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NCT02290431 · FLOW

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Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma · Source last updated 2019-11-18

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

groups
  1. description
    Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
    id
    FG000
    title
    LBH589 + Bortezomib + Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        20
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Progressive disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Study terminated by Sponsor
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        31
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      Subjects. Discont. Prematurely
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      type
      Subjects Completed Study Per Protocol
    4. achievements
      1. group Id
        FG000
        num Subjects
        31
      type
      Subjs. Ntered Post-treatment Eval. Phase
    5. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      Subjects Entered Survival f/u Phase
    6. achievements
      1. group Id
        FG000
        num Subjects
        17
      type
      Entered Treatment Phase 2
    7. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      COMPLETED
    8. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Approximately 33 eligible subjects were planned to be enrolled. 31 eligible subjects were enrolled and treated with PAN+BTZ+Dex (Treatment phase 1), of which 17 subjects entered Treatment phase 2. All 31 subjects entered the post-treatment evaluation phase, of which 22 discontinued the study. 24 subjects entered the survival follow-up phase.
Complete source fields
groups
  1. description
    Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
    id
    FG000
    title
    LBH589 + Bortezomib + Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        20
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Progressive disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Study terminated by Sponsor
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        31
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      Subjects. Discont. Prematurely
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      type
      Subjects Completed Study Per Protocol
    4. achievements
      1. group Id
        FG000
        num Subjects
        31
      type
      Subjs. Ntered Post-treatment Eval. Phase
    5. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      Subjects Entered Survival f/u Phase
    6. achievements
      1. group Id
        FG000
        num Subjects
        17
      type
      Entered Treatment Phase 2
    7. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      COMPLETED
    8. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Approximately 33 eligible subjects were planned to be enrolled. 31 eligible subjects were enrolled and treated with PAN+BTZ+Dex (Treatment phase 1), of which 17 subjects entered Treatment phase 2. All 31 subjects entered the post-treatment evaluation phase, of which 22 discontinued the study. 24 subjects entered the survival follow-up phase.

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Preserved source evidence · Not medical advice