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NCT00322491 · OUTCOME

Number of Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor

Mobilization of Stem Cells With AMD3100 (Plerixafor) and G-CSF in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients · Source last updated 2014-03-13

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Days 4-5 (first dose of plerixafor to apheresis)

What was measured

The number of participants mobilized with G-CSF + plerixafor injection who have a ≥ 2-fold increase in CD34+ cells. Fold increase was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL) / (pre-plerixafor dosing PB CD34+ cells/µL)

Analysis population: The intent-to-treat population (defined as participants who received at least 1 dose of plerixafor).

Groups in this outcome

Non-Hodgkin's Lymphoma (NHL)

Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

Multiple Myeloma (MM)

Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

All Participants

Not reported

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

Analysis denominator · Participants

GroupSource count
Non-Hodgkin's Lymphoma (NHL)23
Multiple Myeloma (MM)26
All Participants49

Reported measurements

≥ 2-fold Increase
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Non-Hodgkin's Lymphoma (NHL)20Not reportedNot reportedNot reportedNot reported
Multiple Myeloma (MM)17Not reportedNot reportedNot reportedNot reported
All Participants37Not reportedNot reportedNot reportedNot reported
< 2-fold Increase
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Non-Hodgkin's Lymphoma (NHL)3Not reportedNot reportedNot reportedNot reported
Multiple Myeloma (MM)9Not reportedNot reportedNot reportedNot reported
All Participants12Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        17
      3. group Id
        OG002
        value
        37
    title
    ≥ 2-fold Increase
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        12
    title
    < 2-fold Increase
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      26
    3. group Id
      OG002
      value
      49
    units
    Participants
description
The number of participants mobilized with G-CSF + plerixafor injection who have a ≥ 2-fold increase in CD34+ cells. Fold increase was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL) / (pre-plerixafor dosing PB CD34+ cells/µL)
groups
  1. description
    Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
    id
    OG000
    title
    Non-Hodgkin's Lymphoma (NHL)
  2. description
    Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
    id
    OG001
    title
    Multiple Myeloma (MM)
  3. id
    OG002
    title
    All Participants
param Type
NUMBER
population Description
The intent-to-treat population (defined as participants who received at least 1 dose of plerixafor).
reporting Status
POSTED
time Frame
Days 4-5 (first dose of plerixafor to apheresis)
title
Number of Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice