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NCT01592370 · FLOW

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An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma · Source last updated 2025-10-22

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

groups
  1. description
    3mg/kg of nivolumab
    id
    FG000
    title
    Nivolumab Monotherapy (Expansion)
  2. description
    3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
    id
    FG001
    title
    Nivolumab + Ipilimumab
  3. description
    3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
    id
    FG002
    title
    Nivolumab + Lirilumab
  4. description
    ND regimen: Nivolumab (240 mg up to cycle 6, then 480 mg) + Daratumumab (16 mg/Kg)
    id
    FG003
    title
    Nivolumab + Daratumumab_Cohort A1
  5. description
    ND-PD regimen; Nivolumab + Daratumumab + Pomalidomide + Dexamethasone
    id
    FG004
    title
    Nivolumab + Daratumumab_Cohort A2
  6. description
    ND regimen: Nivolumab (240 mg cycle 1, then 480 mg) + Daratumumab (16 mg/Kg)
    id
    FG005
    title
    Nivolumab + Daratumumab_Cohort B1
  7. description
    D regimen: Daratumumab alone
    id
    FG006
    title
    Nivolumab + Daratumumab_Cohort B2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        62
      2. group Id
        FG001
        num Subjects
        16
      3. group Id
        FG002
        num Subjects
        52
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        31
      7. group Id
        FG006
        num Subjects
        14
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      type
      Study Drug Toxicity
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      type
      AE unrelated to study drug
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      type
      Request to discontinue study treatment
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Withdrew consent
    6. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Maximum clinical benefit
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      No longer meets study criteria
    8. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      type
      Other Reasons
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      type
      Not Treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        105
      2. group Id
        FG001
        num Subjects
        65
      3. group Id
        FG002
        num Subjects
        72
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        7
      6. group Id
        FG005
        num Subjects
        43
      7. group Id
        FG006
        num Subjects
        22
      comment
      = Number of participants randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        40
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        104
      2. group Id
        FG001
        num Subjects
        25
      3. group Id
        FG002
        num Subjects
        72
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        36
      7. group Id
        FG006
        num Subjects
        16
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
316 participants treated
recruitment Details
For the phase 1 nivo monotherapy dose escalation included in this study, it was derived from CA209-003. It was concluded that 3mg/kg of nivolumab would be used for the dose expansion phase 2 of this study (CA209-039) based on the conclusions derived from CA209-003.
Complete source fields
groups
  1. description
    3mg/kg of nivolumab
    id
    FG000
    title
    Nivolumab Monotherapy (Expansion)
  2. description
    3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
    id
    FG001
    title
    Nivolumab + Ipilimumab
  3. description
    3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
    id
    FG002
    title
    Nivolumab + Lirilumab
  4. description
    ND regimen: Nivolumab (240 mg up to cycle 6, then 480 mg) + Daratumumab (16 mg/Kg)
    id
    FG003
    title
    Nivolumab + Daratumumab_Cohort A1
  5. description
    ND-PD regimen; Nivolumab + Daratumumab + Pomalidomide + Dexamethasone
    id
    FG004
    title
    Nivolumab + Daratumumab_Cohort A2
  6. description
    ND regimen: Nivolumab (240 mg cycle 1, then 480 mg) + Daratumumab (16 mg/Kg)
    id
    FG005
    title
    Nivolumab + Daratumumab_Cohort B1
  7. description
    D regimen: Daratumumab alone
    id
    FG006
    title
    Nivolumab + Daratumumab_Cohort B2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        62
      2. group Id
        FG001
        num Subjects
        16
      3. group Id
        FG002
        num Subjects
        52
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        31
      7. group Id
        FG006
        num Subjects
        14
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      type
      Study Drug Toxicity
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      type
      AE unrelated to study drug
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      type
      Request to discontinue study treatment
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Withdrew consent
    6. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Maximum clinical benefit
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      No longer meets study criteria
    8. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      type
      Other Reasons
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      type
      Not Treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        105
      2. group Id
        FG001
        num Subjects
        65
      3. group Id
        FG002
        num Subjects
        72
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        7
      6. group Id
        FG005
        num Subjects
        43
      7. group Id
        FG006
        num Subjects
        22
      comment
      = Number of participants randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        40
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        104
      2. group Id
        FG001
        num Subjects
        25
      3. group Id
        FG002
        num Subjects
        72
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        36
      7. group Id
        FG006
        num Subjects
        16
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
316 participants treated
recruitment Details
For the phase 1 nivo monotherapy dose escalation included in this study, it was derived from CA209-003. It was concluded that 3mg/kg of nivolumab would be used for the dose expansion phase 2 of this study (CA209-039) based on the conclusions derived from CA209-003.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice