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

• Status: Completed
• Trial end date: 2013-11-12
• Target enrollment: 0
• Participant gender: All

Summary

To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for subjects with relapsed or refractory multiple myeloma."

• 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.

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

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1, or 2

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

Exclusion Criteria:

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

• Pregnant or lactating females

• The development of a desquamating rash while taking thalidomide

• Use of any standard/experimental anti-myeloma therapy within 28 days of randomization or use of any experimental non-drug therapy within 56 days of initiation of drug treatment

• Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm3

• Laboratory abnormalities: Platelet count < 75,000/mm3

• Laboratory abnormalities: Serum creatinine > 2.5 mg/dL

• Laboratory abnormalities: Serum Serum glutamic oxaloacetic transaminase (SGOT)/Aspartate aminotransferase (AST) or Serum glutamic pyruvic transaminase (SGPT)/Alanine aminotransferase (ALT) > 3.0 x upper limit of normal

• Laboratory abnormalities: Serum total bilirubin > 2.0 mg/dL

• Prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for ≥ 3 years.