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NCT02902965 · FLOW

Participant flow

Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed/Relapsed and Refractory Multiple Myeloma · Source last updated 2020-03-16

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

groups
  1. description
    Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age. Following implementation of Protocol Amendment4, D administration was reduced to Days 1, 4, 8, and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter
    id
    FG000
    title
    Ibrutinib+ Bortezomib+ Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        10
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        74
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        64
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age. Following implementation of Protocol Amendment4, D administration was reduced to Days 1, 4, 8, and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter
    id
    FG000
    title
    Ibrutinib+ Bortezomib+ Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        10
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        74
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        64
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice