NCT00396266 · OUTCOME

Single-dose Apparent Volume of Distribution of Plerixafor (Vz/F) in NHL and MM Patients

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

What was measured

Evaluation of Vz/F following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Vz/F was determined from non-compartmental analysis.

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

Group	Source count
PK Subgroup	13

Reported measurements

Source class 1

Values in mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
PK Subgroup	33668	10531	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
10531
value
33668

denoms

counts
group Id
OG000
value
13
units
Participants

description

Evaluation of Vz/F following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Vz/F was determined from non-compartmental analysis.

dispersion Type

Standard Deviation

groups

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 Apparent Volume of Distribution of Plerixafor (Vz/F) in NHL and MM Patients

type

SECONDARY

unit Of Measure

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

Preserved source evidence · Not medical advice