Corneal Toxicity in Patients Treated by Belantamab Mafodotin

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT05887206

Collaborator

(none)

Enrollment

Locations

Actual Duration (Months)

4.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myeloma Multiple	Other: Collection of datas

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 Design

Study Type:

Observational

Actual Enrollment :

43 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

May 2, 2022

Actual Primary Completion Date :

May 2, 2023

Actual Study Completion Date :

May 2, 2023

Arms and Interventions

Arm	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).

Arm

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).

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	CHU Dijon	Dijon	France
2	CHU de Limoges - Hôpital Dupuytren	Limoges	France
3	HCL- Croix Rousse	Lyon	France
4	Clinique Monticelli-Vélodrome	Marseille	France
5	CHRU de Nancy	Nancy	France
6	CHU Nice	Nice	France
7	APHP - Kremlin-Bicêtre	Paris	France
8	CHU Saint-Etienne	Saint-Étienne	France
9	CHRU Strasbourg	Strasbourg	France
10	CHU Toulouse	Toulouse	France