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 range

18 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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