Participant flow

A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2017-04-07

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

groups

1. description

   Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.

   id

   FG000

   title

   Thalidomide + Dexamethasone

2. description

   DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.

   id

   FG001

   title

   DOXIL + Thalidomide + Dexamethasone

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         44

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         8

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol Violation

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      type

      Death

   5. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         1

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         2

      type

      Disease Progression

   7. reasons

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         27

      type

      Transplant planned

   8. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         13

      type

      Other

   milestones

   1. achievements

      1. comment

         Enrollment at randomization

         group Id

         FG000

         num Subjects

         113

      2. comment

         Enrollment at randomization

         group Id

         FG001

         num Subjects

         112

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         110

      2. group Id

         FG001

         num Subjects

         106

      type

      Received Study Medication

   3. achievements

      1. comment

         Completion of 2 or more cycles after CR or nCR, or completion of 12 cycles.

         group Id

         FG000

         num Subjects

         7

      2. comment

         Completion of 2 or more cycles after CR or nCR, or completion of 12 cycles.

         group Id

         FG001

         num Subjects

         12

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         106

      2. group Id

         FG001

         num Subjects

         100

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 225 participants were randomnly assigned to treatment, 113 participants to the thal/dex group and 112 participants to the DOXIL/thal/dex group.

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

Preserved source evidence · Not medical advice