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Safety and efficacy of single-agent CC-5013 in subjects with relapsed and refractory multiple myeloma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Safety and efficacy of single-agent CC-5013 in subjects with relapsed and refractory multiple myeloma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Safety and efficacy of single-agent CC-5013 in subjects with relapsed and refractory multiple myeloma Clinical research trials and Safety and efficacy of single-agent CC-5013 in subjects with relapsed and refractory multiple myeloma medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Safety and efficacy of single-agent CC-5013 in subjects with relapsed and refractory multiple myeloma. Safety and efficacy of single-agent CC-5013 in subjects with relapsed and refractory multiple myeloma Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Safety and efficacy of single-agent CC-5013 in subjects with relapsed and refractory multiple myeloma clinical trial. Participants frequently obtain the most expert healthcare available for their Safety and efficacy of single-agent CC-5013 in subjects with relapsed and refractory multiple myeloma condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and efficacy of single-agent CC-5013 in subjects with relapsed and refractory multiple myeloma  Safety and efficacy of single-agent CC-5013 in subjects with relapsed and refractory multiple myeloma
Safety and efficacy of single-agent CC-5013 in subjects with relapsed and refractory multiple myeloma
For Condition: Multiple Myeloma
Status: No longer recruiting
Sponsor(s): Celgene Corporation ,
Synopsis: For each subject the study will consist of two phases: a treatment phase and a follow-up phase. Screening procedures will take place within 28 days of baseline. Treatment Phase: Subjects who qualify for enrollment into the study will receive single-agent CC-5013 in 28-day cycles. Study visits will occur every 4 weeks and hematologic and myeloma paraprotein laboratory assessments will occur every 2 weeks for the first 6 cycles and every 4 weeks thereafter. Follow-Up Phase: All subjects who discontinue the treatment phase for any reason will continue to be followed for survival and post-treatment phase anti-myeloma treatment.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Understand and voluntarily sign an informed consent form. - Age greater than or equal to 18 years at the time of signing the informed consent form. - Must have a diagnosis of multiple myeloma and have relapsed and refractory disease. Such subjects have relapsed after having had at least a partial myeloma paraprotein response (greater or equal to 50% reduction of myeloma paraprotein) to prior therapy and then continued to develop disease progression despite salvage anti-myeloma therapy. Subjects must have documented evidence of disease progression during therapy with the last prior anti-myeloma treatment regimen (must have received at least 2 cycles) prior to study enrollment.Subjects may have been previously treated with thalidomide and/or radiation therapy. - Measurable levels of myeloma paraprotein in serum (greater or equal to 0.5 g/dL) or urine (greater or equal to 0.2 g excreted in a 24-hour collection sample). - Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (see Appendix II). - 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 starting study drug. Exclusion Criteria: - 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. - WCBP must agree to have pregnancy tests every 4 weeks while on study drug (every 14 days for women with irregular cycles) and 4 weeks after the last dose of study drug. - Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. - Pregnant or lactating females. - Any of the following laboratory abnormalities: A) Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L) B) Platelet count <75,000/mm^3 (75 x 10^9/L) C) Serum creatinine >2.5 mg/dL (221 umol/L) D) Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN) E) Serum total bilirubin >2.0 mg/dL (34 umol/L) - Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. - Prior history of malignancies 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 the disease for greater than or equal to 3 years. - Prior greater than or equal to grade 3 allergic reaction/hypersensitivity to thalidomide. - Prior greater than or equal to grade 3 rash or any desquamating (blistering) rash while taking thalidomide. - Prior use of CC-5013. - Use of any standard/experimental anti-myeloma drug therapy within 28 days of the initiation of study drug therapy or use of any experimental non-drug therapy within 56 days of the initiation of study drug therapy
Total Enrollment: 200
Location and Contact Information:
Northwest Georgia Oncology Centers
Marietta, Georgia, 30060
United States
University of Massachusetts
Worcester, Massachusetts, 01655
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Mayo Clinic
Scottsdale, Arizona, 85259
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Midwest Cancer Research Group
Skokie, Illinois, 60077
United States
Cancer Care Associates
Redondo Beach, California, 90277
United States
Wilshire Oncology Medical Group, Inc.
La Verne, California, 91750
United States
Cleveland Clinic Myeloma Program Hematology & Medical Oncology /R35
Cleveland, Ohio, 44195
United States
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, 15224
United States
Mayo Clinic
Rochester, Minnesota, 55902
United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
Palo Verde Hematology Oncology
Glendale, Arizona, 85304
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Institute for Myeloma and Bone
Los Angeles, California, 90067
United States
Carolina Hematology-Oncology Associates
Charlotte, North Carolina, 28203
United States
SUNY Health Science Center at Brooklyn
Brooklyn, New York, 11203
United States
Nevada Cancer Center
Las Vegas, Nevada, 89109
United States
Atlanta Cancer Care-Roswell
Roswell, Georgia, 30076
United States
University of Maryland Medical Center
Baltimore, Maryland, 21201-1595
United States
Northwestern University Med Ctr
Chicago, Illinois, 60611-2927
United States
Providence St. Joseph Medical Center/Cancer Center
Burbank, California, 91505
United States
St. Vincent's Comprehensive Cancer Center
New York City, New York, 10011
United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20717
United States
Additional Information:
Study ID Numbers: CC-5013-MM-014;
Study Start Date: July 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065351
Other Multiple Myeloma Studies:
1. Xcellerated T CellsTM in Patients with Multiple Myeloma
2. Pyroxamide in Treating Patients With Advanced Cancer
3. Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment
4. Growth Factor to Prevent Oral Mucositis in Patients With Hematologic Cancer
5. Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects with Multiple Myeloma
Related Studies:
Other Multiple Myeloma Clinical Trials
Other North Carolina Clinical Trials
Other Charlotte Clinical Trials
Safety and efficacy of single-agent CC-5013 in subjects with relapsed and refractory multiple myeloma
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