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NCT04075721 · OUTCOME

Part A: Change From Baseline in Free Light Chain Ratio

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
ratio
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 free light chain ratio was reported 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.

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 QD2
M3258 10 mg Twice Per Week1
M3258 20 mg Twice Per Week1

Reported measurements

Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
M3258 10 mg QD1
M3258 10 mg Twice Per Week1
M3258 20 mg Twice Per Week1
Values in ratio · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0.000Not reported0.000.00Not reported
M3258 10 mg Twice Per Week0.000Not reported0.000.00Not reported
M3258 20 mg Twice Per Week0.000Not reported0.000.00Not 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 ratio · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
M3258 10 mg Twice Per Week0.000Not reported0.000.00Not reported
M3258 20 mg Twice Per Week0.010Not reported0.010.01Not 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 ratio · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
M3258 10 mg Twice Per Week0.000Not reported0.000.00Not 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 ratio · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
M3258 10 mg Twice Per Week0.000Not reported0.000.00Not 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 ratio · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
M3258 10 mg Twice Per Week-0.010Not reported-0.01-0.01Not reported
End of Study Intervention

Analysis denominator · Participants

GroupSource count
M3258 10 mg QD2
M3258 10 mg Twice Per Week1
M3258 20 mg Twice Per Week1
Values in ratio · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
M3258 10 mg QD-0.005Not reported-0.010.00Not reported
M3258 10 mg Twice Per Week-0.010Not reported-0.01-0.01Not reported
M3258 20 mg Twice Per Week0.000Not reported0.000.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        0.00
        value
        0.000
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        0.00
        value
        0.000
      3. group Id
        OG002
        lower Limit
        0.00
        upper Limit
        0.00
        value
        0.000
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    Cycle 2 Day 1
  2. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        0.00
        value
        0.000
      2. group Id
        OG002
        lower Limit
        0.01
        upper Limit
        0.01
        value
        0.010
    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
        0.00
        upper Limit
        0.00
        value
        0.000
    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
        0.00
        upper Limit
        0.00
        value
        0.000
    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
        -0.01
        upper Limit
        -0.01
        value
        -0.010
    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
        OG000
        lower Limit
        -0.01
        upper Limit
        0.00
        value
        -0.005
      2. group Id
        OG001
        lower Limit
        -0.01
        upper Limit
        -0.01
        value
        -0.010
      3. group Id
        OG002
        lower Limit
        0.00
        upper Limit
        0.00
        value
        0.000
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    End of Study Intervention
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      1
    units
    Participants
description
Change from baseline in free light chain ratio was reported 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.
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 Free Light Chain Ratio
type
SECONDARY
unit Of Measure
ratio

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

Preserved source evidence · Not medical advice