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NCT01899326 · OUTCOME

Success Rate of Stem Cell Mobilization (SCM) in Participants Who Completed Filgrastim and Desipramine Therapy

Desipramine Hydrochloride and Filgrastim For Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant · Source last updated 2023-03-28

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
Day 5

What was measured

Success rate was assessed as the number of participants with Multiple Myeloma (MM) who were first time mobilizers or unexposed to alkylating agents who completed the full course of filgrastim and desipramine and achieved the target collection of \>=5 x 10\^6 CD34+ cells/kg.

Analysis population: 6 participants underwent stem cell transplantation and completed the full study protocol.

Groups in this outcome

Treatment (Desipramine, Filgrastim)

Patients received 100mg desipramine hydrochloride PO daily from Day -3 to Day +4 (8 days total) and filgrastim PO BID from Day +1 to Day +4. Complete blood count (CBC) and peripheral blood CD34+ counts were determined on Day +4 and Day +5. Leukapheresis was started when peripheral blood CD34+ count exceeded 10/uL. If CD34+ counts were \<10/uL on Day +5, plerixafor was added as a salvage therapy. Daily leukapheresis was performed with four times the estimated blood volume during each collection until a target cell dose of at least 5x10\^6 cells/kg was reached. If the collected CD34+ cell dose was \<0.5x10\^6 on two consecutive days, apheresis was stopped and the patient was taken off study. Despiramine hydrochloride: PO Filgrastim: PO

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 (Desipramine, Filgrastim)6

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Desipramine, Filgrastim)6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Success rate was assessed as the number of participants with Multiple Myeloma (MM) who were first time mobilizers or unexposed to alkylating agents who completed the full course of filgrastim and desipramine and achieved the target collection of \>=5 x 10\^6 CD34+ cells/kg.
groups
  1. description
    Patients received 100mg desipramine hydrochloride PO daily from Day -3 to Day +4 (8 days total) and filgrastim PO BID from Day +1 to Day +4. Complete blood count (CBC) and peripheral blood CD34+ counts were determined on Day +4 and Day +5. Leukapheresis was started when peripheral blood CD34+ count exceeded 10/uL. If CD34+ counts were \<10/uL on Day +5, plerixafor was added as a salvage therapy. Daily leukapheresis was performed with four times the estimated blood volume during each collection until a target cell dose of at least 5x10\^6 cells/kg was reached. If the collected CD34+ cell dose was \<0.5x10\^6 on two consecutive days, apheresis was stopped and the patient was taken off study. Despiramine hydrochloride: PO Filgrastim: PO
    id
    OG000
    title
    Treatment (Desipramine, Filgrastim)
param Type
COUNT_OF_PARTICIPANTS
population Description
6 participants underwent stem cell transplantation and completed the full study protocol.
reporting Status
POSTED
time Frame
Day 5
title
Success Rate of Stem Cell Mobilization (SCM) in Participants Who Completed Filgrastim and Desipramine Therapy
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice