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NCT01380145 · OUTCOME

Assessment of Tumor Response

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
At 3 and 12 months after auto-SCT

What was measured

Tumor responses were evaluated using appropriate imaging methods and were categorized according to the IMWG criteria, which includes the following response designations: Complete Response (CR): negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, \<5% plasma cells in bone marrow; Stringent CR (sCR): CR + normal free light chain (FLC) ratio and absence of clonal cells in bone marrow; Very Good Partial Response (VGPR): Serum/urine M-component detectable by immunofixation but not electropheresis OR ≥90% reduction in serum M-component + urine M-component \<100 mg/24 hrs; Partial Response (PR): ≥50% reduction of serum M-protein and reduction in 24-hr urinary M-protein by ≥90% or to \<200 mg/24 hrs Stable disease: not response or progression

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

Groups in this outcome

Evaluable Analysis Set

Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease 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
Evaluable Analysis Set13

Reported measurements

Day 94: Stringent Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Evaluable Analysis Set2Not reportedNot reportedNot reportedNot reported
Day 94: Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Evaluable Analysis Set3Not reportedNot reportedNot reportedNot reported
Day 94: Very Good Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Evaluable Analysis Set8Not reportedNot reportedNot reportedNot reported
Day 360: Stringent Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Evaluable Analysis Set4Not reportedNot reportedNot reportedNot reported
Day 360: Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Evaluable Analysis Set1Not reportedNot reportedNot reportedNot reported
Day 360: Very Good Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Evaluable Analysis Set4Not reportedNot reportedNot reportedNot reported
Day 360: Progressive Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Evaluable Analysis Set4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Day 94: Stringent Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Day 94: Complete Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Day 94: Very Good Partial Response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Day 360: Stringent Complete Response
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Day 360: Complete Response
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Day 360: Very Good Partial Response
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Day 360: Progressive Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Tumor responses were evaluated using appropriate imaging methods and were categorized according to the IMWG criteria, which includes the following response designations: Complete Response (CR): negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, \<5% plasma cells in bone marrow; Stringent CR (sCR): CR + normal free light chain (FLC) ratio and absence of clonal cells in bone marrow; Very Good Partial Response (VGPR): Serum/urine M-component detectable by immunofixation but not electropheresis OR ≥90% reduction in serum M-component + urine M-component \<100 mg/24 hrs; Partial Response (PR): ≥50% reduction of serum M-protein and reduction in 24-hr urinary M-protein by ≥90% or to \<200 mg/24 hrs Stable disease: not response or progression
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 disease assessment.
    id
    OG000
    title
    Evaluable Analysis Set
param Type
NUMBER
population Description
The Evaluable Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.
reporting Status
POSTED
time Frame
At 3 and 12 months after auto-SCT
title
Assessment of Tumor Response
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice