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NCT03029234 · OUTCOME

Area Under the Plasma Concentration Curve From Time 0 Extrapolated to Infinity (AUC0-inf) for Carfilzomib

Carfilzomib in Combination With Dexamethasone (Kd) in Chinese Patients With Relapsed & Refractory Multiple Myeloma · Source last updated 2022-05-25

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

Measure
MEAN
Unit
hr*ng/mL
Interval / dispersion
Standard Deviation
Time frame
Cycles 1 and 2, day 1 at predose, 5 minutes after the start of carfilzomib infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of infusion.

What was measured

AUC0-inf of carfilzomib is the total area under the concentration-time curve beginning from time 0 extrapolated to infinity following carfilzomib dosing.

Analysis population: Pharmacokinetic analyses were conducted on a subset of participants at selected sites. Results are reported for participants in the PK analysis population with available data at each time point. PK profiles with a coefficient of determination (R²; goodness of fit) \< 0.8 or percent extrapolated AUC \> 20% were excluded from the analysis.

Groups in this outcome

Carfilzomib With Dexamethasone

Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 20 mg dexamethasone IV or orally on days 1, 2, 8, 9, 15, 16, 22, and 23. Participants received treatment until disease progression, unacceptable toxicity, initiation of new antimyeloma therapy, withdrawal of consent, subject noncompliance, or intercurrent illness or worsening of a chronic condition, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Carfilzomib With Dexamethasone23

Reported measurements

Cycle 1 Day 1 (20 mg/m²)

Analysis denominator · Participants

GroupSource count
Carfilzomib With Dexamethasone23
Values in hr*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib With Dexamethasone256104Not reportedNot reportedNot reported
Cycle 2 Day 1 (27 mg/m²)

Analysis denominator · Participants

GroupSource count
Carfilzomib With Dexamethasone19
Values in hr*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib With Dexamethasone401173Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        104
        value
        256
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      units
      Participants
    title
    Cycle 1 Day 1 (20 mg/m²)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        173
        value
        401
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      units
      Participants
    title
    Cycle 2 Day 1 (27 mg/m²)
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    units
    Participants
description
AUC0-inf of carfilzomib is the total area under the concentration-time curve beginning from time 0 extrapolated to infinity following carfilzomib dosing.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 20 mg dexamethasone IV or orally on days 1, 2, 8, 9, 15, 16, 22, and 23. Participants received treatment until disease progression, unacceptable toxicity, initiation of new antimyeloma therapy, withdrawal of consent, subject noncompliance, or intercurrent illness or worsening of a chronic condition, whichever occurred first.
    id
    OG000
    title
    Carfilzomib With Dexamethasone
param Type
MEAN
population Description
Pharmacokinetic analyses were conducted on a subset of participants at selected sites. Results are reported for participants in the PK analysis population with available data at each time point. PK profiles with a coefficient of determination (R²; goodness of fit) \< 0.8 or percent extrapolated AUC \> 20% were excluded from the analysis.
reporting Status
POSTED
time Frame
Cycles 1 and 2, day 1 at predose, 5 minutes after the start of carfilzomib infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of infusion.
title
Area Under the Plasma Concentration Curve From Time 0 Extrapolated to Infinity (AUC0-inf) for Carfilzomib
type
SECONDARY
unit Of Measure
hr*ng/mL

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Preserved source evidence · Not medical advice