Participant flow

A Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (AMBER) · Source last updated 2017-06-14

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

groups

1. description

   Participants received bortezomib 1.3 mg/m\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.

   id

   FG000

   title

   BORT + P

2. description

   Participants received bortezomib 1.3 mg/m\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.

   id

   FG001

   title

   BORT + BV

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         2

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         24

      2. group Id

         FG001

         num Subjects

         20

      type

      Progression not resulting in death

   4. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         5

      type

      Non-protocol-specified therapy

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         3

      type

      Withdrawal by Subject

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         53

      2. group Id

         FG001

         num Subjects

         49

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         52

      2. group Id

         FG001

         num Subjects

         48

      type

      Treated

   3. achievements

      1. comment

         2 patients received at least 1 bevacizumab dose \& were analyzed as bevacizumab-treated patients

         group Id

         FG000

         num Subjects

         50

      2. group Id

         FG001

         num Subjects

         50

      type

      Safety Population

   4. achievements

      1. comment

         Continuing on study as of the data cutoff date of 9 November 2009.

         group Id

         FG000

         num Subjects

         8

      2. comment

         Continuing on study as of the data cutoff date of 9 November 2009.

         group Id

         FG001

         num Subjects

         11

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         45

      2. group Id

         FG001

         num Subjects

         38

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Phase II, randomized, blinded, placebo-controlled, multicenter study designed to provide a preliminary assessment of the safety and efficacy of combining bevacizumab with bortezomib in patients with relapsed or refractory multiple myeloma starting 11 July 2007 and completing 9 November 2009.

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Preserved source evidence · Not medical advice