Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01080391 · FLOW

Participant flow

Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma · Source last updated 2022-09-21

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

groups
  1. description
    Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
    id
    FG000
    title
    Lenalidomide and Dexamethasone (Rd)
  2. description
    Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
    id
    FG001
    title
    Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      type
      Randomized but not treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        396
      2. group Id
        FG001
        num Subjects
        396
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        389
      2. group Id
        FG001
        num Subjects
        392
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        389
      2. group Id
        FG001
        num Subjects
        392
      comment
      Completed represents patients who discontinued treatment as of 05 December 2017
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Eligible participants were randomized in a 1:1 ratio to one of two treatment groups. Randomization was stratified by β2 microglobulin level (\< vs. ≥ 2.5 mg/L), prior bortezomib exposure (no vs. yes), and prior lenalidomide exposure (no vs. yes).
recruitment Details
Participants were enrolled from 14 July 2010 to 15 March 2012. The primary analysis was conducted using a data cut-off date of 16 June 2014 and the final safety analysis after last subject last visit date (05 December 2017).
Complete source fields
groups
  1. description
    Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
    id
    FG000
    title
    Lenalidomide and Dexamethasone (Rd)
  2. description
    Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
    id
    FG001
    title
    Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      type
      Randomized but not treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        396
      2. group Id
        FG001
        num Subjects
        396
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        389
      2. group Id
        FG001
        num Subjects
        392
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        389
      2. group Id
        FG001
        num Subjects
        392
      comment
      Completed represents patients who discontinued treatment as of 05 December 2017
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Eligible participants were randomized in a 1:1 ratio to one of two treatment groups. Randomization was stratified by β2 microglobulin level (\< vs. ≥ 2.5 mg/L), prior bortezomib exposure (no vs. yes), and prior lenalidomide exposure (no vs. yes).
recruitment Details
Participants were enrolled from 14 July 2010 to 15 March 2012. The primary analysis was conducted using a data cut-off date of 16 June 2014 and the final safety analysis after last subject last visit date (05 December 2017).

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

Preserved source evidence · Not medical advice