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NCT00911859 · OUTCOME

Duration of Response (DOR)

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 participants achieved CR or PR to either date for disease progression (including relapse from CR) or the censoring date for progressive disease, as assessed Up to 30 days after last dose of study medication

What was measured

DOR was defined as length from the earliest date a participant achieved a complete response (CR) or partial response (PR) to either date for disease progression (including relapse from CR) or the censoring date for progressive disease. Responders without disease progression were censored at the last efficacy assessment for disease progression.

Analysis population: Included participants in the randomized population who achieved CR or PR.

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)39
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab43

Reported measurements

Source class 1
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 2: VMP (Velcade+Melphalan+Prednisone)497Not reported457637Not reported
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab583Not reported449NAInsufficient number of participants with events; therefore, upper limit of 95% CI not reached.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        457
        upper Limit
        637
        value
        497
      2. comment
        Insufficient number of participants with events; therefore, upper limit of 95% CI not reached.
        group Id
        OG001
        lower Limit
        449
        upper Limit
        NA
        value
        583
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    2. group Id
      OG001
      value
      43
    units
    Participants
description
DOR was defined as length from the earliest date a participant achieved a complete response (CR) or partial response (PR) to either date for disease progression (including relapse from CR) or the censoring date for progressive disease. Responders without disease progression were censored at the last efficacy assessment for disease progression.
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
Included participants in the randomized population who achieved CR or PR.
reporting Status
POSTED
time Frame
From the date participants achieved CR or PR to either date for disease progression (including relapse from CR) or the censoring date for progressive disease, as assessed Up to 30 days after last dose of study medication
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice