Clinical trial · Observational
Corneal Toxicity in Patients Treated by Belantamab Mafodotin
Corneal Toxicity in Patients Treated by Belantamab Mafodotin : How to Improve and Facilitate Patients Follow-up Using Refractive Shift ?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Belantamab Mafodotin is the first antibody conjugate targeting B-cell maturation antigen (BCMA) in relapsed or refractory multiple myeloma (RRMM). It is used in multiple myeloma refractory to an immunomodulatory drug or proteasome inhibitor and refractory and/or intolerant to an anti-CD38 monoclonal antibody. It has been found that the immunotherapy causes corneal side effects, Microcyst-like Epithelial Changes (MECs). They are round-shaped corneal inclusions that migrate from the peripheral cornea to the center, causing blurry vision, dryness and refractive shifts depending on their location and density.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloma Multiple | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Collection of datas | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients treated by Belantamab Mafodotin
- description
- patients treated by Belantamab Mafodotin with a refractory multiple myeloma and an ophthalmologic follow-up between January 2020 and February 2022 will be included. Data will be collected for patients coming from multiple French centers which followed patients treated by Belantamab Mafodotin between January 2020 and February 2022. They will be obtained by contacting centers through an email sent with a secure mail address.
- interventionNames
- Other: Collection of datas
Primary outcomes (2)
- measure
- Keratopathy and Visual Acuity (KVA) scale
- timeFrame
- Months: 24
- description
- This scale is defined by 4 values : G1, G2, G3 and G4 (the best value is G1) The severity grade of microcyst-like epithelial changes (MECs) is rated using the Keratopathy and Visual Acuity (KVA) scale after slit lamp examination. The aim is to show a correlation between refractive shift and severity grade of microcyst-like epithelial changes (MECs)
- measure
- Refraction (no unit)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * French patients with a refractory multiple myeloma and an ophthalmologic follow-up between January 2020 and February 2022 * Patients treated by Belantamab Mafodotin Exclusion Criteria: * Patients with more than 50% of missing ophthalmologic data.
References
Publications (0)
Data not yet available