Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin

Study Overview
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Brief Summary
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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.

Official Title
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Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin (GSK2857916)

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Belantamab mafodotin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants undergoing IC<br>IC will be performed on some participants who received or are receiving treatment with belantamab mafodotin for RRMM and have objective evidence of keratopathy with corneal deposits on slit-lamp and/or confocal microscopy examination and who do not agree to undergo SK. | Drug: Belantamab mafodotin<br>* Belantamab mafodotin is a first-in-class immunoconjugate that targets B cell maturation antigen (BCMA), which is highly expressed on malignant plasma cells.<br>|
| Experimental: Participants undergoing SK<br>SK will be performed on some participants who received or are receiving treatment with belantamab mafodotin for RRMM and have objective evidence of keratopathy with corneal deposits on slit-lamp and/or confocal microscopy examination. | Drug: Belantamab mafodotin<br>* Belantamab mafodotin is a first-in-class immunoconjugate that targets B cell maturation antigen (BCMA), which is highly expressed on malignant plasma cells.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin | Corneal tissue samples were collected to evaluate the composition of microcyst-like epithelium observed in participants treated with belantamab mafodotin. | Up to approximately 23 months | 
| Number of Participants With Abnormality in Pathologic Characteristics After Administration of Belantamab Mafodotin | Corneal tissue samples were collected to evaluate pathologic characteristics observed in participants treated with belantamab mafodotin. | Up to approximately 23 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Imaging Data Showing Histopathologic Findings | The eye was visualized using a slit-lamp microscope in a procedure room. | Up to approximately 23 months | 
| Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. | Up to approximately 23 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Belantamab mafodotin, Impression cytology, Superficial keratectomy, Relapsed/Refractory multiple myeloma