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NCT02412878 · FLOW

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Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma · Source last updated 2022-09-23

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

groups
  1. description
    Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
    id
    FG000
    title
    Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone
  2. description
    Participants received carfilzomib administered by IV infusion on days 1, 8, and 15 of each 28-day cycle (20 mg/m² on day 1 of cycle 1 and 70 mg/m² thereafter). Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
    id
    FG001
    title
    Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        10
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        238
      2. group Id
        FG001
        num Subjects
        240
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        235
      2. group Id
        FG001
        num Subjects
        238
      type
      Received Carfilzomib
    3. achievements
      1. group Id
        FG000
        num Subjects
        217
      2. group Id
        FG001
        num Subjects
        227
      comment
      Defined as participants who discontinued due to death or study closure
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        13
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants were randomized in a 1:1 ratio to receive a regimen consisting of either once-weekly or twice weekly carfilzomib in combination with dexamethasone. Randomization was stratified by International Staging System (ISS) stage (stage 1 vs stages 2 or 3), refractory to bortezomib treatment (yes vs no), and age (\< 65 vs ≥ 65 years).
recruitment Details
Participants were enrolled from September 2015 to August 2016 at 118 sites in Australia, New Zealand, Japan, North America, and Europe.
Complete source fields
groups
  1. description
    Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
    id
    FG000
    title
    Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone
  2. description
    Participants received carfilzomib administered by IV infusion on days 1, 8, and 15 of each 28-day cycle (20 mg/m² on day 1 of cycle 1 and 70 mg/m² thereafter). Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
    id
    FG001
    title
    Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        10
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        238
      2. group Id
        FG001
        num Subjects
        240
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        235
      2. group Id
        FG001
        num Subjects
        238
      type
      Received Carfilzomib
    3. achievements
      1. group Id
        FG000
        num Subjects
        217
      2. group Id
        FG001
        num Subjects
        227
      comment
      Defined as participants who discontinued due to death or study closure
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        13
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants were randomized in a 1:1 ratio to receive a regimen consisting of either once-weekly or twice weekly carfilzomib in combination with dexamethasone. Randomization was stratified by International Staging System (ISS) stage (stage 1 vs stages 2 or 3), refractory to bortezomib treatment (yes vs no), and age (\< 65 vs ≥ 65 years).
recruitment Details
Participants were enrolled from September 2015 to August 2016 at 118 sites in Australia, New Zealand, Japan, North America, and Europe.

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Preserved source evidence · Not medical advice