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NCT01045460 · OUTCOME

Response Rates by Blade Criteria

Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic Granulocyte Macrophage Colony-stimulating Factor (GM-CSF)-Based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma · Source last updated 2021-04-09

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
Up to 1 year

What was measured

Number of participants with each disease response category utilizing the Blade criteria: * Complete Response (CR): Defined as negative serum and urine immunofixation and a bone marrow aspirate with \< 5% plasma cells. * Near Complete Response (nCR): Defined as negative serum and urine paraprotein, positive serum and/or urine immunofixation, and a bone marrow aspirate with \< 5% plasma cells. * Very Good Partial Response (VGPR): Defined as negative serum and urine paraprotein with positive serum and/or urine immunofixation; or a 90% decrease in serum paraprotein with urine paraprotein \< 100 mg/24 hours. * Partial Response (PR): Defined as a 50-89% decrease in serum paraprotein. * Minimal Response (MR): Defined as a 25-49% decrease in serum paraprotein. * Stable Disease (SD): Defined as not falling into any other response category. * Overall response rate (ORR): Total of CR, nCR, VGPR, and PR.

Analysis population: Only participants who had ASCT were evaluated for response. Three participants on the ASCT + MILs arm and two participants on the ASCT + MILs + vaccine arm were removed from study prior to ASCT and were therefore not evaluable for this outcome.

Groups in this outcome

ASCT + MILs

Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.

ASCT + MILs + Vaccine

Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.

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

Analysis denominator · Participants

GroupSource count
ASCT + MILs14
ASCT + MILs + Vaccine16

Reported measurements

CR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ASCT + MILs2Not reportedNot reportedNot reportedNot reported
ASCT + MILs + Vaccine5Not reportedNot reportedNot reportedNot reported
nCR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ASCT + MILs3Not reportedNot reportedNot reportedNot reported
ASCT + MILs + Vaccine2Not reportedNot reportedNot reportedNot reported
VGPR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ASCT + MILs1Not reportedNot reportedNot reportedNot reported
ASCT + MILs + Vaccine1Not reportedNot reportedNot reportedNot reported
PR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ASCT + MILs4Not reportedNot reportedNot reportedNot reported
ASCT + MILs + Vaccine5Not reportedNot reportedNot reportedNot reported
MR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ASCT + MILs0Not reportedNot reportedNot reportedNot reported
ASCT + MILs + Vaccine1Not reportedNot reportedNot reportedNot reported
SD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ASCT + MILs4Not reportedNot reportedNot reportedNot reported
ASCT + MILs + Vaccine2Not reportedNot reportedNot reportedNot reported
ORR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ASCT + MILs10Not reportedNot reportedNot reportedNot reported
ASCT + MILs + Vaccine13Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        5
    title
    CR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
    title
    nCR
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    VGPR
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        5
    title
    PR
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    MR
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        2
    title
    SD
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        13
    title
    ORR
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      16
    units
    Participants
description
Number of participants with each disease response category utilizing the Blade criteria: * Complete Response (CR): Defined as negative serum and urine immunofixation and a bone marrow aspirate with \< 5% plasma cells. * Near Complete Response (nCR): Defined as negative serum and urine paraprotein, positive serum and/or urine immunofixation, and a bone marrow aspirate with \< 5% plasma cells. * Very Good Partial Response (VGPR): Defined as negative serum and urine paraprotein with positive serum and/or urine immunofixation; or a 90% decrease in serum paraprotein with urine paraprotein \< 100 mg/24 hours. * Partial Response (PR): Defined as a 50-89% decrease in serum paraprotein. * Minimal Response (MR): Defined as a 25-49% decrease in serum paraprotein. * Stable Disease (SD): Defined as not falling into any other response category. * Overall response rate (ORR): Total of CR, nCR, VGPR, and PR.
groups
  1. description
    Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.
    id
    OG000
    title
    ASCT + MILs
  2. description
    Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.
    id
    OG001
    title
    ASCT + MILs + Vaccine
param Type
COUNT_OF_PARTICIPANTS
population Description
Only participants who had ASCT were evaluated for response. Three participants on the ASCT + MILs arm and two participants on the ASCT + MILs + vaccine arm were removed from study prior to ASCT and were therefore not evaluable for this outcome.
reporting Status
POSTED
time Frame
Up to 1 year
title
Response Rates by Blade Criteria
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice