NCT00057564

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

A Multicenter, Randomized, Parallel-group , Double Blind, Placebo-controlled Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone as Induction Therapy for Previously Untreated Subjects With Multiple Myeloma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 470 (actual)
• Sponsor: Celgene Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	A (Thalidomide + Dexamethasone)	Thalidomide 50mg/day + Dexamethasone 40mg
DRUG	B (Placebo + Dexamethasone)	Placebo + Dexamethasone 40mg

Timeline

• Start date: 2003-02-01
• Primary completion: 2006-04-01
• Completion: 2013-08-01
• First posted: 2003-04-07
• Last updated: 2015-09-11

Locations

99 sites across 16 countries: United States, Australia, Belgium, Bulgaria, Canada, Germany, Hungary, Ireland, Israel, Italy, Poland, Russia, Spain, Switzerland, Ukraine, United Kingdom