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NCT00439465 · OUTCOME

Number of Participants With Adverse Events in All Subjects

Adoptive Cellular Immunotherapy Following Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma · Source last updated 2019-03-26

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
From initiation of treatment on protocol until Day 100

What was measured

To establish the safety (toxicity) of myeloma patients treated with high dose melphalan, autologous peripheral blood stem cell transplantation (APBSCT) \& adoptive transfer of cytotoxic effector cells with Interleukin-2 (IL-2) and Recombinant Human Granulocyte Colony Stimulating Factor (GM-CSF).

Groups in this outcome

Ex-vivo Expanded Effector Cells

Infusing IL-2 and GM-CSF post-Hematopoietic Stem-Cell Transplant (HSCT) Ex-vivo expanded effector cells: This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes.

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

Analysis denominator · Participants

GroupSource count
Ex-vivo Expanded Effector Cells23

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ex-vivo Expanded Effector Cells11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    units
    Participants
description
To establish the safety (toxicity) of myeloma patients treated with high dose melphalan, autologous peripheral blood stem cell transplantation (APBSCT) \& adoptive transfer of cytotoxic effector cells with Interleukin-2 (IL-2) and Recombinant Human Granulocyte Colony Stimulating Factor (GM-CSF).
groups
  1. description
    Infusing IL-2 and GM-CSF post-Hematopoietic Stem-Cell Transplant (HSCT) Ex-vivo expanded effector cells: This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes.
    id
    OG000
    title
    Ex-vivo Expanded Effector Cells
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
From initiation of treatment on protocol until Day 100
title
Number of Participants With Adverse Events in All Subjects
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice