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NCT03934684 · FLOW

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Study to Evaluate Safety Tolerability & Efficacy of Kyprolis (Carfilzomib) in Relapsed or Refractory Multiple Myeloma · Source last updated 2026-05-11

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

groups
  1. description
    Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute intravenous (IV) infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.
    id
    FG000
    title
    Carfilzomib, Lenalidomide and Dexamethasone (KRd)
  2. description
    Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or IV infusion on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
    id
    FG001
    title
    Carfilzomib and Dexamethasone (Kd)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        8
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        5
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        33
      type
      Discontinuation of carfilzomib
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        52
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        4
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        48
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Screening assessments were conducted within 28 days before enrollment into the trial.
recruitment Details
101 participants were enrolled at 15 centers in India between September 2019 and June 2025.
Complete source fields
groups
  1. description
    Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute intravenous (IV) infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.
    id
    FG000
    title
    Carfilzomib, Lenalidomide and Dexamethasone (KRd)
  2. description
    Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or IV infusion on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
    id
    FG001
    title
    Carfilzomib and Dexamethasone (Kd)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        8
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        5
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        33
      type
      Discontinuation of carfilzomib
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        49
      2. group Id
        FG001
        num Subjects
        52
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        4
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        48
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Screening assessments were conducted within 28 days before enrollment into the trial.
recruitment Details
101 participants were enrolled at 15 centers in India between September 2019 and June 2025.

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Preserved source evidence · Not medical advice