Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00615589 · OUTCOME

The Percentage of Patients Free From Progression at 1 Year

Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen · Source last updated 2016-04-04

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
95% Confidence Interval
Time frame
1 Year

What was measured

One of the secondary outcomes that will be measured is progression free survival at 1 Year. Progressive Disease (PD) is defined as a \>25% increase in serum monoclonal paraprotein, a \>25% increase in 24-hour urinary light chain excretion, a \>25% increase in plasma cells in bone marrow aspirate, an increase in the size or the development of new bone lesions/soft tissue plasmacytomas, or the development of hypercalcemia.

Groups in this outcome

Flu-Bu4

Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor. Fludarabine/Busulfan x 4 days: Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant. Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2. The Fludarabine shall be administered prior to the Busulfan each day.

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

Analysis denominator · Participants

GroupSource count
Flu-Bu422

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Flu-Bu440Not reported2367Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23
        upper Limit
        67
        value
        40
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    units
    Participants
description
One of the secondary outcomes that will be measured is progression free survival at 1 Year. Progressive Disease (PD) is defined as a \>25% increase in serum monoclonal paraprotein, a \>25% increase in 24-hour urinary light chain excretion, a \>25% increase in plasma cells in bone marrow aspirate, an increase in the size or the development of new bone lesions/soft tissue plasmacytomas, or the development of hypercalcemia.
dispersion Type
95% Confidence Interval
groups
  1. description
    Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor. Fludarabine/Busulfan x 4 days: Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant. Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2. The Fludarabine shall be administered prior to the Busulfan each day.
    id
    OG000
    title
    Flu-Bu4
param Type
NUMBER
reporting Status
POSTED
time Frame
1 Year
title
The Percentage of Patients Free From Progression at 1 Year
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice