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

Sponsor:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00056160

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	Intervention	Phase
Multiple Myeloma	Drug: CC-5013	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Lenalidomide CC 5013 Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Time to tumor progression (TTP) [ Time Frame: randomization to progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: randomization to progression ] [ Designated as safety issue: Yes ]

Enrollment:	351
Study Start Date:	January 2003
Study Completion Date:	October 2008
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental CC-5013	Drug: CC-5013
2: Experimental CC-5013	Drug: CC-5013

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056160

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Locations

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

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Robert Knight, MD

Celgene Corporation

More Information

No publications provided by Celgene Corporation

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Wang M, Dimopoulos MA, Chen C, Cibeira MT, Attal M, Spencer A, Rajkumar SV, Yu Z, Olesnyckyj M, Zeldis JB, Knight RD, Weber DM. Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure. Blood. 2008 Dec 1;112(12):4445-51. Epub 2008 Sep 17.

Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, Siegel D, Borrello I, Rajkumar SV, Chanan-Khan AA, Lonial S, Yu Z, Patin J, Olesnyckyj M, Zeldis JB, Knight RD; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007 Nov 22;357(21):2133-42.

Responsible Party:	Celgene Corporation ( Robert Knight MD - VP Oncology )
Study ID Numbers:	CC-5013-MM-009
Study First Received:	March 6, 2003
Last Updated:	September 21, 2009
ClinicalTrials.gov Identifier:	NCT00056160 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

Multiple Myeloma
Refractory and Relapsed
Revlimid
CC5013

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Dexamethasone acetate
Immunoproliferative Disorders

Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Vascular Diseases
Lenalidomide
Gastrointestinal Agents
Glucocorticoids
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Autonomic Agents
Peripheral Nervous System Agents
Lymphoproliferative Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 25, 2009