Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04191616 · FLOW

Participant flow

Study of Early Relapsed, Lenalidomide-refractory Subjects Eligible for Carfilzomib Triplet · Source last updated 2025-09-04

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

groups
  1. description
    Carfilzomib was administered intravenously on days 1, 8, and 15 (± 2 days) of each 28-day cycle for up to 12 cycles or progression or end of study. A dose of 20 mg/m\^2 was administered on day 1 of cycle 1; all subsequent doses were 56 mg/m\^2. From cycle 13, the frequency of carfilzomib administration was reduced to days 1 and 15 (± 2 days) per cycle until progression or end of study. Dexamethasone was administered orally or intravenously at a dose of 40 mg on days 1, 8, 15, and 22 of each cycle during cycles 1 to 12, and at a dose of 20 mg on days 1 and 15 from cycle 13 until progression or end of study. Pomalidomide 4 mg was administered orally on days 1 to 21 of each cycle until progression or end of study.
    id
    FG000
    title
    Carfilzomib With Pomalidomide and Dexamethasone (KPd)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Did not receive study treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        54
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        52
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Pre-assignment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        37
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Sponsor decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        52
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        52
      type
      Received Carfilzomib
    3. achievements
      1. group Id
        FG000
        num Subjects
        52
      type
      Received Pomalidomide
    4. achievements
      1. group Id
        FG000
        num Subjects
        52
      type
      Received Dexamethasone
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        52
      type
      NOT COMPLETED
    title
    Treatment Period
pre Assignment Details
Participants with relapsed multiple myeloma whose disease was refractory to lenalidomide were enrolled.
recruitment Details
Participants were enrolled at 25 study centers in Denmark, France, Germany, Greece, Italy, Spain, and the United States from 06 August 2020 to 01 October 2024.
Complete source fields
groups
  1. description
    Carfilzomib was administered intravenously on days 1, 8, and 15 (± 2 days) of each 28-day cycle for up to 12 cycles or progression or end of study. A dose of 20 mg/m\^2 was administered on day 1 of cycle 1; all subsequent doses were 56 mg/m\^2. From cycle 13, the frequency of carfilzomib administration was reduced to days 1 and 15 (± 2 days) per cycle until progression or end of study. Dexamethasone was administered orally or intravenously at a dose of 40 mg on days 1, 8, 15, and 22 of each cycle during cycles 1 to 12, and at a dose of 20 mg on days 1 and 15 from cycle 13 until progression or end of study. Pomalidomide 4 mg was administered orally on days 1 to 21 of each cycle until progression or end of study.
    id
    FG000
    title
    Carfilzomib With Pomalidomide and Dexamethasone (KPd)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Did not receive study treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        54
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        52
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Pre-assignment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        37
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Sponsor decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        52
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        52
      type
      Received Carfilzomib
    3. achievements
      1. group Id
        FG000
        num Subjects
        52
      type
      Received Pomalidomide
    4. achievements
      1. group Id
        FG000
        num Subjects
        52
      type
      Received Dexamethasone
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        52
      type
      NOT COMPLETED
    title
    Treatment Period
pre Assignment Details
Participants with relapsed multiple myeloma whose disease was refractory to lenalidomide were enrolled.
recruitment Details
Participants were enrolled at 25 study centers in Denmark, France, Germany, Greece, Italy, Spain, and the United States from 06 August 2020 to 01 October 2024.

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

Preserved source evidence · Not medical advice