Last updated: 05/28/2025 09:10:26

Characterization of Corneal Epithelial Changes in Participants Treated with Belantamab Mafodotin

GSK study ID
214098
See study documents
Clinicaltrials.gov ID
NCT04549363
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Characterization of Corneal Epithelial Changes in Participants Treated with Belantamab Mafodotin (GSK2857916)
Trial description: This study will be available to any participant who has received or is currently receiving belantamab mafodotin treatment through either a clinical trial, an access program, or a physician prescription. Participants do not need to be on active treatment. The purpose of this study is to gain a more complete understanding of the pathophysiology of the corneal events seen in some participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. A superficial corneal epithelial tissue specimen will be obtained by performing impression cytology (IC) or superficial keratectomy (SK) procedure in participants treated with belantamab mafodotin. The procedure will only be performed in one eye, most affected by the corneal epithelial changes. This specimen will undergo pathologic examination and composition analysis.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of participants with abnormality in composition of corneal epithelium after administration of belantamab mafodotin

Timeframe: Up to approximately 23 months

Number of participants with abnormality in pathologic characteristics after administration of belantamab mafodotin

Timeframe: Up to approximately 23 months

Secondary outcomes:

Number of participants with imaging data showing histopathologic findings

Timeframe: Up to approximately 23 months

Number of participants with adverse events (AEs)

Timeframe: Up to approximately 23 months

Interventions:
  • Drug: Belantamab mafodotin
    • Enrollment:
    16
    Primary completion date:
    2022-21-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Vivian Lee, Malin Hultcrantz, Stephanie Petrone, Eric W Lewis, Hussam Banna, Eben Lichtman, Praneetha Thulasi, Anjulie A Quick, Bennie H Jeng, Sarah B Sunshine, Jasmine H Francis, Julia Canestraro, Asim V Farooq, Peter Clements, Nicola Robertson, Mark Burman, Tom McKevitt, Herbert Struemper, Lucinda Weir. Characterization of Belantamab Mafodotin-Induced Corneal Changes in Patients With Multiple Myeloma. JAMA ophthalmology. 2025-May-08; doi:10.1001/jamaophthalmol.2025.1008 http://dx.doi.org/10.1001/jamaophthalmol.2025.1008 PMID: 40338596 DOI: 10.1001/jamaophthalmol.2025.1008
    Medical condition
    Multiple Myeloma
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    December 2020 to November 2022
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Male or female, aged 18 years or older (at the time consent is obtained).
    • Capable of providing signed written informed consent, which includes compliance with the requirements and restrictions listed on the consent form.
    • Any serious and or/unstable medical or psychiatric disorder, or other conditions that could interfere with the participant’s safety.
    • Any excess risk of delayed wound healing (For example, diabetes mellitus).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Male or female, aged 18 years or older (at the time consent is obtained).
    • Capable of providing signed written informed consent, which includes compliance with the requirements and restrictions listed on the consent form.
    • Participants with RRMM who have received or are currently receiving treatment with belantamab mafodotin and diagnosed with microcyst-like epithelial changes (MECs) on slit-lamp examination or confocal microscopy, with or without symptoms, in at least one eye. a) If participants only had superficial punctate keratopathy with no evidence of MEC’s they are not eligible.
    • If undergoing SK procedure, treating provider has determined there is no excessive risk to the participant.
    Exclusion criteria:
    • Any serious and or/unstable medical or psychiatric disorder, or other conditions that could interfere with the participant’s safety.
    • Any excess risk of delayed wound healing (For example, diabetes mellitus).
    • Do not meet criteria specified by the study or program through which they would receive belantamab mafodotin.
    • Any participant taking concurrent medication that may affect the cornea (that is. amiodarone, some chloroquines).
    • Any participant with decreased corneal sensation.
    • Eye infections, including infectious keratopathy, stye, blepharitis, and conjunctivitis.
    • An active uveitis including anterior, posterior, or panuveitis in either eye.
    • Permanent legal blindness in the fellow (non-study) eye.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Atlanta, GA, United States, 30322
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chapel Hill, NC, United States, 27517
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New York, NY, United States, 10065
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Francisco, CA, United States, 94143
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Westwood, KS, United States, 66205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Baltimore, MD, United States, 21201
    Status
    Study Complete
    Contact us

    Study documents

    Study report synopsis
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Other
    Actual primary completion date
    2022-21-11
    Actual study completion date
    2022-21-11

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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