Clinical trial NCT05887206: Corneal Toxicity in Patients Treated by Belantamab Mafodotin
Official title: Corneal Toxicity in Patients Treated by Belantamab Mafodotin : How to Improve and Facilitate Patients Follow-up Using Refractive Shift ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myeloma Multiple
Keywords: Myeloma
relapsed or refractory multiple myeloma (RRMM)
Belantamab mafodotin
microcyst-like epithelial changes (MECs)
microcyst
corneal toxicity
refractive shift
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a refractory multiple myeloma, treated by Belantamab Mafodotin, and an ophthalmologic follow-up between January 2020 and February 2022 will be included.

Brief summary: 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.

Detailed description: This study aims at analysing the refractive shifts caused by Microcyst-like Epithelial Changes (MECs) and whether it can be used to monitor patients and facilitate their follow up.

Constitution of a French multicenter cohort.

Eligibility criteria: 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.

Primary outcomes:
measure: Keratopathy and Visual Acuity (KVA) scale
timeFrame: Months: 24
measure: Refraction (no unit)
timeFrame: Months: 24
Secondary outcomes:
measure: Monoyer scale
timeFrame: Months: 24
measure: Parinaud scale
timeFrame: Months: 24
measure: Keratometry (diopter = 1/m)
timeFrame: Months: 24
measure: Epithelial pachymetry (µm)
timeFrame: Months: 24
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon
city: Limoges
country: France
facility: CHU de Limoges - Hôpital Dupuytren
city: Lyon
country: France
facility: HCL- Croix Rousse
city: Marseille
country: France
facility: Clinique Monticelli-Vélodrome
city: Nancy
country: France
facility: CHRU de Nancy
city: Nice
country: France
facility: CHU Nice
city: Paris
country: France
facility: APHP - Kremlin-Bicêtre
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
city: Strasbourg
country: France
facility: CHRU Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Marie Caroline TRONE, MD
role: PRINCIPAL_INVESTIGATOR
References: