Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01292486 · FLOW

Participant flow

Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure · Source last updated 2013-05-01

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

groups
  1. description
    This was a single arm study, which evaluated Multiple Myeloma patients who received autologous stem-cell transplants collected using the Spectra Optia Apheresis System, following myeloablative therapy. The study was limited to subjects who were expected to demonstrate normal neutrophil recovery.
    id
    FG000
    title
    All Per Protocol Patients
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Protocol Violation
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Did not meet screening criteria
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        32
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        26
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
This was a single arm study, which evaluated Multiple Myeloma patients who received autologous stem-cell transplants collected using the Spectra Optia Apheresis System, following myeloablative therapy. The study was limited to subjects who were expected to demonstrate normal neutrophil recovery.
recruitment Details
Patients requiring a first peripheral blood stem cell collection and transplant for multiple myeloma were recruited at four clinical centers from March through October, 2011.
Complete source fields
groups
  1. description
    This was a single arm study, which evaluated Multiple Myeloma patients who received autologous stem-cell transplants collected using the Spectra Optia Apheresis System, following myeloablative therapy. The study was limited to subjects who were expected to demonstrate normal neutrophil recovery.
    id
    FG000
    title
    All Per Protocol Patients
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Protocol Violation
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Did not meet screening criteria
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        32
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        26
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
This was a single arm study, which evaluated Multiple Myeloma patients who received autologous stem-cell transplants collected using the Spectra Optia Apheresis System, following myeloablative therapy. The study was limited to subjects who were expected to demonstrate normal neutrophil recovery.
recruitment Details
Patients requiring a first peripheral blood stem cell collection and transplant for multiple myeloma were recruited at four clinical centers from March through October, 2011.

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

Preserved source evidence · Not medical advice