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NCT01827137 · OUTCOME

Progression-free Survival (PFS) From Autologous Stem Cell Transplant (ASCT)

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
MEDIAN
Unit
days
Interval / dispersion
95% Confidence Interval
Time frame
3 years and 8 months

What was measured

PFS measured from ASCT to time of myeloma progression (as defined by the International Myeloma Working Group \[IMW\] consensus criteria or subject death.

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-CSF19

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Galinpepimut-S + Montanide + GM-CSF717Not reported286NAUpper 95%CI not reached due to end of study monitoring duration
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper 95%CI not reached due to end of study monitoring duration
        group Id
        OG000
        lower Limit
        286
        upper Limit
        NA
        value
        717
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    units
    Participants
description
PFS measured from ASCT to time of myeloma progression (as defined by the International Myeloma Working Group \[IMW\] consensus criteria or subject death.
dispersion Type
95% Confidence Interval
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
MEDIAN
reporting Status
POSTED
time Frame
3 years and 8 months
title
Progression-free Survival (PFS) From Autologous Stem Cell Transplant (ASCT)
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice