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NCT00858234 · FLOW

Participant flow

Phase I Study of MK-0683 in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-098) · Source last updated 2021-04-09

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

groups
  1. description
    Participants undergo ≤3 successive 21-day treatment cycles. During Cycle 1, participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.3 mg/m\^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 2 participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 3 participants receive vorinostat (300 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\^2 IV on Days 1, 4, 8, and 11).
    id
    FG000
    title
    Vorinostat + Bortezomib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Progressive disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Status unknown
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        9
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        9
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Adult male and female participants with relapsed and/or refractory multiple myeloma (MM) were enrolled at study sites in Japan.
Complete source fields
groups
  1. description
    Participants undergo ≤3 successive 21-day treatment cycles. During Cycle 1, participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.3 mg/m\^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 2 participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 3 participants receive vorinostat (300 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\^2 IV on Days 1, 4, 8, and 11).
    id
    FG000
    title
    Vorinostat + Bortezomib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Progressive disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Status unknown
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        9
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        9
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Adult male and female participants with relapsed and/or refractory multiple myeloma (MM) were enrolled at study sites in Japan.

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Preserved source evidence · Not medical advice