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NCT01380145 · OUTCOME

Induction or Augmentation of MAGE-A3-Specific Cellular Immunity

MAGE-A3 Protein + AS15 as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation · Source last updated 2022-10-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Baseline, first immunization, and first and second leukopheresis prior to auto-SCT; Days 31, 73, 194, 284, and 374 after auto-SCT

What was measured

Cellular immunity was determined by enzyme-linked immunosorbent spot assay (ELISPOT) or intracellular flow cytometry to determine peripheral blood levels of interferon gamma-producing CD4+ and CD8+ T cells specific for MAGE-A3. Results were considered significant if \> 50 spots and \> 2 times the number of spots to negative control were observed.

Analysis population: The Immunogenicity Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.

Groups in this outcome

Immunogenicity Analysis Set

Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.

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

Analysis denominator · Participants

GroupSource count
Immunogenicity Analysis Set13

Reported measurements

Baseline CD4 T cell response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Immunogenicity Analysis Set6Not reportedNot reportedNot reportedNot reported
Post-immunization CD4 T-cell response/increase
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Immunogenicity Analysis Set13Not reportedNot reportedNot reportedNot reported
Baseline CD8 T cell response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Immunogenicity Analysis Set0Not reportedNot reportedNot reportedNot reported
Post-immunization CD8 T-cell response/increase
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Immunogenicity Analysis Set3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Baseline CD4 T cell response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Post-immunization CD4 T-cell response/increase
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Baseline CD8 T cell response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Post-immunization CD8 T-cell response/increase
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Cellular immunity was determined by enzyme-linked immunosorbent spot assay (ELISPOT) or intracellular flow cytometry to determine peripheral blood levels of interferon gamma-producing CD4+ and CD8+ T cells specific for MAGE-A3. Results were considered significant if \> 50 spots and \> 2 times the number of spots to negative control were observed.
groups
  1. description
    Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.
    id
    OG000
    title
    Immunogenicity Analysis Set
param Type
NUMBER
population Description
The Immunogenicity Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.
reporting Status
POSTED
time Frame
Baseline, first immunization, and first and second leukopheresis prior to auto-SCT; Days 31, 73, 194, 284, and 374 after auto-SCT
title
Induction or Augmentation of MAGE-A3-Specific Cellular Immunity
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice