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NCT01899326 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      6
    units
    Participants
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, aperheris was stopped and the patient was taken off study. Despiramine hydrochloride: PO Filgrastim: PO
    id
    BG000
    title
    Treatment (Desipramine, Filgrastim)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          58
          upper Limit
          70
          value
          59.5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Age range of the 6 patients who completed the study.
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Gender of the 6 patients who completed the study.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      United States
    param Type
    NUMBER
    population Description
    Region of enrollment of the 6 patients who completed the study.
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        No
    description
    Number of patients who had received Lenalidomide prior to the trial.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Number of patients who had received Lenalidomide prior to the trial who completed the study.
    title
    Prior Lenalidomide therapy
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      One prior chemotherapy treatment
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      >1 prior chemotherapy treatment
    description
    Number of prior chemotherapy treatments.
    param Type
    NUMBER
    population Description
    Number of prior chemotherapy treatments for the study participants who completed the trial.
    title
    Prior chemotherapies
    unit Of Measure
    participants
population Description
The respective baseline measures were provided for the 6 participants who completed the protocol.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    units
    Participants
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, aperheris was stopped and the patient was taken off study. Despiramine hydrochloride: PO Filgrastim: PO
    id
    BG000
    title
    Treatment (Desipramine, Filgrastim)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          58
          upper Limit
          70
          value
          59.5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Age range of the 6 patients who completed the study.
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Gender of the 6 patients who completed the study.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      United States
    param Type
    NUMBER
    population Description
    Region of enrollment of the 6 patients who completed the study.
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        No
    description
    Number of patients who had received Lenalidomide prior to the trial.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Number of patients who had received Lenalidomide prior to the trial who completed the study.
    title
    Prior Lenalidomide therapy
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      One prior chemotherapy treatment
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      >1 prior chemotherapy treatment
    description
    Number of prior chemotherapy treatments.
    param Type
    NUMBER
    population Description
    Number of prior chemotherapy treatments for the study participants who completed the trial.
    title
    Prior chemotherapies
    unit Of Measure
    participants
population Description
The respective baseline measures were provided for the 6 participants who completed the protocol.

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Preserved source evidence · Not medical advice