Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02863991 · OUTCOME

Response of Participants at Last On-study Visit (End of Treatment/Follow-up)

Oral ONC201 in Relapsed/Refractory Multiple Myeloma · Source last updated 2024-07-03

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
The response assessment data reported was conducted at the last on-study visit (end of treatment/follow-up), up to a maximum of 7 months following treatment initiation.

What was measured

Assessments of response were made using the International Myeloma Working Group (IMWG) response criteria and were assessed by magnetic resonance imaging (MRI), computed tomography (CT), or positron emission tomography (PET)/CT scans (when applicable). Per IMWG response criteria, objective response could be defined as follows: complete response (CR), disappearance of any soft tissue plasmacytomas; partial response (PR), a \>50% reduction in size of soft tissue plasmacytomas; progressive disease (PD), definite development of new or a definite increase of size of existing soft tissue plasmacytomas; and stable disease (SD), not meeting criteria for CR, PR, or PD.

Groups in this outcome

Phase 1: 375 mg ONC201 + 20 mg Dexamethasone

Participants received 375 mg ONC201 once weekly in combination with 20 mg dexamethasone.

Phase 2: 625 mg ONC201 + 20 mg Dexamethasone

Participants received 625 mg ONC201 once weekly in combination with 20 mg dexamethasone.

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

Analysis denominator · Participants

GroupSource count
Phase 1: 375 mg ONC201 + 20 mg Dexamethasone2
Phase 2: 625 mg ONC201 + 20 mg Dexamethasone15

Reported measurements

Stable disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: 375 mg ONC201 + 20 mg Dexamethasone1Not reportedNot reportedNot reportedNot reported
Phase 2: 625 mg ONC201 + 20 mg Dexamethasone2Not reportedNot reportedNot reportedNot reported
Progressive disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: 375 mg ONC201 + 20 mg Dexamethasone1Not reportedNot reportedNot reportedNot reported
Phase 2: 625 mg ONC201 + 20 mg Dexamethasone13Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
    title
    Stable disease
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        13
    title
    Progressive disease
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      15
    units
    Participants
description
Assessments of response were made using the International Myeloma Working Group (IMWG) response criteria and were assessed by magnetic resonance imaging (MRI), computed tomography (CT), or positron emission tomography (PET)/CT scans (when applicable). Per IMWG response criteria, objective response could be defined as follows: complete response (CR), disappearance of any soft tissue plasmacytomas; partial response (PR), a \>50% reduction in size of soft tissue plasmacytomas; progressive disease (PD), definite development of new or a definite increase of size of existing soft tissue plasmacytomas; and stable disease (SD), not meeting criteria for CR, PR, or PD.
groups
  1. description
    Participants received 375 mg ONC201 once weekly in combination with 20 mg dexamethasone.
    id
    OG000
    title
    Phase 1: 375 mg ONC201 + 20 mg Dexamethasone
  2. description
    Participants received 625 mg ONC201 once weekly in combination with 20 mg dexamethasone.
    id
    OG001
    title
    Phase 2: 625 mg ONC201 + 20 mg Dexamethasone
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
The response assessment data reported was conducted at the last on-study visit (end of treatment/follow-up), up to a maximum of 7 months following treatment initiation.
title
Response of Participants at Last On-study Visit (End of Treatment/Follow-up)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice