A Phase II Study of Continuous Versus Syncopated Dosing of CC-5013 for the Treatment of Refractory Multiple Myeloma

This study has been completed.

First Received: January 3, 2003 Last Updated: September 22, 2009 History of Changes

Sponsor:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00051116

Purpose

To evaluate the response rate, response duration, and survival of patients treated with CC-5013 in a chronic dosing schedule versus a syncopated dosing schedule.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Continuous Versus Syncopated Dosing of CC-5013 for the Treatment of Refractory Multiple Myeloma

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:

Enrollment:	100
Study Start Date:	May 2002
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

History of histologically documented multiple myeloma with relapsed or resistant disease
Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
Signed written informed consent and willingness to meet follow-up schedule and study procedure obligations

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051116

Locations

United States, Arkansas
Myeloma Institute University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Robert Knight, MD

Celgene Corporation

More Information

No publications provided

Responsible Party:	Celgene Corporation ( Robert Knight MD - VP Hematology )
Study ID Numbers:	CC-5013-MM-008
Study First Received:	January 3, 2003
Last Updated:	September 22, 2009
ClinicalTrials.gov Identifier:	NCT00051116 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

Multiple Myeloma
Revimid
CC5013
CC-5013

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 November 27, 2009