Trials / Terminated
TerminatedNCT04549363
Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin
Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin (GSK2857916)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-12-21
- Primary completion
- 2022-11-21
- Completion
- 2022-11-21
- First posted
- 2020-09-16
- Last updated
- 2023-12-13
- Results posted
- 2023-12-13
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04549363. Inclusion in this directory is not an endorsement.