Participant flow

Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma · Source last updated 2012-10-04

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

groups

1. description

   Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.

   id

   FG000

   title

   Bendamustine 50 mg/m^2 Cohort

2. description

   Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.

   id

   FG001

   title

   Bendamustine 70 mg/m^2 Cohort

3. description

   Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.

   id

   FG002

   title

   Bendamustine 90 mg/m^2 Cohort

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         4

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         6

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         10

      type

      Disease progression

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Noncompliance to study medication

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Response plateau; started maintenance

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         31

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         31

      type

      Safety and Efficacy Populations

   3. achievements

      1. comment

         completed eight cycles of treatment

         group Id

         FG000

         num Subjects

         0

      2. comment

         completed eight cycles of treatment

         group Id

         FG001

         num Subjects

         1

      3. comment

         completed eight cycles of treatment

         group Id

         FG002

         num Subjects

         9

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         22

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Fifty-one patients were screened and forty from 10 U.S. centers were enrolled. Reasons for not enrolling were failed to meet inclusion and/or exclusion criteria (10) and an adverse event (1).

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Preserved source evidence · Not medical advice