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NCT01292486 · OUTCOME

Mononuclear Cel (MNC) Collection Efficiency

Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure · Source last updated 2013-05-01

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

Measure
MEDIAN
Unit
% of processed MNCs that were collected
Interval / dispersion
Full Range
Time frame
up to 7 days

What was measured

Collection efficiency (CE) is defined as the percentage of any given cellular subset, processed by the system, that is collected from the subject. Determination of collection efficiency depends on an estimate of the average concentration of target cells in the patient's blood. Because these cells are continuously being removed during the collection, and are undergoing variable replacement from the bone marrow, this estimate will not be completely accurate. Underestimation of the concentration of target cells processed can lead to collection efficiencies of greater than 100%.

Analysis population: Data was available to calculate MNC collection efficiency on 35 collections performed on 22 of the 26 per protocol patients.

Groups in this outcome

All Per Protocol Patients

Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.

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 Per Protocol Patients22

Analysis denominator · MNC collections

GroupSource count
All Per Protocol Patients35

Reported measurements

Source class 1
Values in % of processed MNCs that were collected · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
All Per Protocol Patients60Not reported35115Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        35
        upper Limit
        115
        value
        60
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      35
    units
    MNC collections
description
Collection efficiency (CE) is defined as the percentage of any given cellular subset, processed by the system, that is collected from the subject. Determination of collection efficiency depends on an estimate of the average concentration of target cells in the patient's blood. Because these cells are continuously being removed during the collection, and are undergoing variable replacement from the bone marrow, this estimate will not be completely accurate. Underestimation of the concentration of target cells processed can lead to collection efficiencies of greater than 100%.
dispersion Type
Full Range
groups
  1. description
    Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
    id
    OG000
    title
    All Per Protocol Patients
param Type
MEDIAN
population Description
Data was available to calculate MNC collection efficiency on 35 collections performed on 22 of the 26 per protocol patients.
reporting Status
POSTED
time Frame
up to 7 days
title
Mononuclear Cel (MNC) Collection Efficiency
type
SECONDARY
type Units Analyzed
MNC collections
unit Of Measure
% of processed MNCs that were collected

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

Preserved source evidence · Not medical advice