Corneal Toxicity in Patients Treated by Belantamab Mafodotin

NCT05887206 | Completed

• 1 other identifier: IRBN292021/CHUSTE
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 10

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.

Conditions

Myeloma Multiple

Keywords

Myeloma; relapsed or refractory multiple myeloma (RRMM); Belantamab mafodotin; microcyst-like epithelial changes (MECs); microcyst; corneal toxicity; refractive shift

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Monoyer scale

  Months: 24

• Parinaud scale

  Months: 24

• Keratometry (diopter = 1/m)

  Months: 24

• Epithelial pachymetry (µm)

  Months: 24

Study Arms (1)

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

Interventions

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).

Patients treated by Belantamab Mafodotin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• French patients with a refractory multiple myeloma and an ophthalmologic follow-up between January 2020 and February 2022
• Patients treated by Belantamab Mafodotin

You may not qualify if:

• Patients with more than 50% of missing ophthalmologic data.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (10)

CHU Dijon

Dijon, France

Location

CHU de Limoges - Hôpital Dupuytren

Limoges, France

Location

HCL- Croix Rousse

Lyon, France

Location

Clinique Monticelli-Vélodrome

Marseille, France

Location

CHRU de Nancy

Nancy, France

Location

CHU Nice

Nice, France

Location

APHP - Kremlin-Bicêtre

Paris, France

Location

CHU Saint-Etienne

Saint-Etienne, France

Location

CHRU Strasbourg

Strasbourg, France

Location

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell; Recurrence

Condition Hierarchy (Ancestors)

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

Study Officials

• Marie Caroline TRONE, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 2, 2023
• Study Start: May 2, 2022
• Primary Completion: May 2, 2023
• Study Completion: May 2, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)