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Interferon alfa Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Multiple Myeloma Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Interferon alfa Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Multiple Myeloma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Interferon alfa Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Multiple Myeloma Clinical research trials and Interferon alfa Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Multiple Myeloma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Interferon alfa Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Multiple Myeloma. Interferon alfa Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Multiple Myeloma Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Interferon alfa Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Multiple Myeloma clinical trial. Subjects often receive the most expert healthcare possible for their Interferon alfa Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Multiple Myeloma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Interferon alfa Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Multiple Myeloma  Interferon alfa Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Multiple Myeloma
Interferon alfa Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Multiple Myeloma
For Condition: refractory plasma cell neoplasm,stage 3 multiple myeloma
Status: Completed
Sponsor(s): University of Tennessee ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Interferon alfa may interfere with the growth of cancer cells. PURPOSE: Phase II trial to determine the effectiveness of giving interferon alfa after chemotherapy and peripheral stem cell transplantation to patients who have stage III or stage IV multiple myeloma and who have been treated with high-dose melphalan.
Details: OBJECTIVES: I. Determine the effectiveness of interferon alfa-2b maintenance following high dose melphalan chemotherapy for patients with advanced multiple myeloma. II. Determine the response rate to high dose dexamethasone therapy using sequential noncrossresistant chemotherapies for patients with advanced multiple myeloma. PROTOCOL OUTLINE: Patients receive high dose dexamethasone on days 1-4, 9-12, and 17-20, followed by 4 weeks rest. Cyclophosphamide (CTX) is administered intravenously in combination with mesna following dexamethasone therapy. Sargramostim (GM-CSF) is initiated subcutaneously 1 day later and is continued for 10 days to support stem cell collections, which begin 10-14 days after CTX induction. Following 4 weeks of rest, melphalan (L-PAM) is administered over 1 hour. Stem cell rescue is begun 48 hours after L-PAM therapy. Three to 4 months after the first L-PAM course, a second L-PAM and stem cell rescue is undertaken. Interferon alfa-2b (IFN-A) maintenance is administered 3 times per week following bone marrow recovery from the first or second L-PAM courses. Patients achieving complete remission following the first course of L-PAM may proceed directly to IFN-A maintenance. Patients achieving greater than grade 3 nonhematologic toxicity or not achieving an absolute neutrophil count of greater than 1,000/mm3 by day 21 posttransplant are not eligible for dose escalation. PROJECTED ACCRUAL: A minimum of 30 patients will be enrolled.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 19 Years/64 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristic-- - Histologically proven Stage III or IV advanced multiple myeloma --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No more than 12 months of prior alkylator therapy - Endocrine Therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified --Patient Characteristics-- - Age: 19 to 64 - Performance Status: Zubrod 0-3 - Hematopoietic: Not specified - Hepatic: Bilirubin less than 2 mg/dL; SGOT and SGPT less than 3 times normal; Alkaline phosphatase less than 3 times normal - Renal: Creatinine clearance at least 60 mL/min - Cardiovascular: Cardiac ejection fraction at least 50% - Pulmonary: No history of severe chronic obstructive lung disease; No history of recurrent pulmonary emboli - Other: Not pregnant or nursing; Effective contraception should be practiced by fertile patients; No history of diabetes mellitus complicated by ketoacidosis; No history of depression or psychosis; No history of autoimmune disorders; No concurrent thyroid disorders unable to be maintained on replacement therapy; No prior hypersensitivity to interferon alfa-2b
Total Enrollment:
Location and Contact Information:
Overall Study Official:
C.Jones, Study Chair, University of Tennessee
Baptist Memorial Hospital
Memphis, Tennessee, 38146
United States
University of Tennessee, Memphis
Memphis, Tennessee, 38163
United States
William F. Bowld Hospital
Memphis, Tennessee, 38103
United States
Methodist Healthcare - Hospital of Memphis
Memphis, Tennessee, 38104
United States
Additional Information:
Study ID Numbers: CDR0000065577; UTENNM-BCG-5889,NCI-V97-1263,BCG-5889,INTTHERA-UTENNM-BCG-5889
Study Start Date: July 1996
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003007
Other Stage 3 Multiple Myeloma Studies:
1. Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma
2. Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma
3. Interleukin-12 in Treating Patients With Multiple Myeloma
4. Melphalan and Filgrastim to Stimulate Peripheral Stem Cells in Patients With Multiple Myeloma
5. Interferon alfa Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Multiple Myeloma
Related Studies:
Other stage 3 multiple myeloma Clinical Trials
Other Tennessee Clinical Trials
Other Memphis Clinical Trials
Interferon alfa Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Multiple Myeloma
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