An observational study in Myeloma Multiple, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 10 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-02.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 43 is below the median of 140 across 468 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with a refractory multiple myeloma, treated by Belantamab Mafodotin, and an ophthalmologic follow-up between January 2020 and February 2022 will be included.
Exclusion Criteria:
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.
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).
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
Plan to share: No
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Centre Hospitalier Universitaire de Saint Etienne