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NCT05064358 · OUTCOME

Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC)

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
GEOMETRIC_MEAN
Unit
Microgram/ millilitre (ug/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle(C)1 Day(D) 1 Pre-dose, End of Infusion (EOI), Start of Infusion (SOI) + 2 hours (H); C1D2 SOI+24H; C1D4; C1D8-15

What was measured

Plasma samples were collected for PK analysis for belantamab mafodotin antibody-drug conjugate (ADC).

Analysis population: Pharmacokinetic (PK) Population included all participants in the Safety Population from whom at least 1 post-treatment PK sample was obtained and analyzed. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.

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)38
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W41
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

Source class 1
Values in Microgram/ millilitre (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)44.822.8Not reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W33.123.2Not reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)42.124.7Not reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W33.118.3Not reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)34.126.8Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.8
        value
        44.8
      2. group Id
        OG001
        spread
        23.2
        value
        33.1
      3. group Id
        OG002
        spread
        24.7
        value
        42.1
      4. group Id
        OG003
        spread
        18.3
        value
        33.1
      5. group Id
        OG004
        spread
        26.8
        value
        34.1
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    2. group Id
      OG001
      value
      41
    3. group Id
      OG002
      value
      39
    4. group Id
      OG003
      value
      40
    5. group Id
      OG004
      value
      17
    units
    Participants
description
Plasma samples were collected for PK analysis for belantamab mafodotin antibody-drug conjugate (ADC).
dispersion Type
Geometric Coefficient of Variation
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
GEOMETRIC_MEAN
population Description
Pharmacokinetic (PK) Population included all participants in the Safety Population from whom at least 1 post-treatment PK sample was obtained and analyzed. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.
reporting Status
POSTED
time Frame
Cycle(C)1 Day(D) 1 Pre-dose, End of Infusion (EOI), Start of Infusion (SOI) + 2 hours (H); C1D2 SOI+24H; C1D4; C1D8-15
title
Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC)
type
SECONDARY
unit Of Measure
Microgram/ millilitre (ug/mL)

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Preserved source evidence · Not medical advice