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.
Authors
- Inés Zugasti (ORCID: https://orcid.org/0000-0002-7666-5055)
- Juan Luis Reguera (ORCID: https://orcid.org/0009-0009-6408-1747)
- Eulàlia Olesti (ORCID: https://orcid.org/0000-0001-8677-9964)
- Xavier Setoaín (ORCID: https://orcid.org/0000-0001-8675-971X)
- Sara Varea (ORCID: https://orcid.org/0000-0002-0002-6492)
- Álvaro Urbano-Ispizúa (ORCID: https://orcid.org/0000-0002-7529-9399)
- Laura Rosiñol (ORCID: https://orcid.org/0000-0002-2534-9239)
- Juan Carlos Soler-Perromat (ORCID: https://orcid.org/0000-0002-2552-3903)
- R.M. Álvarez Pérez (ORCID: https://orcid.org/0000-0001-6279-5628)
- Luis Gerardo Rodríguez‐Lobato (ORCID: https://orcid.org/0000-0001-5694-0921)
- María‐Victoria Mateos (ORCID: https://orcid.org/0000-0003-2390-1218)
- Marta Español‐Rego (ORCID: https://orcid.org/0000-0001-5497-2276)
- Joaquín Martínez‐López (ORCID: https://orcid.org/0000-0001-7908-0063)
- Natalia Tovar (ORCID: https://orcid.org/0000-0001-5525-476X)
- Carlos Fernández de Larrea (ORCID: https://orcid.org/0000-0003-4930-9255)
- Verónica González‐Calle (ORCID: https://orcid.org/0000-0002-5493-6707)
- Aina Oliver‐Caldés (ORCID: https://orcid.org/0000-0002-7921-5420)
- Lucía López‐Corral (ORCID: https://orcid.org/0000-0003-1908-5596)
- Nieves López‐Muñoz (ORCID: https://orcid.org/0000-0003-0090-6673)
- Xavier Tomàs (ORCID: https://orcid.org/0000-0003-2189-8721)
- Valentín Cabañas (ORCID: https://orcid.org/0000-0002-6248-2549)
- David F. Moreno (ORCID: https://orcid.org/0000-0002-1752-3081)
- Adolfo Gómez‐Grande (ORCID: https://orcid.org/0000-0002-7925-8826)
- Europa Azucena González‐Navarro (ORCID: https://orcid.org/0000-0003-3310-5557)
- Manel Juan (ORCID: https://orcid.org/0000-0002-3064-1648)
- José M. Moraleda (ORCID: https://orcid.org/0000-0001-9080-1466)
- Marta Tormo-Ratera (ORCID: https://orcid.org/0000-0002-6500-063X)
- Álvaro Bartolomé-Solanas (ORCID: https://orcid.org/0000-0002-2307-0007)
- Laura Frutos (ORCID: https://orcid.org/0000-0003-2128-9504)
- Pilar Tamayo (ORCID: https://orcid.org/0000-0002-7466-514X)
Institutions
- 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)
Publication Details
- Journal
- Blood Advances
- Published
- 2024-11-27
- DOI
- https://doi.org/10.1182/bloodadvances.2024014360
- Citations
- 11
- Primary Topic
- Multiple Myeloma Research and Treatments
- Type
- article
- Field-Weighted Citation Impact
- 5.00