Corneal Findings in Patients Treated With Belantamab Mafodotin

NCT05833737 | Terminated FDA Drug

• 1 other identifier: CoFiBe2023
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

In the upcoming years, more and more ophthalmologists will be confronted with patients receiving Belantamab mafodotin (Belamaf) treatment due to the promising effects on survival in multiple myeloma patients. Early, at best subclinical detection of corneal damage may contribute to the definition of the optimal dosing regimen as well as therapy interval in each patient without the need to stop this lifesaving treatment. However, until today, studies focusing on the development, morphology, and evolution of corneal epithelial changes associated with Belamaf treatment are scarce. In order to clarify the precise pathomechanism of the associated keratopathy, innovative imaging techniques such as corneal confocal microscopy (CCM) need to be used to follow patients prior to therapy and on a regular basis during treatment intervals. In specific, different regions of the cornea, including the central apex, the (mid-) periphery and the limbus need to be explored. The latter, in specific, is often claimed to play an important role in the uptake of Belamaf into the cornea, but has not been studied in any approach so far. Likewise, there are no reports on the effects of Belamaf on corneal layers adjacent to the corneal epithelium, in specific the subepithelial nerve plexus (SNP). Changes in this layer may suggest a potential peripheral neurotoxic/neurodegenerative effect, associated with Belamaf. Furthermore, there is a lack of evidence from literature on how changes in the anterior layers of the cornea as studied with confocal microscopy in patients on Belamaf treatment differ from distinct corneal changes in these same layers in patients with other anterior corneal diseases including keratokonjunctivits sicca, epithelium basement membrane dystrophy and limbal stem cell disease. At last, regeneration of the corneal surface after Belamaf discontinuation has been described and is expected, but detailed information on the time to corneal rehabilitation as well as confocal microscopic follow-up of epithelial and neuronal layers during this time is warranted. The purpose of this monocentric, prospective longitudinal study is to answer these specific research questions in a combined clinical approach using corneal confocal microscopy.

Conditions

Multiple Myeloma; Corneal Diseases; Corneal Cyst

Outcome Measures

Primary Outcomes (1)

• change in corneal nerve fibre density (CNFD) treatment using

  change in CNFD measured with confocal microscopy

  three weeks after completion of the third cycle of Belamaf infusion

Interventions

Belantamab mafodotin DRUG

Injection for refractory/relapsed multiple myeloma

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

This study will include about 50 consecutive patients referred from the Department of Internal Medicine I, Division of Hematology and Hemostaseology, who are scheduled for treatment with Belamaf due to multiple myeloma. Patients will be receiving Belamaf per standard of care.

You may qualify if:

• Provide signed written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• Participant must be ≥ 18 years of age at the start of belantamab mafodotin treatment
• Confirmed diagnosis of multiple myeloma

You may not qualify if:

• Participant must not have any signs of corneal disease before study entry.
• Uncontrolled glaucoma
• Medical history of (diabetic) polyneuropathy
• Inability to comply with follow-up visits
• Participant must not have known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Multiple Myeloma; Corneal Diseases

Interventions

belantamab mafodotin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; 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; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 27, 2023
• Study Start: June 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)