NCT01827137 · ADVERSE EVENTS

Adverse events

WT1 Vaccine Treatment of Patients With Multiple Myeloma After Autologous Stem Cell Transplantation · Source last updated 2024-09-19

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: 4.5 years
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Galinpepimut-S + Montanide + GM-CSF 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	0 / 20	20 / 20	2 / 20

Group identifiers: EG000: Galinpepimut-S + Montanide + GM-CSF

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.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
20
num At Risk
20
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
20
num At Risk
20
term
Hyperglycemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
20
num At Risk
20
term
Hypoalbuminemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
20
num At Risk
20
term
Lymphocyte count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
20
num At Risk
20
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
20
num At Risk
20
term
Platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
20
num At Risk
20
term
White blood cell decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
19
num At Risk
20
term
Hypocalcemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
14
num At Risk
20
term
Alanine aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
12
num At Risk
20
term
Aspartate aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
12
num At Risk
20
term
Hypokalemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
10
num At Risk
20
term
Hypomagnesemia

Complete source fields

event Groups

deaths Num Affected
2
deaths Num At Risk
20
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
EG000
other Num Affected
20
other Num At Risk
20
serious Num Affected
0
serious Num At Risk
20
title
Galinpepimut-S + Montanide + GM-CSF

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
20
num At Risk
20
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
20
num At Risk
20
term
Hyperglycemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
20
num At Risk
20
term
Hypoalbuminemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
20
num At Risk
20
term
Lymphocyte count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
20
num At Risk
20
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
20
num At Risk
20
term
Platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
20
num At Risk
20
term
White blood cell decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
19
num At Risk
20
term
Hypocalcemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
14
num At Risk
20
term
Alanine aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
12
num At Risk
20
term
Aspartate aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
12
num At Risk
20
term
Hypokalemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
10
num At Risk
20
term
Hypomagnesemia

time Frame

4.5 years

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

Preserved source evidence · Not medical advice