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NCT04549363 · REGISTRY CONDITION SEARCH

Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
TERMINATED
Registry last update
2023-12-13

This study will be available to any participant who has received or is currently receiving belantamab mafodotin treatment through either a clinical trial, an access program, or a physician prescription. Participants do not need to be on active treatment. The purpose of this study is to gain a more complete understanding of the pathophysiology of the corneal events seen in some participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. A superficial corneal epithelial tissue specimen will be obtained by performing impression cytology (IC) or superficial keratectomy (SK) procedure in participants treated with belantamab mafodotin. The procedure will only be performed in one eye, most affected by the corneal epithelial changes. This specimen will undergo pathologic examination and composition analysis.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin

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outcome · POSTED

Number of Participants With Abnormality in Pathologic Characteristics After Administration of Belantamab Mafodotin

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outcome · POSTED

Number of Participants With Imaging Data Showing Histopathologic Findings

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outcome · POSTED

Number of Participants With Adverse Events (AEs)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Male or female, aged 18 years or older (at the time consent is obtained). * Capable of providing signed written informed consent, which includes compliance with the requirements and restrictions listed on the consent form. * Participants with RRMM who have received or are currently receiving treatment with belantamab mafodotin and diagnosed with microcyst-like epithelial changes (MECs) on slit-lamp examination or confocal microscopy, with or without symptoms, in at least one eye. a) If participants only had superficial punctate keratopathy with no evidence of MEC's they are not eligible. * If undergoing SK procedure, treating provider has determined there is no excessive risk to the participant. Exclusion Criteria: * Any serious and or/unstable medical or psychiatric disorder, or other conditions that could interfere with the participant's safety. * Any excess risk of delayed wound healing (For example, diabetes mellitus). * Do not meet criteria specified by the study or program through which they would receive belantamab mafodotin. * Any participant taking concurrent medication that may affect the cornea (that is. amiodarone, some chloroquines). * Any participant with decreased corneal sensation. * Eye infections, including infectious keratopathy, stye, blepharitis, and conjunctivitis. * An active uveitis including anterior, posterior, or panuveitis in either eye. * Permanent legal blindness in the fellow (non-study) eye.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    IC will be performed on some participants who received or are receiving treatment with belantamab mafodotin for RRMM and have objective evidence of keratopathy with corneal deposits on slit-lamp and/or confocal microscopy examination and who do not agree to undergo SK.
    intervention Names
    1. Drug: Belantamab mafodotin
    label
    Participants undergoing IC
    type
    EXPERIMENTAL
  2. description
    SK will be performed on some participants who received or are receiving treatment with belantamab mafodotin for RRMM and have objective evidence of keratopathy with corneal deposits on slit-lamp and/or confocal microscopy examination.
    intervention Names
    1. Drug: Belantamab mafodotin
    label
    Participants undergoing SK
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Participants undergoing IC
    2. Participants undergoing SK
    description
    Belantamab mafodotin is a first-in-class immunoconjugate that targets B cell maturation antigen (BCMA), which is highly expressed on malignant plasma cells.
    name
    Belantamab mafodotin
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
BASIC_SCIENCE
Enrollment
count
16
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Corneal tissue samples were collected to evaluate the composition of microcyst-like epithelium observed in participants treated with belantamab mafodotin.
    measure
    Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin
    time Frame
    Up to approximately 23 months
  2. description
    Corneal tissue samples were collected to evaluate pathologic characteristics observed in participants treated with belantamab mafodotin.
    measure
    Number of Participants With Abnormality in Pathologic Characteristics After Administration of Belantamab Mafodotin
    time Frame
    Up to approximately 23 months
secondary Outcomes
  1. description
    The eye was visualized using a slit-lamp microscope in a procedure room.
    measure
    Number of Participants With Imaging Data Showing Histopathologic Findings
    time Frame
    Up to approximately 23 months
  2. description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
    measure
    Number of Participants With Adverse Events (AEs)
    time Frame
    Up to approximately 23 months
Full study description
brief Summary
This study will be available to any participant who has received or is currently receiving belantamab mafodotin treatment through either a clinical trial, an access program, or a physician prescription. Participants do not need to be on active treatment. The purpose of this study is to gain a more complete understanding of the pathophysiology of the corneal events seen in some participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. A superficial corneal epithelial tissue specimen will be obtained by performing impression cytology (IC) or superficial keratectomy (SK) procedure in participants treated with belantamab mafodotin. The procedure will only be performed in one eye, most affected by the corneal epithelial changes. This specimen will undergo pathologic examination and composition analysis.
Source references
references
  1. citation
    Lee V, Hultcrantz M, Petrone S, Lewis EW, Banna H, Lichtman E, Thulasi P, Quick AA, Jeng BH, Sunshine SB, Francis JH, Canestraro J, Farooq AV, Clements P, Robertson N, Burman M, McKevitt T, Struemper H, Weir L. Characterization of Belantamab Mafodotin-Induced Corneal Changes in Patients With Multiple Myeloma. JAMA Ophthalmol. 2025 Jun 1;143(6):507-514. doi: 10.1001/jamaophthalmol.2025.1008.
    pmid
    40338596
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      offset unit
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      query cond
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice