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NCT05064358 · OUTCOME

Overall Survival (OS)

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
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 152 weeks

What was measured

OS defined as the time from randomization until the date of death due to any cause.

Analysis population: Intent-to-Treat Population. Only those participants with documented death due to any cause 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)23
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W23
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)25
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W21
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)5

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)20.9Not reported8.1NAThe upper limit of 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W15.0Not reported7.620.1Not reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)13.5Not reported7.521.2Not reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W14.5Not reported7.7NAThe upper limit of 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)NANot reported4.8NAThe median and upper limit 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper limit of 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
        group Id
        OG000
        lower Limit
        8.1
        upper Limit
        NA
        value
        20.9
      2. group Id
        OG001
        lower Limit
        7.6
        upper Limit
        20.1
        value
        15.0
      3. group Id
        OG002
        lower Limit
        7.5
        upper Limit
        21.2
        value
        13.5
      4. comment
        The upper limit of 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
        group Id
        OG003
        lower Limit
        7.7
        upper Limit
        NA
        value
        14.5
      5. comment
        The median and upper limit 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
        group Id
        OG004
        lower Limit
        4.8
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      23
    3. group Id
      OG002
      value
      25
    4. group Id
      OG003
      value
      21
    5. group Id
      OG004
      value
      5
    units
    Participants
description
OS defined as the time from randomization until the date of death due to any cause.
dispersion Type
95% Confidence Interval
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
Intent-to-Treat Population. Only those participants with documented death due to any cause have been analyzed.
reporting Status
POSTED
time Frame
Up to 152 weeks
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice