NCT00622336

A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for Subjects With Multiple Myeloma

Open-Label, Single-Arm Study of the Safety and Efficacy of CC-5013 Monotherapy for Subjects With Multiple Myeloma: A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study evaluated the safety of Lenalidomide monotherapy in participants with advanced multiple myeloma who had discontinued treatment with combination thalidomide plus high-dose dexamethasone or high-dose dexamethasone alone in studies Thal-MM-003, CC-5013-MM-009 and CC-5013-MM-010 due to the development of documented disease progression or the inability to tolerate the lowest dosing regimen per previous protocol of thalidomide and/or high-dose dexamethasone without grade 3 or 4 toxicity.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	CC-5013	Oral 25mg daily on Days 1-21 every 28 days.
DRUG	Lenalidomide	Oral Lenalidomide 25mg daily on Days 1-21 every 28 days.

Timeline

• Start date: 2003-04-01
• Primary completion: 2013-11-25
• Completion: 2013-11-25
• First posted: 2008-02-25
• Last updated: 2019-11-20
• Results posted: 2014-12-30

Locations

7 sites across 2 countries: Russia, Ukraine