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NCT02939183 · OUTCOME

Number of Participants With Progression Free Survival (PFS) Events

Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma · Source last updated 2024-09-26

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
Day 1 of cycle 1 up to the end of study visit (where each cycle was 28 days); median treatment duration in Part 1 was 11.43 weeks and in Part 2 was 28 weeks

What was measured

PFS was defined as the number of months from a participant's first dose of study treatment to the earlier of disease progression or death due to any cause. The number of participants who had a PFS event or who were censored are presented. PFS events were an assessment of progressive disease according to the IMWG-URC or death due to any cause. PFS data was censored: participants alive and no documented disease progression at time of analysis were censored at date of last disease assessment; participants alive with no disease assessment were censored at the first study dose date; participants alive without documented disease progression, with withdrawn consent were censored at date of last disease assessment before consent withdrawal; and for participants who started anti-cancer therapy other than study treatment prior to documentation of disease progression were censored at date of last disease assessment prior to starting new therapy.

Analysis population: The efficacy analysis set included all participants, excluding roll-over participants, who were included in the safety analysis set, and had a baseline disease assessment and at least 1 post-baseline disease assessment.

Groups in this outcome

Oprozomib IR 150 mg/Day + Dexamethsone

In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.

Oprozomib GR 150 mg/Day + Dexamethasone

In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.

Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone

In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.

Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone

In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.

Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone

In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.

Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone

In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.

Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone

In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.

Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone

In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
Oprozomib IR 150 mg/Day + Dexamethsone3
Oprozomib GR 150 mg/Day + Dexamethasone6
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone3
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone3
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone7
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone5
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone10
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone8

Reported measurements

Source class 1

Participants with PFS events

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Oprozomib IR 150 mg/Day + Dexamethsone0Not reportedNot reportedNot reportedNot reported
Oprozomib GR 150 mg/Day + Dexamethasone1Not reportedNot reportedNot reportedNot reported
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone1Not reportedNot reportedNot reportedNot reported
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone2Not reportedNot reportedNot reportedNot reported
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone4Not reportedNot reportedNot reportedNot reported
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone1Not reportedNot reportedNot reportedNot reported

Participants who were censored

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Oprozomib IR 150 mg/Day + Dexamethsone3Not reportedNot reportedNot reportedNot reported
Oprozomib GR 150 mg/Day + Dexamethasone5Not reportedNot reportedNot reportedNot reported
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone2Not reportedNot reportedNot reportedNot reported
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone3Not reportedNot reportedNot reportedNot reported
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone7Not reportedNot reportedNot reportedNot reported
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone3Not reportedNot reportedNot reportedNot reported
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone6Not reportedNot reportedNot reportedNot reported
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        4
      8. group Id
        OG007
        value
        1
      title
      Participants with PFS events
    2. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        7
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        6
      8. group Id
        OG007
        value
        7
      title
      Participants who were censored
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      7
    6. group Id
      OG005
      value
      5
    7. group Id
      OG006
      value
      10
    8. group Id
      OG007
      value
      8
    units
    Participants
description
PFS was defined as the number of months from a participant's first dose of study treatment to the earlier of disease progression or death due to any cause. The number of participants who had a PFS event or who were censored are presented. PFS events were an assessment of progressive disease according to the IMWG-URC or death due to any cause. PFS data was censored: participants alive and no documented disease progression at time of analysis were censored at date of last disease assessment; participants alive with no disease assessment were censored at the first study dose date; participants alive without documented disease progression, with withdrawn consent were censored at date of last disease assessment before consent withdrawal; and for participants who started anti-cancer therapy other than study treatment prior to documentation of disease progression were censored at date of last disease assessment prior to starting new therapy.
groups
  1. description
    In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
    id
    OG000
    title
    Oprozomib IR 150 mg/Day + Dexamethsone
  2. description
    In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
    id
    OG001
    title
    Oprozomib GR 150 mg/Day + Dexamethasone
  3. description
    In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    OG002
    title
    Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
  4. description
    In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    OG003
    title
    Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
  5. description
    In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    OG004
    title
    Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
  6. description
    In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    OG005
    title
    Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
  7. description
    In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    OG006
    title
    Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
  8. description
    In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    OG007
    title
    Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
param Type
COUNT_OF_PARTICIPANTS
population Description
The efficacy analysis set included all participants, excluding roll-over participants, who were included in the safety analysis set, and had a baseline disease assessment and at least 1 post-baseline disease assessment.
reporting Status
POSTED
time Frame
Day 1 of cycle 1 up to the end of study visit (where each cycle was 28 days); median treatment duration in Part 1 was 11.43 weeks and in Part 2 was 28 weeks
title
Number of Participants With Progression Free Survival (PFS) Events
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice