients with multiple myeloma: the Italian, multicenter, retrospective clinical experience with 270 cases outside of controlled clinical trials

Giovanni Reddiconto, Concetta Conticello, Giuseppina Uccello, Flavia Lotti et al.
3 citations
Haematologica
Multiple Myeloma Research and Treatments
1.36
article

Isatuximab, pomalidomide, and dexamethasone as salvage therapy for patients with multiple myeloma: the Italian, multicenter, retrospective clinical experience with 270 cases outside of controlled clinical trials

Giovanni Reddiconto, Concetta Conticello, Giuseppina Uccello, Flavia Lotti, Elena Rivolti, Gabriele Buda, Pietro Benvenuti, Nicola Di Renzo, Enrica Antonia Martino, Emilia Cotzia, Emiliano Barbieri, Annalisa Citro, Massimo Gentile, Angela Maria Quinto, Alessandro Maggi, Ombretta Annibali, Valeria Amico, Lorenzo De Paoli, Cirino Botta, Giuseppe Pietrantuono, Claudio De Magistris, Angela Rago, Fortunato Morabito, Daniela Roccotelli, Rosario Bianco, Velia Bongarzoni, Alessandro Gozzetti, Raffaele Fontana, Francesco Di Raimondo, Marta Coscia, Anna Maria Cafro, Antonella Bruzzese, Antonino Neri, Marino Brunori, Silvia Mangiacavalli, Pellegrino Musto, Angela Amendola, Giuseppe Mele, Maria Teresa Petrucci, Giuseppe Bertuglia, Francesca Farina, Alessandra Lombardo, Mario Monachesi, Katia Mancuso, Valerio De Stefano, Elena Zamagni, Roberta Della Pepa, Antonio Lazzaro, Salvatore Palmieri, Sara Aquino, Anna Mele, Santo Neri, Claudio Cerchione, Gloria Margiotta Casaluci, Renato Zambello, Davide Nappi, Vittorio Montefusco, Massimiliano Arangio Febbo, Carmine Liberatore, Gregorio Barilà, Daniele Derudas, Elisabetta Antonioli, Nicola Sgherza, Anna Furlan, Mónica Galli, Massimo Offidani, Catello Califano, Ernesto Vigna, Jacopo Micozzi, Paola Stefanoni, Sonia Morè, Sofia Terlizzi, Elena Rossi
article en
3 citations

Abstract

Isatuximab, pomalidomide, and dexamethasone as salvage therapy for patients with multiple myeloma: the Italian, multicenter, retrospective clinical experience with cases outside of controlled clinical trialsThis real-world multicenter study aimed to evaluate the efficacy and tolerability of the isatuximab, pomalidomide, and dexamethasone (IsaPd) combination in relapsed/refractory multiple myeloma (RRMM).Our results confirm the safety and efficacy of IsaPd, in line with findings from the pivotal ICARIA-MM clinical trial. 1,2satuximab and daratumumab, both anti-CD38 antibodies, have demonstrated high response rates and improved survival in RRMM patients when used with agents like pomalidomide, lenalidomide, carfilzomib, and dexamethasone. [3][4]][5][6][7][8] The pivotal ICARIA-MM trial, demonstrated a significant improvement in progression-free survival (PFS) of IsaPd, compared to pomalidomide-dexamethasone (Pd) with a median PFS of 11.5 months versus 6.5 months in the control group. 1 Extended follow-up confirmed the outcome benefit, with a median overall survival (OS) of 24.6 months compared to 17.7 months in the control arm. 2 Our study analyzed 270 RRMM patients treated with IsaPd across 51 Italian centers between January 2021 and June 2024.This study was approved by the ethics committee at all participating hospitals.It adhered to the principles of the Declaration of Helsinki and Good Clinical Practice guidelines.All patients received prophylactic antibacterial, antiviral, and antithrombotic therapy.PFS, OS, and timeto-next treatment (TTNT) were evaluated as time-to-event endpoints.Safety and treatment responses were also assessed. 9,10At baseline, 13.7% of patients were in stage III according to the International Staging System (ISS), and 26.7% had refractory disease (Table 1).About 29.3% of patients showed a creatinine clearance (CrCl) <60 mL/min.Cytogenetic evaluations performed at IsaPd initiation classified 104 out of 147 evaluable cases as standard-risk and 43 as high-risk (Table 1).Furthermore, 23% of cases showed a gain/amplification of 1q21 (1q21+).About 64% had received two lines of therapy and most cases were refractory to lenalidomide; in addition, 51 patients had been exposed to daratumumab, with 98% refractory to this therapy.Twelve patients received IsaPd immediately after a daratumumab-containing regimen, while 39 patients received other schedules in between.Median time between IsaPd and daratumumab-containing regimen was ten months (range: 0.5-41 months).Compared to the ICARIA-MM trial, 1 our cohort had a lower incidence of renal impairment (29.3% vs. 39%), a higher

HaematologicaVol. 110(4)
University of Siena (IT), University of Pisa (IT), University of Insubria (IT), Marche Polytechnic University (IT), Università degli Studi del Piemonte Orientale “Amedeo Avogadro” (IT), University of Padua (IT), Azienda Ospedaliera San Giovanni Addolorata (IT), Casa Sollievo della Sofferenza (IT), Policlinico Umberto I (IT), CTO Hospital (IT), Agostino Gemelli University Polyclinic (IT), Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT), University of Catania (IT), University of Chieti-Pescara (IT), Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT), Ospedale Antonio Cardarelli (IT), Azienda Ospedaliera di Perugia (IT), Azienda Sanitaria Unità Locale di Reggio Emilia (IT), ASL Roma (IT), Centro di Riferimento Oncologico della Basilicata (IT), Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (IT), The Dia Foundation for Research on Ageing Societies (JP), Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IT), Ospedale Santa Maria alle Scotte (IT), Azienda Ospedaliera di Cosenza (IT), Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT), Ospedale A. Perrino (IT), Ito Hospital (JP), Ospedale Papa Giovanni XXIII (IT), Ospedale di Santo Spirito (IT), Istituto Oncologico Veneto (IT), Azienda Ospedaliera S.Giuseppe Moscati (IT), Azienda Ospedaliero-Universitaria Careggi (IT), Ospedale Santa Maria (IT), Federico II University Hospital (IT), Istituto di Ematologia di Bologna (IT), Azienda USL di Bologna (IT), Azienda Ospedaliera S.Maria (IT), Azienda Ospedaliera Sant'Andrea (IT), Istituto Tumori Bari (IT), Ospedale Annunziata di Cosenza (IT), IRCCS Ospedale San Raffaele (IT), Ospedali Riuniti San Giovanni di Dio e Ruggi d'Aragona (IT), Guglielmo da Saliceto Hospital (IT), Campus Bio Medico University Hospital (IT), Azienda di Rilievo Nazionale ed Alta Specializzazione (IT), Ca' Foncello Hospital (IT), Ospedale Policlinico San Martino (IT), Azienda USL di Pescara (IT), Ospedale Sant'Anna (IT), Policlinico San Matteo Fondazione (IT), Ospedale San Bortolo (IT), Ospedale Vito Fazzi (IT), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Piedmont University (US), Azienda Sanitaria Locale Roma 3 (IT), Azienda Ospedaliera Ospedale Civile di Legnano (IT), Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte (IT), University of Calabria (IT), University of Bari Aldo Moro (IT), Sapienza University of Rome (IT), University of Bologna (IT)
Openalex Percentile: Top 17%
Multiple Myeloma Research and Treatments
1.36
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