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NCT07217184 · 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 Isatuximab 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 194 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 v 5.0.

Analysis population: Safety population

Groups in this outcome

1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab

Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin end of infusion (EOI), administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W), and thereafter on day 1, 8, 15 and 22 of each 28-day cycle.

1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab

Participants with RRMM received 1.4 mg/kg of belantamab mafodotin IV infusion, once every 8 weeks (Q8W) infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.

1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab

Participants with RRMM received 1.9 mg/kg of belantamab mafodotin IV infusion, Q8W infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.

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 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab10
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab10
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab10

Reported measurements

Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab3Not reportedNot reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab4Not reportedNot reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab3Not reportedNot reportedNot reportedNot reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab1Not reportedNot reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0Not reportedNot reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab1Not reportedNot reportedNot reportedNot reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab0Not reportedNot reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0Not reportedNot reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0Not reportedNot reportedNot reportedNot reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab0Not reportedNot reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0Not reportedNot reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0Not reportedNot reportedNot reportedNot reported
Grade 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab0Not reportedNot reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0Not reportedNot reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
    title
    Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      10
    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 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 once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin end of infusion (EOI), administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W), and thereafter on day 1, 8, 15 and 22 of each 28-day cycle.
    id
    OG000
    title
    1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab
  2. description
    Participants with RRMM received 1.4 mg/kg of belantamab mafodotin IV infusion, once every 8 weeks (Q8W) infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.
    id
    OG001
    title
    1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab
  3. description
    Participants with RRMM received 1.9 mg/kg of belantamab mafodotin IV infusion, Q8W infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.
    id
    OG002
    title
    1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population
reporting Status
POSTED
time Frame
Up to approximately 194 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