Participant flow

Study of Vorinostat (MK-0683) or Placebo, in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-088 AMN) · Source last updated 2021-04-30

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

groups

1. description

   Participants will receive vorinostat four 100 mg capsules (400 mg total) orally 0-30 minutes after a meal on Days 1 through 14 of a 21-day treatment cycle and bortezomib 1.3 mg/m\^2 by intravenous injection on Days 1, 4, 8, and 11 of a 21-day treatment cycle.

   id

   FG000

   title

   Vorinostat + Bortezomib

2. description

   Participants will receive four placebo capsules orally 0-30 minutes after a meal on Days 1 through 14 of a 21-day treatment cycle and bortezomib 1.3 mg/m\^2 by intravenous injection on Days 1, 4, 8, and 11 of a 21-day treatment cycle.

   id

   FG001

   title

   Placebo + Bortezomib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         112

      2. group Id

         FG001

         num Subjects

         144

      type

      Lack of Efficacy

   2. reasons

      1. group Id

         FG000

         num Subjects

         26

      2. group Id

         FG001

         num Subjects

         18

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      Protocol Violation

   5. reasons

      1. group Id

         FG000

         num Subjects

         89

      2. group Id

         FG001

         num Subjects

         61

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         61

      2. group Id

         FG001

         num Subjects

         62

      type

      Adverse Event

   7. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         8

      type

      Death

   8. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Not Treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         317

      2. group Id

         FG001

         num Subjects

         320

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         315

      2. group Id

         FG001

         num Subjects

         320

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         24

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         297

      2. group Id

         FG001

         num Subjects

         296

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

637 participants were randomized to treatment and 635 participants received at least 1 dose of MK-0683 or placebo: 315 participants were treated with vorinostat + bortezomib and 320 participants were treated with placebo + bortezomib.

recruitment Details

This study enrolled participants with an established diagnosis of multiple myeloma based on standard criteria that have received at least 1 but not more than 3 prior anti-myeloma regimens and have demonstrated progressive disease after the most recent treatment regimen. Additional inclusion and exclusion criteria applied.

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

Preserved source evidence · Not medical advice