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NCT00090493 · FLOW

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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.

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
    FG000
    title
    MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Pre-study: hemogram, blood chemistry, Helper/Suppressor Panel, Immunoknow count, serum protein electrophoresis and immunofixation , serum freelites, 24-hr urine (protein and immunofixation), quantitation of immunoglobulins, B2M, IL6, bone marrow aspiration and biopsy, MRI, bone marrow collection for gene-array.
recruitment Details
All patients of the Myeloma Institute who have "high-risk" multiple myeloma because of abnormalities in their cytogenetics, could participate in this study at UAMS only. Final IRB approval was 6/14/04. The 1st participant was enrolled 4/4/05.
Complete source fields
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
    FG000
    title
    MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Pre-study: hemogram, blood chemistry, Helper/Suppressor Panel, Immunoknow count, serum protein electrophoresis and immunofixation , serum freelites, 24-hr urine (protein and immunofixation), quantitation of immunoglobulins, B2M, IL6, bone marrow aspiration and biopsy, MRI, bone marrow collection for gene-array.
recruitment Details
All patients of the Myeloma Institute who have "high-risk" multiple myeloma because of abnormalities in their cytogenetics, could participate in this study at UAMS only. Final IRB approval was 6/14/04. The 1st participant was enrolled 4/4/05.

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Preserved source evidence · Not medical advice