NCT00424047

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

The Official Title is A Multi-center, Randomized, Parallel-group, Double-blind, Placebo Controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 351 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Multiple Myeloma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2003-01-01
• Primary completion: 2005-11-01
• Completion: 2013-11-12
• First posted: 2007-01-18
• Last updated: 2017-10-19
• Results posted: 2015-03-04

Locations

69 sites across 15 countries: Australia, Austria, Belgium, France, Germany, Greece, Ireland, Israel, Italy, Poland, Spain, Sweden, Switzerland, Ukraine, United Kingdom