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NCT01850524 · OUTCOME

Cmax: Maximum Plasma Concentration for Ixazomib

IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2023-07-21

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

Measure
MEAN
Unit
nanograms per milliliter
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 Day 1: Post-dose at multiple timepoints up to 4 hours; Pre-dose at Cycle 1 Day 14, Cycles 2-3 Day 1 and Day 14, Cycles 4-11 Day 1 (Each cycle length = 28 days)

Analysis population: Pharmacokinetic (PK) analysis population is defined as subjects with at least one PK sample that was collected and analyzed. Overall number of participants analyzed is the number of participants available for analyses. Number analyzed indicates the number of participants available for analysis at the given timepoint.

Groups in this outcome

Ixazomib

Participants who were randomly assigned to receive Ixazomib 4.0 mg capsules orally once on Days 1,8,15 and lenalidomide 25 mg capsules orally on days 1-21 and dexamethasone 40 mg tablets orally on Days 1,8, 15 and 22, during every 28-day cycle for the first 18 cycles. After Cycle 18 dexamethasone was discontinued and participants continued to receive ixazomib capsule and lenalidomide at reduced doses until progressive disease or unacceptable toxicity, whichever comes first, up to end of study (up to approximately 109 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
Ixazomib331

Reported measurements

Cycle 1 Day 1: 1 Hour Post-dose

Analysis denominator · Participants

GroupSource count
Ixazomib331
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib44.74535.9404Not reportedNot reportedNot reported
Cycle 1 Day 1: 4 Hours Post-dose

Analysis denominator · Participants

GroupSource count
Ixazomib320
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib16.25317.0407Not reportedNot reportedNot reported
Cycle 1 Day 14: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib327
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib7.86715.4420Not reportedNot reportedNot reported
Cycle 2 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib320
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib2.6642.2770Not reportedNot reportedNot reported
Cycle 2 Day 14: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib302
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib8.52114.7411Not reportedNot reportedNot reported
Cycle 3 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib300
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib2.7631.6318Not reportedNot reportedNot reported
Cycle 3 Day 14: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib275
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib8.49017.6720Not reportedNot reportedNot reported
Cycle 4 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib284
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib3.2846.1116Not reportedNot reportedNot reported
Cycle 5 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib270
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib3.59413.2046Not reportedNot reportedNot reported
Cycle 6 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib260
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib2.6031.5242Not reportedNot reportedNot reported
Cycle 7 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib258
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib2.5981.4658Not reportedNot reportedNot reported
Cycle 8 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib251
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib2.5391.5549Not reportedNot reportedNot reported
Cycle 9 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib242
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib2.5932.0867Not reportedNot reportedNot reported
Cycle 10 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib238
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib2.5361.7431Not reportedNot reportedNot reported
Cycle 11 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib224
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib2.6674.5448Not reportedNot reportedNot reported
Cycle 12 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Ixazomib217
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib2.6861.8949Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.9404
        value
        44.745
    denoms
    1. counts
      1. group Id
        OG000
        value
        331
      units
      Participants
    title
    Cycle 1 Day 1: 1 Hour Post-dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.0407
        value
        16.253
    denoms
    1. counts
      1. group Id
        OG000
        value
        320
      units
      Participants
    title
    Cycle 1 Day 1: 4 Hours Post-dose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.4420
        value
        7.867
    denoms
    1. counts
      1. group Id
        OG000
        value
        327
      units
      Participants
    title
    Cycle 1 Day 14: Pre-dose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.2770
        value
        2.664
    denoms
    1. counts
      1. group Id
        OG000
        value
        320
      units
      Participants
    title
    Cycle 2 Day 1: Pre-dose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.7411
        value
        8.521
    denoms
    1. counts
      1. group Id
        OG000
        value
        302
      units
      Participants
    title
    Cycle 2 Day 14: Pre-dose
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.6318
        value
        2.763
    denoms
    1. counts
      1. group Id
        OG000
        value
        300
      units
      Participants
    title
    Cycle 3 Day 1: Pre-dose
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.6720
        value
        8.490
    denoms
    1. counts
      1. group Id
        OG000
        value
        275
      units
      Participants
    title
    Cycle 3 Day 14: Pre-dose
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.1116
        value
        3.284
    denoms
    1. counts
      1. group Id
        OG000
        value
        284
      units
      Participants
    title
    Cycle 4 Day 1: Pre-dose
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.2046
        value
        3.594
    denoms
    1. counts
      1. group Id
        OG000
        value
        270
      units
      Participants
    title
    Cycle 5 Day 1: Pre-dose
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.5242
        value
        2.603
    denoms
    1. counts
      1. group Id
        OG000
        value
        260
      units
      Participants
    title
    Cycle 6 Day 1: Pre-dose
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.4658
        value
        2.598
    denoms
    1. counts
      1. group Id
        OG000
        value
        258
      units
      Participants
    title
    Cycle 7 Day 1: Pre-dose
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.5549
        value
        2.539
    denoms
    1. counts
      1. group Id
        OG000
        value
        251
      units
      Participants
    title
    Cycle 8 Day 1: Pre-dose
denoms
  1. counts
    1. group Id
      OG000
      value
      331
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Participants who were randomly assigned to receive Ixazomib 4.0 mg capsules orally once on Days 1,8,15 and lenalidomide 25 mg capsules orally on days 1-21 and dexamethasone 40 mg tablets orally on Days 1,8, 15 and 22, during every 28-day cycle for the first 18 cycles. After Cycle 18 dexamethasone was discontinued and participants continued to receive ixazomib capsule and lenalidomide at reduced doses until progressive disease or unacceptable toxicity, whichever comes first, up to end of study (up to approximately 109 months).
    id
    OG000
    title
    Ixazomib
param Type
MEAN
population Description
Pharmacokinetic (PK) analysis population is defined as subjects with at least one PK sample that was collected and analyzed. Overall number of participants analyzed is the number of participants available for analyses. Number analyzed indicates the number of participants available for analysis at the given timepoint.
reporting Status
POSTED
time Frame
Cycle 1 Day 1: Post-dose at multiple timepoints up to 4 hours; Pre-dose at Cycle 1 Day 14, Cycles 2-3 Day 1 and Day 14, Cycles 4-11 Day 1 (Each cycle length = 28 days)
title
Cmax: Maximum Plasma Concentration for Ixazomib
type
SECONDARY
unit Of Measure
nanograms per milliliter

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice