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NCT02489500 · OUTCOME

Overall Survival

Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib · Source last updated 2018-09-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
days
Interval / dispersion
Not reported
Time frame
5 years

What was measured

duration of overall survival measured in days

Analysis population: The protocol was closed prior to the 5-year period of assessment, so 5-year survival assessment of only two participants was assessed.

Groups in this outcome

Melphalan

Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion Melphalan: Conditioning Regimen: Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0 Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells Stem cell infusion: infusion of previously collected autologous stem cells

Melphalan + Bortezomib

Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion Bortezomib: Conditioning Regimen: Drug: Bortezomib: 1.0 mg/m2/dose D -6, D -3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Melphalan: Conditioning Regimen: Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0 Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells Stem cell infusion: infusion of previously collected autologous stem cells

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

Analysis denominator · Participants

GroupSource count
Melphalan1
Melphalan + Bortezomib1

Reported measurements

Source class 1
Values in days · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melphalan43Not reportedNot reportedNot reportedNot reported
Melphalan + Bortezomib29Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        29
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    units
    Participants
description
duration of overall survival measured in days
groups
  1. description
    Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion Melphalan: Conditioning Regimen: Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0 Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells Stem cell infusion: infusion of previously collected autologous stem cells
    id
    OG000
    title
    Melphalan
  2. description
    Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion Bortezomib: Conditioning Regimen: Drug: Bortezomib: 1.0 mg/m2/dose D -6, D -3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Melphalan: Conditioning Regimen: Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0 Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells Stem cell infusion: infusion of previously collected autologous stem cells
    id
    OG001
    title
    Melphalan + Bortezomib
param Type
NUMBER
population Description
The protocol was closed prior to the 5-year period of assessment, so 5-year survival assessment of only two participants was assessed.
reporting Status
POSTED
time Frame
5 years
title
Overall Survival
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice