Participant flow

Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients · Source last updated 2022-11-14

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

groups

1. description

   Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.

   id

   FG000

   title

   Bortezomib + DEX

2. description

   Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.

   id

   FG001

   title

   Carfilzomib + DEX

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         208

      2. group Id

         FG001

         num Subjects

         183

      type

      Disease Progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         94

      2. group Id

         FG001

         num Subjects

         96

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         55

      2. group Id

         FG001

         num Subjects

         71

      type

      Patient Request

   4. reasons

      1. group Id

         FG000

         num Subjects

         40

      2. group Id

         FG001

         num Subjects

         32

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         11

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         18

      type

      Death

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      type

      Protocol Non-compliance

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   9. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         1

      type

      Randomized but Not Dosed

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         465

      2. group Id

         FG001

         num Subjects

         464

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         456

      2. group Id

         FG001

         num Subjects

         463

      type

      Received Treatment

   3. achievements

      1. comment

         Indicates participants still receiving treatment

         group Id

         FG000

         num Subjects

         27

      2. comment

         Indicates participants still receiving treatment

         group Id

         FG001

         num Subjects

         48

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         438

      2. group Id

         FG001

         num Subjects

         416

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Randomization was stratified by previous proteasome inhibitor therapy (yes vs no), previous lines of treatment (1 vs 2 or 3), International Staging System stage (I vs II-III), and planned route of bortezomib administration (intravenous vs subcutaneous) if randomly assigned to the bortezomib group.

recruitment Details

Adults with relapsed multiple myeloma were enrolled between 20 June 2012 and 30 June 2014 at 198 centers in 27 countries in Europe, North America, South America, and the Asia-Pacific region. Results are reported as of the data cut-off date of 03 January 2017, the pre-specified 2nd interim analysis of the secondary endpoint of overall survival.

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Preserved source evidence · Not medical advice