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NCT04075721 · OUTCOME

Part A: Change From Baseline in Urine M-protein Level Using Electrophoresis

First in Human Dose Escalation of M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone · Source last updated 2023-03-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
milligrams per day (mg/day)
Interval / dispersion
Full Range
Time frame
Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 and end of study intervention (Week 20.1) (each Cycle is of 28 days)

What was measured

Change from baseline in urine M-protein level was measured by using electrophoresis at Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 and end of study intervention.

Analysis population: Safety analysis set included all participants who were administered any dose of the trial medication. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable for specified timepoints. None of the participants were analyzed in M3258 10 mg QD arm at specified timepoints.

Groups in this outcome

M3258 10 mg QD

Participants received M3258 at a dose of 10 milligrams (mg) orally, once daily (QD) until disease progression.

M3258 10 mg Twice Per Week

Participants received M3258 at a dose of 10 mg orally, twice per week on Day 1 and Day 4 until disease progression.

M3258 20 mg Twice Per Week

Participants received M3258 at a dose of 20 mg orally, twice per week on Day 1 and Day 4 until 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
M3258 10 mg QD0
M3258 10 mg Twice Per Week2
M3258 20 mg Twice Per Week1

Reported measurements

Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
M3258 10 mg QD0
M3258 10 mg Twice Per Week2
M3258 20 mg Twice Per Week1
Values in milligrams per day (mg/day) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
M3258 10 mg Twice Per Week25.25Not reported-59.5110.0Not reported
M3258 20 mg Twice Per Week26.50Not reported26.526.5Not reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
M3258 10 mg QD0
M3258 10 mg Twice Per Week1
M3258 20 mg Twice Per Week1
Values in milligrams per day (mg/day) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
M3258 10 mg Twice Per Week256.00Not reported256.0256.0Not reported
M3258 20 mg Twice Per Week67.00Not reported67.067.0Not reported
Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
M3258 10 mg QD0
M3258 10 mg Twice Per Week1
M3258 20 mg Twice Per Week0
Values in milligrams per day (mg/day) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
M3258 10 mg Twice Per Week-130.00Not reported-130.0130.0Not reported
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
M3258 10 mg QD0
M3258 10 mg Twice Per Week1
M3258 20 mg Twice Per Week0
Values in milligrams per day (mg/day) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
M3258 10 mg Twice Per Week268.00Not reported268.0268.0Not reported
Cycle 6 Day 1

Analysis denominator · Participants

GroupSource count
M3258 10 mg QD0
M3258 10 mg Twice Per Week1
M3258 20 mg Twice Per Week0
Values in milligrams per day (mg/day) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
M3258 10 mg Twice Per Week3320.00Not reported3320.03320.0Not reported
End of Study Intervention

Analysis denominator · Participants

GroupSource count
M3258 10 mg QD0
M3258 10 mg Twice Per Week2
M3258 20 mg Twice Per Week0
Values in milligrams per day (mg/day) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
M3258 10 mg Twice Per Week610.50Not reported51.01170.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        -59.5
        upper Limit
        110.0
        value
        25.25
      2. group Id
        OG002
        lower Limit
        26.5
        upper Limit
        26.5
        value
        26.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    Cycle 2 Day 1
  2. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        256.0
        upper Limit
        256.0
        value
        256.00
      2. group Id
        OG002
        lower Limit
        67.0
        upper Limit
        67.0
        value
        67.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    Cycle 3 Day 1
  3. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        -130.0
        upper Limit
        130.0
        value
        -130.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Cycle 4 Day 1
  4. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        268.0
        upper Limit
        268.0
        value
        268.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Cycle 5 Day 1
  5. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        3320.0
        upper Limit
        3320.0
        value
        3320.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Cycle 6 Day 1
  6. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        51.0
        upper Limit
        1170.0
        value
        610.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    End of Study Intervention
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      1
    units
    Participants
description
Change from baseline in urine M-protein level was measured by using electrophoresis at Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 and end of study intervention.
dispersion Type
Full Range
groups
  1. description
    Participants received M3258 at a dose of 10 milligrams (mg) orally, once daily (QD) until disease progression.
    id
    OG000
    title
    M3258 10 mg QD
  2. description
    Participants received M3258 at a dose of 10 mg orally, twice per week on Day 1 and Day 4 until disease progression.
    id
    OG001
    title
    M3258 10 mg Twice Per Week
  3. description
    Participants received M3258 at a dose of 20 mg orally, twice per week on Day 1 and Day 4 until disease progression.
    id
    OG002
    title
    M3258 20 mg Twice Per Week
param Type
MEAN
population Description
Safety analysis set included all participants who were administered any dose of the trial medication. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable for specified timepoints. None of the participants were analyzed in M3258 10 mg QD arm at specified timepoints.
reporting Status
POSTED
time Frame
Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 and end of study intervention (Week 20.1) (each Cycle is of 28 days)
title
Part A: Change From Baseline in Urine M-protein Level Using Electrophoresis
type
SECONDARY
unit Of Measure
milligrams per day (mg/day)

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

Preserved source evidence · Not medical advice