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NCT01345019 · FLOW

Participant flow

Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma · Source last updated 2022-11-08

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

groups
  1. description
    Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously (SC) once every 4 weeks (Q4W) in the double-blind treatment phase. In the open-label treatment phase, remaining participants received denosumab 120 mg SC Q4W.
    id
    FG000
    title
    Zoledronic Acid
  2. description
    Participants randomized to receive denosumab 120 mg subcutaneously (SC) plus placebo to zoledronic acid intravenously once every 4 weeks (Q4W) in the double-blind treatment phase. In the open-label treatment phase, remaining participants received denosumab 120 mg SC Q4W.
    id
    FG001
    title
    Denosumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        147
      2. group Id
        FG001
        num Subjects
        137
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        103
      2. group Id
        FG001
        num Subjects
        112
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        9
      type
      Completed Survival Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        10
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        13
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        8
      type
      Administrative Decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      type
      Noncompliance
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        6
      type
      Ineligibility Determined
    9. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Protocol Deviation
    10. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Other, Not Specified
    11. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        859
      2. group Id
        FG001
        num Subjects
        859
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        852
      2. group Id
        FG001
        num Subjects
        850
      type
      Received Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        541
      2. group Id
        FG001
        num Subjects
        555
      comment
      Still on-study as of blinded treatment analysis cutoff date of 05 January 2017
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        318
      2. group Id
        FG001
        num Subjects
        304
      type
      NOT COMPLETED
    title
    Blinded Treatment Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        48
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        47
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        30
      2. group Id
        FG001
        num Subjects
        51
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        30
      2. group Id
        FG001
        num Subjects
        15
      type
      Administrative Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        18
      type
      Disease Progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        4
      type
      Noncompliance
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Lost to Follow-up
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Pregnancy
    9. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        7
      type
      Other, Not Specified
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Protocol Violation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        418
      2. group Id
        FG001
        num Subjects
        426
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        227
      2. group Id
        FG001
        num Subjects
        233
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        191
      2. group Id
        FG001
        num Subjects
        193
      type
      NOT COMPLETED
    title
    Open Label Treatment Phase
pre Assignment Details
Randomization was stratified according to: * intent to undergo autologous peripheral blood stem cell (PBSC) transplantation * the antimyeloma agent being utilized/planned to be utilized in first-line therapy * stage (International Staging System \[ISS\]) at diagnosis * previous SRE (yes or no) * region (Japan yes or no)
recruitment Details
This study was conducted at 259 centers across 29 countries in Europe, North America, Asia, Australia/New Zealand, and Japan. Participants were enrolled from 17 May 2012 to 29 March 2016.
Complete source fields
groups
  1. description
    Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously (SC) once every 4 weeks (Q4W) in the double-blind treatment phase. In the open-label treatment phase, remaining participants received denosumab 120 mg SC Q4W.
    id
    FG000
    title
    Zoledronic Acid
  2. description
    Participants randomized to receive denosumab 120 mg subcutaneously (SC) plus placebo to zoledronic acid intravenously once every 4 weeks (Q4W) in the double-blind treatment phase. In the open-label treatment phase, remaining participants received denosumab 120 mg SC Q4W.
    id
    FG001
    title
    Denosumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        147
      2. group Id
        FG001
        num Subjects
        137
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        103
      2. group Id
        FG001
        num Subjects
        112
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        9
      type
      Completed Survival Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        10
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        13
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        8
      type
      Administrative Decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      type
      Noncompliance
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        6
      type
      Ineligibility Determined
    9. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Protocol Deviation
    10. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Other, Not Specified
    11. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        859
      2. group Id
        FG001
        num Subjects
        859
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        852
      2. group Id
        FG001
        num Subjects
        850
      type
      Received Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        541
      2. group Id
        FG001
        num Subjects
        555
      comment
      Still on-study as of blinded treatment analysis cutoff date of 05 January 2017
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        318
      2. group Id
        FG001
        num Subjects
        304
      type
      NOT COMPLETED
    title
    Blinded Treatment Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        48
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        47
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        30
      2. group Id
        FG001
        num Subjects
        51
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        30
      2. group Id
        FG001
        num Subjects
        15
      type
      Administrative Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        18
      type
      Disease Progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        4
      type
      Noncompliance
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Lost to Follow-up
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Pregnancy
    9. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        7
      type
      Other, Not Specified
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Protocol Violation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        418
      2. group Id
        FG001
        num Subjects
        426
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        227
      2. group Id
        FG001
        num Subjects
        233
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        191
      2. group Id
        FG001
        num Subjects
        193
      type
      NOT COMPLETED
    title
    Open Label Treatment Phase
pre Assignment Details
Randomization was stratified according to: * intent to undergo autologous peripheral blood stem cell (PBSC) transplantation * the antimyeloma agent being utilized/planned to be utilized in first-line therapy * stage (International Staging System \[ISS\]) at diagnosis * previous SRE (yes or no) * region (Japan yes or no)
recruitment Details
This study was conducted at 259 centers across 29 countries in Europe, North America, Asia, Australia/New Zealand, and Japan. Participants were enrolled from 17 May 2012 to 29 March 2016.

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Preserved source evidence · Not medical advice