CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.

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

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

• Prior or current diagnosis Durie-Salmon stage II or III multiple myeloma.

• No more than 3 previous anti-myeloma regimens

• No high-dose dexamethasone (total monthly dose of dexamethasone greater than 200 mg) within 6 months of study randomization.

• Measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample).

Exclusion Criteria:

• Prior development of disease progression during high-dose dexamethasone containing therapy.

• Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm cubed

• Laboratory abnormalities: Platelet count less than 75,000/mm cubed

• Laboratory abnormalities: Serum creatinine greater than 2.5 mg/dL

• Laboratory abnormalities: Serum glutamic oxaloacetic transaminase (SGOT, aspartate transaminase [AST]) or serum glutamic pyruvic transaminase (SGPT, alanine transaminase [ALT])greater than 3.0 x upper limit of normal

• Laboratory abnormalities: Serum total bilirubin greater than 2.0 mg/dL

• Prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for greater than or equal to 5 years.

• Known hypersensitivity to thalidomide or dexamethasone.

• Development of a desquamating rash while taking thalidomide.