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NCT01177683 · FLOW

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Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma · Source last updated 2023-10-06

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

groups
  1. description
    Bendamustine: At Phase I level I, Bendamustine will be administered at 90 mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Filgrastim (if defined in MTD) will be administered at 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC \>1000. Doxorubicin: Pegylated liposomal doxorubicin at phase I will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase I will be administered at 1.3 mg/m2 by IV bolus on days 1, 4, 8, and 11 of the 28 day cycle.
    id
    FG000
    title
    Phase I Level 1 : Bendamustine at 90mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.
  2. description
    Bendamustine: At Phase I level 2, Bendamustine will be administered at 120 mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Filgrastim (if defined in MTD) will be administered at 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC \>1000. Doxorubicin: Pegylated liposomal doxorubicin at phase I will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase I will be administered at 1.3 mg/m2 by IV bolus on days 1, 4, 8, and 11 of the 28 day cycle.
    id
    FG001
    title
    Phase I Level 2 : Bendamustine at 120mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.
  3. description
    Bendamustine: At phase II, Bendamustine will be administered at 90mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Doxorubicin: Pegylated liposomal doxorubicin at phase II will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase II will be administered at 1.3 mg/m2 by IV bolus or SQ injection on days 1, 4, 8, and 11 of the 28 day cycle.
    id
    FG002
    title
    Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Disease Progressions during treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        12
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      Patient Withdrawal After Therapy Start
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      type
      Alternative therapy
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Patient withdrawal before therapy start
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Symptomatic Deterioration
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Subject came off study without receiving any treatment.
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        26
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Study Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Patient lost to follow up
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        7
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        15
      type
      Study closed by Sponsor due slow enrollment.
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Follow up
Complete source fields
groups
  1. description
    Bendamustine: At Phase I level I, Bendamustine will be administered at 90 mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Filgrastim (if defined in MTD) will be administered at 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC \>1000. Doxorubicin: Pegylated liposomal doxorubicin at phase I will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase I will be administered at 1.3 mg/m2 by IV bolus on days 1, 4, 8, and 11 of the 28 day cycle.
    id
    FG000
    title
    Phase I Level 1 : Bendamustine at 90mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.
  2. description
    Bendamustine: At Phase I level 2, Bendamustine will be administered at 120 mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Filgrastim (if defined in MTD) will be administered at 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC \>1000. Doxorubicin: Pegylated liposomal doxorubicin at phase I will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase I will be administered at 1.3 mg/m2 by IV bolus on days 1, 4, 8, and 11 of the 28 day cycle.
    id
    FG001
    title
    Phase I Level 2 : Bendamustine at 120mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.
  3. description
    Bendamustine: At phase II, Bendamustine will be administered at 90mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Doxorubicin: Pegylated liposomal doxorubicin at phase II will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase II will be administered at 1.3 mg/m2 by IV bolus or SQ injection on days 1, 4, 8, and 11 of the 28 day cycle.
    id
    FG002
    title
    Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Disease Progressions during treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        12
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      Patient Withdrawal After Therapy Start
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      type
      Alternative therapy
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Patient withdrawal before therapy start
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Symptomatic Deterioration
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Subject came off study without receiving any treatment.
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        26
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Study Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Patient lost to follow up
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        7
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        15
      type
      Study closed by Sponsor due slow enrollment.
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Follow up

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

Preserved source evidence · Not medical advice