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NCT03828292 · OUTCOME

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

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

Temperature was measured after resting for at least 5 minutes. The abnormal ranges for body temperature were (\<=35 degrees Celsius or \>=38 degrees Celsius). 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.

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 =<35

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

Change to Normal or to No Change

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/kg4Not reportedNot reportedNot reportedNot reported

Increase to >=38

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
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      Decrease to =<35
    2. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      title
      Change to Normal or to No Change
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      Increase to >=38
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    units
    Participants
description
Temperature was measured after resting for at least 5 minutes. The abnormal ranges for body temperature were (\<=35 degrees Celsius or \>=38 degrees Celsius). 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.
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: Temperature
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice