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NCT01564537 · OUTCOME

Plasma Concentration Over Time for Ixazomib

A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2023-03-10

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

Measure
MEAN
Unit
μg/mL
Interval / dispersion
Standard Deviation
Time frame
Pre-dose and post-dose at multiple timepoints up to Cycle 10 Day 1 (each cycle length = 28 days)

Analysis population: Safety population is defined as all subjects who received at least 1 dose of any study drug. Overall number analyzed is the number of participants available for analysis. Number analyzed is the number of participants available for analysis at the given timepoint.

Groups in this outcome

Ixazomib+ Lenalidomide + Dexamethasone

Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months).

Placebo + Lenalidomide + Dexamethasone

Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).

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

Analysis denominator · Participants

GroupSource count
Ixazomib+ Lenalidomide + Dexamethasone335
Placebo + Lenalidomide + Dexamethasone5

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Ixazomib+ Lenalidomide + Dexamethasone1
Placebo + Lenalidomide + Dexamethasone0
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib+ Lenalidomide + Dexamethasone4.79NANot reportedNot reportedThe SD was not estimable due to single participant with event.
Cycle 1 Day 1, 1 Hour Post-Dose

Analysis denominator · Participants

GroupSource count
Ixazomib+ Lenalidomide + Dexamethasone330
Placebo + Lenalidomide + Dexamethasone4
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib+ Lenalidomide + Dexamethasone36.331.3Not reportedNot reportedNot reported
Placebo + Lenalidomide + Dexamethasone00Not reportedNot reportedNot reported
Cycle 1 Day 1, 4 Hours Post-Dose

Analysis denominator · Participants

GroupSource count
Ixazomib+ Lenalidomide + Dexamethasone321
Placebo + Lenalidomide + Dexamethasone4
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib+ Lenalidomide + Dexamethasone15.611.1Not reportedNot reportedNot reported
Placebo + Lenalidomide + Dexamethasone00Not reportedNot reportedNot reported
Cycle 1 Day 14, Pre-Dose

Analysis denominator · Participants

GroupSource count
Ixazomib+ Lenalidomide + Dexamethasone335
Placebo + Lenalidomide + Dexamethasone4
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib+ Lenalidomide + Dexamethasone6.8310.5Not reportedNot reportedNot reported
Placebo + Lenalidomide + Dexamethasone00Not reportedNot reportedNot reported
Cycle 2 Day 1, Pre-Dose

Analysis denominator · Participants

GroupSource count
Ixazomib+ Lenalidomide + Dexamethasone331
Placebo + Lenalidomide + Dexamethasone5
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib+ Lenalidomide + Dexamethasone2.42.4Not reportedNot reportedNot reported
Placebo + Lenalidomide + Dexamethasone00Not reportedNot reportedNot reported
Cycle 2 Day 14, Pre-Dose

Analysis denominator · Participants

GroupSource count
Ixazomib+ Lenalidomide + Dexamethasone324
Placebo + Lenalidomide + Dexamethasone5
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib+ Lenalidomide + Dexamethasone7.128.44Not reportedNot reportedNot reported
Placebo + Lenalidomide + Dexamethasone00Not reportedNot reportedNot reported
Cycle 3 Day 1, Pre-Dose

Analysis denominator · Participants

GroupSource count
Ixazomib+ Lenalidomide + Dexamethasone329
Placebo + Lenalidomide + Dexamethasone5
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib+ Lenalidomide + Dexamethasone2.481.69Not reportedNot reportedNot reported
Placebo + Lenalidomide + Dexamethasone00Not reportedNot reportedNot reported
Cycle 4 Day 1, Pre-Dose

Analysis denominator · Participants

GroupSource count
Ixazomib+ Lenalidomide + Dexamethasone319
Placebo + Lenalidomide + Dexamethasone4
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib+ Lenalidomide + Dexamethasone2.411.35Not reportedNot reportedNot reported
Placebo + Lenalidomide + Dexamethasone00Not reportedNot reportedNot reported
Cycle 5 Day 1, Pre-Dose

Analysis denominator · Participants

GroupSource count
Ixazomib+ Lenalidomide + Dexamethasone307
Placebo + Lenalidomide + Dexamethasone4
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib+ Lenalidomide + Dexamethasone2.421.49Not reportedNot reportedNot reported
Placebo + Lenalidomide + Dexamethasone00Not reportedNot reportedNot reported
Cycle 6 Day 1, Pre-Dose

Analysis denominator · Participants

GroupSource count
Ixazomib+ Lenalidomide + Dexamethasone290
Placebo + Lenalidomide + Dexamethasone4
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib+ Lenalidomide + Dexamethasone2.573.89Not reportedNot reportedNot reported
Placebo + Lenalidomide + Dexamethasone00Not reportedNot reportedNot reported
Cycle 7 Day 1, Pre-Dose

Analysis denominator · Participants

GroupSource count
Ixazomib+ Lenalidomide + Dexamethasone279
Placebo + Lenalidomide + Dexamethasone3
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib+ Lenalidomide + Dexamethasone2.714.79Not reportedNot reportedNot reported
Placebo + Lenalidomide + Dexamethasone00Not reportedNot reportedNot reported
Cycle 8 Day 1, Pre-Dose

Analysis denominator · Participants

GroupSource count
Ixazomib+ Lenalidomide + Dexamethasone268
Placebo + Lenalidomide + Dexamethasone2
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib+ Lenalidomide + Dexamethasone2.371.47Not reportedNot reportedNot reported
Placebo + Lenalidomide + Dexamethasone00Not reportedNot reportedNot reported
Cycle 9 Day 1, Pre-Dose

Analysis denominator · Participants

GroupSource count
Ixazomib+ Lenalidomide + Dexamethasone262
Placebo + Lenalidomide + Dexamethasone4
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib+ Lenalidomide + Dexamethasone2.512.13Not reportedNot reportedNot reported
Placebo + Lenalidomide + Dexamethasone00Not reportedNot reportedNot reported
Cycle 10 Day 1, Pre-Dose

Analysis denominator · Participants

GroupSource count
Ixazomib+ Lenalidomide + Dexamethasone239
Placebo + Lenalidomide + Dexamethasone2
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib+ Lenalidomide + Dexamethasone2.825.98Not reportedNot reportedNot reported
Placebo + Lenalidomide + Dexamethasone00Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The SD was not estimable due to single participant with event.
        group Id
        OG000
        spread
        NA
        value
        4.79
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.3
        value
        36.3
      2. group Id
        OG001
        spread
        0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        330
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Cycle 1 Day 1, 1 Hour Post-Dose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.1
        value
        15.6
      2. group Id
        OG001
        spread
        0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        321
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Cycle 1 Day 1, 4 Hours Post-Dose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.5
        value
        6.83
      2. group Id
        OG001
        spread
        0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        335
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Cycle 1 Day 14, Pre-Dose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.4
        value
        2.4
      2. group Id
        OG001
        spread
        0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        331
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Cycle 2 Day 1, Pre-Dose
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.44
        value
        7.12
      2. group Id
        OG001
        spread
        0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        324
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Cycle 2 Day 14, Pre-Dose
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.69
        value
        2.48
      2. group Id
        OG001
        spread
        0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        329
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Cycle 3 Day 1, Pre-Dose
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.35
        value
        2.41
      2. group Id
        OG001
        spread
        0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        319
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Cycle 4 Day 1, Pre-Dose
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.49
        value
        2.42
      2. group Id
        OG001
        spread
        0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        307
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Cycle 5 Day 1, Pre-Dose
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.89
        value
        2.57
      2. group Id
        OG001
        spread
        0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        290
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Cycle 6 Day 1, Pre-Dose
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.79
        value
        2.71
      2. group Id
        OG001
        spread
        0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        279
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Cycle 7 Day 1, Pre-Dose
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.47
        value
        2.37
      2. group Id
        OG001
        spread
        0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        268
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    Cycle 8 Day 1, Pre-Dose
denoms
  1. counts
    1. group Id
      OG000
      value
      335
    2. group Id
      OG001
      value
      5
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months).
    id
    OG000
    title
    Ixazomib+ Lenalidomide + Dexamethasone
  2. description
    Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).
    id
    OG001
    title
    Placebo + Lenalidomide + Dexamethasone
param Type
MEAN
population Description
Safety population is defined as all subjects who received at least 1 dose of any study drug. Overall number analyzed is the number of participants available for analysis. Number analyzed is the number of participants available for analysis at the given timepoint.
reporting Status
POSTED
time Frame
Pre-dose and post-dose at multiple timepoints up to Cycle 10 Day 1 (each cycle length = 28 days)
title
Plasma Concentration Over Time for Ixazomib
type
SECONDARY
unit Of Measure
μg/mL

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Preserved source evidence · Not medical advice