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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05887206
Other study ID # IRBN292021/CHUSTE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2, 2022
Est. completion date May 2, 2023

Study information

Verified date May 2023
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date May 2, 2023
Est. primary completion date May 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Collection of datas
The collected data are : sex, age, date of first immunotherapy cycle, dose, date of first consultation, objective refraction in spheric equivalent, keratometry, visual acuity, microcyst-like epithelial changes (MECs), location and density, corneal toxicity grade and complementary exams (topography, in vivo confocal microscopy).

Locations

Country Name City State
France CHU Dijon Dijon
France CHU de Limoges - Hôpital Dupuytren Limoges
France HCL- Croix Rousse Lyon
France Clinique Monticelli-Vélodrome Marseille
France CHRU de Nancy Nancy
France CHU Nice Nice
France APHP - Kremlin-Bicêtre Paris
France CHU Saint-Etienne Saint-Étienne
France CHRU Strasbourg Strasbourg
France CHU Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Keratopathy and Visual Acuity (KVA) scale 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)
Months: 24
Primary Refraction (no unit) The refraction is measured in spheric equivalent (SEQ) with an automated refractometer
The aim is to show a correlation between refractive shift and severity grade of microcyst-like epithelial changes (MECs)
Months: 24
Secondary Monoyer scale The score is from 10/10 (best visual acuity) to 1/10 (worth visual acuity) Correlation between visual acuity and severity grade of microcyst-like epithelial changes (MECs) Months: 24
Secondary Parinaud scale The score is from 10/10 (best visual acuity) to 1/10 (worth visual acuity) Correlation between visual acuity and severity grade of microcyst-like epithelial changes (MECs) Months: 24
Secondary Keratometry (diopter = 1/m) Keratometry is measured in diopter using an autorefractometer or a topograph. This device measures the curvature of the anterior corneal surface based on the power of a reflecting surface. It does this by measuring the size of an image reflected from 2 paracentral points and utilizes doubling prisms to stabilize the image enabling more accurate focusing.
Correlation between keratometry and severity grade of microcyst-like epithelial changes (MECs)
Months: 24
Secondary Epithelial pachymetry (µm) Epithelial pachymetry is measured in micrometer (µm) using a topograph
Correlation between epithelial pachymetry and severity grade of microcyst-like epithelial changes (MECs)
Months: 24
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