Participant flow

Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma · Source last updated 2019-08-26

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

groups

1. description

   Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².

   id

   FG000

   title

   Bortezomib, Melphalan, Prednisone

2. description

   Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².

   id

   FG001

   title

   Carfilzomib, Melphalan, Prednisone

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         64

      2. group Id

         FG001

         num Subjects

         74

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         18

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         20

      type

      Non-compliance

   4. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         14

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         8

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         54

      2. group Id

         FG001

         num Subjects

         48

      type

      Disease Progression

   7. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         8

      type

      Other

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         4

      type

      Continuing Treatment

   9. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         4

      type

      Randomized but not Dosed

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         477

      2. group Id

         FG001

         num Subjects

         478

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         470

      2. group Id

         FG001

         num Subjects

         474

      type

      Received Treatment

   3. achievements

      1. comment

         Completed treatment

         group Id

         FG000

         num Subjects

         290

      2. comment

         Completed treatment

         group Id

         FG001

         num Subjects

         280

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         187

      2. group Id

         FG001

         num Subjects

         198

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Eligible participants were randomized in a 1:1 ratio. Randomization was stratified by International Staging System (ISS) stage (stage 1 versus stages 2 or 3), choice of route of bortezomib administration (intravenous \[IV\] versus subcutaneous \[SC\]), region (North America, Europe, Asia Pacific, or other), and age (\< 75 years versus ≥ 75 years).

recruitment Details

This study was conducted at 183 centers in Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Romania, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, and United States.

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

Preserved source evidence · Not medical advice