TerminatedPhase 3

Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin

Stopped: The study has been terminated for reasons pertaining to feasibility

United States16 participantsStarted 2020-12-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin

Timeframe: Up to approximately 23 months

Number of Participants With Abnormality in Pathologic Characteristics After Administration of Belantamab Mafodotin

Timeframe: Up to approximately 23 months

Trial details

NCT IDNCT04549363

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-21

Results submitted2023-11-21

View on ClinicalTrials.gov More Multiple Myeloma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin

Timeframe: Up to approximately 23 months

Number of Participants With Abnormality in Pathologic Characteristics After Administration of Belantamab Mafodotin

Timeframe: Up to approximately 23 months