Corneal Findings in Patients Treated With Belantamab Mafodotin

April 25, 2023 updated by: Julia Aschauer, Medical University of Vienna

Corneal Findings in Patients Treated With Belantamab Mafodotin - a Prospective Study Focusing on Corneal Nerves

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  1. Provide signed written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  2. Participant must be ≥ 18 years of age at the start of belantamab mafodotin treatment
  3. Confirmed diagnosis of multiple myeloma
  4. Due to receive belantamab mafodotin per routine clinical care by a hematologist consistent with the approved labelling (received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy). The inclusion will be based on the clinical judgement of the hematologists and the estimation about the patient´s ability to co-operate during the ophthalmological examinations. All inclusion and exclusion criteria for belamaf medication are upon judgment of the prescribing hematooncologist and are therefore not part of this study protocol.

Exclusion Criteria:

  1. Participant must not have any signs of corneal disease before study entry.
  2. As stated above, the inclusion and exclusion criteria for belamaf medication are upon judgment of the prescribing hemato-oncologist, and are therefore not part of this study protocol.
  3. Uncontrolled glaucoma
  4. Medical history of (diabetic) polyneuropathy
  5. Inability to comply with follow-up visits
  6. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in corneal nerve fibre density (CNFD) treatment using
Time Frame: three weeks after completion of the third cycle of Belamaf infusion
change in CNFD measured with confocal microscopy
three weeks after completion of the third cycle of Belamaf infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

June 1, 2026

Study Completion (Anticipated)

August 1, 2026

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CoFiBe2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on Belantamab mafodotin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe