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NCT01110135 · OUTCOME

Successful Mobilization and Collection of PBSCs

Bendamustine Hydrochloride, Etoposide, Dexamethasone, and Filgrastim For Peripheral Blood Stem Cell Mobilization in Treating Patients With Refractory or Recurrent Lymphoma or Multiple Myeloma · Source last updated 2017-05-24

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 7 days of apheresis and within 6 weeks of receiving bendamustine hydrochloride

What was measured

Count of participants with successful mobilization and collection of PBSCs. Defined as collection of \> 2 x 10\^6 CD34/kg. The current study will be deemed to be potentially efficacious if the observed rate of success is at least 80%.

Groups in this outcome

Treatment (Chemotherapy and Colony-stimulating Factor)

Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until \> 5 x 10\^6 CD34+/kg has been collected. . bendamustine hydrochloride: Given IV dexamethasone: Given PO filgrastim: Given SC leukapheresis: Given IV laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies etoposide: Given IV

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

Analysis denominator · Participants

GroupSource count
Treatment (Chemotherapy and Colony-stimulating Factor)34

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy and Colony-stimulating Factor)34Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        34
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    units
    Participants
description
Count of participants with successful mobilization and collection of PBSCs. Defined as collection of \> 2 x 10\^6 CD34/kg. The current study will be deemed to be potentially efficacious if the observed rate of success is at least 80%.
groups
  1. description
    Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until \> 5 x 10\^6 CD34+/kg has been collected. . bendamustine hydrochloride: Given IV dexamethasone: Given PO filgrastim: Given SC leukapheresis: Given IV laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies etoposide: Given IV
    id
    OG000
    title
    Treatment (Chemotherapy and Colony-stimulating Factor)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Within 7 days of apheresis and within 6 weeks of receiving bendamustine hydrochloride
title
Successful Mobilization and Collection of PBSCs
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice