Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma.

• Status: Completed
• Trial end date: 2005-07-15
• Target enrollment: 0
• Participant gender: All

Summary

Subjects are randomized to one of two treatment arms. All subjects are screened for eligibility within 28 days prior to randomization. The study consists of a treatment phase and a follow-up phase. Subjects are treated in repeating 4 week cycles.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Collaborator: ICON Clinical Research
• Treatments: Lenalidomide; Thalidomide

Criteria

• Understand and voluntarily sign an informed consent form

• Able to adhere to the study visit schedule and other protocol requirements

• Metastatic malignant melanoma now stage IV, relapsed or refractory to standard metastatic therapy

• Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug

• Patients with active brain disease, or newly diagnosed brain metastases, within 4 weeks prior to the start of study treatment are excluded.