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NCT01651039 · FLOW

Participant flow

Phase II, Single-Center, Oral Panobinostat in Combination With Lenalidomide and Dexamethasone in Multiple Myeloma (MM) · Source last updated 2018-04-09

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

groups
  1. description
    All patients will receive oral panobinostat, lenalidomide and dexamethasone as per protocol. Panobinostat, Lenalidomide and Dexamethasone: Each cycle is 28 days. Panobinostat will be given 20 mg: Days 1,3,5,15,17,19. Lenalidomide will be given 25 mg: Days 1-21. Dexamethasone will be given for patients 75 years old and younger a dose of 40 mg on Days 1, 8 and 15. Dexamethasone will be given for patients older than 75 years old, 20 mg on Days 1, 8 and 15.
    id
    FG000
    title
    Panobinostat, Lenalidomide and Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Non-evaluables
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        22
      type
      Progressive Disease
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        32
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        30
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Recruitment began in July 2012 with enrollment from Sept 2012 to August 2015. 41 subjects signed consent (7 screened failed, 32 received study treatment, 5 non-evaluables). 27 out of the 32 subjects are evaluable.
Complete source fields
groups
  1. description
    All patients will receive oral panobinostat, lenalidomide and dexamethasone as per protocol. Panobinostat, Lenalidomide and Dexamethasone: Each cycle is 28 days. Panobinostat will be given 20 mg: Days 1,3,5,15,17,19. Lenalidomide will be given 25 mg: Days 1-21. Dexamethasone will be given for patients 75 years old and younger a dose of 40 mg on Days 1, 8 and 15. Dexamethasone will be given for patients older than 75 years old, 20 mg on Days 1, 8 and 15.
    id
    FG000
    title
    Panobinostat, Lenalidomide and Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Non-evaluables
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        22
      type
      Progressive Disease
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        32
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        30
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Recruitment began in July 2012 with enrollment from Sept 2012 to August 2015. 41 subjects signed consent (7 screened failed, 32 received study treatment, 5 non-evaluables). 27 out of the 32 subjects are evaluable.

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

Preserved source evidence · Not medical advice