Corneal Toxicity in Patients Treated by Belantamab Mafodotin

Myeloma Multiple Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05887206
• Other study ID #: IRBN292021/CHUSTE
• Status: Completed
• Start date: May 2, 2022
• Est. completion date: May 2, 2023

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2, 2023
• Est. primary completion date: May 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma Multiple
• Neoplasms, Plasma Cell

Intervention

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).

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Months: 24
Primary	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)	Months: 24
Secondary	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)	Months: 24
Secondary	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)	Months: 24
Secondary	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)	Months: 24
Secondary	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)	Months: 24