Corneal Toxicity in Patients Treated by Belantamab Mafodotin

May 31, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France
        • CHU Dijon
      • Limoges, France
        • CHU de Limoges - Hôpital Dupuytren
      • Lyon, France
        • HCL- Croix Rousse
      • Marseille, France
        • Clinique Monticelli-Vélodrome
      • Nancy, France
        • CHRU de Nancy
      • Nice, France
        • CHU Nice
      • Paris, France
        • APHP - Kremlin-Bicêtre
      • Saint-Étienne, France
        • CHU Saint-Etienne
      • Strasbourg, France
        • CHRU Strasbourg
      • Toulouse, France
        • CHU Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with a refractory multiple myeloma, treated by Belantamab Mafodotin, and an ophthalmologic follow-up between January 2020 and February 2022 will be included.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Months: 24
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)
Months: 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Months: 24
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)
Months: 24
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)
Months: 24
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)
Months: 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Marie Caroline TRONE, MD, CHU Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2022

Primary Completion (Actual)

May 2, 2023

Study Completion (Actual)

May 2, 2023

Study Registration Dates

First Submitted

May 17, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Estimated)

June 2, 2023

Study Record Updates

Last Update Posted (Estimated)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBN292021/CHUSTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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