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NCT03828292 · OUTCOME

Part 2: Change From Baseline in Urine Specific Gravity by Dipstick

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
MEAN
Unit
Ratio
Interval / dispersion
Standard Deviation
Time frame
Baseline (Day 1) and up to approximately 212 weeks

What was measured

Urine samples were collected to analyze urine specific gravity. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.

Analysis population: All treated population. Only those participants with data available at specified time points have been analyzed.

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)3
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)4

Reported measurements

Baseline (Day 1)

Analysis denominator · Participants

GroupSource count
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)3
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)4
Values in Ratio · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)1.01670.00723Not reportedNot reportedNot reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)1.02180.00608Not reportedNot reportedNot reported
CFB to 212 Weeks

Analysis denominator · Participants

GroupSource count
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)1
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)2
Values in Ratio · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)-0.0070Not reportedNot reportedNot reportedNot reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)-0.00550.00354Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.00723
        value
        1.0167
      2. group Id
        OG001
        spread
        0.00608
        value
        1.0218
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Baseline (Day 1)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        -0.0070
      2. group Id
        OG001
        spread
        0.00354
        value
        -0.0055
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    CFB to 212 Weeks
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    units
    Participants
description
Urine samples were collected to analyze urine specific gravity. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
dispersion Type
Standard Deviation
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
MEAN
population Description
All treated population. Only those participants with data available at specified time points have been analyzed.
reporting Status
POSTED
time Frame
Baseline (Day 1) and up to approximately 212 weeks
title
Part 2: Change From Baseline in Urine Specific Gravity by Dipstick
type
PRIMARY
unit Of Measure
Ratio

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Preserved source evidence · Not medical advice