Clinical trial NCT04549363: Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin
Official title: Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin (GSK2857916)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Belantamab mafodotin
Impression cytology
Superficial keratectomy
Relapsed/Refractory multiple myeloma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin
timeFrame: Up to approximately 23 months
measure: Number of Participants With Abnormality in Pathologic Characteristics After Administration of Belantamab Mafodotin
timeFrame: Up to approximately 23 months
Secondary outcomes:
measure: Number of Participants With Imaging Data Showing Histopathologic Findings
timeFrame: Up to approximately 23 months
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to approximately 23 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Westwood
country: United States
facility: GSK Investigational Site
state: Kansas
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: