Participant flow

Study to Evaluate the Safety and Efficacy of Pomalidomide Monotherapy in Subjects With Refractory or Relapsed Refractory Multiple Myeloma · Source last updated 2019-11-19

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

groups

1. description

   Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity

   id

   FG000

   title

   Pomalidomide

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         7

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         10

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Other

   4. reasons

      1. group Id

         FG000

         num Subjects

         50

      type

      Progressive Disease

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      1 discontinued before starting drug

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         74

      type

      STARTED

   2. achievements

      1. comment

         Safety Population includes those who were enrolled and received at least one dose of study drug

         group Id

         FG000

         num Subjects

         73

      type

      Safety Population

   3. achievements

      1. comment

         Participants who received ≥ 1 dose of study drug and had at least 1 postbaseline efficacy assessment

         group Id

         FG000

         num Subjects

         64

      type

      Efficacy Evaluable Population (EEP)

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         74

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

CC-4047-MM003C is a companion study for the trial CC-4047-MM-003 (NCT01311687). CC-4047-MM-003C enrolled those who discontinued treatment with dexamethasone alone (Treatment Arm B) in the CC-4047-MM-003 trial due to disease progression; those who had discontinued treatment with pomalidomide plus dexamethasone (Arm A) were not eligible to enroll

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Preserved source evidence · Not medical advice