Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma
Intervention: Belantamab mafodotin
Intervention description: Belantamab mafodotin is a first-in-class immunoconjugate that targets B cell maturation antigen (BCMA), which is highly expressed on malignant plasma cells.
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Belantamab mafodotin; Impression cytology; Superficial keratectomy; Relapsed/Refractory multiple myeloma

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.
    

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.