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NCT04177823 · OUTCOME

Observed Plasma Concentration at the End of Infusion (CEOI) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)

A Study of Belantamab Mafodotin to Investigate Safety, Tolerability, Pharmacokinetics, Immunogenicity and Clinical Activity in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2025-03-20

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

Measure
GEOMETRIC_MEAN
Unit
Micrograms per milliliter (ug/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-dose (within 30 minutes prior to start of infusion) on day 1 of cycle 2, 4, 6, 9 and 12 (each cycle is of 21 days)

What was measured

Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.

Analysis population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.

Groups in this outcome

Belantamab Mafodotin

Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.

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

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin6

Reported measurements

Cycle 1

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin6
Values in Micrograms per milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin41.5059.71Not reportedNot reportedNot reported
Cycle 2

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin5
Values in Micrograms per milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin36.9976.89Not reportedNot reportedNot reported
Cycle 4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin3
Values in Micrograms per milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin41.7617.35Not reportedNot reportedNot reported
Cycle 6

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin2
Values in Micrograms per milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin43.697.61Not reportedNot reportedNot reported
Cycle 9

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin1
Values in Micrograms per milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin40.10Not reportedNot reportedNot reportedNot reported
Cycle 12

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin1
Values in Micrograms per milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin33.20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        59.71
        value
        41.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        76.89
        value
        36.99
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    Cycle 2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.35
        value
        41.76
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Cycle 4
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.61
        value
        43.69
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Cycle 6
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        40.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Cycle 9
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        33.20
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Cycle 12
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
    id
    OG000
    title
    Belantamab Mafodotin
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
reporting Status
POSTED
time Frame
Pre-dose (within 30 minutes prior to start of infusion) on day 1 of cycle 2, 4, 6, 9 and 12 (each cycle is of 21 days)
title
Observed Plasma Concentration at the End of Infusion (CEOI) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
type
SECONDARY
unit Of Measure
Micrograms per milliliter (ug/mL)

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Preserved source evidence · Not medical advice