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A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma

NCT00057564 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2015-09-11

No results posted yet for this study

Summary

To compare the efficacy of combination oral thalidomide plus oral dexamethasone treatment to that of oral dexamethasone-alone treatments as induction (first-line) therapy for subjects with active multiple myeloma

Conditions

Interventions

DRUG

A (Thalidomide + Dexamethasone)

Thalidomide 50mg/day + Dexamethasone 40mg

DRUG

B (Placebo + Dexamethasone)

Placebo + Dexamethasone 40mg

Sponsors & Collaborators

  • Celgene Corporation

    lead INDUSTRY

Principal Investigators

  • Robert Knight, MD · Celgene Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2006-04-30
Completion
2013-08-31

Countries

  • United States
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Poland
  • Russia
  • Spain
  • Switzerland
  • 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 NCT00057564 on ClinicalTrials.gov