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NCT01899326 · OUTCOME

Incidence of Adverse Events

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
NUMBER
Unit
Adverse Events
Interval / dispersion
Not reported
Time frame
Up to 1 week following completion of study treatment, up to 15 days

What was measured

Incidence of adverse events up to 1 week following completion of study treatment. Adverse events were graded using Version 4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).

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 Adverse Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Desipramine, Filgrastim)9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Incidence of adverse events up to 1 week following completion of study treatment. Adverse events were graded using Version 4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
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
NUMBER
population Description
6 participants underwent stem cell transplantation and completed the full study protocol.
reporting Status
POSTED
time Frame
Up to 1 week following completion of study treatment, up to 15 days
title
Incidence of Adverse Events
type
SECONDARY
unit Of Measure
Adverse Events

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

Preserved source evidence · Not medical advice