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NCT00396331 · OUTCOME

Number of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Collected During Both Courses of Treatment With Plerixafor and G-CSF

AMD3100 (Plerixafor) With G-CSF in Poor Mobilizing Adult Patients Who Previously Failed Hematopoietic Stem Cell (HSC) Collection/Attempts · 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
Day 5 up to Month 6 (up to 7 aphereses in each course of treatment)

What was measured

Number of participants who had at least 2\*10\^6 CD34+ cells/kg collected by apheresis during both the first and the second courses of treatment together.

Analysis population: Participants who received one course or two courses of plerixafor. Four NHL participants and 3 HD participants had two courses of plerixafor and the sum of CD34+ cells/kg collected in both courses is included.

Groups in this outcome

Non-Hodgkin's Lymphoma

Participants with non-Hodgkin's lymphoma (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 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.

Hodgkin's Disease

Participants with Hodgkin's disease (HD) 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 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.

Multiple Myeloma

Participants with multiple myeloma (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 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.

Other Cancers

Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) 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 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.

All Patients

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 Lymphoma66
Hodgkin's Disease21
Multiple Myeloma10
Other Cancers3
All Patients100

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Non-Hodgkin's Lymphoma54Not reportedNot reportedNot reportedNot reported
Hodgkin's Disease18Not reportedNot reportedNot reportedNot reported
Multiple Myeloma10Not reportedNot reportedNot reportedNot reported
Other Cancers2Not reportedNot reportedNot reportedNot reported
All Patients84Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        54
      2. group Id
        OG001
        value
        18
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        84
denoms
  1. counts
    1. group Id
      OG000
      value
      66
    2. group Id
      OG001
      value
      21
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      100
    units
    Participants
description
Number of participants who had at least 2\*10\^6 CD34+ cells/kg collected by apheresis during both the first and the second courses of treatment together.
groups
  1. description
    Participants with non-Hodgkin's lymphoma (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 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.
    id
    OG000
    title
    Non-Hodgkin's Lymphoma
  2. description
    Participants with Hodgkin's disease (HD) 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 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.
    id
    OG001
    title
    Hodgkin's Disease
  3. description
    Participants with multiple myeloma (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 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.
    id
    OG002
    title
    Multiple Myeloma
  4. description
    Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) 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 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.
    id
    OG003
    title
    Other Cancers
  5. id
    OG004
    title
    All Patients
param Type
NUMBER
population Description
Participants who received one course or two courses of plerixafor. Four NHL participants and 3 HD participants had two courses of plerixafor and the sum of CD34+ cells/kg collected in both courses is included.
reporting Status
POSTED
time Frame
Day 5 up to Month 6 (up to 7 aphereses in each course of treatment)
title
Number of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Collected During Both Courses of Treatment With Plerixafor and G-CSF
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice