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NCT01962792 · FLOW

Participant flow

Study of BTK Inhibitor, Ibrutinib in Combination With Carfilzomib in Subjects With Relapsed and Refractory Multiple Myeloma · Source last updated 2021-12-21

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

groups
  1. description
    Ibrutinib PO 560mg + Carfilzomib IV 20/27 mg/m2 Ibrutinib Carfilzomib
    id
    FG000
    title
    Cohort 1 (560 mg)
  2. description
    Ibrutinib PO 560 mg + Carfilzomib IV 20/36 mg/m2 Ibrutinib Carfilzomib
    id
    FG001
    title
    Cohort 2a (560 mg)
  3. description
    Ibrutinib PO 560 mg+ Carfilzomib IV 20/36 mg/m2 Dexamethasone PO 20 mg Ibrutinib Carfilzomib Dexamethasone
    id
    FG002
    title
    Cohort 2b (560 mg)
  4. description
    Ibrutinib PO 840 mg + Carfilzomib IV 20/36 mg/m2 + Dexamethasone PO 20 mg Ibrutinib Carfilzomib Dexamethasone
    id
    FG003
    title
    All RP2D (840 mg)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        59
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        59
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 84 participants were enrolled and received at least 1 dose of study treatment (All-treated population); of these participants, a total of 59 received treatment at the recommended Phase 2 dose of study drug (All RP2D population).
Complete source fields
groups
  1. description
    Ibrutinib PO 560mg + Carfilzomib IV 20/27 mg/m2 Ibrutinib Carfilzomib
    id
    FG000
    title
    Cohort 1 (560 mg)
  2. description
    Ibrutinib PO 560 mg + Carfilzomib IV 20/36 mg/m2 Ibrutinib Carfilzomib
    id
    FG001
    title
    Cohort 2a (560 mg)
  3. description
    Ibrutinib PO 560 mg+ Carfilzomib IV 20/36 mg/m2 Dexamethasone PO 20 mg Ibrutinib Carfilzomib Dexamethasone
    id
    FG002
    title
    Cohort 2b (560 mg)
  4. description
    Ibrutinib PO 840 mg + Carfilzomib IV 20/36 mg/m2 + Dexamethasone PO 20 mg Ibrutinib Carfilzomib Dexamethasone
    id
    FG003
    title
    All RP2D (840 mg)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        59
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        59
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 84 participants were enrolled and received at least 1 dose of study treatment (All-treated population); of these participants, a total of 59 received treatment at the recommended Phase 2 dose of study drug (All RP2D population).

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

Preserved source evidence · Not medical advice