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CDC-501 Therapy in Relapsed or Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00044018
Recruitment Status : Completed
First Posted : August 20, 2002
Last Update Posted : November 12, 2019
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: CDC-501 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2002
Actual Primary Completion Date : December 1, 2004
Actual Study Completion Date : February 15, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Primary Outcome Measures :
  1. Confirmed M-Protein Response During Single Agent CDC-501 Therapy [ Time Frame: Response assessed every 4 weeks; up to 62 months ]
    M-Protein response evaluated every 4 weeks through urine and serum electrophoresis.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00044018

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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
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Study Director: Robert Knight, MD Celgene Corporation

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Responsible Party: Celgene Identifier: NCT00044018    
Other Study ID Numbers: CC-5013-MM-007
First Posted: August 20, 2002    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Keywords provided by Celgene:
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents