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A Phase II Study of Continuous Versus Syncopated Dosing of CC-5013 for the Treatment of 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.
 
ClinicalTrials.gov Identifier: NCT00051116
Recruitment Status : Completed
First Posted : January 7, 2003
Last Update Posted : September 23, 2009
Sponsor:
Information provided by:
Celgene

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Drug: CC-5013 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Continuous Versus Syncopated Dosing of CC-5013 for the Treatment of Refractory Multiple Myeloma
Study Start Date : May 2002
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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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
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00051116


Locations
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United States, Arkansas
Myeloma Institute University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
Celgene Corporation
Investigators
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Study Director: Robert Knight, MD Celgene Corporation
More Information
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Responsible Party: Robert Knight MD - VP Hematology, Celgene Corporation
ClinicalTrials.gov Identifier: NCT00051116    
Other Study ID Numbers: CC-5013-MM-008
First Posted: January 7, 2003    Key Record Dates
Last Update Posted: September 23, 2009
Last Verified: September 2009
Keywords provided by Celgene:
Multiple Myeloma
Revimid
CC5013
CC-5013
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
 Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents