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NCT00742560 · FLOW

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A Phase 1b/2, Dose-Escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Relapsed Multiple Myeloma · Source last updated 2018-01-10

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

groups
  1. description
    Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    FG000
    title
    Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
  2. description
    Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    FG001
    title
    Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
  3. description
    Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    FG002
    title
    Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
  4. description
    Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    FG003
    title
    Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
  5. description
    Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    FG004
    title
    Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        3
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        3
      type
      Subject's Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      Investigator's Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        17
      5. group Id
        FG004
        num Subjects
        16
      type
      Disease Progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        4
      type
      New Multiple Myeloma Therapy
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        9
      type
      Other
    8. 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
        1
      type
      MIssing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        36
      5. group Id
        FG004
        num Subjects
        37
      comment
      Safety population: all randomized participants who received at least 1 dose of study drug
      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
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        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
        22
      4. group Id
        FG003
        num Subjects
        36
      5. group Id
        FG004
        num Subjects
        37
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 101 participants were randomized (intent-to-treat \[ITT\] population); 1 subject did not receive study drug and is excluded from the analyses.
Complete source fields
groups
  1. description
    Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    FG000
    title
    Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
  2. description
    Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    FG001
    title
    Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
  3. description
    Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    FG002
    title
    Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
  4. description
    Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    FG003
    title
    Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
  5. description
    Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    FG004
    title
    Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        3
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        3
      type
      Subject's Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      Investigator's Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        17
      5. group Id
        FG004
        num Subjects
        16
      type
      Disease Progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        4
      type
      New Multiple Myeloma Therapy
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        9
      type
      Other
    8. 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
        1
      type
      MIssing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        36
      5. group Id
        FG004
        num Subjects
        37
      comment
      Safety population: all randomized participants who received at least 1 dose of study drug
      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
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        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
        22
      4. group Id
        FG003
        num Subjects
        36
      5. group Id
        FG004
        num Subjects
        37
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 101 participants were randomized (intent-to-treat \[ITT\] population); 1 subject did not receive study drug and is excluded from the analyses.

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

Preserved source evidence · Not medical advice