Participant flow

Japanese Phase 2 Study to Evaluate the Efficacy and Safety of Pomalidomide in Subjects With Relapsed and Refractory Multiple Myeloma · Source last updated 2016-11-01

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

groups

1. description

   Pomalidomide 4 mg by mouth (PO) daily (QD) on Days 1-21 of each 28-day cycle. Dexamethasone 40 mg PO once daily on Days 1, 8, 15, 22 of each 28-day cycle for those who are ≤ 75 years of age Dexamethasone 20 mg PO once daily on Days 1, 8, 15, 22 of each 28-day cycle for those who are \> 75 years of age

   id

   FG000

   title

   Pomalidomide Plus Dexamethasone

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         16

      type

      Disease Progression (DP)

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Insufficient effect of Pomalidomide

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Investigator's judgement- DP

   6. reasons

      1. group Id

         FG000

         num Subjects

         11

      type

      Study terminated by sponsor

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         36

      type

      STARTED

   2. achievements

      1. comment

         Completed = participants with progressive disease were considered as completed.

         group Id

         FG000

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         36

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Treatment phase discontinuation occurred when a participant had confirmed progressive disease, development of unacceptable toxicity, voluntary withdrawal or met other criteria for treatment discontinuation.

recruitment Details

All study participants who were on pomalidomide were transferred to the post-marketing study and continued the study treatment when pomalidomide became commercially available.

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

Preserved source evidence · Not medical advice