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NCT00396266 · OUTCOME

Maximum Fold Increase in Peripheral Blood CD34+ Cells From Baseline Following Initial Administration of Plerixafor

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
MEDIAN
Unit
ratio
Interval / dispersion
Full Range
Time frame
Day 4 (10 hours post first plerixafor dose)

What was measured

A pharmacodynamic evaluation to determine the maximum fold increase in peripheral blood CD34+ cells following the initial administration of plerixafor by measuring the fold increase at time points up to 10 hours post plerixafor relative to baseline (immediately prior to plerixafor).

Analysis population: Pharmacodynamic analysis was performed on a subgroup of participants from both treatment arms (1 NHL and 3 MM). The maximum fold increase was observed at 10 hours for all participants.

Groups in this outcome

PD Subgroup

Subgroup of 4 patients (3 MM and 1 NHL) for which a pharmacodynamic (PD) 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
PD Subgroup4

Reported measurements

Source class 1
Values in ratio · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
PD Subgroup4.2Not reported3.05.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.0
        upper Limit
        5.5
        value
        4.2
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
description
A pharmacodynamic evaluation to determine the maximum fold increase in peripheral blood CD34+ cells following the initial administration of plerixafor by measuring the fold increase at time points up to 10 hours post plerixafor relative to baseline (immediately prior to plerixafor).
dispersion Type
Full Range
groups
  1. description
    Subgroup of 4 patients (3 MM and 1 NHL) for which a pharmacodynamic (PD) 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
    PD Subgroup
param Type
MEDIAN
population Description
Pharmacodynamic analysis was performed on a subgroup of participants from both treatment arms (1 NHL and 3 MM). The maximum fold increase was observed at 10 hours for all participants.
reporting Status
POSTED
time Frame
Day 4 (10 hours post first plerixafor dose)
title
Maximum Fold Increase in Peripheral Blood CD34+ Cells From Baseline Following Initial Administration of Plerixafor
type
SECONDARY
unit Of Measure
ratio

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

Preserved source evidence · Not medical advice