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NCT00395967 · OUTCOME

Number of Patients Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor 240 µg/kg and G-CSF for up to 3 Consecutive Days

AMD3100 (Plerixafor) in Multiple Myeloma (MM) or Non-Hodgkin's Lymphoma (NHL) Patients Predicted to be Unable to Mobilize With G-CSF Alone · Source last updated 2015-05-01

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
approximately days 6-9

What was measured

The number of patients with a circulating CD34+ count \>= 5 and \< 20 cells/ml after 5 days of mobilization with G-CSF alone who achieved cumulative apheresis yields of ≥2\*10\^6 CD34+ cells/kg within 3 days of apheresis after receiving G-CSF plus plerixafor. Outcome was based on laboratory results from a central lab.

Analysis population: All patients who received plerixafor.

Groups in this outcome

All Patients

Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.

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

Analysis denominator · Participants

GroupSource count
All Patients5

Reported measurements

Participants with ≥2*10^6 CD34+ cells/kg
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients3Not reportedNot reportedNot reportedNot reported
Participants with <2*10^6 CD34+ cells/kg
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Participants with ≥2*10^6 CD34+ cells/kg
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Participants with <2*10^6 CD34+ cells/kg
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
The number of patients with a circulating CD34+ count \>= 5 and \< 20 cells/ml after 5 days of mobilization with G-CSF alone who achieved cumulative apheresis yields of ≥2\*10\^6 CD34+ cells/kg within 3 days of apheresis after receiving G-CSF plus plerixafor. Outcome was based on laboratory results from a central lab.
groups
  1. description
    Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
    id
    OG000
    title
    All Patients
param Type
NUMBER
population Description
All patients who received plerixafor.
reporting Status
POSTED
time Frame
approximately days 6-9
title
Number of Patients Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor 240 µg/kg and G-CSF for up to 3 Consecutive Days
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice