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

Sponsored by:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00424047

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, 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)

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.

Estimated Enrollment:	302
Study Start Date:	January 2003
Estimated Study Completion Date:	December 2010
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Eligibility

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/mm3
Laboratory abnormalities: Platelet count less than 75,000/mm3
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424047

Show 68 Study Locations

Sponsors and Collaborators

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.

Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foà R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22;357(21):2123-32.

Study ID Numbers:	CC-5013-MM-010
Study First Received:	January 17, 2007
Last Updated:	May 18, 2009
ClinicalTrials.gov Identifier:	NCT00424047 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

Multiple Myeloma
Celgene
Revlimid
CC-5013

Study placed in the following topic categories:

Anti-Inflammatory Agents
Dexamethasone
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Blood Protein Disorders
Hematologic Diseases
Hormone Antagonists
Blood Coagulation Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Lenalidomide
Vascular Diseases

Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Glucocorticoids
Multiple Myeloma
Hemorrhagic Disorders
Peripheral Nervous System Agents
Lymphoproliferative Disorders
Dexamethasone acetate
Neoplasms, Plasma Cell

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 September 02, 2009