Corneal Toxicity in Patients Treated by Belantamab Mafodotin

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Myeloma Multiple

Treatments: Other: Collection of datas

Study type: Observational

Funder types: Other

Identifiers

NCT05887206

IRBN292021/CHUSTE

Details and patient eligibility

About

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 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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

43 participants in 1 patient group

Patients treated by Belantamab Mafodotin

Description:

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.

Treatment:

Other: Collection of datas