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CC-5013 in Treating Patients With Advanced Multiple Myeloma Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about CC-5013 in Treating Patients With Advanced Multiple Myeloma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. CC-5013 in Treating Patients With Advanced Multiple Myeloma Clinical research trials and CC-5013 in Treating Patients With Advanced Multiple Myeloma medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as CC-5013 in Treating Patients With Advanced Multiple Myeloma. CC-5013 in Treating Patients With Advanced Multiple Myeloma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a CC-5013 in Treating Patients With Advanced Multiple Myeloma clinical trial. Participants frequently get the best healthcare available for their CC-5013 in Treating Patients With Advanced Multiple Myeloma condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > CC-5013 in Treating Patients With Advanced Multiple Myeloma  CC-5013 in Treating Patients With Advanced Multiple Myeloma
CC-5013 in Treating Patients With Advanced Multiple Myeloma
For Condition: stage 2 multiple myeloma,refractory plasma cell neoplasm,stage 3 multiple myeloma
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: CC-5013 may kill cancer cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of CC-5013 in treating patients who have advanced multiple myeloma.
Details: OBJECTIVES: Primary - Determine the safety of CC-5013 in patients with advanced multiple myeloma. Secondary - Determine the efficacy of this drug, in terms of response rate, duration of response, and time to progression, in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive oral CC-5013 once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 738 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of multiple myeloma - Advanced disease - Prior enrollment on protocol Thal-MM-003, CC-5013-MM-009, or CC-5013-MM-010 - Discontinued prior study therapy with thalidomide and high-dose dexamethasone OR high-dose dexamethasone alone due to 1 of the following reasons: - Documented disease progression - Inability to tolerate the lowest dosing regimen allowed per protocol without grade 3 or 4 toxicity - Last dose of study drug within the past 4 months PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count 1,000/mm^3 - Platelet count 75,000/mm^3 Hepatic - AST or ALT 3.0 times upper limit of normal - Bilirubin 2.0 mg/dL Renal - Creatinine 2.5 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No thalidomide- or dexamethasone-related toxicity of grade 3 - No prior allergic reaction/hypersensitivity to thalidomide of grade 2 - No prior rash or any desquamation related to thalidomide of grade 3 - No psychiatric illness that would preclude study participation - No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast - No other serious medical condition or laboratory abnormality that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior CC-5013 Chemotherapy - Not specified Endocrine therapy - See Disease Characteristics Radiotherapy - Concurrent palliative radiotherapy allowed Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GarySchiller, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Gary Schiller 310-825-5513
Additional Information:
Study ID Numbers: CDR0000357574; UCLA-0308049,CELGENE-CC-5013-MM-012
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080964
Other Refractory Plasma Cell Neoplasm Studies:
1. O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma
2. Dexamethasone With or Without CC-5013 in Treating Patients With Newly Diagnosed Multiple Myeloma
3. Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon alfa in Treating Patients With Advanced Multiple Myeloma
4. High-Dose Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Amyloidosis
5. Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma
Related Studies:
Other refractory plasma cell neoplasm Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
CC-5013 in Treating Patients With Advanced Multiple Myeloma
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