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NCT04177823 · OUTCOME

Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters

A Study of Belantamab Mafodotin to Investigate Safety, Tolerability, Pharmacokinetics, Immunogenicity and Clinical Activity in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2025-03-20

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 21 months

What was measured

Blood samples were collected at indicated time points to assess change from baseline in albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, creatine kinase, gamma glutamyl transferase, potassium, lactate dehydrogenase, magnesium. Worst case grade (G) increase from baseline grade was provided for all the chemistry tests that were gradable by National Cancer Institute Common Terminology Criteria (NCI CTCAE, Version 5.0, 2017). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE. Data for any participants with worst-case grade changes (Increase to Grade 3 or Increase to Grade 4) post-baseline were presented. Baseline was defined as latest pre-dose assessment (day 1) with a non-missing value, including those from unscheduled visits.

Analysis population: All treated population

Groups in this outcome

Belantamab Mafodotin

Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin6

Reported measurements

Albumin, increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Albumin, increase to G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase, increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase, increase to G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase, increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase, increase to G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase, increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase, increase to G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Bilirubin, increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Bilirubin, increase to G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Creatine Kinase, increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Creatine Kinase, increase to G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Gamma Glutamyl Transferase, increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Gamma Glutamyl Transferase, increase to G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Potassium, increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Potassium, increase to G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Lactate Dehydrogenase, increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Lactate Dehydrogenase, increase to G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Magnesium, increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Magnesium, increase to G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Albumin, increase to G3
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Albumin, increase to G4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Alkaline Phosphatase, increase to G3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Alkaline Phosphatase, increase to G4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Alanine Aminotransferase, increase to G3
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Alanine Aminotransferase, increase to G4
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Aspartate Aminotransferase, increase to G3
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Aspartate Aminotransferase, increase to G4
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Bilirubin, increase to G3
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Bilirubin, increase to G4
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Creatine Kinase, increase to G3
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Creatine Kinase, increase to G4
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Blood samples were collected at indicated time points to assess change from baseline in albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, creatine kinase, gamma glutamyl transferase, potassium, lactate dehydrogenase, magnesium. Worst case grade (G) increase from baseline grade was provided for all the chemistry tests that were gradable by National Cancer Institute Common Terminology Criteria (NCI CTCAE, Version 5.0, 2017). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE. Data for any participants with worst-case grade changes (Increase to Grade 3 or Increase to Grade 4) post-baseline were presented. Baseline was defined as latest pre-dose assessment (day 1) with a non-missing value, including those from unscheduled visits.
groups
  1. description
    Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
    id
    OG000
    title
    Belantamab Mafodotin
param Type
COUNT_OF_PARTICIPANTS
population Description
All treated population
reporting Status
POSTED
time Frame
Baseline (day 1) and up to 21 months
title
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice