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Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma Clinical research trials and Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma. Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma clinical trial. Participants typically obtain the most effective healthcare available for their Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma  Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma
Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma
For Condition: stage 3 multiple myeloma,refractory plasma cell neoplasm,stage 1 multiple myeloma,stage 2 multiple myeloma
Status: No longer recruiting
Sponsor(s): Riverside Haematology Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Steroids, such as dexamethasone or prednisolone, may help relieve some of the side effects of chemotherapy. It is not yet known which regimen of chemotherapy plus steroid therapy is more effective in treating patients with multiple myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy plus steroid therapy in treating patients with multiple myeloma that has recurred for the first time.
Details: OBJECTIVES: - Compare the response rate, response duration, and survival of patients with relapsed multiple myeloma after treatment with lomustine, idarubicin, and dexamethasone vs melphalan and prednisolone. OUTLINE: This is a randomized study. Patients are stratified according to prior autologous transplant (yes vs no). Patients are randomized to one of two treatment arms. - Arm I: Patients receive oral lomustine on day 1, oral idarubicin once daily on days 1-3, and oral dexamethasone twice a day on days 1-4. Treatment is repeated every 28 days for 6-9 courses in the absence of unacceptable toxicity or disease progression. - Arm II: Patients receive oral melphalan once daily on days 1-4 and oral prednisolone twice a day on days 1-4. Treatment is repeated every 28 days for 6-9 courses in the absence of unacceptable toxicity or disease progression. Some patients may receive oral cyclophosphamide every 7 days and oral prednisolone on alternate days for 6 weeks concurrently with chemotherapy in either treatment arm. Quality of life is assessed at baseline, at 3, 6, 9, and 12 months, and then every 6 months thereafter. Patients are followed until death. PROJECTED ACCRUAL: A total of 660 patients will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of multiple myeloma based on at least two of the following: - Paraprotein in serum and/or urine - Greater than 10% plasma cells in bone marrow - Lytic bone lesions - Measurable serum and/or urine paraprotein - Progression from first or second stable plateau phase - No non-secretory myeloma or plasma cell leukemia (greater than 2,000/mm^3 circulating plasma cells) - No primary refractory disease or second or later relapse PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - 0-3 Life expectancy: - Not specified Hematopoietic: - Neutrophil count at least 1,000/mm^3 - Platelet count at least 75,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - ALT/AST no greater than 2.5 times ULN Renal: - Creatinine less than 3.4 mg/dL Cardiovascular: - No clinically significant cardiac insufficiency - No uncontrolled hypertension Other: - No uncontrolled diabetes mellitus - No recent history of peptic ulceration - HIV-1 and HIV-2 negative - Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior allogeneic peripheral blood stem cell or bone marrow transplantation - No planned future autologous transplantation unless sufficient stored stem cells available - Prior interferon allowed if administered as maintenance of stable plateau phase - No concurrent epoetin alfa Chemotherapy: - At least 3 months since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Concurrent radiotherapy for pain or to treat localized tumors allowed Surgery: - Not specified Other: - No prior participation in any clinical trial with an unlicensed product
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DianaSamson, Study Chair, Hammersmith Hospital
Hammersmith Hospital
London, England, W12 ONN
United Kingdom
Additional Information:
Study ID Numbers: CDR0000066676; RHG-MM97,EU-98030
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003603
Other Stage 3 Multiple Myeloma Studies:
1. Combination Chemotherapy Following GM-CSF in Treating Patients With Multiple Myeloma
2. Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma
3. Music Therapy to Ease Pain and Emotional Distress in Patients With Hematologic Cancer Who Are Undergoing High-Dose Therapy and Stem Cell Transplantation
4. Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
5. Vaccine Therapy Plus GM-CSF in Treating Patients With Multiple Myeloma Undergoing Bone Marrow or Peripheral Stem Cell Transplantation
Related Studies:
Other stage 3 multiple myeloma Clinical Trials
Other England Clinical Trials
Other London Clinical Trials
Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma
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