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NCT01827137 · OUTCOME

WT1 T-cell Immune Response (IR) After Completion of All GPS Administrations

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
38 weeks after the initial GPS vaccine (end of booster series [GPS x 12 administrations])

What was measured

Number and percentage of participants with CD4 and/or CD8 immune responses against WT1 measured after all GPS administrations (12 x administrations)

Analysis population: 12 patients completed all 12 x GPS administrations

Groups in this outcome

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Galinpepimut-S + Montanide + GM-CSF12

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Galinpepimut-S + Montanide + GM-CSF12Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
Number and percentage of participants with CD4 and/or CD8 immune responses against WT1 measured after all GPS administrations (12 x administrations)
groups
  1. 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
    OG000
    title
    Galinpepimut-S + Montanide + GM-CSF
param Type
COUNT_OF_PARTICIPANTS
population Description
12 patients completed all 12 x GPS administrations
reporting Status
POSTED
time Frame
38 weeks after the initial GPS vaccine (end of booster series [GPS x 12 administrations])
title
WT1 T-cell Immune Response (IR) After Completion of All GPS Administrations
type
POST_HOC
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice