Participant flow

S1304, Carfilzomib and Dexamethasone for Treating Patients With Relapsed or Refractory Myeloma · Source last updated 2024-12-20

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

groups

1. description

   Patients receive dexamethasone IV and low-dose carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with progression cross-over to Arm II. Carfilzomib: Given IV Dexamethasone: Given IV Laboratory Biomarker Analysis: Correlative studies

   id

   FG000

   title

   Arm I (Dexamethasone, Low-dose Carfilzomib)

2. description

   Patients receive dexamethasone IV and high-dose carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose over 2-10 minutes.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Carfilzomib: Given IV Dexamethasone: Given IV Laboratory Biomarker Analysis: Correlative studies

   id

   FG001

   title

   Arm II (Dexamethasone, High-dose Carfilzomib)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      No measurable disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Incomplete/discontinued prior therapy

   3. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         11

      type

      Baseline lab missing/incomplete/untimely

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         72

      2. group Id

         FG001

         num Subjects

         71

      type

      STARTED

   2. achievements

      1. comment

         Following disease progression on Arm I. Note: these patients are also counted in 'Completed'.

         group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         0

      type

      Crossover to Arm II

   3. achievements

      1. group Id

         FG000

         num Subjects

         64

      2. group Id

         FG001

         num Subjects

         57

      comment

      Completed implies patients were eligible for study treatment and analyzable for study endpoints.

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         14

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice