CDC-501 Therapy in Relapsed or Refractory Multiple Myeloma

This study has been completed.

First Received: August 16, 2002 Last Updated: September 22, 2009 History of Changes

Sponsor:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00044018

Purpose

The purpose of the study is to select the dose regimen of CDC-501 that provides the most promising evidence of efficacy.

Condition	Intervention	Phase
Multiple Myeloma	Drug: CDC-501	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	An Open-Label Study to Evaluate the Efficacy and Safety of Two CDC-501 Dose Regimens When Used Alone or in Combination With Dexamethasone for the Treatment Relapsed or Refractory Multiple Myeloma

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Enrollment:	102
Study Start Date:	April 2002
Study Completion Date:	December 2004
Primary Completion Date:	December 2004 (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

Subject must be diagnosed with multiple myeloma (with measurable M-Protein in serum and/or urine), and be considered to have disease progression after at least two cycles of treatment or have relapsed after treatment.
Subject must understand and voluntarily sign an informed consent document.
Subject must not have received corticosteroids, other chemotherapy, thalidomide, or other investigational agents, within 21 days of baseline
ECOG (Zubrod) performance status of 0 to 2.
Subject must be able to adhere to the study visit schedule and other protocol requirements.
Women of childbearing potential (WCBP ) must have a negative serum or urine pregnancy test within 7 days of baseline. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044018

Locations

United States, Florida
H Lee Moffit Cancer Center
Tampa, Florida, United States, 33612
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
United States, New York
St Vincent's Cancer Center
New York, New York, United States, 10011

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-007
Study First Received:	August 16, 2002
Last Updated:	September 22, 2009
ClinicalTrials.gov Identifier:	NCT00044018 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

Revimid
CC5013

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