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NCT04398745 · OUTCOME

Part 1: Area Under the Concentration-time Curve During the Dosing Interval up to 168 Hours (AUC (0-168h)) 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
GEOMETRIC_MEAN
Unit
h*ng/mL
Interval / dispersion
Geometric Coefficient of Variation
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, and D15; Anytime on C3 D4, D8, and D15

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. In cases where the nominal Day 8 sample was collected prior to 168 hours and earlier time points did not permit reliable extrapolation to 168 hours, a later sample (e.g., Day 15) with a measurable concentration was used to support estimation of the concentration at 168 hours. Outcome data are reported only for AUC over 0-168 hours.

Analysis population: Pharmacokinetic Evaluable population. 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)6
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)6
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)8
Values in h*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)134.799.8Not reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)75.248.2Not reportedNot reportedNot 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)3
Values in h*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)61.26.0Not reportedNot reportedNot reported
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)79.639.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        99.8
        value
        134.7
      2. group Id
        OG001
        spread
        48.2
        value
        75.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.0
        value
        61.2
      2. group Id
        OG001
        spread
        39.3
        value
        79.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Cycle 3
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    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. In cases where the nominal Day 8 sample was collected prior to 168 hours and earlier time points did not permit reliable extrapolation to 168 hours, a later sample (e.g., Day 15) with a measurable concentration was used to support estimation of the concentration at 168 hours. Outcome data are reported only for AUC over 0-168 hours.
dispersion Type
Geometric Coefficient of Variation
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
GEOMETRIC_MEAN
population Description
Pharmacokinetic Evaluable population. 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, and D15; Anytime on C3 D4, D8, and D15
title
Part 1: Area Under the Concentration-time Curve During the Dosing Interval up to 168 Hours (AUC (0-168h)) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
type
PRIMARY
unit Of Measure
h*ng/mL

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Preserved source evidence · Not medical advice