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NCT01547806 · OUTCOME

Number of Hematopoietic Progenitor Cell (HPC) Apheresis Products Collected and Cryopreserved for Subsequent Use in Autologous Hematopoietic Cell Transplantation (AHCT) in Subjects With Plasma Cell Myeloma (PCM)

Collection of Transplant Stem Cells for Plasma Cell Myeloma · Source last updated 2018-03-07

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

Measure
NUMBER
Unit
products
Interval / dispersion
Not reported
Time frame
Indefinitely until a referring physician requests the product for standard clinical care or until product(s) is no longer needed and disposed of

What was measured

The cryopreserved stem cells are stored under Good Manufacturing Practice (GMP) conditions in the National Institutes of Health (NIH) Department of Transfusion Medicine until a referring physician requests the products for standard clinical care.

Groups in this outcome

Hematopoietic Progenitor Cells (HPC)

Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols. Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10\^6 CD34+ cells/kg.

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

Analysis denominator · Participants

GroupSource count
Hematopoietic Progenitor Cells (HPC)49

Reported measurements

Source class 1
Values in products · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematopoietic Progenitor Cells (HPC)49Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        49
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    units
    Participants
description
The cryopreserved stem cells are stored under Good Manufacturing Practice (GMP) conditions in the National Institutes of Health (NIH) Department of Transfusion Medicine until a referring physician requests the products for standard clinical care.
groups
  1. description
    Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols. Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10\^6 CD34+ cells/kg.
    id
    OG000
    title
    Hematopoietic Progenitor Cells (HPC)
param Type
NUMBER
reporting Status
POSTED
time Frame
Indefinitely until a referring physician requests the product for standard clinical care or until product(s) is no longer needed and disposed of
title
Number of Hematopoietic Progenitor Cell (HPC) Apheresis Products Collected and Cryopreserved for Subsequent Use in Autologous Hematopoietic Cell Transplantation (AHCT) in Subjects With Plasma Cell Myeloma (PCM)
type
PRIMARY
unit Of Measure
products

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

Preserved source evidence · Not medical advice