A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for Subjects With Multiple Myeloma

This study is ongoing, but not recruiting participants.

First Received: February 14, 2008 Last Updated: May 18, 2009 History of Changes

Sponsored by:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00622336

Purpose

This is an international, multicenter, open-label, single-arm study for advanced Multiple Myeloma patients who had previously taken high-dose dexamethasone alone or thalidomide plus high-dose dexamethasone and developed disease progression or that were unable to tolerate the lowest dosing regimen of thalidomide and/or high-dose dexamethasone without grade 3 or 4 toxicity.

Condition	Intervention	Phase
Multiple Myeloma	Drug: CC-5013	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Open-Label, Single-Arm Study of the Safety and Efficacy of CC-5013 Monotherapy for Subjects With Multiple Myeloma: A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Evaluate the safety of CC-5013 monotherapy in subjects with advanced multiple myeloma. [ Time Frame: 2003-2008 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate the efficacy of CC-5013 monotherapy in subjects with advanced multiple myeloma. [ Time Frame: 2003-2008 ] [ Designated as safety issue: No ]

Estimated Enrollment:	700
Study Start Date:	April 2003
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Oral 25mg daily on Days 1-21 every 28 days.

Eligibility

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

Criteria

Inclusion Criteria:

Understand and voluntarily sign an informed consent form.
Age > or = to 18 years at time of signing the informed consent form.
Have multiple myeloma and were enrolled in either THAL-MM-003, CC-5013-MM-009, or CC-5013-MM-010 and discontinued study therapy with thalidomide and high-dose dexamethasone or high-dose dexamethasone alone due to: documented disease progression OR inability to tolerate the lowest dosing regimen allowed on previous protocol without a grade 3 or 4 toxicity.

Exclusion Criteria:

Any serious medical condition, laboratory abnormality, or psychiatric illness that will prevent the patient from signing the informed consent form or that will place the subject at an unacceptable risk for toxicity if he/she participates in the study.
Pregnant or lactating females.
Prior therapy with 5013.
Prior history of malignancy, other than multiple myeloma, (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for more than 5 years.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622336

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Robert Knight, MD

Celgene Corporation

More Information

No publications provided

Responsible Party:	Celgene Corporation ( Kim Joyce Baez, Manager Clinical Operations )
Study ID Numbers:	CC-5013-MM-012
Study First Received:	February 14, 2008
Last Updated:	May 18, 2009
ClinicalTrials.gov Identifier:	NCT00622336 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Immunoproliferative Disorders
Hemorrhagic Disorders
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders
Lenalidomide

Vascular Diseases
Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Blood Protein Disorders
Hematologic Diseases
Lenalidomide
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on September 03, 2009