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

Completed · Phase 3 · Has a placebo group

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT00056160

Run by

Celgene

People needed

353

Starts

2003-01-01

Expected to finish

2008-10-01

Last updated by the study team

2017-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Clinical Research Consultants, Inc. — Hoover, Alabama, United States
• City of Hope National Medical Center — Duarte, California, United States
• UCLA School of Medicine — Los Angeles, California, United States
• UCSF California — San Francisco, California, United States
• Stanford University Medical Center, Division of Hematology — Stanford, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• Mayo Clinic- Jacksonville — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Oncology Hematology Consultants — Sarasota, Florida, United States
• H Lee Moffitt Cancer Center — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Northwestern University Med Ctr — Chicago, Illinois, United States
• Rush Cancer Institute Section of Hematology — Chicago, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Indiana Cancer Research Institute — Indianapolis, Indiana, United States
• University of Iowa Hospital Clinic — Iowa City, Iowa, United States
• Ocshner Clinical Foundation — New Orleans, Louisiana, United States
• Johns Hopkins Medicine Department of Oncology — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University Of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States
• Washington University School of Medicine- Sherman Cancer Center — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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