Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin

Part of paid clinical trials in San Francisco, California.

Sponsor
GlaxoSmithKline
Study ID
NCT04549363
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belantamab mafodotin — DRUG
    Belantamab mafodotin is a first-in-class immunoconjugate that targets B cell maturation antigen (BCMA), which is highly expressed on malignant plasma cells.

Study Details

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.

Key Dates

Start date
Dec 21, 2020
Status verified
Nov 2023
Primary completion
Nov 21, 2022
Completion
Nov 21, 2022

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Participants undergoing IC
    IC will be performed on some participants who received or are receiving treatment with belantamab mafodotin for RRMM and have objective evidence of keratopathy with corneal deposits on slit-lamp and/or confocal microscopy examination and who do not agree to undergo SK.
  • Experimental: Participants undergoing SK
    SK will be performed on some participants who received or are receiving treatment with belantamab mafodotin for RRMM and have objective evidence of keratopathy with corneal deposits on slit-lamp and/or confocal microscopy examination.

Primary Outcome Measure

Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin [ Time Frame: Up to approximately 23 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteSan FranciscoCalifornia94143-
GSK Investigational SiteAtlantaGeorgia30322-
GSK Investigational SiteWestwoodKansas66205-
GSK Investigational SiteBaltimoreMaryland21201-
GSK Investigational SiteNew YorkNew York10065-
GSK Investigational SiteChapel HillNorth Carolina27517-

Find similar trials in San Francisco, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
GSK Investigational Site· San Francisco, CAGSK Investigational Site· Atlanta, GAGSK Investigational Site· Westwood, KSGSK Investigational Site· Baltimore, MDGSK Investigational Site· New York, NYGSK Investigational Site· Chapel Hill, NC

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