Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00911859 · OUTCOME

Progression-Free Survival (PFS)

A Study to Compare CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone (VMP) With VMP Alone in Previously Untreated Multiple Myeloma Patients · Source last updated 2014-11-18

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

Measure
MEDIAN
Unit
Days
Interval / dispersion
95% Confidence Interval
Time frame
From the date of randomization until disease progression or death, whichever occurred first, as assessed up to the last efficacy assessment for disease progression (approximately 3 years)

What was measured

PFS was defined as the time between randomization and either disease progression or death, whichever occurred first.

Analysis population: Intent-to-treat (ITT) population: all randomized participants.

Groups in this outcome

Part 2: VMP (Velcade+Melphalan+Prednisone)

Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.

Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab

Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.

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

Analysis denominator · Participants

GroupSource count
Part 2: VMP (Velcade+Melphalan+Prednisone)54
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab52

Reported measurements

Source class 1
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 2: VMP (Velcade+Melphalan+Prednisone)518Not reported460582Not reported
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab519Not reported443673Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        460
        upper Limit
        582
        value
        518
      2. group Id
        OG001
        lower Limit
        443
        upper Limit
        673
        value
        519
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    2. group Id
      OG001
      value
      52
    units
    Participants
description
PFS was defined as the time between randomization and either disease progression or death, whichever occurred first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
    id
    OG000
    title
    Part 2: VMP (Velcade+Melphalan+Prednisone)
  2. description
    Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
    id
    OG001
    title
    Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab
param Type
MEDIAN
population Description
Intent-to-treat (ITT) population: all randomized participants.
reporting Status
POSTED
time Frame
From the date of randomization until disease progression or death, whichever occurred first, as assessed up to the last efficacy assessment for disease progression (approximately 3 years)
title
Progression-Free Survival (PFS)
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice