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NCT03828292 · OUTCOME

Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate

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

Heart rate was measured after resting for at least 5 minutes. The abnormal ranges for heart rate were (low \<60 beats per minute \[bpm\] and high \>100 bpm). 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. Data for participants with worst case change from baseline was presented as Baseline to low, Baseline to Normal or No change and Baseline to High.

Analysis population: All treated population.

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

Source class 1

Decrease to Low (<60 bpm)

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

Change to Normal or No Change

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)3Not reportedNot reportedNot reportedNot reported
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg3Not reportedNot reportedNot reportedNot reported

Increase to High (>100 bpm)

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
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      title
      Decrease to Low (<60 bpm)
    2. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      title
      Change to Normal or No Change
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      title
      Increase to High (>100 bpm)
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    units
    Participants
description
Heart rate was measured after resting for at least 5 minutes. The abnormal ranges for heart rate were (low \<60 beats per minute \[bpm\] and high \>100 bpm). 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. Data for participants with worst case change from baseline was presented as Baseline to low, Baseline to Normal or No change and Baseline to High.
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.
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 Vital Sign Parameters: Heart Rate
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice