Clinical impact of [18F]FDG-PET/CT in ARI0002h treatment, a CAR-T against BCMA for relapsed/refractory multiple myeloma

Multiple myeloma (MM) remains incurable, with poor outcomes in heavily pretreated patients. Chimeric antigen receptor (CAR) T-cell therapy has emerged as a promising treatment; however, outcomes after such therapy in patients with soft-tissue plasmacytomas and other bone lesions remain poorly understood. This study included 63 patients with relapsed/refractory MM treated either in the CARTBCMA-HCB-01 clinical trial (ARI0002h; academic B-cell maturation antigen [BCMA]-targeted CAR T-cell therapy) or in compassionate use. The aim was to evaluate the impact of soft-tissue involvement (extramedullary [EMD] and paraskeletal [PS] plasmacytomas) in response, survival and safety. Baseline [18F]fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) from 5 participating centers were reviewed centrally. Of 63 patients, 52.4% presented plasmacytomas at the time of inclusion (21 PS, exclusively; and 12 EMD). Per responses, there were no significant differences between patients with and without plasmacytomas. A correlation was present between International Myeloma Working Group responses and those obtained by [18F]FDG-PET/CT at day 100 (Bologna criteria). No differences were observed in progression-free survival (PFS) or overall survival (OS) between patients with or without plasmacytomas. However, both PFS and OS were significantly shorter in patients with EMD. Interestingly, [18F]FDG-PET/CT response assessed on day 100, in accordance with the Bologna criteria, was predictive of survival outcomes. A metabolic tumor volume of ≥25 cm3 at baseline [18F]FDG-PET/CT was associated with earlier disease progression and shorter OS. These results highlight the importance of EMD evaluation by [18F]FDG-PET/CT before and after CAR T-cell infusion. This trial was registered at www.ClinicalTrials.gov as #NCT04309981; and EudraCT, 2019-001472-11.

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Journal
Blood Advances
Published
2024-11-27
DOI
https://doi.org/10.1182/bloodadvances.2024014360
Citations
11
Primary Topic
Multiple Myeloma Research and Treatments
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article
Field-Weighted Citation Impact
5.00
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article

Clinical impact of [18F]FDG-PET/CT in ARI0002h treatment, a CAR-T against BCMA for relapsed/refractory multiple myeloma

Inés Zugasti, Juan Luis Reguera, Eulàlia Olesti, Xavier Setoaín et al.
11 citations
Blood Advances
Multiple Myeloma Research and Treatments
5.00
article

Clinical impact of [18F]FDG-PET/CT in ARI0002h treatment, a CAR-T against BCMA for relapsed/refractory multiple myeloma

Inés Zugasti, Juan Luis Reguera, Eulàlia Olesti, Xavier Setoaín, Sara Varea, Álvaro Urbano-Ispizúa, Laura Rosiñol, Juan Carlos Soler-Perromat, R.M. Álvarez Pérez, Luis Gerardo Rodríguez‐Lobato, María‐Victoria Mateos, Marta Español‐Rego, Joaquín Martínez‐López, Natalia Tovar, Carlos Fernández de Larrea, Verónica González‐Calle, Aina Oliver‐Caldés, Lucía López‐Corral, Nieves López‐Muñoz, Xavier Tomàs, Valentín Cabañas, David F. Moreno, Adolfo Gómez‐Grande, Europa Azucena González‐Navarro, Manel Juan, José M. Moraleda, Marta Tormo-Ratera, Álvaro Bartolomé-Solanas, Laura Frutos, Pilar Tamayo
article en
11 citations

Abstract

Multiple myeloma (MM) remains incurable, with poor outcomes in heavily pretreated patients. Chimeric antigen receptor (CAR) T-cell therapy has emerged as a promising treatment; however, outcomes after such therapy in patients with soft-tissue plasmacytomas and other bone lesions remain poorly understood. This study included 63 patients with relapsed/refractory MM treated either in the CARTBCMA-HCB-01 clinical trial (ARI0002h; academic B-cell maturation antigen [BCMA]-targeted CAR T-cell therapy) or in compassionate use. The aim was to evaluate the impact of soft-tissue involvement (extramedullary [EMD] and paraskeletal [PS] plasmacytomas) in response, survival and safety. Baseline [18F]fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) from 5 participating centers were reviewed centrally. Of 63 patients, 52.4% presented plasmacytomas at the time of inclusion (21 PS, exclusively; and 12 EMD). Per responses, there were no significant differences between patients with and without plasmacytomas. A correlation was present between International Myeloma Working Group responses and those obtained by [18F]FDG-PET/CT at day 100 (Bologna criteria). No differences were observed in progression-free survival (PFS) or overall survival (OS) between patients with or without plasmacytomas. However, both PFS and OS were significantly shorter in patients with EMD. Interestingly, [18F]FDG-PET/CT response assessed on day 100, in accordance with the Bologna criteria, was predictive of survival outcomes. A metabolic tumor volume of ≥25 cm3 at baseline [18F]FDG-PET/CT was associated with earlier disease progression and shorter OS. These results highlight the importance of EMD evaluation by [18F]FDG-PET/CT before and after CAR T-cell infusion. This trial was registered at www.ClinicalTrials.gov as #NCT04309981; and EudraCT, 2019-001472-11.

Blood AdvancesVol. 9(3)
Universidad de Salamanca (ES), Spanish National Cancer Research Centre (ES), Hospital Universitario 12 De Octubre (ES), Biomedical Research Networking Center in Bioengineering, Biomaterials and Nanomedicine (ES), Centro de Investigación Biomédica en Red (ES), Hospital Clínic de Barcelona (ES), Health Research Institute of the Balearic Islands (ES), Instituto de Biomedicina de Sevilla (ES), Instituto de Investigación Biomédica de Salamanca (ES), Centro de Investigación del Cáncer (ES), Hospital Universitario Virgen de la Arrixaca (ES), Hospital Universitario Son Espases (ES), Hospital Universitario Virgen del Rocío (ES), Centro de Investigación Biomédica en Red de Cáncer (ES), Consorci Institut D'Investigacions Biomediques August Pi I Sunyer (ES), Universitat de Barcelona (ES), Universidad de Sevilla (ES), Universidad de Murcia (ES)
Good health and well-being
Openalex Percentile: Top 4%
Multiple Myeloma Research and Treatments
5.00
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