CDC-501 Therapy in Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Trial end date: 2007-02-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to select the dose regimen of CDC-501 that provides the most promising evidence of efficacy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Lenalidomide

Criteria

• Subject must be diagnosed with multiple myeloma (with measurable M-Protein in serum and/or urine), and be considered to have disease progression after at least two cycles of treatment or have relapsed after treatment.

• Subject must understand and voluntarily sign an informed consent document.

• Subject must not have received corticosteroids, other chemotherapy, thalidomide, or other investigational agents, within 21 days of baseline

• ECOG (Zubrod) performance status of 0 to 2.

• Subject must be able to adhere to the study visit schedule and other protocol requirements.

• Women of childbearing potential (WCBP ) must have a negative serum or urine pregnancy test within 7 days of baseline. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.