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.
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.
Study Type
OBSERVATIONAL
Enrollment
43
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).
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-Etienne, France
CHRU Strasbourg
Strasbourg, France
CHU Toulouse
Toulouse, France
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)
Time frame: Months: 24
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)
Time frame: Months: 24
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)
Time frame: Months: 24
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)
Time frame: Months: 24
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)
Time frame: Months: 24
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)
Time frame: Months: 24
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