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NCT01045460 · OUTCOME

The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (bAlkaline Phosphatase Levels)

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Days 60, 180, 360

What was measured

bAlkaline phosphatase

Analysis population: This measure was not assessed. Data was not collected.

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. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Cyclophosphamide: Administered at 2.5 g/m\^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m\^2/day given on Days -2 and -1. Autologous stem cell transplant: Infused on Day 0.

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. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Allogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300. Cyclophosphamide: Administered at 2.5 g/m\^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m\^2/day given on Days -2

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 + MILs0
ASCT + MILs + Vaccine0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
bAlkaline phosphatase
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. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Cyclophosphamide: Administered at 2.5 g/m\^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m\^2/day given on Days -2 and -1. Autologous stem cell transplant: Infused on Day 0.
    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. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Allogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300. Cyclophosphamide: Administered at 2.5 g/m\^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m\^2/day given on Days -2
    id
    OG001
    title
    ASCT + MILs + Vaccine
population Description
This measure was not assessed. Data was not collected.
reporting Status
POSTED
time Frame
Days 60, 180, 360
title
The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (bAlkaline Phosphatase Levels)
type
SECONDARY

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

Preserved source evidence · Not medical advice