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NCT05064358 · OUTCOME

Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade

Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2026-05-05

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

Measure
NUMBER
Unit
Events per 100 patient years
Interval / dispersion
Not reported
Time frame
Up to 152 weeks

What was measured

Exposure adjusted incidence rate of corneal events is defined as the number of participants with corneal events divided by the total exposure time for all participants at risk in the treatment group. Incidence rate for corneal events was assessed using Common Terminology Criteria for Adverse Events (CTCAE). Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grades indicate greater severity. The number of participants with Grades 3,4, and 5 are presented.

Analysis population: Safety Population

Groups in this outcome

Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)

Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.

Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W

Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.

Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)

Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.

Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W

Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.

Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)

Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.

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

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)39
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W40
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)39
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W40
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)17

Reported measurements

Grade 3
Values in Events per 100 patient years · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)4Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W2Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)4Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W0Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)3Not reportedNot reportedNot reportedNot reported
Grade 4
Values in Events per 100 patient years · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)0Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W0Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)0Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W0Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)0Not reportedNot reportedNot reportedNot reported
Grade 5
Values in Events per 100 patient years · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)0Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W0Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)0Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W0Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        3
    title
    Grade 3
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Grade 4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    2. group Id
      OG001
      value
      40
    3. group Id
      OG002
      value
      39
    4. group Id
      OG003
      value
      40
    5. group Id
      OG004
      value
      17
    units
    Participants
description
Exposure adjusted incidence rate of corneal events is defined as the number of participants with corneal events divided by the total exposure time for all participants at risk in the treatment group. Incidence rate for corneal events was assessed using Common Terminology Criteria for Adverse Events (CTCAE). Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grades indicate greater severity. The number of participants with Grades 3,4, and 5 are presented.
groups
  1. description
    Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
    id
    OG000
    title
    Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
  2. description
    Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
    id
    OG001
    title
    Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
  3. description
    Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
    id
    OG002
    title
    Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
  4. description
    Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
    id
    OG003
    title
    Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
  5. description
    Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
    id
    OG004
    title
    Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
param Type
NUMBER
population Description
Safety Population
reporting Status
POSTED
time Frame
Up to 152 weeks
title
Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade
type
SECONDARY
unit Of Measure
Events per 100 patient years

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

Preserved source evidence · Not medical advice