Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01632150 · FLOW

Participant flow

Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma · Source last updated 2017-04-14

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

groups
  1. description
    Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles and beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
    id
    FG000
    title
    Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        27
      type
      Disease progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Study drug toxicity
    3. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Unrelated adverse event
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Patient underwent autologous transplant
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Moved to compassionate program
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        40
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      Received Cyclophosphamide
    3. achievements
      1. comment
        Completed=still receiving treatment
        group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        40
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of 51 participants enrolled, 40 received treatment. Of those 40, 11 had cyclophosphamide added to their regimens.
Complete source fields
groups
  1. description
    Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles and beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
    id
    FG000
    title
    Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        27
      type
      Disease progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Study drug toxicity
    3. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Unrelated adverse event
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Patient underwent autologous transplant
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Moved to compassionate program
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        40
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      Received Cyclophosphamide
    3. achievements
      1. comment
        Completed=still receiving treatment
        group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        40
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of 51 participants enrolled, 40 received treatment. Of those 40, 11 had cyclophosphamide added to their regimens.

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

Preserved source evidence · Not medical advice