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NCT01045460 · ADVERSE EVENTS

Adverse events

Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic Granulocyte Macrophage Colony-stimulating Factor (GM-CSF)-Based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma · Source last updated 2021-04-09

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

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Up to 1 year
Other-event reporting threshold
0%

All adverse events related to MILs or vaccine administration were collected. Adverse events related to ASCT were not collected.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
ASCT + MILs

Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.

0 / 176 / 177 / 17
ASCT + MILs + Vaccine

Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.

0 / 1815 / 186 / 18

Group identifiers: EG000: ASCT + MILs · EG001: ASCT + MILs + Vaccine

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        17
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        18
        num Events
        1
      term
      Anemia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        17
        num Events
        3
      2. group Id
        EG001
        num Affected
        5
        num At Risk
        18
        num Events
        6
      term
      Diarrhea
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        17
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        18
        num Events
        1
      term
      Fever
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        17
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        18
        num Events
        1
      term
      Flu-like symptoms
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        17
        num Events
        0
      2. group Id
        EG001
        num Affected
        14
        num At Risk
        18
        num Events
        40
      term
      Injection site reaction
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        17
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        18
        num Events
        1
      term
      Pancytopenia
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        17
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        18
        num Events
        1
      term
      Pruritis
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        17
        num Events
        6
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        18
        num Events
        3
      term
      Rash
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        17
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        18
        num Events
        1
      term
      Thrombocytopenia
    Complete source fields
    description
    All adverse events related to MILs or vaccine administration were collected. Adverse events related to ASCT were not collected.
    event Groups
    1. deaths Num Affected
      7
      deaths Num At Risk
      17
      description
      Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.
      id
      EG000
      other Num Affected
      6
      other Num At Risk
      17
      serious Num Affected
      0
      serious Num At Risk
      17
      title
      ASCT + MILs
    2. deaths Num Affected
      6
      deaths Num At Risk
      18
      description
      Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.
      id
      EG001
      other Num Affected
      15
      other Num At Risk
      18
      serious Num Affected
      0
      serious Num At Risk
      18
      title
      ASCT + MILs + Vaccine
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        17
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        18
        num Events
        1
      term
      Anemia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        17
        num Events
        3
      2. group Id
        EG001
        num Affected
        5
        num At Risk
        18
        num Events
        6
      term
      Diarrhea
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        17
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        18
        num Events
        1
      term
      Fever
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        17
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        18
        num Events
        1
      term
      Flu-like symptoms
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        17
        num Events
        0
      2. group Id
        EG001
        num Affected
        14
        num At Risk
        18
        num Events
        40
      term
      Injection site reaction
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        17
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        18
        num Events
        1
      term
      Pancytopenia
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        17
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        18
        num Events
        1
      term
      Pruritis
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        17
        num Events
        6
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        18
        num Events
        3
      term
      Rash
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        17
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        18
        num Events
        1
      term
      Thrombocytopenia
    time Frame
    Up to 1 year

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

    Preserved source evidence · Not medical advice