Participant flow

Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma · Source last updated 2018-01-23

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

groups

1. description

   Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.

   id

   FG000

   title

   Elotuzumab, 20 mg/kg

2. description

   Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.

   id

   FG001

   title

   Elotuzumab, 10 mg/kg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         6

      type

      Disease progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      type

      Adverse event unrelated to study drug

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Participant request to discontinue

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Poor compliance/noncompliance

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         5

      type

      Administrative reason by sponsor

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Participant withdrew consent

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         16

      type

      STARTED

   2. achievements

      1. comment

         Still receiving treatment

         group Id

         FG000

         num Subjects

         0

      2. comment

         Still receiving treatment

         group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         16

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

The study enrolled a total of 41 participants, and 31 received treatment. The 10 participants enrolled who did not receive treatment failed to meet the inclusion criteria.

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

Preserved source evidence · Not medical advice