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NCT01241292 · FLOW

Participant flow

Japanese Study of BMS-901608 (Elotuzumab) in Combination With Lenalidomide and Low Dose Dexamethasone · Source last updated 2018-02-15

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

groups
  1. description
    Elotuzumab 10 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
    id
    FG000
    title
    Elotuzumab 10 mg/kg
  2. description
    Elotuzumab 20 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
    id
    FG001
    title
    Elotuzumab 20 mg/kg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Administrative Reason by Sponsor
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Disease Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Study Drug Toxicity
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Participant Discontinued Treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      Entered Treatment Period
    3. achievements
      1. comment
        completed=treatment on-going
        group Id
        FG000
        num Subjects
        0
      2. comment
        completed=treatment on-going
        group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Seven participants were enrolled and 6 entered the treatment period. Reason for 1 participant not entering treatment period: participant no longer met study criteria.
Complete source fields
groups
  1. description
    Elotuzumab 10 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
    id
    FG000
    title
    Elotuzumab 10 mg/kg
  2. description
    Elotuzumab 20 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
    id
    FG001
    title
    Elotuzumab 20 mg/kg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Administrative Reason by Sponsor
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Disease Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Study Drug Toxicity
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Participant Discontinued Treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      Entered Treatment Period
    3. achievements
      1. comment
        completed=treatment on-going
        group Id
        FG000
        num Subjects
        0
      2. comment
        completed=treatment on-going
        group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Seven participants were enrolled and 6 entered the treatment period. Reason for 1 participant not entering treatment period: participant no longer met study criteria.

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Preserved source evidence · Not medical advice