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NCT04398745 · OUTCOME

Part 1: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

A Study of Belantamab Mafodotin Monotherapy in Multiple Myeloma Participants With Normal and Varying Degree of Impaired Renal Function · Source last updated 2026-07-01

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

Measure
MEDIAN
Unit
Hour
Interval / dispersion
Full Range
Time frame
Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

What was measured

Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

Analysis population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.

Groups in this outcome

Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)

Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)

Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

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

Analysis denominator · Participants

GroupSource count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)8
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)8

Reported measurements

Cycle 1

Analysis denominator · Participants

GroupSource count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)8
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)8
Values in Hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)16.017Not reported0.91792.600Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)23.400Not reported7.40030.700Not reported
Cycle 3

Analysis denominator · Participants

GroupSource count
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)3
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)5
Values in Hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)8.000Not reported0.58322.167Not reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)23.967Not reported0.60072.583Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.917
        upper Limit
        92.600
        value
        16.017
      2. group Id
        OG001
        lower Limit
        7.400
        upper Limit
        30.700
        value
        23.400
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.583
        upper Limit
        22.167
        value
        8.000
      2. group Id
        OG001
        lower Limit
        0.600
        upper Limit
        72.583
        value
        23.967
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Cycle 3
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      8
    units
    Participants
description
Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
dispersion Type
Full Range
groups
  1. description
    Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
    id
    OG000
    title
    Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
  2. description
    Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
    id
    OG001
    title
    Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
param Type
MEDIAN
population Description
Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
reporting Status
POSTED
time Frame
Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.
title
Part 1: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
type
PRIMARY
unit Of Measure
Hour

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Preserved source evidence · Not medical advice