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TerminatedNCT05833737Updated May 8, 2025

Corneal Findings in Patients Treated With Belantamab Mafodotin

An observational study in Multiple Myeloma, Corneal Diseases and Corneal Cyst, sponsored by Medical University of Vienna. Terminated at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-08.

Sponsored by Medical University of Vienna · Observational

Why this study was terminated
Study medication market withdrawal by FDA.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Myeloma
  • Corneal Diseases
  • Corneal Cyst
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 12 is below the median of 140 across 468 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (actual)
Patient registry
No

Interventions

  • DrugBelantamab mafodotin

    Injection for refractory/relapsed multiple myeloma

06

What researchers measure

Primary outcomes

  1. change in corneal nerve fibre density (CNFD) treatment using

    change in CNFD measured with confocal microscopy

    Time frame: three weeks after completion of the third cycle of Belamaf infusion

07

Study locations

1 site
  • Medical University of Vienna
    Vienna, 1090, Austria
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05833737
Lead sponsor
Medical University of Vienna
Responsible party
Julia Aschauer (Principal Investigator, Medical University of Vienna) — Principal investigator
First posted
Apr 27, 2023
Start date
Jun 1, 2023
Primary completion
Jan 1, 2025
Completion
Jan 1, 2025
Last update
May 8, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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