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NCT03029234 · FLOW

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Carfilzomib in Combination With Dexamethasone (Kd) in Chinese Patients With Relapsed & Refractory Multiple Myeloma · Source last updated 2022-05-25

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 20 mg dexamethasone IV or orally on days 1, 2, 8, 9, 15, 16, 22, and 23. Participants received treatment until disease progression, unacceptable toxicity, initiation of new antimyeloma therapy, withdrawal of consent, subject noncompliance, or intercurrent illness or worsening of a chronic condition, whichever occurred first.
    id
    FG000
    title
    Carfilzomib With Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Sponsor Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        91
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        126
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        123
      type
      Received Carfilzomib
    3. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        99
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
This study was conducted at 18 centers in China. The primary efficacy analysis was prespecified to occur when all enrolled participants had received 6 cycles of therapy or discontinued treatment. This occurred on November 5, 2018. A final analysis for efficacy was prespecified when all enrolled participants had the opportunity to be treated with at least 12 cycles. This occurred on March 15, 2019. The final analysis for safety occurred once all participants completed the study, 4 June 2021.
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 20 mg dexamethasone IV or orally on days 1, 2, 8, 9, 15, 16, 22, and 23. Participants received treatment until disease progression, unacceptable toxicity, initiation of new antimyeloma therapy, withdrawal of consent, subject noncompliance, or intercurrent illness or worsening of a chronic condition, whichever occurred first.
    id
    FG000
    title
    Carfilzomib With Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Sponsor Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        91
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        126
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        123
      type
      Received Carfilzomib
    3. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        99
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
This study was conducted at 18 centers in China. The primary efficacy analysis was prespecified to occur when all enrolled participants had received 6 cycles of therapy or discontinued treatment. This occurred on November 5, 2018. A final analysis for efficacy was prespecified when all enrolled participants had the opportunity to be treated with at least 12 cycles. This occurred on March 15, 2019. The final analysis for safety occurred once all participants completed the study, 4 June 2021.

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

Preserved source evidence · Not medical advice