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NCT02703779 · OUTCOME

Multiparametric Flow Cytometry - Cluster of Differentiation 34 (CD34)Assessment

Exploratory Trial to Estimate Proportion of Patients With Tumor Cell Contaminated Leukapheresis Products With and Without Bortezomib With In-vivo Purging - Multiple Myeloma (MM) · Source last updated 2021-06-18

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Within the first 30 days after stem cell collection

What was measured

Estimate the proportion of subjects who have a successful collection of stem cells (\> 2 million Cluster of Differentiation 34 (CD34) cells/Kg of body weight) for autologous transplant in both treatment groups.

Groups in this outcome

Stem Cell Collection Without In-vivo Purging With Bortezomib

Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed). NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.

Stem Cell Collection With In-vivo Purging With Bortezomib

Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed. There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection. Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.

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

Analysis denominator · Participants

GroupSource count
Stem Cell Collection Without In-vivo Purging With Bortezomib51
Stem Cell Collection With In-vivo Purging With Bortezomib50

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stem Cell Collection Without In-vivo Purging With Bortezomib51Not reportedNot reportedNot reportedNot reported
Stem Cell Collection With In-vivo Purging With Bortezomib50Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        51
      2. group Id
        OG001
        value
        50
denoms
  1. counts
    1. group Id
      OG000
      value
      51
    2. group Id
      OG001
      value
      50
    units
    Participants
description
Estimate the proportion of subjects who have a successful collection of stem cells (\> 2 million Cluster of Differentiation 34 (CD34) cells/Kg of body weight) for autologous transplant in both treatment groups.
groups
  1. description
    Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed). NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.
    id
    OG000
    title
    Stem Cell Collection Without In-vivo Purging With Bortezomib
  2. description
    Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed. There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection. Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.
    id
    OG001
    title
    Stem Cell Collection With In-vivo Purging With Bortezomib
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Within the first 30 days after stem cell collection
title
Multiparametric Flow Cytometry - Cluster of Differentiation 34 (CD34)Assessment
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice