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NCT02726581 · FLOW

Participant flow

An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma · Source last updated 2023-03-27

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

groups
  1. description
    Nivolumab: * Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. * Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
    id
    FG000
    title
    Arm A: N-Pd
  2. description
    Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
    id
    FG001
    title
    Arm B: Pd
  3. description
    Nivolumab: * Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. * Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Elotuzumab: * Cycles 1 - 2: 10 mg/kg IV Days 1, 8, 15, and 22 of each 28-day cycle. * Cycle 3 and 4: 10mg/kg IV Day 1 and 15 of each 28-day cycle. * Cycles 5 and beyond: 20 mg/kg IV Day 1 of each 28-day cycle. Pomalidomide: 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Days 1, 8, 15, and 22 of each cycle. * Participants \</= 75 years old: weeks with elotuzumab dosing: 28 mg PO + 8 mg IV and 40 mg PO on non-elotuzumab dosing weeks. * Participants \> 75 years old: weeks with elotuzumab dosing: 8 mg PO + 8 mg IV and 20 mg PO on non-elotuzumab dosing weeks.
    id
    FG002
    title
    Arm C: NE-Pd
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Participant request to discontinue study treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Administrative reason by sponsor
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Participant no longer meets study criteria
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        75
      2. group Id
        FG001
        num Subjects
        71
      3. group Id
        FG002
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        72
      2. group Id
        FG001
        num Subjects
        70
      3. group Id
        FG002
        num Subjects
        24
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Pre-Treatment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        47
      2. group Id
        FG001
        num Subjects
        50
      3. group Id
        FG002
        num Subjects
        16
      type
      Disease progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        2
      type
      Other reasons
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      type
      Study drug toxicity
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        2
      type
      Adverse event unrelated to study drug
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Participant withdrew consent
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Participant request to discontinue study treatment
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Maximum clinical benefit
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Poor/non-compliance
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Participant no longer meets study criteria
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        72
      2. group Id
        FG001
        num Subjects
        70
      3. group Id
        FG002
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        0
      type
      NE-Pd Crossover
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      comment
      Completed treatment
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        72
      2. group Id
        FG001
        num Subjects
        70
      3. group Id
        FG002
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Treatment Period
pre Assignment Details
This study contains an exploratory third arm evaluating the clinical benefit and the safety of the combination therapy of elotuzumab, nivolumab, pomalidomide and dexamethasone (Arm C: NE-Pd). Participants randomized to the Pd arm were allowed to cross over to this exploratory NE-Pd arm at the time of progression.
Complete source fields
groups
  1. description
    Nivolumab: * Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. * Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
    id
    FG000
    title
    Arm A: N-Pd
  2. description
    Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
    id
    FG001
    title
    Arm B: Pd
  3. description
    Nivolumab: * Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. * Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Elotuzumab: * Cycles 1 - 2: 10 mg/kg IV Days 1, 8, 15, and 22 of each 28-day cycle. * Cycle 3 and 4: 10mg/kg IV Day 1 and 15 of each 28-day cycle. * Cycles 5 and beyond: 20 mg/kg IV Day 1 of each 28-day cycle. Pomalidomide: 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Days 1, 8, 15, and 22 of each cycle. * Participants \</= 75 years old: weeks with elotuzumab dosing: 28 mg PO + 8 mg IV and 40 mg PO on non-elotuzumab dosing weeks. * Participants \> 75 years old: weeks with elotuzumab dosing: 8 mg PO + 8 mg IV and 20 mg PO on non-elotuzumab dosing weeks.
    id
    FG002
    title
    Arm C: NE-Pd
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Participant request to discontinue study treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Administrative reason by sponsor
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Participant no longer meets study criteria
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        75
      2. group Id
        FG001
        num Subjects
        71
      3. group Id
        FG002
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        72
      2. group Id
        FG001
        num Subjects
        70
      3. group Id
        FG002
        num Subjects
        24
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Pre-Treatment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        47
      2. group Id
        FG001
        num Subjects
        50
      3. group Id
        FG002
        num Subjects
        16
      type
      Disease progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        2
      type
      Other reasons
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      type
      Study drug toxicity
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        2
      type
      Adverse event unrelated to study drug
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Participant withdrew consent
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Participant request to discontinue study treatment
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Maximum clinical benefit
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Poor/non-compliance
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Participant no longer meets study criteria
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        72
      2. group Id
        FG001
        num Subjects
        70
      3. group Id
        FG002
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        0
      type
      NE-Pd Crossover
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      comment
      Completed treatment
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        72
      2. group Id
        FG001
        num Subjects
        70
      3. group Id
        FG002
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Treatment Period
pre Assignment Details
This study contains an exploratory third arm evaluating the clinical benefit and the safety of the combination therapy of elotuzumab, nivolumab, pomalidomide and dexamethasone (Arm C: NE-Pd). Participants randomized to the Pd arm were allowed to cross over to this exploratory NE-Pd arm at the time of progression.

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

Preserved source evidence · Not medical advice