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OpenTrials
Completed

NCT Number: NCT05887206

Corneal Toxicity in Patients Treated by Belantamab Mafodotin

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.

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Key information

Conditions

Myeloma Multiple Blood Protein Disorders Cardiovascular Diseases Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon, Dijon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Collection of datas

Other

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).

Primary outcomes

  1. 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)

  2. 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 outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Corneal Toxicity in Patients Treated by Belantamab Mafodotin : How to Improve and Facilitate Patients Follow-up Using Refractive Shift ?

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 2, 2023
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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