Participant flow

A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma · Source last updated 2011-11-03

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

groups

1. description

   Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.

   id

   FG000

   title

   Lenalidomide Plus Dexamethasone

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         29

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         23

      type

      Lack of Efficacy

   3. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Death

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Protocol Violation

   6. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Lost to Follow-up

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Physician Decision

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Intolerance of therapy

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Lack of compliance

   10. reasons

       1. group Id

          FG000

          num Subjects

          1

       type

       Lymphocytes infusion

   11. reasons

       1. group Id

          FG000

          num Subjects

          2

       type

       End of therapy

   12. reasons

       1. group Id

          FG000

          num Subjects

          6

       type

       Not treated with lenalidomide

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         150

      type

      STARTED

   2. achievements

      1. comment

         6 enrolled participants did not receive lenalidomide.

         group Id

         FG000

         num Subjects

         144

      type

      Safety and Full Analysis Set (FAS)

   3. achievements

      1. comment

         10 participants had \>= 6 months and 63 participants \< 6 months treatment prior to study termination.

         group Id

         FG000

         num Subjects

         73

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         77

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

A total of 150 participants in 37 sites in Germany were enrolled when lenalidomide became commercially available in Germany. Study completion (end of study) was the time point when participants discontinued study drug and could switch to commercial lenalidomide.

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Preserved source evidence · Not medical advice