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NCT02939183 · OUTCOME

Kaplan-Meier Estimate of Duration of Response (DOR)

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
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

DOR, presented in months, was defined as the number of days between the date of the first tumor assessment indicating an objective response (PR or better) through to the subsequent date of progression or death due to any cause, or where applicable date of censoring (date of first progressive disease assessment or death or date of censoring - date of the first objective response result + 1/30.4). Median PFS was estimated using the Kaplan-Meier method. 95% confidence intervals were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.

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. Participants who did not achieve an objective response were excluded from the analysis of DOR. Participants who responded and had not progressed while on study were censored at the date of assessment of the last evaluable tumor 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 + Dexamethsone2
Oprozomib GR 150 mg/Day + Dexamethasone1
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone1
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone0
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone6
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone3
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone6
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone7

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Oprozomib IR 150 mg/Day + DexamethsoneNANot reportedNANAThe median, upper and lower 95% CIs could not be estimated due to too few events.
Oprozomib GR 150 mg/Day + DexamethasoneNANot reportedNANAThe median, upper and lower 95% CIs could not be estimated due to too few events.
Oprozomib IR 150 mg/Day + Pomalidomide + DexamethasoneNANot reportedNANAThe median, upper and lower 95% CIs could not be estimated due to too few events.
Oprozomib IR 200 mg/Day + Pomalidomide + DexamethasoneNANot reportedNANAThe median, upper and lower 95% CIs could not be estimated due to too few events.
Oprozomib GR 200 mg/Day + Pomalidomide + DexamethasoneNANot reportedNANAThe median, upper and lower 95% CIs could not be estimated due to too few events.
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone16.6Not reported3.7NAThe upper 95% CI could not be estimated due to too few events.
Oprozomib IR 250 mg/Day + Pomalidomide + DexamethasoneNANot reported28.6NAThe median could not be estimated due to too few events. The lower bound 95% CI was estimated from observed data that were available (25% percentile).
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The median, upper and lower 95% CIs could not be estimated due to too few events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        The median, upper and lower 95% CIs could not be estimated due to too few events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        The median, upper and lower 95% CIs could not be estimated due to too few events.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. comment
        The median, upper and lower 95% CIs could not be estimated due to too few events.
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      5. comment
        The median, upper and lower 95% CIs could not be estimated due to too few events.
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      6. comment
        The upper 95% CI could not be estimated due to too few events.
        group Id
        OG006
        lower Limit
        3.7
        upper Limit
        NA
        value
        16.6
      7. comment
        The median could not be estimated due to too few events. The lower bound 95% CI was estimated from observed data that were available (25% percentile).
        group Id
        OG007
        lower Limit
        28.6
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      6
    8. group Id
      OG007
      value
      7
    units
    Participants
description
DOR, presented in months, was defined as the number of days between the date of the first tumor assessment indicating an objective response (PR or better) through to the subsequent date of progression or death due to any cause, or where applicable date of censoring (date of first progressive disease assessment or death or date of censoring - date of the first objective response result + 1/30.4). Median PFS was estimated using the Kaplan-Meier method. 95% confidence intervals were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.
dispersion Type
95% Confidence Interval
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
MEDIAN
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. Participants who did not achieve an objective response were excluded from the analysis of DOR. Participants who responded and had not progressed while on study were censored at the date of assessment of the last evaluable tumor 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
Kaplan-Meier Estimate of Duration of Response (DOR)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice