Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04549363
• Other study ID #: 214098
• Status: Terminated
• Phase: Phase 3
• Start date: December 21, 2020
• Est. completion date: November 21, 2022

Study information

• Verified date: November 2023
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: November 21, 2022
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma

Intervention

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.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Chapel Hill	North Carolina
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Westwood	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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