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Dexamethasone With or Without CC-5013 in Treating Patients With Newly Diagnosed Multiple Myeloma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Dexamethasone With or Without CC-5013 in Treating Patients With Newly Diagnosed Multiple Myeloma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Dexamethasone With or Without CC-5013 in Treating Patients With Newly Diagnosed Multiple Myeloma Clinical research trials and Dexamethasone With or Without CC-5013 in Treating Patients With Newly Diagnosed Multiple Myeloma healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Dexamethasone With or Without CC-5013 in Treating Patients With Newly Diagnosed Multiple Myeloma. Dexamethasone With or Without CC-5013 in Treating Patients With Newly Diagnosed Multiple Myeloma Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Dexamethasone With or Without CC-5013 in Treating Patients With Newly Diagnosed Multiple Myeloma clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Dexamethasone With or Without CC-5013 in Treating Patients With Newly Diagnosed Multiple Myeloma condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Dexamethasone With or Without CC-5013 in Treating Patients With Newly Diagnosed Multiple Myeloma  Dexamethasone With or Without CC-5013 in Treating Patients With Newly Diagnosed Multiple Myeloma
Dexamethasone With or Without CC-5013 in Treating Patients With Newly Diagnosed Multiple Myeloma
For Condition: stage 3 multiple myeloma,stage 1 multiple myeloma,stage 2 multiple myeloma
Status: Not yet recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as dexamethasone use different ways to stop cancer cells from dividing so they stop growing or die. CC-5013 may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether dexamethasone is more effective with or without CC-5013 in treating multiple myeloma. PURPOSE: Randomizedphase III trial to compare the effectiveness of dexamethasone with or without CC-5013 in treating patients who have newly diagnosed multiple myeloma.
Details: OBJECTIVES: - Compare the progression-free survival of patients with newly diagnosed multiple myeloma treated with dexamethasone with vs without CC-5013. - Compare the overall response rate in patients treated with these regimens. - Compare the major response rate (indicated by greater than 75% decrease in M-protein) in patients treated with these regimens. - Compare the overall survival and time to best response in patients treated with these regimens. - Compare the toxicity profile of these regimens, including thrombotic complications, in these patients. - Compare the effect of these regimens on gene expression and proteomic analysis in these patients. OUTLINE: This is a randomized, double-blind, crossover, multicenter study. Patients are stratified according to SWOG clinical stage (I or II vs III or IV) and Zubrod performance status (0-1 vs 2-3). Patients are randomized to 1 of 2 treatment arms. Arm I: - Induction therapy: Patients receive oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral CC-5013 on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. - Maintenance therapy: Patients receive oral DM on days 1-4 and 14-17 and oral CC-5013 on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Arm II: - Patients receive DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Patients with responding or stable disease proceed to maintenance therapy. Patients with disease progression during induction therapy cross over and receive unblinded treatment with DM and CC-5013 as in arm I induction. Patients with responding or stable disease after unblinded induction therapy receive unblinded maintenance therapy with DM and CC-5013 as in arm I maintenance. - Patients receive oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance. Patients with disease progression during maintenance therapy cross over and receive unblinded treatment with DM and CC-5013 as in arm I induction. Patients with responding or stable disease after unblinded induction therapy proceed to unblinded maintenance therapy with DM and CC-5013 as in arm I maintenance. Patients are followed every 6 months for up to 5 years. PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Newly diagnosed multiple myeloma - Measurable M-protein as defined by 1 of the following: - Serum M-protein at least 1.0 g/dL by serum protein electrophoresis or immunoelectrophoresis - Urinary M-protein excretion at least 200 mg/24 hours - No nonsecretory multiple myeloma PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-3* NOTE: *Zubrod 3 allowed only if multiple myeloma is the central cause of disability Life expectancy - Not specified Hematopoietic - Platelet count at least 80,000/mm^3* - Absolute neutrophil count at least 1,000/mm^3* - Hemoglobin at least 9 g/dL* (epoetin alfa or transfusion allowed) NOTE: *Unless due to greater than 50% marrow involvement by myeloma on biopsy Hepatic - AST/ALT no greater than 3 times upper limit of normal* NOTE: *Values outside of this range are allowed at the investigator's discretion Renal - Creatinine no greater than 2.5 mg/dL* NOTE: *Values outside of this range are allowed at the investigator's discretion Cardiovascular - No New York Heart Association class III or IV heart failure - No myocardial infarction within the past 6 months - No poorly controlled hypertension Other - Not pregnant or nursing - Negative pregnancy test - Fertile female patients must use 1 highly effective method and 1 additional method of contraception - Male patients must use effective barrier contraception during and for 4 weeks after study participation - No uncontrolled active infection requiring IV antibiotics - No poorly controlled diabetes mellitus that would preclude ability to take oral glucocorticoids - No other serious medical condition that would preclude study participation - No psychiatric illness that would preclude study participation - No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent filgrastim (G-CSF) - No prior interferon or thalidomide - Epoetin alfa allowed Chemotherapy - No prior chemotherapy Endocrine therapy - Prior high-dose dexamethasone allowed provided duration of administration was no more than 4 days Radiotherapy - Prior localized radiotherapy allowed provided it was not to the sole site of evaluable disease Surgery - Not specified Other - No prior treatment for clinically significant ventricular cardiac arrhythmias - Bisphosphonates allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeffreyZonder, Study Chair, Barbara Ann Karmanos Cancer Institute
Additional Information:
Study ID Numbers: CDR0000306449; SWOG-S0232
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064038
Other Stage 2 Multiple Myeloma Studies:
1. Combination Chemotherapy, Peripheral Stem Cell Transplantation, Biological Therapy, Pamidronate and Thalidomide in Treating Patients With Multiple Myeloma
2. Dexamethasone With or Without CC-5013 in Treating Patients With Newly Diagnosed Multiple Myeloma
3. Combination Chemotherapy With or Without Interferon alfa in Treating Patients With Previously Untreated Multiple Myeloma
4. Melphalan and Filgrastim to Stimulate Peripheral Stem Cells in Patients With Multiple Myeloma
5. Beta Alethine in Treating Patients With Myeloma
Related Studies:
Other stage 2 multiple myeloma Clinical Trials
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Dexamethasone With or Without CC-5013 in Treating Patients With Newly Diagnosed Multiple Myeloma
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