Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin

• Status: Recruiting
• Trial end date: 2022-02-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

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.