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NCT03748953 · OUTCOME

Plasma Concentration of Ixazomib

Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Participants With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation (SCT) · Source last updated 2025-03-21

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

Measure
GEOMETRIC_MEAN
Unit
nanograms 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: ISP=all participants who received atleast 1 dose of ixazomib. Number analyzed=participants with data available for analysis at specified time point. As prespecified in SAP, ISP had only 1 arm:Ixazomib (participants originally randomized to ixazomib + participants randomized to placebo arm prior to implementation of Amendment 08 \& crossed over to ixazomib arm contributing data for this OM from time they initiated ixazomib onward), thus data is presented accordingly.

Groups in this outcome

Ixazomib

Participants received ixazomib 3 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 1 through 4, during which if the participants tolerated the initial dose, the dose was escalated to ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 5 through 26, or until documented progressive disease (PD) or intolerable toxicity, whichever occurred first (cycle length=28 days).

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

Analysis denominator · Participants

GroupSource count
Ixazomib35

Reported measurements

Cycle 1 Day 1: 1 Hour Post-dose

Analysis denominator · Participants

GroupSource count
Ixazomib35
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib15.3181Not reportedNot reportedNot reported
Cycle 1 Day 1: 4 Hours Post-dose

Analysis denominator · Participants

GroupSource count
Ixazomib35
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib16.694.4Not reportedNot reportedNot reported
Cycle 1 Day 8: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib34
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib2.2551.5Not reportedNot reportedNot reported
Cycle 1 Day 15: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib35
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib453.6Not reportedNot reportedNot reported
Cycle 2 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib35
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib2.9246.8Not reportedNot reportedNot reported
Cycle 2 Day 8: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib34
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib4.3742.5Not reportedNot reportedNot reported
Cycle 3 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib34
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib3.1541.9Not reportedNot reportedNot reported
Cycle 4 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib31
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib3.1659.4Not reportedNot reportedNot reported
Cycle 5 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib29
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib3.2542.1Not reportedNot reportedNot reported
Cycle 5 Day 8: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib21
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib5.2936.9Not reportedNot reportedNot reported
Cycle 6 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib29
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib3.5841.3Not reportedNot reportedNot reported
Cycle 7 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib28
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib4.0448.5Not reportedNot reportedNot reported
Cycle 8 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib23
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib3.2864.7Not reportedNot reportedNot reported
Cycle 9 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib19
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib3.731.3Not reportedNot reportedNot reported
Cycle 10 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib19
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ixazomib2.9937.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        181
        value
        15.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      units
      Participants
    title
    Cycle 1 Day 1: 1 Hour Post-dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        94.4
        value
        16.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      units
      Participants
    title
    Cycle 1 Day 1: 4 Hours Post-dose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        51.5
        value
        2.25
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      units
      Participants
    title
    Cycle 1 Day 8: Pre-dose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        53.6
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      units
      Participants
    title
    Cycle 1 Day 15: Pre-dose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        46.8
        value
        2.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      units
      Participants
    title
    Cycle 2 Day 1: Pre-dose
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        42.5
        value
        4.37
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      units
      Participants
    title
    Cycle 2 Day 8: Pre-dose
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        41.9
        value
        3.15
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      units
      Participants
    title
    Cycle 3 Day 1: Pre-dose
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        59.4
        value
        3.16
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      units
      Participants
    title
    Cycle 4 Day 1: Pre-dose
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        42.1
        value
        3.25
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      units
      Participants
    title
    Cycle 5 Day 1: Pre-dose
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        36.9
        value
        5.29
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      units
      Participants
    title
    Cycle 5 Day 8: Pre-dose
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        41.3
        value
        3.58
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      units
      Participants
    title
    Cycle 6 Day 1: Pre-dose
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        48.5
        value
        4.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      units
      Participants
    title
    Cycle 7 Day 1: Pre-dose
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    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
    Participants received ixazomib 3 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 1 through 4, during which if the participants tolerated the initial dose, the dose was escalated to ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 5 through 26, or until documented progressive disease (PD) or intolerable toxicity, whichever occurred first (cycle length=28 days).
    id
    OG000
    title
    Ixazomib
param Type
GEOMETRIC_MEAN
population Description
ISP=all participants who received atleast 1 dose of ixazomib. Number analyzed=participants with data available for analysis at specified time point. As prespecified in SAP, ISP had only 1 arm:Ixazomib (participants originally randomized to ixazomib + participants randomized to placebo arm prior to implementation of Amendment 08 \& crossed over to ixazomib arm contributing data for this OM from time they initiated ixazomib onward), thus data is presented accordingly.
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
Plasma Concentration of Ixazomib
type
SECONDARY
unit Of Measure
nanograms per milliliter (ng/mL)

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Preserved source evidence · Not medical advice