Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin
Study Details
Study Description
Brief Summary
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. Study duration will be approximately 4 months. Approximately 25 participants will be enrolled in the study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Participants undergoing IC 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
Belantamab mafodotin is a first-in-class immunoconjugate that targets B cell maturation antigen (BCMA), which is highly expressed on malignant plasma cells.
|
| Experimental: Participants undergoing SK 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
Belantamab mafodotin is a first-in-class immunoconjugate that targets B cell maturation antigen (BCMA), which is highly expressed on malignant plasma cells.
|
Outcome Measures
Primary Outcome Measures
- Number of participants with abnormality in composition of corneal epithelium after administration of belantamab mafodotin [Up to 4 months]
Corneal tissue samples will be collected to evaluate the composition of microcyst-like epithelium observed in participants treated with belantamab mafodotin.
- Number of participants with abnormality in pathologic characteristics after administration of belantamab mafodotin [Up to 4 months]
Corneal tissue samples will be collected to evaluate pathologic characteristics observed in participants treated with belantamab mafodotin.
Secondary Outcome Measures
- Number of participants with non-serious adverse events (non-SAEs) and serious adverse events (SAEs) associated with IC or SK procedure [Up to 4 months]
Non-SAEs and SAEs will be collected.
- Number of participants with abnormal best corrected visual acuity (BCVA) scores [Up to 4 months]
Number of participants with abnormal BCVA scores will be evaluated. The BCVA score is the number of letters read correctly by the participant. A decrease in the BCVA score indicates a worsening of vision while higher scores indicates improvement of visual acuity.
- Number of participants with abnormal corneal symptoms [Up to 4 months]
Number of participants with abnormal corneal symptoms will be evaluated.
- Number of participants with abnormal corneal epithelial lesions [Up to 4 months]
Imaging of the corneal epithelial lesions will be done from slit-lamp examination and/or confocal microscopy, for evaluation of corneal epithelial lesions. Number of participants with abnormal corneal epithelial lesions will be evaluated.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female, aged 18 years or older (at the time consent is obtained).
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Capable of providing signed written informed consent, which includes compliance with the requirements and restrictions listed on the consent form.
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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.
- 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:
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Any serious and or/unstable medical or psychiatric disorder, or other conditions that could interfere with the participant's safety.
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Any excess risk of delayed wound healing (For example, diabetes mellitus).
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Do not meet criteria specified by the study or program through which they would receive belantamab mafodotin.
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Any participant taking concurrent medication that may affect the cornea (that is. amiodarone, some chloroquines).
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Any participant with decreased corneal sensation.
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Eye infections, including infectious keratopathy, stye, blepharitis, and conjunctivitis.
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An active uveitis including anterior, posterior, or panuveitis in either eye.
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Permanent legal blindness in the fellow (non-study) eye.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | San Francisco | California | United States | 94143 |
| 2 | GSK Investigational Site | Atlanta | Georgia | United States | 30322 |
| 3 | GSK Investigational Site | Westwood | Kansas | United States | 66205 |
| 4 | GSK Investigational Site | New York | New York | United States | 10065 |
| 5 | GSK Investigational Site | Chapel Hill | North Carolina | United States | 27517 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 214098