Last updated: 08/07/2025 05:20:14
Pooled analysis to characterize the corneal deposits and mechanisms by which belantamab mafodotin causes ocular toxicity in relapsed refractory multiple myeloma (RRMM) participants
GSK study ID
218103
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Trial overview
Official title: Pooled analysis and other data to characterize the corneal deposits and mechanisms by which belantamab mafodotin causes ocular toxicity in patients with relapsed refractory multiple myeloma
Trial description: This study is to characterize the microcyst-like corneal deposits observed in participants with RRMM treated with belantamab mafodotin, via superficial keratectomy assessments. The following studies will be presented in a single report to further characterize the mechanisms by which belantamab mafodotin causes ocular toxicity: DREAMM-2 (NCT03525678), DREAMM-3 (NCT04162210), NCT04549363, and DREAMM-12 (NCT04398745).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with corneal events
Timeframe: Up to 42 months
Change from Baseline in best-corrected visual acuity (BCVA)
Timeframe: Baseline and up to 42 months
Time to onset of the first occurrence of ocular symptom
Timeframe: Up to 42 months
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2025-31-12
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Multiple Myeloma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2025 to December 2025
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Participants in DREAMM-2 (NCT03525678),DREAMM-3 (NCT04162210), DREAMM-12 (NCT04398745) were required to have a histologically or cytologically confirmed diagnosis of multiple myeloma as defined according to the International Myeloma Working Group criteria and have undergone an autologous stem cell transplant or be considered transplant ineligible.
- Participants must have had measurable disease, and an Eastern Cooperative Oncology Group performance status of 0-2.
- Participants were excluded if they had current corneal epithelial disease with the exception of mild punctate keratopathy with no evidence of MECs.
- Participants were excluded if they have any excess risk of delayed wound healing; are taking concurrent medication that may affect the cornea; have decreased corneal sensation; have eye infections including infectious keratopathy, stye, blepharitis and conjunctivitis; have an active uveitis including anterior, posterior, or panuveitis in either eye; or have permanent legal blindness in the fellow eye.
Inclusion and exclusion criteria
Inclusion criteria:
- Participants in DREAMM-2 (NCT03525678),DREAMM-3 (NCT04162210), DREAMM-12 (NCT04398745) were required to have a histologically or cytologically confirmed diagnosis of multiple myeloma as defined according to the International Myeloma Working Group criteria and have undergone an autologous stem cell transplant or be considered transplant ineligible.
- Participants must have had measurable disease, and an Eastern Cooperative Oncology Group performance status of 0-2.
- In DREAMM-2 (NCT03525678), participants must have failed at least 3 prior lines of anti myeloma treatments, including an anti-cluster of differentiation (CD)38 antibody alone or in combination, and be refractory to an immunomodulatory drug and a proteasome inhibitor (PI).
- In DREAMM-3 (NCT04162210), participants must have received at least 2 prior lines of anti myeloma treatments, including at least 2 consecutive cycles of both lenalidomide and a PI (given separately or in combination), and must have had documented disease progression on, or within 60 days of, completion of the last treatment.
- In Study 214098 (NCT04549363), participants must have RRMM and have received or be currently receiving treatment with belantamab mafodotin.
- Participants must be diagnosed with microcyst-like epithelial changes (MECs) on slit-lamp examination or confocal microscopy, with or without symptoms, in at least 1 eye.
- In DREAMM-12 (NCT04398745), participants must have failed at least 2 prior lines of anti myeloma treatments, including an immunomodulatory drug and a PI. Participants enrolled into the control Group 1 must match at least 1 severely renal impaired participant by Baseline body weight (+/-20 percent [%]) and Baseline albumin levels (+/-10%).
Exclusion criteria:
- Participants were excluded if they had current corneal epithelial disease with the exception of mild punctate keratopathy with no evidence of MECs.
- Participants were excluded if they have any excess risk of delayed wound healing; are taking concurrent medication that may affect the cornea; have decreased corneal sensation; have eye infections including infectious keratopathy, stye, blepharitis and conjunctivitis; have an active uveitis including anterior, posterior, or panuveitis in either eye; or have permanent legal blindness in the fellow eye.
- Participants were excluded if they had renal impairment that was due to hepatic disease (hepatorenal syndrome).
- Participants were excluded if they had previously received belantamab mafodotin therapy, received an organic-anion transporting polypeptide inhibitor in the previous 14 days or 5 half-lives, had a systemic active infection requiring treatment or had undergone plasmapheresis in the previous 7 days.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Will be recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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