Participant flow

Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients · Source last updated 2014-03-13

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

groups

1. description

   Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6\*10\^6 CD34+ cells/kg were collected.

   id

   FG000

   title

   G-CSF Plus Plerixafor

2. description

   Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6\*10\^6 CD34+ cells/kg were collected.

   id

   FG001

   title

   G-CSF Plus Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         7

      type

      Entered Rescue Procedure

   2. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         7

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         5

      type

      Elective Withdrawal

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         9

      type

      Other

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         4

      type

      Failed mobilization

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Intercurrent illness

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         148

      2. group Id

         FG001

         num Subjects

         154

      type

      STARTED

   2. achievements

      1. comment

         1 participant was wrongly terminated due to 'other'; the participant stayed on study until death.

         group Id

         FG000

         num Subjects

         129

      2. comment

         1 participant was wrongly terminated due to 'other'; the participant stayed on study until death.

         group Id

         FG001

         num Subjects

         121

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         33

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Participants with multiple myeloma (MM) eligible for autologous hematopoietic stem cell transplant were recruited from 40 centers (38 in the U.S., 1 in Germany, 1 in Canada). The first participant was randomized on 04 February 2005 and the last participant's last study visit occurred on 22 January 2008. A total of 302 participants were randomized.

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Preserved source evidence · Not medical advice