Last updated: 05/28/2025 09:10:26
Characterization of Corneal Epithelial Changes in Participants Treated with Belantamab Mafodotin
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
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
Observational study model:
Not applicable
Primary completion date:
2022-21-11
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
GSK Investigational Site
San Francisco, CA, United States, 94143
Status
Study Complete
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Terminated (halted prematurely)
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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