Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04075721 · OUTCOME

Part A: Number of Participants With Overall Response (OR) as Assessed by Investigator Using International Myeloma Working Group (IMWG) Criteria

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Time from first dose of study treatment up to 18.2 months

What was measured

OR is defined as a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IMWG Criteria: sCR: CR (negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow); normal free light chain (FLC) ratio and no clonal cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis/\>= 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: \>= 50% reduction of serum M-Protein and reduction in urinary M-protein by \>= 90%/to \< 200 mg/24 hours. In addition to the above, if present at baseline a \>= 50% reduction in the size of soft tissue plasmacytomas is also required.

Analysis population: Safety analysis set included all participants who were administered any dose of the trial medication.

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 Week4
M3258 20 mg Twice Per Week4

Reported measurements

Stringent Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Very good Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Stringent Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Complete Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Very good Partial Response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Partial Response
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      4
    units
    Participants
description
OR is defined as a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IMWG Criteria: sCR: CR (negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow); normal free light chain (FLC) ratio and no clonal cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis/\>= 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: \>= 50% reduction of serum M-Protein and reduction in urinary M-protein by \>= 90%/to \< 200 mg/24 hours. In addition to the above, if present at baseline a \>= 50% reduction in the size of soft tissue plasmacytomas is also required.
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
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set included all participants who were administered any dose of the trial medication.
reporting Status
POSTED
time Frame
Time from first dose of study treatment up to 18.2 months
title
Part A: Number of Participants With Overall Response (OR) as Assessed by Investigator Using International Myeloma Working Group (IMWG) Criteria
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice