Practical Guidance on Clinical Management of Belantamab Mafodotin-Associated Ocular Events

Evangelos Terpos¹, Suzanne Trudel², María-Victoria Mateos³, Nicolás Alejandre⁴, Kathryn Colby⁵, Meletios A Dimopoulos^{1

6}, Simona Degli Esposti⁷, Asim V Farooq⁸, Maria Gavriatopoulou¹, Francesca Gay⁹, Vania Hungria¹⁰, K Martin Kortüm¹¹, Xavier Leleu¹², Sagar Lonial¹³, Hang Quach¹⁴, Lugui Qiu¹⁵, Karthik Ramasamy¹⁶, Kazuhito Suzuki¹⁷, Katja C Weisel¹⁸, Paul Richardson¹⁹

Affiliations

¹ Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
² Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
³ Institute of Cancer Molecular and Cellular Biology, University Hospital of Salamanca/Institute of Biomedical Research of Salamanca, Salamanca University, Salamanca, Spain.
⁴ Department of Ophthalmology, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.
⁵ Department of Ophthalmology, New York University Grossman School of Medicine, New York, New York, USA.
⁶ Department of Medicine, Korea University, Seoul, South Korea.
⁷ Moorfields Eye Hospital NHS Foundation Trust, London, UK.
⁸ Department of Ophthalmology and Visual Science, University of Chicago Medical Center, Chicago, Illinois, USA.
⁹ Division of Hematology, University of Turin, Azienda Ospedaliero-Universitaria Città Della Salute e Della Scienza di Torino, Turin, Italy.
¹⁰ Clínica São Germano, São Paulo, Brazil.
¹¹ Department of Internal Medicine 2, University Hospital of Würzburg, Würzburg, Germany.
¹² Service D'hématologie et Thérapie Cellulaire, Hôpital La Milétrie, and Centre D'investigation Clinique INSERM 1402, Poitiers University Hospital, Poitiers, France.
¹³ Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia, USA.
¹⁴ St. Vincent's Hospital Melbourne, University of Melbourne, Melbourne, Victoria, Australia.
¹⁵ National Clinical Research Center for Blood Diseases, State Key Laboratory of Experimental Hematology, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (PUMC), Tianjin, China.
¹⁶ Department of Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK; Oxford Translational Myeloma Centre, NDORMS, University of Oxford, Oxford, UK.
¹⁷ Division of Clinical Oncology/Hematology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.
¹⁸ University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
¹⁹ Jerome Lipper Multiple Myeloma Center, Division of Hematologic Malignancies, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA.

PMID: 40717676
PMCID: PMC12417747
DOI: 10.1002/ajh.70015

Review

Practical Guidance on Clinical Management of Belantamab Mafodotin-Associated Ocular Events

Evangelos Terpos et al. Am J Hematol. 2025 Oct.

. 2025 Oct;100(10):1839-1850.

doi: 10.1002/ajh.70015. Epub 2025 Jul 28.

Authors

Affiliations

¹ Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
² Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
³ Institute of Cancer Molecular and Cellular Biology, University Hospital of Salamanca/Institute of Biomedical Research of Salamanca, Salamanca University, Salamanca, Spain.
⁴ Department of Ophthalmology, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.
⁵ Department of Ophthalmology, New York University Grossman School of Medicine, New York, New York, USA.
⁶ Department of Medicine, Korea University, Seoul, South Korea.
⁷ Moorfields Eye Hospital NHS Foundation Trust, London, UK.
⁸ Department of Ophthalmology and Visual Science, University of Chicago Medical Center, Chicago, Illinois, USA.
⁹ Division of Hematology, University of Turin, Azienda Ospedaliero-Universitaria Città Della Salute e Della Scienza di Torino, Turin, Italy.
¹⁰ Clínica São Germano, São Paulo, Brazil.
¹¹ Department of Internal Medicine 2, University Hospital of Würzburg, Würzburg, Germany.
¹² Service D'hématologie et Thérapie Cellulaire, Hôpital La Milétrie, and Centre D'investigation Clinique INSERM 1402, Poitiers University Hospital, Poitiers, France.
¹³ Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia, USA.
¹⁴ St. Vincent's Hospital Melbourne, University of Melbourne, Melbourne, Victoria, Australia.
¹⁵ National Clinical Research Center for Blood Diseases, State Key Laboratory of Experimental Hematology, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (PUMC), Tianjin, China.
¹⁶ Department of Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK; Oxford Translational Myeloma Centre, NDORMS, University of Oxford, Oxford, UK.
¹⁷ Division of Clinical Oncology/Hematology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.
¹⁸ University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
¹⁹ Jerome Lipper Multiple Myeloma Center, Division of Hematologic Malignancies, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA.

PMID: 40717676
PMCID: PMC12417747
DOI: 10.1002/ajh.70015

Abstract

Importance: Belantamab mafodotin (belamaf)-containing regimens are effective treatment options for patients with relapsed and/or refractory multiple myeloma. Ocular events are a common adverse effect of belamaf treatment, which can be managed by physicians, following appropriate training, to minimize their impact on the patient.

Objective: To develop clinical recommendations for the identification, monitoring, and management of ocular events associated with belamaf therapy, and guidance for any required dose modification.

Evidence review: A systematic literature review was conducted and an international group of hematologists and ophthalmologists reviewed clinical trial data, real-world evidence, and published literature on belamaf-associated ocular events. This literature review and the collective experience and expertise of the panel of experts informed the recommendations.

Findings: Belamaf-associated ocular events are common side effects of treatment, which are managed primarily with appropriate dose modification and decreased frequency of dosing, as well as the use of artificial tears. These events affect the corneal epithelium, are mainly Grade 1 and 2 per the Keratopathy and Visual Acuity scale and are reversible in almost all patients. In general, before initiating belamaf therapy, all patients should undergo a baseline ophthalmic evaluation with an eye specialist. However, if there are delays in obtaining ophthalmic evaluation, or if a patient is rapidly progressing, treatment should be initiated, and ophthalmic evaluation should be undertaken as soon as possible. Patients should be also evaluated by an eye specialist before administering the next three belamaf doses (i.e., before Cycles 2, 3, and 4); dose modifications, as described in this paper, may apply if required. Importantly, modifying the belamaf dose in response to an ocular event is not associated with any reductions in treatment efficacy. After Cycle 4, the treating physician may use the Vision-Related Anamnestic tool, alongside clinical judgment, to decide whether to administer the next dose of belamaf or to refer the patient to an eye specialist (i.e., if the patient experiences new worsening of vision or if the ocular events have neither improved after 8 weeks nor resolved after 12 weeks).

Conclusions and relevance: The expert panel developed recommendations for managing belamaf-associated ocular events, with the aim of contributing to the ease of clinical use of belamaf and improving patient outcomes.

Keywords: belantamab mafodotin; clinical recommendations; multiple myeloma.

PubMed Disclaimer

Conflict of interest statement

E.T., Advisory boards: Amgen, AstraZeneca, EUSA Pharma, BMS, GSK, J&J, Menarini/Stemline, Pfizer, Sanofi, Takeda. Honoraria: Amgen, Antengene, AstraZeneca, EUSA Pharma, BMS, Forus, GSK, J&J, Menarini/Stemline, Novartis, Pfizer, Sanofi, Swixx, Takeda. Research funding: Amgen, GSK, J&J, Sanofi, Takeda. Travel expenses: Takeda; S.T., Grants: Janssen, GSK, BMS, Pfizer, K36 Therapeutics, Roche, Genentech. Consultancy: GSK, Roche, BMS. Honoraria: GSK, Janssen, Pfizer, AstraZeneca, Kite; M.‐V.M., Honoraria: J&J, BMS, Sanofi, GSK, Pfizer, Roche, Kite, Menarini/Stemline, Oncopeptides, Regeneron; N.A., Advisory board and honorarium: GSK; K.C., Honorarium: GSK; M.A.D., Advisory boards and satellite symposia: Amgen, Sanofi, Regeneron, Menarini, Takeda, GSK, BMS, Janssen, BeiGene, Swixx, AstraZeneca. Honorarium: GSK; S.D.E., Advisory boards: GSK, Annexon Biosciences, Roche UK. Speaker's fee: Bayer UK. Travel support: Bayer UK, Roche UK. Consultancy and honorarium: GSK; A.V.F., GSK, Amgen, Ambrx, Sanofi, Seagen, Eisai, AstraZeneca (Data Monitoring Committee), Skye Bioscience, Mythic Therapeutics; M.G., Honoraria: Menarini, Janssen, Integris Pharma, Takeda, GSK, Innovis, Teva, AbbVie; F.G., Honoraria and advisory boards: Janssen, BMS, Celgene, Takeda, GSK, Roche, AbbVie, Pfizer, AstraZeneca, Kite, Amgen, Menarini; V.H., Honoraria: BMS, GSK, J&J, Regeneron, Sanofi, Takeda; K.M.K., Consultancy and honoraria: BMS, GSK, Janssen, Pfizer, Sanofi, Menarini/Stemline, Takeda. Research funding: Janssen; X.L., Consultancy and honoraria: Janssen, Sanofi, AbbVie, Roche, Amgen, Novartis, Kite, BMS, GSK, Takeda, Oncopeptide, Pfizer; S.L., Advisory boards: Takeda, Amgen, Novartis, BMS, GSK, AbbVie, Genentech, Pfizer, Regeneron, Janssen, BMS. Research support for clinical trials: Novartis, BMS, Janssen, Takeda. Board of directors with stock: TG Therapeutics (neurology and autoimmune indications). Honorarium: GSK; H.Q., Research funding: AbbVie, BMS, GSK. Advisory board: BMS, AbbVie, GSK, J&J, Pfizer, Antengene, Sanofi. Honorarium: GSK; L.Q., Consulting fees, payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events: BeiGene, AbbVie, Takeda, Janssen, Roche, Sanofi, GSK. Support for attending meetings and/or travel: BeiGene, Janssen, Takeda, Roche. Participation on a data safety monitoring board or advisory board: BeiGene, Janssen, Takeda, Sanofi; K.R., Advisory board and honoraria: AbbVie, Amgen, Adaptive Biotechnologies, BMS/Celgene, EUSA Pharma, GSK, J&J, Karyopharm Therapeutics, Menarini/Stemline, Pfizer, Sanofi, Takeda, Recordati, CellCentric, Oncopeptides; K.S., Honorarium: GSK; K.C.W., Advisory role or expert testimony: AbbVie, Adaptive, Amgen, AstraZeneca, BeiGene, BMS, Janssen, GSK, Karyopharm Therapeutics, Oncopeptides, Pfizer, Regeneron, Roche Pharma, Sanofi, Menarini/Stemline, Takeda. Honoraria: AbbVie, Adaptive, Amgen, AstraZeneca, BeiGene, BMS, Janssen, GSK, Karyopharm Therapeutics, Novartis, Oncopeptides, Pfizer, Regeneron, Roche Pharma, Sanofi, Menarini/Stemline, Takeda. Research funding: Amgen, BMS/Celgene, Janssen, Sanofi, GSK, AbbVie; P.R., Consulting: BMS/Celgene, GSK, Karyopharm Therapeutics, Oncopeptides, Regeneron, Sanofi. Research funding: Oncopeptides. Honorarium: GSK.

References

1. McCurdy A., Reece D., Louzada M. L., et al., “Belantamab Mafodotin, Pomalidomide, and Dexamethasone for Triple Class Exposed/Refractory Relapsed Multiple Myeloma: A Subgroup Analysis of the ALGONQUIN Trial,” Blood Cancer Journal 14, no. 1 (2024): 155, 10.1038/s41408-024-01135-2. - DOI - PMC - PubMed
1. Malard F., Neri P., Bahlis N. J., et al., “Multiple Myeloma,” Nature Reviews Disease Primers 10, no. 1 (2024): 45, 10.1038/s41572-024-00529-7. - DOI - PubMed
1. Loubert A., Bunod L., M'Hari M., Pompilus F., Purser M., and McNamara S., “The Impact of Patient‐Reported Adverse Events on Quality of Life: An Analysis of the DREAMM‐7 and DREAMM‐8 Randomized Controlled Trials,” Poster presented at: 66th ASH Annual Meeting and Exposition; December 7–10, 2024; San Diego, CA, USA.
1. Dimopoulos M. A., Hungria V. T. M., Radinoff A., et al., “Efficacy and Safety of Single‐Agent Belantamab Mafodotin Versus Pomalidomide Plus Low‐Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma (DREAMM‐3): A Phase 3, Open‐Label, Randomised Study,” Lancet Haematology 10, no. 10 (2023): e801–e812, 10.1016/S2352-3026(23)00243-0. - DOI - PubMed
1. Lu R., Morphey A., Diaz F., Chen J., Razmandi A., and Richards T., “Management of Ocular Toxicity in Patients Receiving Belantamab Mafodotin,” Journal of the Advanced Practitioner in Oncology 14, no. 4 (2023): 300–306, 10.6004/jadpro.2023.14.4.4. - DOI - PMC - PubMed

Publication types

Actions
Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Practical Guidance on Clinical Management of Belantamab Mafodotin-Associated Ocular Events

Affiliations

Practical Guidance on Clinical Management of Belantamab Mafodotin-Associated Ocular Events

Authors

Affiliations

Abstract

Conflict of interest statement

References

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Medical