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NCT01245673 · OUTCOME

Primary Myeloma Endpoint

Combination Immunotherapy and Autologous Stem Cell Transplantation for Myeloma · Source last updated 2020-04-06

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
Between day 100 and 180 post transplant

What was measured

To determine whether lenalidomide maintenance plus the late booster immunizations leads to improved myeloma clinical responses between day 180 and day 100 post-transplant.

Analysis population: Subjects that reached D100 and D180

Groups in this outcome

Prevnar, T Cells, Lenalidomide, MAGE A-3

All patients will receive a priming immunization with a MAGE-A3/GM-CSF vaccine with adjuvant Hiltonol® (Poly-ICLC) along with the pneumococcal conjugate vaccine/PCV control vaccine about 10 days before a steady-state mononuclear cell apheresis. Patients will then undergo hematopoietic stem cell mobilization. All patients will receive high-dose melphalan followed by hematopoietic stem cells on day 0.

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

Analysis denominator · Participants

GroupSource count
Prevnar, T Cells, Lenalidomide, MAGE A-326

Reported measurements

Source class 1

Subjects in CR D100 and D180

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Prevnar, T Cells, Lenalidomide, MAGE A-34Not reportedNot reportedNot reportedNot reported

Subjects in sCR D100 and 180

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Prevnar, T Cells, Lenalidomide, MAGE A-31Not reportedNot reportedNot reportedNot reported

Subjects in VGPR D100 and D180

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Prevnar, T Cells, Lenalidomide, MAGE A-31Not reportedNot reportedNot reportedNot reported

Subjects in PR D100 and D180

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Prevnar, T Cells, Lenalidomide, MAGE A-35Not reportedNot reportedNot reportedNot reported

Subjects with SD at D+100 and 180

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Prevnar, T Cells, Lenalidomide, MAGE A-33Not reportedNot reportedNot reportedNot reported

Subjects with improved response at D100 and D180

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Prevnar, T Cells, Lenalidomide, MAGE A-36Not reportedNot reportedNot reportedNot reported

Subjects with poorer response at D100 and D180

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Prevnar, T Cells, Lenalidomide, MAGE A-34Not reportedNot reportedNot reportedNot reported

Subjects with no disease response reported

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Prevnar, T Cells, Lenalidomide, MAGE A-32Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      title
      Subjects in CR D100 and D180
    2. measurements
      1. group Id
        OG000
        value
        1
      title
      Subjects in sCR D100 and 180
    3. measurements
      1. group Id
        OG000
        value
        1
      title
      Subjects in VGPR D100 and D180
    4. measurements
      1. group Id
        OG000
        value
        5
      title
      Subjects in PR D100 and D180
    5. measurements
      1. group Id
        OG000
        value
        3
      title
      Subjects with SD at D+100 and 180
    6. measurements
      1. group Id
        OG000
        value
        6
      title
      Subjects with improved response at D100 and D180
    7. measurements
      1. group Id
        OG000
        value
        4
      title
      Subjects with poorer response at D100 and D180
    8. measurements
      1. group Id
        OG000
        value
        2
      title
      Subjects with no disease response reported
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
To determine whether lenalidomide maintenance plus the late booster immunizations leads to improved myeloma clinical responses between day 180 and day 100 post-transplant.
groups
  1. description
    All patients will receive a priming immunization with a MAGE-A3/GM-CSF vaccine with adjuvant Hiltonol® (Poly-ICLC) along with the pneumococcal conjugate vaccine/PCV control vaccine about 10 days before a steady-state mononuclear cell apheresis. Patients will then undergo hematopoietic stem cell mobilization. All patients will receive high-dose melphalan followed by hematopoietic stem cells on day 0.
    id
    OG000
    title
    Prevnar, T Cells, Lenalidomide, MAGE A-3
param Type
COUNT_OF_PARTICIPANTS
population Description
Subjects that reached D100 and D180
reporting Status
POSTED
time Frame
Between day 100 and 180 post transplant
title
Primary Myeloma Endpoint
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice