Participant flow

A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for Subjects With Multiple Myeloma · Source last updated 2019-11-20

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

groups

1. description

   Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle

   id

   FG000

   title

   Lenalidomide 25mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         181

      type

      Progression of Disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         46

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         40

      type

      Other

   4. reasons

      1. group Id

         FG000

         num Subjects

         14

      type

      Death

   5. reasons

      1. group Id

         FG000

         num Subjects

         13

      type

      Lack of therapeutic effect

   6. reasons

      1. group Id

         FG000

         num Subjects

         13

      type

      Withdrawal by Subject

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         330

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         330

      type

      Safety Population

   3. achievements

      1. comment

         Completed = those who completed the treatment phase and were ongoing in the extension study

         group Id

         FG000

         num Subjects

         21

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         309

      type

      NOT COMPLETED

   title

   Treatment Phase

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         6

      type

      Progressive Disease

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Lack of therapeutic effect

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Lost to Follow-up

   6. reasons

      1. group Id

         FG000

         num Subjects

         9

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         21

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         21

      type

      NOT COMPLETED

   title

   Extension Phase

pre Assignment Details

To be eligible participants must have developed disease progression or were unable to tolerate the lowest dosing regimen of thalidomide and/or high-dose dexamethasone without Grade 3 or 4 toxicity

recruitment Details

This was an international, open-label single arm study of oral lenalidomide in participants with multiple myeloma who had previously received high dose dexamethasone alone or in combination with thalidomide in the study NCT 00057564, or previously received high dose dexamethasone alone in studies NCT 00056160 and NCT 00424047.

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

Preserved source evidence · Not medical advice