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NCT04177823 · OUTCOME

Maximum Observed Concentration (Cmax) 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
ug/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (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. Maximum observed plasma concentration, determined directly from the concentration-time data for each cycle.

Analysis population: Pharmacokinetic (PK) population

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

Source class 1
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin45.3654.69Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        54.69
        value
        45.36
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. Maximum observed plasma concentration, determined directly from the concentration-time data for each cycle.
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
reporting Status
POSTED
time Frame
Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)
title
Maximum Observed Concentration (Cmax) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
type
SECONDARY
unit Of Measure
ug/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice