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NCT01999335 · OUTCOME

Area Under the Plasma Concentration-time Curve From Time 0 to Time Infinity (AUCinf) of Oprozomib

A Study of Oprozomib, Pomalidomide, and Dexamethasone in Adults With Primary Refractory or Relapsed and Refractory Multiple Myeloma · Source last updated 2021-04-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
hr*ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 day 1 at predose and 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours postdose. Cycle 2 day 1 at predose and 0.25, 0.5, 1, 2, 3, 4, and 6 hours postdose.

What was measured

Oprozomib plasma concentrations were determined using liquid chromatography with tandem mass spectrometry. The area under the plasma concentration-time curve from time 0 to time infinity (AUCinf), estimated as the sum of AUClast and Clast/λz, where Clast is the last predicted concentration and λz is the first-order terminal rate constant estimated via linear regression of the terminal log-linear decay phase.

Analysis population: Participants with adequate oprozomib plasma concentration-versus-time data to allow estimation of pharmacokinetic (PK) parameters. Treatment groups receiving the same dose of oprozomib were combined for PK analyses.

Groups in this outcome

Oprozomib 150 mg 5/14 + Pomalidomide + Dexamethasone

Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 or 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.

Oprozomib 210 mg 2/7 + Pomalidomide + Dexamethasone

Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.

Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone

Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.

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 150 mg 5/14 + Pomalidomide + Dexamethasone2
Oprozomib 210 mg 2/7 + Pomalidomide + Dexamethasone8
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone5

Reported measurements

Cycle 1 day 1

Analysis denominator · Participants

GroupSource count
Oprozomib 150 mg 5/14 + Pomalidomide + Dexamethasone2
Oprozomib 210 mg 2/7 + Pomalidomide + Dexamethasone5
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone4
Values in hr*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Oprozomib 150 mg 5/14 + Pomalidomide + Dexamethasone2250NANot reportedNot reportedNot calculated when N ≤ 2
Oprozomib 210 mg 2/7 + Pomalidomide + Dexamethasone344096.1Not reportedNot reportedNot reported
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone166035.8Not reportedNot reportedNot reported
Cycle 2 day 1

Analysis denominator · Participants

GroupSource count
Oprozomib 150 mg 5/14 + Pomalidomide + Dexamethasone0
Oprozomib 210 mg 2/7 + Pomalidomide + Dexamethasone8
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone5
Values in hr*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Oprozomib 210 mg 2/7 + Pomalidomide + Dexamethasone183087.7Not reportedNot reportedNot reported
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone190012.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not calculated when N ≤ 2
        group Id
        OG000
        spread
        NA
        value
        2250
      2. group Id
        OG001
        spread
        96.1
        value
        3440
      3. group Id
        OG002
        spread
        35.8
        value
        1660
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        4
      units
      Participants
    title
    Cycle 1 day 1
  2. categories
    1. measurements
      1. group Id
        OG001
        spread
        87.7
        value
        1830
      2. group Id
        OG002
        spread
        12.4
        value
        1900
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        5
      units
      Participants
    title
    Cycle 2 day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      5
    units
    Participants
description
Oprozomib plasma concentrations were determined using liquid chromatography with tandem mass spectrometry. The area under the plasma concentration-time curve from time 0 to time infinity (AUCinf), estimated as the sum of AUClast and Clast/λz, where Clast is the last predicted concentration and λz is the first-order terminal rate constant estimated via linear regression of the terminal log-linear decay phase.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 or 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
    id
    OG000
    title
    Oprozomib 150 mg 5/14 + Pomalidomide + Dexamethasone
  2. description
    Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
    id
    OG001
    title
    Oprozomib 210 mg 2/7 + Pomalidomide + Dexamethasone
  3. description
    Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
    id
    OG002
    title
    Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
param Type
GEOMETRIC_MEAN
population Description
Participants with adequate oprozomib plasma concentration-versus-time data to allow estimation of pharmacokinetic (PK) parameters. Treatment groups receiving the same dose of oprozomib were combined for PK analyses.
reporting Status
POSTED
time Frame
Cycle 1 day 1 at predose and 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours postdose. Cycle 2 day 1 at predose and 0.25, 0.5, 1, 2, 3, 4, and 6 hours postdose.
title
Area Under the Plasma Concentration-time Curve From Time 0 to Time Infinity (AUCinf) of Oprozomib
type
SECONDARY
unit Of Measure
hr*ng/mL

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Preserved source evidence · Not medical advice