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NCT03828292 · OUTCOME

Part 1: Area Under the Concentration-time Curve During the Dosing Interval (AUC (0-tau)) Following Single Dose Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC))

An Open-label, Dose Escalation Study in Japanese Participants With Relapsed/Refractory Multiple Myeloma Who Have Failed Prior Anti Myeloma Treatments · Source last updated 2025-08-19

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

Measure
GEOMETRIC_MEAN
Unit
Hour*microgram/millilitre (h*ug/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-Dose; End of Infusion (EOI); 1 hour (h), 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1

What was measured

Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.

Analysis population: Pharmacokinetic (PK) population included all participants in all treated population from whom at least one PK sample was obtained, analyzed, and was measurable. Only those participants with data available at specified time points have been analyzed.

Groups in this outcome

Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)

Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.

Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg

Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.

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

Analysis denominator · Participants

GroupSource count
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)4
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg3

Reported measurements

Source class 1
Values in Hour*microgram/millilitre (h*ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)3694.596526.33Not reportedNot reportedNot reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg3807.917941.80Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.33
        value
        3694.5965
      2. group Id
        OG001
        spread
        41.80
        value
        3807.9179
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      3
    units
    Participants
description
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
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 via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
    id
    OG000
    title
    Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
  2. description
    Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
    id
    OG001
    title
    Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic (PK) population included all participants in all treated population from whom at least one PK sample was obtained, analyzed, and was measurable. Only those participants with data available at specified time points have been analyzed.
reporting Status
POSTED
time Frame
Pre-Dose; End of Infusion (EOI); 1 hour (h), 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
title
Part 1: Area Under the Concentration-time Curve During the Dosing Interval (AUC (0-tau)) Following Single Dose Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC))
type
SECONDARY
unit Of Measure
Hour*microgram/millilitre (h*ug/mL)

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

Preserved source evidence · Not medical advice