Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
NCT ID:
NCT00090493
Group ID:
EG000
Title:
MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY
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.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
3
Serious Number At Risk:
4
Other Number Affected:
0
Other Number At Risk:
4
Study:
NCT00090493
Results Section:
NCT00090493
Adverse Events Module:
NCT00090493