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NCT00773838 · FLOW

Participant flow

Study of Vorinostat (MK0683), an Histone Deacetylase (HDAC) Inhibitor in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (MK-0683-095) · Source last updated 2021-04-01

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

groups
  1. description
    Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m\^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
    id
    FG000
    title
    Vorinostat + Bortezomib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        29
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        82
      type
      Progressive Disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Protocol Violation
    6. reasons
      1. group Id
        FG000
        num Subjects
        21
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        143
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        143
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of 143 participants enrolled, 142 participants were allocated to treatment. Five participants received additional treatment for about 1 year during an extension as per investigator's discretion based on clinical benefit of the treatment received. All 5 participants discontinued extension treatment and were followed for survival up to 2 years post last dose of treatment.
Complete source fields
groups
  1. description
    Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m\^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
    id
    FG000
    title
    Vorinostat + Bortezomib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        29
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        82
      type
      Progressive Disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Protocol Violation
    6. reasons
      1. group Id
        FG000
        num Subjects
        21
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        143
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        143
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of 143 participants enrolled, 142 participants were allocated to treatment. Five participants received additional treatment for about 1 year during an extension as per investigator's discretion based on clinical benefit of the treatment received. All 5 participants discontinued extension treatment and were followed for survival up to 2 years post last dose of treatment.

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Preserved source evidence · Not medical advice