Evidence map›Paper›PMID 36509945›Full record

ArticleOncology and therapy2023

Real-World Outcomes of Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results of a Spanish Expanded Access Program (EAP).

Adrián Alegre, Gonzalo Benzo, Rafael Alonso, Joaquín Martínez-López, Ana Jimenez-Ubieto, Clara Cuéllar, Elham Askari, Elena Prieto, Concepción Aláez, Beatriz Aguado and 13 more

Open access · goldAbstract read
In one paragraph

Article in Oncology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
2.4field-weighted citation impact, top 9% 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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.

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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

23 authors at 14 institutions in 1 country.

Adrián AlegreHospital Universitario La Princesa, Madrid, Spain.
Gonzalo BenzoHospital Universitario La Princesa, Madrid, Spain. gonzalo.benzo@gmail.com.
Rafael AlonsoHospital Universitario 12 de Octubre, Madrid, Spain.
Joaquín Martínez-LópezHospital Universitario 12 de Octubre, Madrid, Spain.
Ana Jimenez-UbietoHospital Universitario 12 de Octubre, Madrid, Spain.
Clara CuéllarHospital Universitario 12 de Octubre, Madrid, Spain.
Elham AskariFundación Jiménez Díaz, Madrid, Spain.
Elena PrietoFundación Jiménez Díaz, Madrid, Spain.
Concepción AláezHospital HLA Universitario Moncloa, Madrid, Spain.
Beatriz AguadoHospital Universitario La Princesa, Madrid, Spain.
Alberto VelascoHospital Rey Juan Carlos, Madrid, Spain.
Isabel KrsnikHospital U. Puerta de Hierro, Majadahonda, Madrid, Spain.
Ana BocanegraHospital U. Puerta de Hierro, Majadahonda, Madrid, Spain.
Laura LlorenteHospital Universitario HM Sanchinarro, Madrid, Spain.
Cristina Muñoz-LinaresHospital Universitario del Henares, Madrid, Spain.
Ana MoralesHospital Universitario de Torrejón, Madrid, Spain.
Eugenio GiménezHospital Universitario Infanta Sofía, Madrid, Spain.
Rebeca IglesiasMD Anderson Cancer Center Madrid, Madrid, Spain.
Carmen Martínez-ChamorroHospital Universitario Quirón Pozuelo, Madrid, Spain.
Aránzazu AlonsoHospital Ruber Juan Bravo, Madrid, Spain.
Carmen Jiménez-MontesHospital Universitario La Princesa, Madrid, Spain.
María J BlanchardHospital Universitario Ramón y Cajal, Madrid, Spain.
Grupo GM-GM
Hospital Universitario 12 De Octubre · ESHospital Universitario de La Princesa · ESHospital Universitario Puerta de Hierro Majadahonda · ESHospital Ruber Internacional · ESHospital Universitario de Torrejón · ESHospital Universitario Fundación Jiménez Díaz · ESHospital Universitario Quirónsalud Madrid · ESHospital Universitario Rey Juan Carlos · ESHospital Universitario del Henares · ESHospital Universitario HM Madrid · ESHospital Universitario Ramón y Cajal · ESHospital Universitario HM Sanchinarro · ESHospital Universitario Infanta Sofía · ESMD Anderson Cancer Center Madrid · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBelantamab mafodotin (BM) is a new anti-BCMA antibody-drug conjugate, recently approved for triple-class relapsed and refractory multiple myeloma (RRMM). We assessed real-world outcomes with BM in patients under the Spanish Expanded Access Program (EAP).

methodsWe conducted an observational, retrospective, multicenter study including RRMM patients who received ≥ 1 dose of BM (Nov 2019 to Jun 2021). The primary endpoint was overall response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and incidence of treatment-emergent adverse events (TEAEs).

resultsThirty-three patients were included with a median of 70 years of age (range, 46-79 years). Median time from diagnosis was 71 months (range, 10-858 months). Median prior lines was 5 (range, 3-8 lines); 90% of patients were triple-/quad-/penta-refractory; 48% showed high-risk cytogenetics. Median BM doses was 3 (range 1-16 doses), with a median follow-up of 11 months (6-15 months). ORR was 42.2% (≥ VGPR, 18.2%). Median PFS was 3 months (95% CI 0.92-5.08) in the overall population, and 11 months (HR 0.26; 95% CI 0.10-0.68) for patients who achieved ≥ PR. PFS was not significantly different according to age, cytogenetic risk, and prior therapy lines. OS was 424 days (95% CI 107-740). Non-hematological TEAEs (57.6% of patients; 30.3% ≥ G3) included keratopathy (51.5%; 21.2% ≥ G3) and patient-reported vision-related symptoms (45.5%). Keratopathy was resolved in 70.6% of patients. G3 hematological TEAEs was 18.2%, thrombocytopenia (21.2%). Dose reductions due to TEAEs: 30.3%; delays: 36.4%. Treatment discontinuation causes: progression (54.5%), toxicity (non-ocular; 6%/ocular; 6% /ocular + non-ocular toxicity; 3%), death (6%), and patient's decision (3%).

conclusionsBM showed relevant anti-myeloma activity in RRMM with a manageable safety profile. These results corroborate those observed in the BM pivotal trial.

Indexed as

Belantamab mafodotinEffectivenessReal-world outcomesSafetyTriple-class relapsed and refractory multiple myeloma

Identifiers

PMID36509945
PMCPMC9744371
OpenAlexW4312065937

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.