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NCT01453101 · OUTCOME

Progression Free Survival

Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma · Source last updated 2026-04-08

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
Full Range
Time frame
Subjects will be followed for progression-free survival for at least 36 months

What was measured

The main primary endpoint of this study is two-year progression free survival. Patients are considered a failure with respect to PFS if they die or experience disease progression or relapse. The time to this event is the time from transplantation to relapse/progression, initiation of non-protocol anti-myeloma therapy, or death from any cause. Subjects alive without confirmed disease progression will be censored at the time of last disease evaluation. Deaths without progression are treated as failures no matter when they occur.

Groups in this outcome

Fludarabine, Melphalan, Bortezomib

Fludarabine monophosphate, melphalan, Bortezomib: •Fludarabine will be administered at a dose of 30/mg/m2 IV daily for 4 days starting on transplant day -5. * Melphalan will be administered at a dose of 140 mg/m2 on transplant day-2 * Bortezomib will be administered by rapid IV push at a dose of 1.6mg/m2 on days-4 and -1. The bortezomib should be given at least 20 hours after the melphalan.

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

Analysis denominator · Participants

GroupSource count
Fludarabine, Melphalan, Bortezomib54

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Fludarabine, Melphalan, Bortezomib16.7Not reported0.361.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.3
        upper Limit
        61.1
        value
        16.7
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    units
    Participants
description
The main primary endpoint of this study is two-year progression free survival. Patients are considered a failure with respect to PFS if they die or experience disease progression or relapse. The time to this event is the time from transplantation to relapse/progression, initiation of non-protocol anti-myeloma therapy, or death from any cause. Subjects alive without confirmed disease progression will be censored at the time of last disease evaluation. Deaths without progression are treated as failures no matter when they occur.
dispersion Type
Full Range
groups
  1. description
    Fludarabine monophosphate, melphalan, Bortezomib: •Fludarabine will be administered at a dose of 30/mg/m2 IV daily for 4 days starting on transplant day -5. * Melphalan will be administered at a dose of 140 mg/m2 on transplant day-2 * Bortezomib will be administered by rapid IV push at a dose of 1.6mg/m2 on days-4 and -1. The bortezomib should be given at least 20 hours after the melphalan.
    id
    OG000
    title
    Fludarabine, Melphalan, Bortezomib
param Type
MEDIAN
reporting Status
POSTED
time Frame
Subjects will be followed for progression-free survival for at least 36 months
title
Progression Free Survival
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice