NCT03828292 · OUTCOME

Part 1: Systemic Clearance (CL) Following Single Dose Administration of Belantamab Mafodotin (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: milliliter per hour (mL/h)
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Pre-Dose; EOI; 1 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 PK analysis. PK parameter was determined using standard non-compartmental methods.

Analysis population: Pharmacokinetic population. 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

Group	Source count
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)	4
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg	3

Reported measurements

Source class 1

Values in milliliter per hour (mL/h) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)	35.026301	37.38	Not reported	Not reported	Not reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg	45.340473	37.25	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
37.38
value
35.026301
group Id
OG001
spread
37.25
value
45.340473

denoms

counts
group Id
OG000
value
4
group Id
OG001
value
3
units
Participants

description

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

dispersion Type

Geometric Coefficient of Variation

groups

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)
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 population. Only those participants with data available at specified time points have been analyzed.

reporting Status

POSTED

time Frame

Pre-Dose; EOI; 1 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: Systemic Clearance (CL) Following Single Dose Administration of Belantamab Mafodotin (ADC)

type

SECONDARY

unit Of Measure

milliliter per hour (mL/h)

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

Preserved source evidence · Not medical advice