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NCT03828292 · OUTCOME

Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline (Day 1) and up to approximately 141 weeks

What was measured

Blood samples were collected for analysis of clinical chemistry parameters: C Reactive Protein, Chloride, Direct Bilirubin (DB), Lactate Dehydrogenase, Protein and Urea. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE v4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. 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. Participants are counted twice if the participant has values that changed "Decreased to Low" and "Increased to High", so the sum of the percentages may not add to 100% for each category.

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/kg4

Reported measurements

C Reactive Protein, Decrease to Low

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
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)0Not reportedNot reportedNot reportedNot reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg0Not reportedNot reportedNot reportedNot reported
C Reactive Protein, Change to Normal or No Change

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
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)2Not reportedNot reportedNot reportedNot reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg1Not reportedNot reportedNot reportedNot reported
C Reactive Protein, Increase to High

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
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)2Not reportedNot reportedNot reportedNot reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg2Not reportedNot reportedNot reportedNot reported
Chloride, Decrease to Low

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/kg4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)2Not reportedNot reportedNot reportedNot reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg2Not reportedNot reportedNot reportedNot reported
Chloride, Change to Normal or No Change

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/kg4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)0Not reportedNot reportedNot reportedNot reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg2Not reportedNot reportedNot reportedNot reported
Chloride, Increase to High

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/kg4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)2Not reportedNot reportedNot reportedNot reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg1Not reportedNot reportedNot reportedNot reported
Direct Bilirubin, Decrease to Low

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/kg4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)0Not reportedNot reportedNot reportedNot reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg0Not reportedNot reportedNot reportedNot reported
Direct Bilirubin, Change to Normal or No Change

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/kg4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)4Not reportedNot reportedNot reportedNot reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg3Not reportedNot reportedNot reportedNot reported
Direct Bilirubin, Increase to High

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/kg4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)0Not reportedNot reportedNot reportedNot reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg1Not reportedNot reportedNot reportedNot reported
Lactate Dehydrogenase, Decrease to Low

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/kg4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)0Not reportedNot reportedNot reportedNot reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg0Not reportedNot reportedNot reportedNot reported
Lactate Dehydrogenase, Change to Normal or No Change

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/kg4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)2Not reportedNot reportedNot reportedNot reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg2Not reportedNot reportedNot reportedNot reported
Lactate Dehydrogenase, Increase to High

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/kg4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)2Not reportedNot reportedNot reportedNot reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg2Not reportedNot reportedNot reportedNot reported
Protein, Decrease to Low

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/kg4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)1Not reportedNot reportedNot reportedNot reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg2Not reportedNot reportedNot reportedNot reported
Protein, Change to Normal or No Change

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/kg4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)2Not reportedNot reportedNot reportedNot reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg2Not reportedNot reportedNot reportedNot reported
Protein, Increase to High

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/kg4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)1Not reportedNot reportedNot reportedNot reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg0Not reportedNot reportedNot reportedNot reported
Urea, Decrease to Low

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/kg4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)2Not reportedNot reportedNot reportedNot reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg1Not reportedNot reportedNot reportedNot reported
Urea, Change to Normal or No Change

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/kg4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)1Not reportedNot reportedNot reportedNot reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg2Not reportedNot reportedNot reportedNot reported
Urea, Increase to High

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/kg4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)1Not reportedNot reportedNot reportedNot reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    C Reactive Protein, Decrease to Low
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    C Reactive Protein, Change to Normal or No Change
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    C Reactive Protein, Increase to High
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Chloride, Decrease to Low
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Chloride, Change to Normal or No Change
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Chloride, Increase to High
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Direct Bilirubin, Decrease to Low
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Direct Bilirubin, Change to Normal or No Change
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Direct Bilirubin, Increase to High
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Lactate Dehydrogenase, Decrease to Low
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Lactate Dehydrogenase, Change to Normal or No Change
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Lactate Dehydrogenase, Increase to High
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    units
    Participants
description
Blood samples were collected for analysis of clinical chemistry parameters: C Reactive Protein, Chloride, Direct Bilirubin (DB), Lactate Dehydrogenase, Protein and Urea. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE v4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. 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.
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
COUNT_OF_PARTICIPANTS
population Description
All treated population. Participants are counted twice if the participant has values that changed "Decreased to Low" and "Increased to High", so the sum of the percentages may not add to 100% for each category.
reporting Status
POSTED
time Frame
Baseline (Day 1) and up to approximately 141 weeks
title
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice