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NCT02098109 · OUTCOME

Comparison of the Time to Neutrophil Engraftment Between the Two Arms

Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) in Combination With Plerixafor for Autologous Stem Cell Mobilization in Patients With Multiple Myeloma or Non-Hodgkin Lymphoma · Source last updated 2017-07-18

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

Measure
MEDIAN
Unit
days
Interval / dispersion
95% Confidence Interval
Time frame
Up to Day 30 post-infusion

What was measured

Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/µl following conditioning regimen-induced nadir. Patients who do not have neutrophil engraftment by Day 30 post-infusion of mobilized PBSC product will be considered a neutrophil engraftment failure.

Analysis population: (2) participants in the XM02 Filgrastim (Granix) \& Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure. (1) participant in the Filgrastim (Neupogen) \& Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure.

Groups in this outcome

XM02 Filgrastim (Granix) and Plerixafor

XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)

Filgrastim (Neupogen) and Plerixafor

Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)

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

Analysis denominator · Participants

GroupSource count
XM02 Filgrastim (Granix) and Plerixafor44
Filgrastim (Neupogen) and Plerixafor50

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
XM02 Filgrastim (Granix) and Plerixafor11Not reported1112Not reported
Filgrastim (Neupogen) and Plerixafor11.5Not reported1112Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11
        upper Limit
        12
        value
        11
      2. group Id
        OG001
        lower Limit
        11
        upper Limit
        12
        value
        11.5
denoms
  1. counts
    1. group Id
      OG000
      value
      44
    2. group Id
      OG001
      value
      50
    units
    Participants
description
Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/µl following conditioning regimen-induced nadir. Patients who do not have neutrophil engraftment by Day 30 post-infusion of mobilized PBSC product will be considered a neutrophil engraftment failure.
dispersion Type
95% Confidence Interval
groups
  1. description
    XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
    id
    OG000
    title
    XM02 Filgrastim (Granix) and Plerixafor
  2. description
    Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
    id
    OG001
    title
    Filgrastim (Neupogen) and Plerixafor
param Type
MEDIAN
population Description
(2) participants in the XM02 Filgrastim (Granix) \& Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure. (1) participant in the Filgrastim (Neupogen) \& Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Up to Day 30 post-infusion
title
Comparison of the Time to Neutrophil Engraftment Between the Two Arms
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice