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

Condition(s) targeted: Multiple Myeloma

Intervention: CC-5013 (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Celgene Corporation

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Time to tumor progression (TTP)

Secondary outcome: Overall survival. Myeloma response rate. Safety. Time to first symptomatic skeletal-related event (SRE) (clinical need for radiation or surgery to bone). Time to first decrease in ECOG performance status score.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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.

Clinical Research Consultants, Inc., Hoover, Alabama 35216, United States

Cross Cancer Institute, Edmonton, Alberta T6G1Z2, Canada

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

Yale University School of Medicine, New Haven, Connecticut 06520, United States

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

Medical College of Georgia, Augusta, Georgia 30912-3125, United States

Emory University, Atlanta, Georgia 30322, United States

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 Cancer Research Institute, Indianapolis, Indiana 46202-5254, United States

University of Iowa Hospital Clinic, Iowa City, Iowa 52242, United States

Ocshner Clinical Foundation, New Orleans, Louisiana 70121, United States

Johns Hopkins Medicine Department of Oncology, Baltimore, Maryland 21231, United States

Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States

Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States

Karmanos Cancer Institute, Detroit, Michigan 48201, United States

University Of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan 48109, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

Washington University School of Medicine- Sherman Cancer Center, St. Louis, Missouri 63110, United States

Hackensack University Medical Center, Hackensack, New Jersey 07601, United States

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

Wake Forest University School of Medicine, Winston-Salem, North Carolina 27157-1023, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Dalhousie University, Halifax, Nova Scotia B3H2Y9, Canada

Ohio State University, Columbus, Ohio 43210, United States

Cleveland Clinic Myeloma Program, Cleveland, Ohio 44195, United States

Princess Margaret Hospital, Toronto, Ontario M5J2M9, Canada

Kaiser Permanente Northwest Region Center for Health Research, Portland, Oregon 97227, United States

University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania 19104, United States

University of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

Hospital Charles LeMoyne, Greenfield Park, Quebec J4V2H1, Canada

McGill University, Montreal, Quebec PQH2W1S6, Canada

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

Sarah Cannon Cancer Center, Nashville, Tennessee 37203-1632, United States

MD Anderson Cancer Center, Houston, Texas 77030-4009, United States

Froedtert Hospital/BMT Medical College of Wisconsin, Milwaukee, Wisconsin 53226-3522, United States

Starting date: January 2003
Ending date: December 2005
Last updated: July 27, 2007