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NCT00322842 · OUTCOME

Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant

Treatment With AMD3100 (Plerixafor) 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
number of transplants
Interval / dispersion
Not reported
Time frame
2 months

What was measured

Participants were monitored for platelet (PLT) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.

Analysis population: Participants who had transplants. Fifteen participants had tandem transplants.

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)3
Multiple Myeloma (MM)30
All Participants33

Analysis denominator · transplants

GroupSource count
Non-Hodgkin's Lymphoma (NHL)3
Multiple Myeloma (MM)45
All Participants48

Reported measurements

≤ Day 12
Values in number of transplants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Non-Hodgkin's Lymphoma (NHL)0Not reportedNot reportedNot reportedNot reported
Multiple Myeloma (MM)32Not reportedNot reportedNot reportedNot reported
All Participants32Not reportedNot reportedNot reportedNot reported
Day 13 to Day 21
Values in number of transplants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Non-Hodgkin's Lymphoma (NHL)2Not reportedNot reportedNot reportedNot reported
Multiple Myeloma (MM)13Not reportedNot reportedNot reportedNot reported
All Participants15Not reportedNot reportedNot reportedNot reported
≥ Day 22
Values in number of transplants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Non-Hodgkin's Lymphoma (NHL)1Not reportedNot reportedNot reportedNot reported
Multiple Myeloma (MM)0Not reportedNot reportedNot reportedNot reported
All Participants1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        32
      3. group Id
        OG002
        value
        32
    title
    ≤ Day 12
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        15
    title
    Day 13 to Day 21
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    ≥ Day 22
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      30
    3. group Id
      OG002
      value
      33
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      45
    3. group Id
      OG002
      value
      48
    units
    transplants
description
Participants were monitored for platelet (PLT) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.
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
Participants who had transplants. Fifteen participants had tandem transplants.
reporting Status
POSTED
time Frame
2 months
title
Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant
type
OTHER_PRE_SPECIFIED
type Units Analyzed
transplants
unit Of Measure
number of transplants

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Preserved source evidence · Not medical advice