Evidence map›Paper›PMID 37078253›Full record

Observational studyHaematologica2023

Real-world study of the efficacy and safety of belantamab mafodotin (GSK2857916) in relapsed or refractory multiple myeloma based on data from the nominative ATU in France: the IFM 2020-04 study.

Alexis Talbot, Arthur Bobin, Léa Tabone, Jérôme Lambert, Catherine Boccaccio, Cécile Deal, Marie-Odile Petillon, Olivier Allangba, Philippe Agape, Pierre Arnautou and 40 more

Open access · goldAbstract readObservational StudyMulticenter Study
In one paragraph

Observational study in Haematologica, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
4.6field-weighted citation impact, top 5% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
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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

50 authors at 20 institutions in 3 countries.

Alexis TalbotHôpital Saint Louis, APHP, Immuno-Hématologie, INSERM U976, équipe 5. alexis.talbot.fr@gmail.com.
Arthur BobinCHU de Poitiers, Service d'Hématologie et Thérapie cellulaire, CIC U1402, Poitiers.
Léa TaboneIFM Intergroupe Francophone du Myélome.
Jérôme LambertECSTRA, Centre de Recherche en Epidémiologie et Statistiques, INSERM UMR 1153.
Catherine BoccaccioIFM Intergroupe Francophone du Myélome.
Cécile DealIFM Intergroupe Francophone du Myélome.
Marie-Odile PetillonHôpital Claude Huriez, Hématologie, Lille.
Olivier AllangbaCentre Hospitalier Yves Le Foll, Hématologie-Oncologie, Saint Brieuc.
Philippe AgapeCentre hospitalier de Laval, Hématologie, Laval.
Pierre ArnautouHôpital d'Instruction des Armées Percy, Hématologie, Clamart.
Rakiba BelkhirAPHP Bicêtre, Rhumatologie, Kremlin-Bicetre.
Sylvie CailleresCentre Hospitalier du Pays d'Aix, Service hématologie oncologie, Aix-enProvence.
Driss ChaouiCentre Hospitalier Victor Dupouy, Hématologie, Argenteuil.
Marie-Lorraine ChrétienCHU Dijon Bourgogne, Hématologie, Dijon.
Olivier DecauxCHRU Hôpital de Pontchaillou, Hématologie, Rennes.
Samantha SchulmannCHRU Hôpitaux de Brabois, Hématologie, Nancy.
Laurent FrenzelAPHP, Hôpital Universitaire Necker Enfants Malades, Hématologie adultes.
Lauris GastaudCentre Antoine Lacassagne, service onco-hématologie, Nice.
Antoine HuartCHU Toulouse - Hôpital de Rangueil, Néphrologie, Toulouse.
Cyrille HulinCHU Bordeaux, Hématologie et thérapie cellulaire, Bordeaux.
Lionel KarlinCentre Hospitalier Lyon Sud, Hématologie, Lyon Sud.
Kamel LaribiCentre Hospitalier du Mans, Hématologie clinique, Le Mans.
Ronan Le CallochCentre Hospitalier de Quimper Cornouaille, Service d'hématologie, Quimper.
Pascal LenainCentre Henri Becquerel, Hématologie, Rouen.
Margaret MacroCHU Caen, Hématologie, Caen.
Salomon ManierCHRU Hôpital Claude Huriez, Maladie du sang, Lille.
Lydia MontesCHU Amiens, Hématologie Clinique, Amiens.
Stéphane MoreauCHU de Limoges, Hématologie clinique et thérapie cellulaire, Limoges.
Philippe MoreauCHU de Nantes - Hôtel Dieu, Hématologie clinique, Nantes.
Véronique MorelAPHP Pitié-Salpêtrière, Hématologie Clinique.
James NorwoodHôpital du Scorff, Hématologie, Lorient.
Frédérique Orsini PiocelleCH Annecy Genevois, Hématologie, Annecy.
Aurore PerrotCHU de Toulouse, IUCT-O, Service Hématologie, Université de Toulouse UPS, Toulouse.
Gian Matteo PicaCentre Hospitalier Métropole Savoie, Hématologie, Chambéry.
Philippe ReyCentre Léon Bérard, Onco-Hématologie, Lyon CAC.
Anna SchmittBordeaux Unicancer, Onco-Hématologie, Bordeaux.
Anne-Marie StoppaIPC Unicancer Marseille, Hématologie, Marseille.
Mourad TiabCHD Vendée, Médecine Interne, La Roche-sur-Yon.
Cyrille TouzeauCHU de Nantes - Hôtel Dieu, Hématologie clinique, Nantes.
Valérie VidalAPHP Avicenne, Hématologie Clinique.
Marguerite VignonAPHP Cochin, Hématologie clinique.
Laure VincentCHU Montpellier - Hôpital Saint Eloi, Hématologie, Montpellier.
Zoé Van De WyngaertAPHP Saint Antoine, Hématologie clinique et thérapie cellulaire.
Charles ZarnitskyHôpital Jacques Monod, Rhumatologie, Le Havre.
Naima KerboucheGSK (GlaxoSmithKline).
Prani PakaGSK (GlaxoSmithKline).
Xavier LeleuCHU de Poitiers, Service d'Hématologie et Thérapie cellulaire, CIC U1402, Poitiers.
Bertrand ArnulfHôpital Saint Louis, APHP, Immuno-Hématologie, INSERM U976, équipe 5.
Hervé Avet-LoiseauIUC-T Oncopole, Unité de Génomique du Myélome, Toulouse, France.
Ifm Intergroupe Francophone Du Myélome.
Intergroupe Francophone du Myélome · FRCentre d'Investigation Clinique de Nantes · FRGlaxoSmithKline (India) · INHôpital Claude Huriez · FRBicêtre Hospital · FRCentre Antoine Lacassagne · FRCentre de Recherche Épidémiologie et Statistique · FRCentre Henri BecquerelCentre Hospitalier Annecy Genevois · FRCentre Hospitalier de Cornouaille · FRCentre Hospitalier Départemental Vendée · FRCentre Hospitalier du Mans · FRCentre Hospitalier du Pays d'Aix · FRCentre Hospitalier Métropole Savoie · FRCentre Hospitalier Régional et Universitaire de Nancy · FRCentre Hospitalier Universitaire Amiens-Picardie · FRCentre Hospitalier Universitaire de Bordeaux · FRCentre Hospitalier Universitaire de Caen Normandie · FRCentre Hospitalier Universitaire de Limoges · FRCentre Hospitalier Universitaire de Toulouse · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Belantamab mafodotin (BM) is an anti-BCMA antibody-drug conjugate (GSK2857916) that represents an alternative option in multiple myeloma. We sought to assess the efficacy and safety of BM in a real-world setting in patients who benefited from an early access program. We conducted an observational, retrospective, multicenter study. Eligibility criteria were treatment of relapsed or refractory multiple myeloma (RRMM) in monotherapy in adult patients who have received at least three lines of therapy previously, including at least one immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody, and whose disease progressed during the last treatment period. The primary endpoint of the study is to assess the overall survival (OS). Between November 2019 and December 2020, 106 patients were treated with BM; 97 were eligible for the efficacy evaluation and 104 for safety. The median age was 66 (range, 37-82) years. High-risk cytogenetics were identified in 40.9% of patients. Fifty-five (56.7%) patients were triple-class refractory and 11 (11.3%) were penta-class refractory. The median number of prior lines of treatment was five (range, 3-12). The median number of BM cycles administered was three (range, 1-22). The overall response rate at best response was 38.1% (37/97). The median OS was 9.3 months (95% confidence interval [CI]: 5.9-15.3), and median progression-free survival was 3.5 months (95% CI: 1.9-4.7). The median duration of response was 9 months (range, 4.65-10.4). Treatment was delayed for 55 (52.9%) patients including 36.5% for treatment-related toxicity. Ophthalmic adverse events, mainly grade ≤2, were the most common toxicity (48%). The occurrence of keratopathy was 37.5%. Overall, our data are concordant with the results from DREAMM-2 in terms of efficacy and safety on a non-biased population.

Indexed as

Multiple MyelomaAdultAgedAntibodies, Monoclonal, HumanizedFranceHumansRetrospective StudiesTreatment OutcomeAntibodies, Monoclonal, Humanizedbelantamab mafodotin

Identifiers

PMID37078253
PMCPMC10543185
OpenAlexW4366463565

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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.