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

Show 50 Study Locations

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 30, 2009