NCT01827137 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Galinpepimut-S (GPS) vaccinations are started 12-22 days following autologous stem cell transplantation (ASCT). GPS and Montanide (in a 1 mL emulsion) are administered subcutaneously (s.c.) Q2W on weeks 0, 2, 4, 6, 8, and 10. GM-CSF (70 μg) are administered s.c. one to two days before and on the day of GPS/Montanide administration. Participants whose disease has not progressed and who are clinically stable (no active infection with fevers and no cardiovascular/respiratory compromise) may receive up to 6 additional monthly vaccinations. The use of post-ASCT maintenance therapy is allowed starting 3 months after ASCT. Galinpepimut-S: Galinpepimut-S admixed with the adjuvant Montanide following specified schedule GM-CSF: subcutaneous injection Montanide: adjuvant lenalidomide: optional post-ASCT therapy bortezomib: optional post-ASCT therapy
- id
- FG000
- title
- Galinpepimut-S + Montanide + GM-CSF
- periods
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 20
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 19
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- Galinpepimut-S (GPS) vaccinations are started 12-22 days following autologous stem cell transplantation (ASCT). GPS and Montanide (in a 1 mL emulsion) are administered subcutaneously (s.c.) Q2W on weeks 0, 2, 4, 6, 8, and 10. GM-CSF (70 μg) are administered s.c. one to two days before and on the day of GPS/Montanide administration. Participants whose disease has not progressed and who are clinically stable (no active infection with fevers and no cardiovascular/respiratory compromise) may receive up to 6 additional monthly vaccinations. The use of post-ASCT maintenance therapy is allowed starting 3 months after ASCT. Galinpepimut-S: Galinpepimut-S admixed with the adjuvant Montanide following specified schedule GM-CSF: subcutaneous injection Montanide: adjuvant lenalidomide: optional post-ASCT therapy bortezomib: optional post-ASCT therapy
- id
- FG000
- title
- Galinpepimut-S + Montanide + GM-CSF
- periods
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 20
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 19
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- type
- NOT COMPLETED
- title
- Overall Study
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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