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NCT00396266 · OUTCOME

Single-dose Maximum Observed Concentration of Plerixafor (Cmax)

AMD3100 (Plerixafor) Given to NHL and MM Patients to Increase the Number of PBSCs When Given a Mobilizing Regimen of G-CSF · Source last updated 2014-03-07

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

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Day 5 - 0 to 10 hours post-first plerixafor dose.

What was measured

Evaluation of Cmax following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Cmax was determined from direct observation of the data.

Analysis population: Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).

Groups in this outcome

PK Subgroup

Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.

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

Analysis denominator · Participants

GroupSource count
PK Subgroup13

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
PK Subgroup926237Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        237
        value
        926
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Evaluation of Cmax following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Cmax was determined from direct observation of the data.
dispersion Type
Standard Deviation
groups
  1. description
    Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
    id
    OG000
    title
    PK Subgroup
param Type
MEAN
population Description
Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).
reporting Status
POSTED
time Frame
Day 5 - 0 to 10 hours post-first plerixafor dose.
title
Single-dose Maximum Observed Concentration of Plerixafor (Cmax)
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice