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NCT05064358 · OUTCOME

Area Under the Concentration-time Curve (AUC) (0-504h) of Belantamab Mafodotin 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
micrograms* hour/ millilitre (ug*h/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15, D21

What was measured

Plasma samples were collected to determine the area under the concentration-time curve (AUC) (0-504h) of Belantamab mafodotin ADC.

Analysis population: Pharmacokinetic (PK) Population. 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 micrograms* hour/ millilitre (ug*h/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)423332.2Not reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W301334.6Not reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)388638.6Not reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W317327.1Not reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)307940.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        32.2
        value
        4233
      2. group Id
        OG001
        spread
        34.6
        value
        3013
      3. group Id
        OG002
        spread
        38.6
        value
        3886
      4. group Id
        OG003
        spread
        27.1
        value
        3173
      5. group Id
        OG004
        spread
        40.6
        value
        3079
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 to determine the area under the concentration-time curve (AUC) (0-504h) of Belantamab mafodotin 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. 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
C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15, D21
title
Area Under the Concentration-time Curve (AUC) (0-504h) of Belantamab Mafodotin ADC
type
SECONDARY
unit Of Measure
micrograms* hour/ millilitre (ug*h/mL)

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Preserved source evidence · Not medical advice