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NCT00911859 · OUTCOME

1-year Survival Rate

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
1 year

What was measured

Percentage of participants who are alive at the end of year 1 after randomization

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 Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: VMP (Velcade+Melphalan+Prednisone)87.8Not reportedNot reportedNot reportedNot reported
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab87.5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        87.8
      2. group Id
        OG001
        value
        87.5
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    2. group Id
      OG001
      value
      52
    units
    Participants
description
Percentage of participants who are alive at the end of year 1 after randomization
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
NUMBER
population Description
Intent-to-treat (ITT) population: all randomized participants
reporting Status
POSTED
time Frame
1 year
title
1-year Survival Rate
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice