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NCT05064358 · OUTCOME

Percentage of Time on Study With Grade 2 or Above Corneal Events

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
MEDIAN
Unit
Percentage of Time
Interval / dispersion
Full Range
Time frame
Up to 152 weeks

What was measured

It is defined as the percentage of time that a participant has corneal events out of the total time that a participant is on the study. Time with corneal events is defined as time from onset of any corneal events (KVA scale) of Grade 2 or above to the first-time resolution to baseline, Grade 1 or below.

Analysis population: Safety Population. Only those participants who experienced corneal events of Grade 2 or above have been analyzed.

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)25
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W16
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)17
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W15
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)11

Reported measurements

Source class 1
Values in Percentage of Time · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)23.27Not reported0.576.7Not reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W24.86Not reported5.169.1Not reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)18.99Not reported0.478.1Not reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W23.67Not reported5.585.6Not reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)35.63Not reported3.961.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        upper Limit
        76.7
        value
        23.27
      2. group Id
        OG001
        lower Limit
        5.1
        upper Limit
        69.1
        value
        24.86
      3. group Id
        OG002
        lower Limit
        0.4
        upper Limit
        78.1
        value
        18.99
      4. group Id
        OG003
        lower Limit
        5.5
        upper Limit
        85.6
        value
        23.67
      5. group Id
        OG004
        lower Limit
        3.9
        upper Limit
        61.6
        value
        35.63
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      17
    4. group Id
      OG003
      value
      15
    5. group Id
      OG004
      value
      11
    units
    Participants
description
It is defined as the percentage of time that a participant has corneal events out of the total time that a participant is on the study. Time with corneal events is defined as time from onset of any corneal events (KVA scale) of Grade 2 or above to the first-time resolution to baseline, Grade 1 or below.
dispersion Type
Full Range
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
MEDIAN
population Description
Safety Population. Only those participants who experienced corneal events of Grade 2 or above have been analyzed.
reporting Status
POSTED
time Frame
Up to 152 weeks
title
Percentage of Time on Study With Grade 2 or Above Corneal Events
type
SECONDARY
unit Of Measure
Percentage of Time

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

Preserved source evidence · Not medical advice