Clinical Trial: CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects with Multiple Myeloma

This study is no longer recruiting patients.

Sponsors and Collaborators: Celgene Corporation
PharmaNet
Information provided by: Celgene Corporation

Purpose

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

MedlinePlus related topics:  Multiple Myeloma

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Multicenter, Parallel-Group, Controlled, Randomized, Double-Blind Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects with Multiple Myeloma

Further Study Details: 

Expected Total Enrollment:  302

Study start: January 2003;  Study completion: December 2005

Eligibility

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.

Location Information


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

More Information

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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