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NCT03828292 · OUTCOME

Part 2: Vss Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)

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
Liter (L)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)

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. Vss was not calculated for some participants as sufficient data was not available.

Groups in this outcome

Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)

Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter\^2 (m\^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles.

Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)

Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day 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 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)0
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)2

Reported measurements

Source class 1
Values in Liter (L) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)4.3676359.29Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        spread
        9.29
        value
        4.367635
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      2
    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
  1. description
    Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter\^2 (m\^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles.
    id
    OG000
    title
    Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
  2. description
    Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression.
    id
    OG001
    title
    Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Vss was not calculated for some participants as sufficient data was not available.
reporting Status
POSTED
time Frame
Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
title
Part 2: Vss Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
type
SECONDARY
unit Of Measure
Liter (L)

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

Preserved source evidence · Not medical advice