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NCT03848845 · OUTCOME

Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results

Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2024-04-09

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 178 weeks

What was measured

Urine samples were collected to assess urine glucose, protein, occult blood and ketones using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for uranalysis parameters were recorded as no change/decreased and any increase. Data for worst-case post baseline are presented.

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

Groups in this outcome

Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion

Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.

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 Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion26

Reported measurements

Glucose, No Change/Decreased

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion26
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion25Not reportedNot reportedNot reportedNot reported
Glucose, Any Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion26
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion1Not reportedNot reportedNot reportedNot reported
Ketones, No Change/Decreased

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion26
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion21Not reportedNot reportedNot reportedNot reported
Ketones, Any Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion26
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion5Not reportedNot reportedNot reportedNot reported
Occult Blood, No Change/Decreased

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion15Not reportedNot reportedNot reportedNot reported
Occult Blood, Any Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion9Not reportedNot reportedNot reportedNot reported
Protein, No Change/Decreased

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion26
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion20Not reportedNot reportedNot reportedNot reported
Protein, Any Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion26
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        25
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      units
      Participants
    title
    Glucose, No Change/Decreased
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      units
      Participants
    title
    Glucose, Any Increase
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        21
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      units
      Participants
    title
    Ketones, No Change/Decreased
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      units
      Participants
    title
    Ketones, Any Increase
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      units
      Participants
    title
    Occult Blood, No Change/Decreased
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      units
      Participants
    title
    Occult Blood, Any Increase
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      units
      Participants
    title
    Protein, No Change/Decreased
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      units
      Participants
    title
    Protein, Any Increase
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
Urine samples were collected to assess urine glucose, protein, occult blood and ketones using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for uranalysis parameters were recorded as no change/decreased and any increase. Data for worst-case post baseline are presented.
groups
  1. description
    Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
    id
    OG000
    title
    Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
param Type
COUNT_OF_PARTICIPANTS
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 178 weeks
title
Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice