Evidence map›Paper›PMID 39602341›Full record

Trial reportBlood advances2025

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

Inés Zugasti, Marta Tormo-Ratera, Aina Oliver-Caldés, Juan Carlos Soler-Perromat, Verónica González-Calle, David F Moreno, Valentín Cabañas, Nieves López-Muñoz, Álvaro Bartolomé-Solanas, Marta Español-Rego and 20 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Blood advances, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04309981 (Pilot Study of the Infusion of Differentiated Autologous T-cells From Peripheral Blood, Expanded and Transduced With a Lentivirus to Express a Chimeric Antigen Receptor With Anti-BCMA), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04309981 phase1 / phase2unknown statusnot on this map

Pilot Study of the Infusion of Differentiated Autologous T-cells From Peripheral Blood, Expanded and Transduced With a Lentivirus to Express a Chimeric Antigen Receptor With Anti-BCMA (TNFRSF17) Specificity Humanized Conjugated With the Co-stimulatory Region 4-1BB and Signal-transduction CD3z (ARI0002h) in Patients With Relapsed/Refractory Multiple Myeloma With Previous Treatment With Proteasome Inhibitor, Immunomodulatory Drug and Anti-CD38 Monoclonal Antibody

TypeinterventionalSponsorSara V. LatorreRan2020 to 2025Enrolled73ConditionsRelapsed/Refractory Multiple MyelomaArmsAdult differentiated autologous T-cells with anti-BCMA specificity
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Predictive values of baselineBone marrow transplantation · 2026
    Article
  2. Baseline [European journal of nuclear medicine and molecular imaging · 2026
    Article
  3. Article
  4. Review
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

30 authors.

Inés ZugastiHospital Clínic de Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.
Marta Tormo-RateraHospital Clínic de Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.ORCID 0000-0002-6500-063X
Aina Oliver-CaldésHospital Clínic de Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.ORCID 0000-0002-7921-5420
Juan Carlos Soler-PerromatHospital Clínic de Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.ORCID 0000-0002-2552-3903
Verónica González-CalleHospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca, Instituto Universitario de Biología Molecular y Celular del Cáncer, Universidad de Salamanca, Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Salamanca, Spain.ORCID 0000-0002-5493-6707
David F MorenoHospital Clínic de Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.ORCID 0000-0002-1752-3081
Valentín CabañasHospital Clínico Universitario Virgen de la Arrixaca, IMIB Pascual Parrilla, Universidad de Murcia, Murcia, Spain.ORCID 0000-0002-6248-2549
Nieves López-MuñozHospital Universitario 12 de Octubre, Complutense University, i+12, Centro Nacional de Investigaciones Oncológicas, Madrid, Spain.
Álvaro Bartolomé-SolanasHospital Clínic de Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.ORCID 0000-0002-2307-0007
Marta Español-RegoHospital Clínic de Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.ORCID 0000-0001-5497-2276
Juan Luis Reguera-OrtegaHospital Universitario Virgen del Rocío, Instituto de Biomedicina de Sevilla (CIBERONC), Universidad de Sevilla, Sevilla, Spain.ORCID 0009-0009-6408-1747
Laura RosiñolHospital Clínic de Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.ORCID 0000-0002-2534-9239
Lucía López-CorralHospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca, Instituto Universitario de Biología Molecular y Celular del Cáncer, Universidad de Salamanca, Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Salamanca, Spain.ORCID 0000-0003-1908-5596
Natalia TovarHospital Clínic de Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.
Luis Gerardo Rodríguez-LobatoHospital Clínic de Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.ORCID 0000-0001-5694-0921
Rosa Maria Alvarez PerezHospital Universitario Virgen del Rocío, Instituto de Biomedicina de Sevilla (CIBERONC), Universidad de Sevilla, Sevilla, Spain.
Sara VareaHospital Clínic de Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.ORCID 0000-0002-0002-6492
Eulàlia OlestiHospital Clínic de Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.ORCID 0000-0001-8677-9964
Adolfo Gomez-GrandeHospital Universitario 12 de Octubre, Complutense University, i+12, Centro Nacional de Investigaciones Oncológicas, Madrid, Spain.
Laura FrutosHospital Clínico Universitario Virgen de la Arrixaca, IMIB Pascual Parrilla, Universidad de Murcia, Murcia, Spain.
Pilar TamayoHospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca, Instituto Universitario de Biología Molecular y Celular del Cáncer, Universidad de Salamanca, Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Salamanca, Spain.ORCID 0000-0002-7466-514X
Manel JuanHospital Clínic de Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.ORCID 0000-0002-3064-1648
José M MoraledaHospital Clínico Universitario Virgen de la Arrixaca, IMIB Pascual Parrilla, Universidad de Murcia, Murcia, Spain.ORCID 0000-0001-9080-1466
Álvaro Urbano-IspizuaHospital Clínic de Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.
E Azucena González-NavarroHospital Clínic de Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.
Joaquín Martínez-LópezHospital Universitario 12 de Octubre, Complutense University, i+12, Centro Nacional de Investigaciones Oncológicas, Madrid, Spain.
Maria-Victoria MateosHospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca, Instituto Universitario de Biología Molecular y Celular del Cáncer, Universidad de Salamanca, Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Salamanca, Spain.ORCID 0000-0003-2390-1218
Xavier TomásHospital Clínic de Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.ORCID 0000-0003-2189-8721
Xavier SetoainHospital Clínic de Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.
Carlos Fernández de LarreaHospital Clínic de Barcelona, Institut d'Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain.ORCID 0000-0003-4930-9255

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractMultiple 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.

Indexed as

B-Cell Maturation AntigenFluorodeoxyglucose F18Immunotherapy, AdoptiveMultiple MyelomaPositron Emission Tomography Computed TomographyReceptors, Chimeric AntigenAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedRecurrenceTreatment OutcomeB-Cell Maturation AntigenFluorodeoxyglucose F18Receptors, Chimeric Antigen

Identifiers

PMID39602341
PMCPMC11821407

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.