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NCT03029234 · OUTCOME

Mean Residence Time Observed From Time Zero to the Last Quantifiable Concentration (MRTlast) 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
hours
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

MRTlast is the mean residence time observed from time 0 until the time of the last quantifiable concentration.

Analysis population: PK analyses were conducted on a subset of participants at selected sites. Results are reported for the participants in PK analysis population with available data at each time point. PK profiles with a coefficient of determination \< 0.8, percent extrapolated AUC \> 20%, or negative values for MRT 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 hours · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib With Dexamethasone0.2250.0856Not reportedNot reportedNot reported
Cycle 2 Day 1 (27 mg/m²)

Analysis denominator · Participants

GroupSource count
Carfilzomib With Dexamethasone19
Values in hours · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib With Dexamethasone0.1960.0975Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0856
        value
        0.225
    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
        0.0975
        value
        0.196
    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
MRTlast is the mean residence time observed from time 0 until the time of the last quantifiable concentration.
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
PK analyses were conducted on a subset of participants at selected sites. Results are reported for the participants in PK analysis population with available data at each time point. PK profiles with a coefficient of determination \< 0.8, percent extrapolated AUC \> 20%, or negative values for MRT 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
Mean Residence Time Observed From Time Zero to the Last Quantifiable Concentration (MRTlast) for Carfilzomib
type
SECONDARY
unit Of Measure
hours

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice