- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04549363
Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin
November 21, 2023 updated by: GlaxoSmithKline
Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin (GSK2857916)
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 Overview
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 3
Expanded Access
Available outside the clinical trial.
See expanded access record.
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94143
- GSK Investigational Site
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Georgia
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Atlanta, Georgia, United States, 30322
- GSK Investigational Site
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Kansas
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Westwood, Kansas, United States, 66205
- GSK Investigational Site
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Maryland
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Baltimore, Maryland, United States, 21201
- GSK Investigational Site
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New York
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New York, New York, United States, 10065
- GSK Investigational Site
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North Carolina
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Chapel Hill, North Carolina, United States, 27517
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Belantamab mafodotin is a first-in-class immunoconjugate that targets B cell maturation antigen (BCMA), which is highly expressed on malignant plasma cells.
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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.
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Belantamab mafodotin is a first-in-class immunoconjugate that targets B cell maturation antigen (BCMA), which is highly expressed on malignant plasma cells.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin
Time Frame: Up to approximately 23 months
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Corneal tissue samples were collected to evaluate the composition of microcyst-like epithelium observed in participants treated with belantamab mafodotin.
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Up to approximately 23 months
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Number of Participants With Abnormality in Pathologic Characteristics After Administration of Belantamab Mafodotin
Time Frame: Up to approximately 23 months
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Corneal tissue samples were collected to evaluate pathologic characteristics observed in participants treated with belantamab mafodotin.
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Up to approximately 23 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Imaging Data Showing Histopathologic Findings
Time Frame: Up to approximately 23 months
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The eye was visualized using a slit-lamp microscope in a procedure room.
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Up to approximately 23 months
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Number of Participants With Adverse Events (AEs)
Time Frame: Up to approximately 23 months
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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.
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Up to approximately 23 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 21, 2020
Primary Completion (Actual)
November 21, 2022
Study Completion (Actual)
November 21, 2022
Study Registration Dates
First Submitted
September 8, 2020
First Submitted That Met QC Criteria
September 8, 2020
First Posted (Actual)
September 16, 2020
Study Record Updates
Last Update Posted (Estimated)
December 13, 2023
Last Update Submitted That Met QC Criteria
November 21, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Multiple Myeloma
Other Study ID Numbers
- 214098
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place.
Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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