Randomized subjects will receive CC-5013 plus high-dose dexamethasone or identically appearing placebo to CC-5013 plus high-dose dexamethasone, in 4-week cycles. For each subject the study will consist of a treatment phase and a follow-up phase.

Condition	Treatment or Intervention	Phase
Multiple Myeloma	Drug: CC-5013	Phase III

Further Study Details: 

Expected Total Enrollment:  302

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 SGOT/AST or SGPT/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.
• The development of a desquamating rash while taking thalidomide.

Alabama
      Clinical Research Consultants, Inc., Hoover,  Alabama,  35216,  United States
California
      Stanford University Medical Center, Division of Hematology, Stanford,  California,  94305-5112,  United States
      UCSF California, San Francisco,  California,  94143,  United States
      City of Hope National Medical Center, Duarte,  California,  91010,  United States
      UCLA School of Medicine, Los Angeles,  California,  90095,  United States
Connecticut
      Yale University School of Medicine, New Haven,  Connecticut,  06520,  United States
Florida
      Oncology Hematology Consultants, Sarasota,  Florida,  34239,  United States
      University of Florida, Gainesville,  Florida,  32610,  United States
      H Lee Moffitt Cancer Center, Tampa,  Florida,  33612-9497,  United States
      Mayo Clinic- Jacksonville, Jacksonville,  Florida,  32224,  United States
      University of Miami, Miami,  Florida,  33136,  United States
Georgia
      Medical College of Georgia, Augusta,  Georgia,  30912-3125,  United States
      Emory University, Atlanta,  Georgia,  30322,  United States
Illinois
      Northwestern University Med Ctr, Chicago,  Illinois,  60611-2927,  United States
      Rush Cancer Institute Section of Hematology, Chicago,  Illinois,  60612-3824,  United States
      Loyola University Medical Center, Maywood,  Illinois,  60153,  United States
Indiana
      Indiana Cancer Research Institute, Indianapolis,  Indiana,  46202-5254,  United States
Iowa
      University of Iowa Hospital Clinic, Iowa City,  Iowa,  52242,  United States
Louisiana
      Ocshner Clinical Foundation, New Orleans,  Louisiana,  70121,  United States
Maryland
      Johns Hopkins Medicine Department of Oncology, Baltimore,  Maryland,  21231,  United States
Massachusetts
      Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
Michigan
      Karmanos Cancer Institute, Detroit,  Michigan,  48201,  United States
      University Of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109,  United States
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Missouri
      Washington University School of Medicine- Sherman Cancer Center, St. Louis,  Missouri,  63110,  United States
New Jersey
      Hackensack University Medical Center, Hackensack,  New Jersey,  07601,  United States
New York
      St. Vincent's Comprehensive Cancer Center, New York,  New York,  10011,  United States
      MBCCOP Our Lady of Mercy Cancer Center New York Medical College, Bronx,  New York,  10466,  United States
      SUNY Upstate Medical University, Syracuse,  New York,  13210,  United States
      New York Presbyterian Hospital, New York,  New York,  10021,  United States
      Roswell Park Cancer Institute, Buffalo,  New York,  14263,  United States
North Carolina
      Wake Forest University School of Medicine, Winston Salem,  North Carolina,  27157-1023,  United States
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States
Ohio
      Ohio State University, Columbus,  Ohio,  43210,  United States
      Cleveland Clinic Myeloma Program, Cleveland,  Ohio,  44195,  United States
Oregon
      Kaiser Permanente Northwest Region Center for Health Research, Portland,  Oregon,  97227,  United States
Pennsylvania
      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104,  United States
      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States
South Carolina
      Charleston Hematology/Oncology P.A., Charleston,  South Carolina,  29403,  United States
      Medical University of SC, Charleston,  South Carolina,  29425,  United States
      South Carolina Oncology Group, West Columbia,  South Carolina,  29169,  United States
Tennessee
      Sarah Cannon Cancer Center, Nashville,  Tennessee,  37203-1632,  United States
Texas
      MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States
Wisconsin
      Froedtert Hospital/BMT Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226-3522,  United States
Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G1Z2,  Canada
Canada, Nova Scotia
      Dalhousie University, Halifax,  Nova Scotia,  B3H2Y9,  Canada
Canada, Ontario
      Princess Margaret Hospital, Toronto,  Ontario,  M5J2M9,  Canada
Canada, Quebec
      Hospital Charles LeMoyne, Greenfield Park,  Quebec,  J4V2H1,  Canada
      McGill University, Montreal,  Quebec,  PQH2W1S6,  Canada

Study ID Numbers:  CC-5013-MM-009
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  March 6, 2003
ClinicalTrials.gov Identifier:  NCT00056160
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08