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A Phase 3 Study of Siltuximab or Placebo in Combination With Velcade and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

NCT01266811 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2013-01-28

No results posted yet for this study

Summary

The purpose of this study is to determine if there is an improvement in progression-free survival (length of time during and after treatment in which a patient is living with a disease that does not get worse) when siltuximab is added to VELCADE and dexamethasone in subjects with relapsed or refractory multiple myeloma.

Conditions

Interventions

DRUG

Placebo, Velcade and dexamethasone

Siltuximab 11 mg/kg as 1 hour IV infusion on Day 1 of every cycle

BIOLOGICAL

Siltuximab, Velcade and dexamethasone

Given in 21-day treatment cycles

Sponsors & Collaborators

  • Centocor, Inc.

    lead INDUSTRY

Principal Investigators

  • Centocor, Inc. Clinical Trial · Centocor, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-04-30
Completion
2014-12-31

Countries

  • United States
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • India
  • Netherlands
  • New Zealand
  • Poland
  • South Korea
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01266811 on ClinicalTrials.gov