MedTrace Logo

Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin

NCT04549363 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-12-13

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Belantamab mafodotin

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-21
Primary Completion
2022-11-21
Completion
2022-11-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04549363 on ClinicalTrials.gov