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NCT02181413 · OUTCOME

Plasma Concentration of Ixazomib

A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant · Source last updated 2024-11-19

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

Measure
MEAN
Unit
nanograms per milliliter (ng/mL)
Interval / dispersion
Standard Deviation
Time frame
Day 1 of Cycle 1: 1 hour and 4 hours post-dose; Predose on Days 8 and 15 of Cycle 1, Days 1 and 8 of Cycle 2, Day 1 of Cycles 3 through 10 (each cycle length= 28 days)

What was measured

Plasma concentrations of the complete hydrolysis product of ixazomib citrate (ixazomib) were measured using a validated Liquid Chromatography-tandem Mass Spectrometry (LC/MS/MS) assay.

Analysis population: The Pharmacokinetic (PK) Analysis Population was defined as participants with at least one PK sample that was collected and analyzed. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Groups in this outcome

Ixazomib Citrate

Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.

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 Citrate393

Reported measurements

Cycle 1 Day 1: 1 Hour Post-dose

Analysis denominator · Participants

GroupSource count
Ixazomib Citrate381
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib Citrate27.91924.7787Not reportedNot reportedNot reported
Cycle 1 Day 1: 4 Hours Post-dose

Analysis denominator · Participants

GroupSource count
Ixazomib Citrate383
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib Citrate10.3529.8078Not reportedNot reportedNot reported
Cycle 1 Day 8

Analysis denominator · Participants

GroupSource count
Ixazomib Citrate387
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib Citrate1.5841.6707Not reportedNot reportedNot reported
Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Ixazomib Citrate382
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib Citrate2.6111.4305Not reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Ixazomib Citrate384
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib Citrate1.9461.0984Not reportedNot reportedNot reported
Cycle 2 Day 8

Analysis denominator · Participants

GroupSource count
Ixazomib Citrate374
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib Citrate3.2322.0069Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Ixazomib Citrate367
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib Citrate2.2581.1508Not reportedNot reportedNot reported
Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Ixazomib Citrate367
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib Citrate2.3961.7822Not reportedNot reportedNot reported
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Ixazomib Citrate360
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib Citrate2.4001.4921Not reportedNot reportedNot reported
Cycle 6 Day 1

Analysis denominator · Participants

GroupSource count
Ixazomib Citrate350
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib Citrate2.6231.6994Not reportedNot reportedNot reported
Cycle 7 Day 1

Analysis denominator · Participants

GroupSource count
Ixazomib Citrate349
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib Citrate2.6911.9842Not reportedNot reportedNot reported
Cycle 8 Day 1

Analysis denominator · Participants

GroupSource count
Ixazomib Citrate338
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib Citrate2.6371.7074Not reportedNot reportedNot reported
Cycle 9 Day 1

Analysis denominator · Participants

GroupSource count
Ixazomib Citrate327
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib Citrate2.6101.9380Not reportedNot reportedNot reported
Cycle 10 Day 1

Analysis denominator · Participants

GroupSource count
Ixazomib Citrate321
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib Citrate2.5941.9509Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.7787
        value
        27.919
    denoms
    1. counts
      1. group Id
        OG000
        value
        381
      units
      Participants
    title
    Cycle 1 Day 1: 1 Hour Post-dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.8078
        value
        10.352
    denoms
    1. counts
      1. group Id
        OG000
        value
        383
      units
      Participants
    title
    Cycle 1 Day 1: 4 Hours Post-dose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.6707
        value
        1.584
    denoms
    1. counts
      1. group Id
        OG000
        value
        387
      units
      Participants
    title
    Cycle 1 Day 8
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.4305
        value
        2.611
    denoms
    1. counts
      1. group Id
        OG000
        value
        382
      units
      Participants
    title
    Cycle 1 Day 15
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.0984
        value
        1.946
    denoms
    1. counts
      1. group Id
        OG000
        value
        384
      units
      Participants
    title
    Cycle 2 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.0069
        value
        3.232
    denoms
    1. counts
      1. group Id
        OG000
        value
        374
      units
      Participants
    title
    Cycle 2 Day 8
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.1508
        value
        2.258
    denoms
    1. counts
      1. group Id
        OG000
        value
        367
      units
      Participants
    title
    Cycle 3 Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.7822
        value
        2.396
    denoms
    1. counts
      1. group Id
        OG000
        value
        367
      units
      Participants
    title
    Cycle 4 Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.4921
        value
        2.400
    denoms
    1. counts
      1. group Id
        OG000
        value
        360
      units
      Participants
    title
    Cycle 5 Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.6994
        value
        2.623
    denoms
    1. counts
      1. group Id
        OG000
        value
        350
      units
      Participants
    title
    Cycle 6 Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.9842
        value
        2.691
    denoms
    1. counts
      1. group Id
        OG000
        value
        349
      units
      Participants
    title
    Cycle 7 Day 1
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.7074
        value
        2.637
    denoms
    1. counts
      1. group Id
        OG000
        value
        338
      units
      Participants
    title
    Cycle 8 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      393
    units
    Participants
description
Plasma concentrations of the complete hydrolysis product of ixazomib citrate (ixazomib) were measured using a validated Liquid Chromatography-tandem Mass Spectrometry (LC/MS/MS) assay.
dispersion Type
Standard Deviation
groups
  1. description
    Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.
    id
    OG000
    title
    Ixazomib Citrate
param Type
MEAN
population Description
The Pharmacokinetic (PK) Analysis Population was defined as participants with at least one PK sample that was collected and analyzed. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
reporting Status
POSTED
time Frame
Day 1 of Cycle 1: 1 hour and 4 hours post-dose; Predose on Days 8 and 15 of Cycle 1, Days 1 and 8 of Cycle 2, Day 1 of Cycles 3 through 10 (each cycle length= 28 days)
title
Plasma Concentration of Ixazomib
type
SECONDARY
unit Of Measure
nanograms per milliliter (ng/mL)

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Preserved source evidence · Not medical advice