Participant flow

Phase 2 Study of Carfilzomib in Relapsed Multiple Myeloma · Source last updated 2017-05-02

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

groups

1. description

   Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.

   id

   FG000

   title

   Part 1: Carfilzomib 20 mg/m²

2. description

   Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.

   id

   FG001

   title

   Part 2: Carfilzomib 20 mg/m²

3. description

   Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of subsequent cycles, for up to 12 cycles.

   id

   FG002

   title

   Part 2: Carfilzomib 20/27 mg/m²

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         24

      3. group Id

         FG002

         num Subjects

         24

      type

      Progressive Disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         13

      3. group Id

         FG002

         num Subjects

         7

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         4

      type

      Other

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         6

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         35

      2. group Id

         FG001

         num Subjects

         59

      3. group Id

         FG002

         num Subjects

         70

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         17

      3. group Id

         FG002

         num Subjects

         29

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         26

      2. group Id

         FG001

         num Subjects

         42

      3. group Id

         FG002

         num Subjects

         41

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Two groups of patients with MM were initially studied: bortezomib-treated (Part 1) and bortezomib-naïve (Part 2). Following Amendment 2, only bortezomib-naïve patients were enrolled. With Amendment 3, a new cohort of "stepped up" dosing was added to the trial. Study results were analyzed in 2 parts, based on previous bortezomib treatment.

recruitment Details

This study enrolled patients with multiple myeloma (MM) who had relapsed or refractory disease after at least 1 but no more than 3 prior therapeutic treatments or regimens. The first patient enrolled on 24 September 2007; the last patient was enrolled and received carfilzomib on 28 May 2009.

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Preserved source evidence · Not medical advice