NCT00737529

A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial

A Phase 2, Multicenter, Single-Arm, Open-Label Study To Determine The Efficacy And Safety Of Single-Agent Lenalidomide (Revlimid®) In Patients With Mantel Cell NHL Who Have Relapsed Or Progressed After Treatment With Bortezomib Or Are Refractory To Bortezomib

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.

Detailed description

Follow up phase will continue until either 100% of the patients have died, are lost to follow up or have withdrawn consent or a maximum of 4 years from the last patient enrolled, whichever comes first. All other efficacy and safety endpoints will be updated at this time. In the unlikely event that the study will be closed and patients are still responding to treatment at this time, Celgene will discuss with the treating physicians options to provide further treatment to the patient after study closure in line with local regulation. Follow up for second primary malignancies and OS will continue until 100% of the patients have died, are lost to follow up, have withdrawn consent, or a maximum of 5 years from the last patient enrolled, whichever comes first. 10 October 2017: In regard to the last subject last visit date/study completion date, the prolongation of timelines is due to the bridging of a treatment gap for a patient responding to study medication until non-study medication is available.

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	lenalidomide	25mg oral capsules continuous days 1-21 each of a 28 day cycle

Timeline

• Start date: 2008-12-22
• Primary completion: 2016-04-06
• Completion: 2017-11-08
• First posted: 2008-08-19
• Last updated: 2018-12-13
• Results posted: 2013-09-09

Locations

70 sites across 14 countries: United States, Austria, Belgium, Colombia, France, Germany, Hungary, Israel, Italy, Puerto Rico, Singapore, Spain, Turkey (Türkiye), United Kingdom