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NCT00911859 · FLOW

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A Study to Compare CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone (VMP) With VMP Alone in Previously Untreated Multiple Myeloma Patients · Source last updated 2014-11-18

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

groups
  1. description
    Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
    id
    FG000
    title
    Part 1: VMP + Siltuximab
  2. description
    Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
    id
    FG001
    title
    Part 2: VMP
  3. description
    Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
    id
    FG002
    title
    Part 2: VMP + Siltuximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        7
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        5
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        5
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        5
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Did not receive study treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        54
      3. group Id
        FG002
        num Subjects
        52
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        53
      3. group Id
        FG002
        num Subjects
        52
      type
      Received Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        33
      3. group Id
        FG002
        num Subjects
        27
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        21
      3. group Id
        FG002
        num Subjects
        25
      type
      NOT COMPLETED
    title
    Treatment Period
  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
        9
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        9
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. comment
        Participants who received siltuximab only during the 18-month maintenance period
        group Id
        FG002
        num Subjects
        21
      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
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        21
      type
      NOT COMPLETED
    title
    Maintainance Period
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        10
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        33
      3. group Id
        FG002
        num Subjects
        27
      type
      Study terminated by sponsor
    milestones
    1. achievements
      1. comment
        Participants followed until death or 3.5 years after the last participant was assigned to treatment
        group Id
        FG000
        num Subjects
        12
      2. comment
        Participants followed until death or 3.5 years after the last participant was assigned to treatment
        group Id
        FG001
        num Subjects
        53
      3. comment
        Participants followed until death or 3.5 years after the last participant was assigned to treatment
        group Id
        FG002
        num Subjects
        52
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        11
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        46
      3. group Id
        FG002
        num Subjects
        41
      type
      NOT COMPLETED
    title
    Follow-up Period
pre Assignment Details
In Part 2, 105 participants received treatment (VMP: 53 and VMP+Siltuximab: 52). In the VMP+Siltuximab arm, 21 participants who achieved partial response or better entered the maintenance period and received only Siltuximab for 18 months, or until disease progression, unacceptable toxicity, or withdrawal from treatment, whichever occurred first.
recruitment Details
The study was conducted at 40 centers in 12 countries: Australia; France; India; Israel; Italy; Poland; Romania; Russian Federation; Singapore; South Korea; Spain; and the United States.
Complete source fields
groups
  1. description
    Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
    id
    FG000
    title
    Part 1: VMP + Siltuximab
  2. description
    Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
    id
    FG001
    title
    Part 2: VMP
  3. description
    Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
    id
    FG002
    title
    Part 2: VMP + Siltuximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        7
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        5
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        5
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        5
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Did not receive study treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        54
      3. group Id
        FG002
        num Subjects
        52
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        53
      3. group Id
        FG002
        num Subjects
        52
      type
      Received Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        33
      3. group Id
        FG002
        num Subjects
        27
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        21
      3. group Id
        FG002
        num Subjects
        25
      type
      NOT COMPLETED
    title
    Treatment Period
  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
        9
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        9
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. comment
        Participants who received siltuximab only during the 18-month maintenance period
        group Id
        FG002
        num Subjects
        21
      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
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        21
      type
      NOT COMPLETED
    title
    Maintainance Period
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        10
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        33
      3. group Id
        FG002
        num Subjects
        27
      type
      Study terminated by sponsor
    milestones
    1. achievements
      1. comment
        Participants followed until death or 3.5 years after the last participant was assigned to treatment
        group Id
        FG000
        num Subjects
        12
      2. comment
        Participants followed until death or 3.5 years after the last participant was assigned to treatment
        group Id
        FG001
        num Subjects
        53
      3. comment
        Participants followed until death or 3.5 years after the last participant was assigned to treatment
        group Id
        FG002
        num Subjects
        52
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        11
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        46
      3. group Id
        FG002
        num Subjects
        41
      type
      NOT COMPLETED
    title
    Follow-up Period
pre Assignment Details
In Part 2, 105 participants received treatment (VMP: 53 and VMP+Siltuximab: 52). In the VMP+Siltuximab arm, 21 participants who achieved partial response or better entered the maintenance period and received only Siltuximab for 18 months, or until disease progression, unacceptable toxicity, or withdrawal from treatment, whichever occurred first.
recruitment Details
The study was conducted at 40 centers in 12 countries: Australia; France; India; Israel; Italy; Poland; Romania; Russian Federation; Singapore; South Korea; Spain; and the United States.

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

Preserved source evidence · Not medical advice