Corneal Toxicity in Patients Treated by Belantamab Mafodotin

Overview

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.

Full Title of Study: “Corneal Toxicity in Patients Treated by Belantamab Mafodotin : How to Improve and Facilitate Patients Follow-up Using Refractive Shift ?”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Retrospective
• Study Primary Completion Date: May 2, 2023

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

• 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).

Arms, Groups and Cohorts

• Patients treated by Belantamab Mafodotin
  • 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.

Clinical Trial Outcome Measures

Primary Measures

• Keratopathy and Visual Acuity (KVA) scale
  • Time Frame: 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)
  • Time Frame: 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 Measures

• Monoyer scale
  • Time Frame: 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
  • Time Frame: 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)
  • Time Frame: 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)
  • Time Frame: 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Centre Hospitalier Universitaire de Saint Etienne
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Marie Caroline TRONE, MD, Principal Investigator, CHU Saint-Etienne