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NCT00719901 · FLOW

Participant flow

Obatoclax and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2015-01-12

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

groups
  1. description
    Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m\^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Treatment (Enzyme Inhibitor Therapy)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Alternate Treatment
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Availability of Study Drug
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
This was a phase I/II trial. A total of 11 participants were accrued, all to the phase I portion. This trial was terminated due to slow accrual and the drug supply of Obatoclax during the phase I; therefore, the phase II portion will never open. No results from the phase II portion are available.
recruitment Details
Participants were recruited from 5 medical clinics in the United States between February 2008 and January 2011.
Complete source fields
groups
  1. description
    Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m\^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Treatment (Enzyme Inhibitor Therapy)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Alternate Treatment
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Availability of Study Drug
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
This was a phase I/II trial. A total of 11 participants were accrued, all to the phase I portion. This trial was terminated due to slow accrual and the drug supply of Obatoclax during the phase I; therefore, the phase II portion will never open. No results from the phase II portion are available.
recruitment Details
Participants were recruited from 5 medical clinics in the United States between February 2008 and January 2011.

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Preserved source evidence · Not medical advice