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NCT02312258 · OUTCOME

Pharmacokinetic Parameter: Plasma Concentration of Ixazomib

A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT) · Source last updated 2023-09-21

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

Measure
GEOMETRIC_MEAN
Unit
nanogram per milliliter (ng/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 (1 and 4 hours post-dose Day 1, Days 8 and 15 pre-dose); Cycle 2 and 5 (Days 1 and 8 pre-dose) and Cycles 3, 4, 6 to 10 (Day 1 pre-dose) (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: Pharmacokinetic Analysis Population included all participants with at least one pharmacokinetic (PK) sample that was collected and analyzed. Number analyzed is the number of participants with data available for analysis at the specified time point.

Groups in this outcome

Ixazomib

Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.

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

Analysis denominator · Participants

GroupSource count
Ixazomib423

Reported measurements

Cycle 1 Day 1 - 1 Hour Post-dose

Analysis denominator · Participants

GroupSource count
Ixazomib413
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib19.35389.2568Not reportedNot reportedNot reported
Cycle 1 Day 1 - 4 Hours Post-dose

Analysis denominator · Participants

GroupSource count
Ixazomib403
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib12.69867.8350Not reportedNot reportedNot reported
Cycle 1 Day 8 - Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib409
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib1.683162.3947Not reportedNot reportedNot reported
Cycle 1 Day 15 - Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib411
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib2.82886.7699Not reportedNot reportedNot reported
Cycle 2 Day 1 - Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib410
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib1.958170.8938Not reportedNot reportedNot reported
Cycle 2 Day 8 - Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib394
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib3.217188.6379Not reportedNot reportedNot reported
Cycle 3 Day 1 - Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib391
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib2.25256.2869Not reportedNot reportedNot reported
Cycle 4 Day 1 - Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib372
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib2.36352.9781Not reportedNot reportedNot reported
Cycle 5 Day 1 - Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib348
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib2.32853.0909Not reportedNot reportedNot reported
Cycle 5 Day 8 - Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib257
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib4.547224.4312Not reportedNot reportedNot reported
Cycle 6 Day 1 - Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib320
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib2.50352.9349Not reportedNot reportedNot reported
Cycle 7 Day 1 - Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib298
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib2.58557.9514Not reportedNot reportedNot reported
Cycle 8 Day 1 - Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib281
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib2.60658.5109Not reportedNot reportedNot reported
Cycle 9 Day 1 - Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib269
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib2.56658.1094Not reportedNot reportedNot reported
Cycle 10 Day 1 - Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib250
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib2.68650.2494Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        89.2568
        value
        19.353
    denoms
    1. counts
      1. group Id
        OG000
        value
        413
      units
      Participants
    title
    Cycle 1 Day 1 - 1 Hour Post-dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        67.8350
        value
        12.698
    denoms
    1. counts
      1. group Id
        OG000
        value
        403
      units
      Participants
    title
    Cycle 1 Day 1 - 4 Hours Post-dose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        162.3947
        value
        1.683
    denoms
    1. counts
      1. group Id
        OG000
        value
        409
      units
      Participants
    title
    Cycle 1 Day 8 - Pre-dose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        86.7699
        value
        2.828
    denoms
    1. counts
      1. group Id
        OG000
        value
        411
      units
      Participants
    title
    Cycle 1 Day 15 - Pre-dose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        170.8938
        value
        1.958
    denoms
    1. counts
      1. group Id
        OG000
        value
        410
      units
      Participants
    title
    Cycle 2 Day 1 - Pre-dose
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        188.6379
        value
        3.217
    denoms
    1. counts
      1. group Id
        OG000
        value
        394
      units
      Participants
    title
    Cycle 2 Day 8 - Pre-dose
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        56.2869
        value
        2.252
    denoms
    1. counts
      1. group Id
        OG000
        value
        391
      units
      Participants
    title
    Cycle 3 Day 1 - Pre-dose
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        52.9781
        value
        2.363
    denoms
    1. counts
      1. group Id
        OG000
        value
        372
      units
      Participants
    title
    Cycle 4 Day 1 - Pre-dose
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        53.0909
        value
        2.328
    denoms
    1. counts
      1. group Id
        OG000
        value
        348
      units
      Participants
    title
    Cycle 5 Day 1 - Pre-dose
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        224.4312
        value
        4.547
    denoms
    1. counts
      1. group Id
        OG000
        value
        257
      units
      Participants
    title
    Cycle 5 Day 8 - Pre-dose
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        52.9349
        value
        2.503
    denoms
    1. counts
      1. group Id
        OG000
        value
        320
      units
      Participants
    title
    Cycle 6 Day 1 - Pre-dose
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        57.9514
        value
        2.585
    denoms
    1. counts
      1. group Id
        OG000
        value
        298
      units
      Participants
    title
    Cycle 7 Day 1 - Pre-dose
denoms
  1. counts
    1. group Id
      OG000
      value
      423
    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
Geometric Coefficient of Variation
groups
  1. description
    Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.
    id
    OG000
    title
    Ixazomib
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic Analysis Population included all participants with at least one pharmacokinetic (PK) sample that was collected and analyzed. Number analyzed is the number of participants with data available for analysis at the specified time point.
reporting Status
POSTED
time Frame
Cycle 1 (1 and 4 hours post-dose Day 1, Days 8 and 15 pre-dose); Cycle 2 and 5 (Days 1 and 8 pre-dose) and Cycles 3, 4, 6 to 10 (Day 1 pre-dose) (cycle length=28 days)
title
Pharmacokinetic Parameter: Plasma Concentration of Ixazomib
type
SECONDARY
unit Of Measure
nanogram per milliliter (ng/mL)

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Preserved source evidence · Not medical advice