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NCT03029234 · OUTCOME

Systemic Clearance (CL) of Carfilzomib After Intravenous Infusion

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
L/hr
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

Systemic clearance is a measure of the ability of the body to eliminate drug, expressed in units of volume per time.

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 L/hr · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib With Dexamethasone15761.4Not reportedNot reportedNot reported
Cycle 2 Day 1 (27 mg/m²)

Analysis denominator · Participants

GroupSource count
Carfilzomib With Dexamethasone19
Values in L/hr · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib With Dexamethasone153112Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        61.4
        value
        157
    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
        112
        value
        153
    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
Systemic clearance is a measure of the ability of the body to eliminate drug, expressed in units of volume per time.
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
Systemic Clearance (CL) of Carfilzomib After Intravenous Infusion
type
SECONDARY
unit Of Measure
L/hr

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

Preserved source evidence · Not medical advice