Myeloma Multiple
Conditions
Keywords
Myeloma, relapsed or refractory multiple myeloma (RRMM), Belantamab mafodotin, microcyst-like epithelial changes (MECs), microcyst, corneal toxicity, refractive shift
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.
Interventions
OTHERCollection 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).
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Keratopathy and Visual Acuity (KVA) scale | Months: 24 | 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) |
| Refraction (no unit) | Months: 24 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monoyer scale | Months: 24 | 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) |
| Parinaud scale | Months: 24 | 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) |
| Keratometry (diopter = 1/m) | Months: 24 | 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) |
| Epithelial pachymetry (µm) | Months: 24 | Epithelial pachymetry is measured in micrometer (µm) using a topograph Correlation between epithelial pachymetry and severity grade of microcyst-like epithelial changes (MECs) |
Countries
France
Outcome results
None listed