Participant flow

Trial of Romidepsin and Bortezomib for Multiple Myeloma · Source last updated 2019-11-25

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

groups

1. description

   Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period. Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.

   id

   FG000

   title

   Romidepsin + Bortezomib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         18

      type

      Progressive disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         6

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Protocol Violation

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         32

      type

      STARTED

   2. achievements

      1. comment

         Completed 8 cycles of treatment

         group Id

         FG000

         num Subjects

         1

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         31

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Stratum 1 (bortezomib resistant) had 19 participants. Stratum 2 (non-bortezomib resistant) had 13 participants.

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

Preserved source evidence · Not medical advice