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A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

NCT00424047 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2017-10-19

Study results available
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Summary

To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for subjects with relapsed or refractory multiple myeloma."

Conditions

Interventions

DRUG

CC-5013 plus dexamethasone

25 mg daily for 21 days every 28 days.

DRUG

Dexamethasone plus Placebo

Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle.

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Robert Knight, MD · Celgene Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-01
Primary Completion
2005-11-01
Completion
2013-11-12

Countries

  • Australia
  • Austria
  • Belgium
  • France
  • Germany
  • Greece
  • Ireland
  • Israel
  • Italy
  • Poland
  • Spain
  • Sweden
  • Switzerland
  • Ukraine
  • United Kingdom

Study Locations

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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 NCT00424047 on ClinicalTrials.gov