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NCT04272775 · OUTCOME

Cmax: Maximum Observed Plasma Concentration for Ixazomib

A Study of MLN9708 in Japanese Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM) · Source last updated 2020-03-17

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
Standard Deviation
Time frame
Days 1 and 15 of Cycle 1: pre-dose and at multiple time points (15, 30, 60, and 90 minutes and 2, 4, 8, 24, 48, 96, and 168 hours) post-dose (Cycle length=28 days)

Analysis population: The pharmacokinetic (PK) analysis set consisted of all participants who received at least one dose of ixazomib and has evaluable PK data. The PK analysis set where data at specified time points was available.

Groups in this outcome

Cohort 1: Ixazomib 4.0 mg

Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.

Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone

Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.

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

Analysis denominator · Participants

GroupSource count
Cohort 1: Ixazomib 4.0 mg7
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone7

Reported measurements

Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1: Ixazomib 4.0 mg7
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone7
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Ixazomib 4.0 mg65.354.6Not reportedNot reportedNot reported
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone32.919.3Not reportedNot reportedNot reported
Day 15

Analysis denominator · Participants

GroupSource count
Cohort 1: Ixazomib 4.0 mg5
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone6
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: Ixazomib 4.0 mg68.859.9Not reportedNot reportedNot reported
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone34.542.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        54.6
        value
        65.3
      2. group Id
        OG001
        spread
        19.3
        value
        32.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        7
      units
      Participants
    title
    Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        59.9
        value
        68.8
      2. group Id
        OG001
        spread
        42.0
        value
        34.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      7
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.
    id
    OG000
    title
    Cohort 1: Ixazomib 4.0 mg
  2. description
    Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
    id
    OG001
    title
    Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone
param Type
GEOMETRIC_MEAN
population Description
The pharmacokinetic (PK) analysis set consisted of all participants who received at least one dose of ixazomib and has evaluable PK data. The PK analysis set where data at specified time points was available.
reporting Status
POSTED
time Frame
Days 1 and 15 of Cycle 1: pre-dose and at multiple time points (15, 30, 60, and 90 minutes and 2, 4, 8, 24, 48, 96, and 168 hours) post-dose (Cycle length=28 days)
title
Cmax: Maximum Observed Plasma Concentration for Ixazomib
type
PRIMARY
unit Of Measure
nanogram per milliliter (ng/mL)

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Preserved source evidence · Not medical advice