Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00090493 · ADVERSE EVENTS

Adverse events

Study of MAGE-A3 and NY-ESO-1 Immunotherapy in Combo With DTPACE Chemo and Auto Transplantation in Multiple Myeloma · Source last updated 2013-06-24

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
Not reported
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY

Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells. MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals. MAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating.

3 / 40 / 4Not reported / Not reported

Group identifiers: EG000: MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY

Serious 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
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
      num Events
      3
    term
    DVT
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Shingles
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
      num Events
      3
    term
    Staphyloccocal infections

Other reported adverse events

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

    Complete source fields
    event Groups
    1. description
      Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells. MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals. MAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating.
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      4
      serious Num Affected
      3
      serious Num At Risk
      4
      title
      MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY
    frequency Threshold
    0
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Vascular disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        4
        num Events
        3
      term
      DVT
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
        num Events
        1
      term
      Shingles
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        4
        num Events
        3
      term
      Staphyloccocal infections

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

    Preserved source evidence · Not medical advice