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NCT07217119 · OUTCOME

DE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Feladilimab (GSK3359609) in Participants With RRMM · Source last updated 2026-06-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to approximately 281 weeks.

What was measured

The corneal events were graded according to CTCAE version 5. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant. Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Results are presented for number of participants with any corneal events by maximum grade as per CTCAE grade version (v) 5.0.

Analysis population: Safety population.

Groups in this outcome

1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab

Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).

2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab

Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab

Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab9
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab10
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab6

Reported measurements

G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab3Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab4Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab2Not reportedNot reportedNot reportedNot reported
G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab2Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab3Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    G1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        2
    title
    G2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        3
    title
    G3
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      6
    units
    Participants
description
The corneal events were graded according to CTCAE version 5. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant. Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Results are presented for number of participants with any corneal events by maximum grade as per CTCAE grade version (v) 5.0.
groups
  1. description
    Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
    id
    OG000
    title
    1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab
  2. description
    Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
    id
    OG001
    title
    2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab
  3. description
    Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
    id
    OG002
    title
    2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population.
reporting Status
POSTED
time Frame
Up to approximately 281 weeks.
title
DE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice