Evidence map›Paper›PMID 42786443›Full record

ArticleBMC cancer2026

Belantamab mafodotin plus venetoclax in t(11;14)-positive relapsed or refractory multiple myeloma - the BELI(E)VE trial.

Christoph Schaefers, Cyrus Khandanpour, Mathias Hänel, Miriam Kull, Winfried Alsdorf, Abdulaziz Kamili, Ricardo Kosch, William Krüger, Stephan Bohl, Elias Karl Mai and 8 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05853965 (Combination Treatment of Belantamab Mafodotin and Venetoclax in Treatment of Relapsed and Refractory t), which is not on this map. Not yet cited in PubMed.

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

What it found

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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.

NCT05853965 phase1 / phase2recruitingnot on this map

Combination Treatment of Belantamab Mafodotin and Venetoclax in Treatment of Relapsed and Refractory t(11;14) Multiple Myeloma (Phase I/IIa) The BELI(E)VE-Trial

TypeinterventionalSponsorUniversitätsklinikum Hamburg-EppendorfRan2023 to 2028Enrolled45ConditionsMultiple Myeloma, Multiple Myeloma in RelapseArmsBelantamab mafodotin, Venetoclax
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

18 authors.

Christoph SchaefersDepartment of Hematology, Oncology and Bone Marrow Transplantation with Section Pneumology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, Hamburg, 20246, Germany.
Cyrus KhandanpourDepartment of Hematology and Oncology, University Hospital of Schleswig-Holstein Campus Lübeck, University Cancer Center Schleswig- Holstein and University of Lübeck, Lübeck, Germany.
Mathias HänelDepartment of Hematology, Oncology and Bone Marrow Transplantation, Klinikum Chemnitz, Chemnitz, Germany.
Miriam KullDepartment III of Internal Medicine University Hospital of Ulm, Ulm, Germany.
Winfried AlsdorfDepartment of Hematology, Oncology and Bone Marrow Transplantation with Section Pneumology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, Hamburg, 20246, Germany.
Abdulaziz KamiliDepartment of Hematology, Oncology and Bone Marrow Transplantation with Section Pneumology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, Hamburg, 20246, Germany.
Ricardo KoschDepartment of Hematology, Oncology and Bone Marrow Transplantation with Section Pneumology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, Hamburg, 20246, Germany.
William KrügerDepartment of Internal Medicine C, University Medicine Greifswald, Greifswald, Germany.
Stephan BohlDepartment of Internal Medicine, Charité-University Medicine Berlin, Berlin, Germany.
Elias Karl MaiHeidelberg Myeloma Center, Internal Medicine V, Hematology, Oncology and Rheumatology, Heidelberg University Hospital and Medical Faculty Heidelberg, Heidelberg, Germany.
Christof ScheidDepartment I of Internal Medicine, University Hospital of Cologne, Cologne, Germany.
Hermann EinseleDepartment of Internal Medicine II, University Hospital Würzburg, Würzburg, Germany.
Monika BrüggemannDepartment of Hematology, University of Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Anna SulingInstitute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Antonia ZapfInstitute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Carsten BokemeyerDepartment of Hematology, Oncology and Bone Marrow Transplantation with Section Pneumology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, Hamburg, 20246, Germany.
Katja WeiselDepartment of Hematology, Oncology and Bone Marrow Transplantation with Section Pneumology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, Hamburg, 20246, Germany.
Lisa LeypoldtDepartment of Hematology, Oncology and Bone Marrow Transplantation with Section Pneumology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, Hamburg, 20246, Germany. l.leypoldt@uke.de.ORCID http://orcid.org/0000-0002-9248-588X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMultiple myeloma (MM) is a widely incurable B-cell malignancy that predominantly affects older adults, representing 10% of hematologic cancers. Despite advancements in therapy that have significantly extended median overall survival (OS), MM remains a clinical challenge with poor prognosis for patients refractory to multiple drug classes. There is a critical need for innovative and personalized treatments, including for patients with translocation (11;14), a subgroup characterized by specific therapeutic vulnerabilities. Combined targeting of B-cell maturation antigen (BCMA) and BCL-2 presents a promising personalized treatment strategy for inducing deep remissions and improving outcomes in this specific subgroup.

methodsThe BELI(E)VE trial (NCT05853965) is a German investigator-initiated, prospective, multicenter, open-label phase I/IIa study designed to evaluate the combination of belantamab mafodotin and venetoclax, with or without dexamethasone, in patients with relapsed or refractory multiple myeloma (RRMM) with ≥1 prior treatment line and t(11;14) translocation. The study consists of a dose escalation phase (phase I) to determine the recommended phase 2 dose (RP2D), followed by a dose expansion phase (phase IIa) to assess clinical activity at the RP2D. The phase I portion employs a traditional 3+3 design across four dose levels, while the phase IIa expansion will include 25 additional patients treated at the RP2D. Safety, tolerability, and preliminary efficacy will be evaluated through comprehensive assessments, including assessment for minimal residual disease negativity and ocular exams. DISCUSSION: The BELI(E)VE trial aims to establish a novel personalized therapeutic approach for a specific subset of MM patients by combining belantamab mafodotin and venetoclax. This combination targets BCMA and BCL-2, potentially inducing deep and durable remissions. The study will provide critical data on the safety and efficacy of this combination, aiming to improve outcomes in t(11;14)-positive RRMM patients. The translational component, examining circulating tumor cells and mitochondrial activity, may identify mechanisms of resistance and response, guiding future personalized therapeutic strategies.

trial registrationNCT05853965 (2023-04-22).

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBridged Bicyclo Compounds, HeterocyclicMultiple MyelomaNeoplasm Recurrence, LocalSulfonamidesChromosomes, Human, Pair 11Chromosomes, Human, Pair 14Clinical Trials, Phase I as TopicClinical Trials, Phase II as TopicDexamethasoneDrug Resistance, NeoplasmHumansMulticenter Studies as TopicProspective StudiesTranslocation, GeneticAntibodies, Monoclonal, Humanizedbelantamab mafodotinBridged Bicyclo Compounds, HeterocyclicDexamethasoneSulfonamidesvenetoclaxBelantamab mafodotinMultiple myelomat(11;14)Trial protocolVenetoclax

Identifiers

PMID42786443
PMCPMC13602635

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Registered trials

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