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Chemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Chemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Chemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma Clinical research trials and Chemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma healthcare trials happen in many 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 generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Chemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma. Chemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Chemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Chemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma  Chemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma
Chemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma
For Condition: stage 2 multiple myeloma,Quality of Life,stage 3 multiple myeloma
Status: No longer recruiting
Sponsor(s): Medsearch ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Enzyme products such as Wobe-Mugos E may help to reduce the side effects of multiple myeloma therapy. It is not yet known if chemotherapy is more effective with or without Wobe-Mugos E in treating multiple myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without Wobe-Mugos E in treating patients who have stage II or stage III multiple myeloma.
Details: OBJECTIVES: I. Compare the long-term survival of patients with chemotherapy-naive stage II or III multiple myeloma treated with standard melphalan and prednisone with or without adjuvant Wobe-Mugos E. II. Compare the effect of these two regimens on the reduction of the side effects from chemotherapy in these patients, using 2 quality of life questionnaires. III. Compare the effect of these two regimens on tumor response rate and new metastasis development in these patients. PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral melphalan and oral prednisone on days 1-4. Patients also receive adjuvant enzyme therapy with oral Wobe-Mugos E 3 times daily beginning prior to or on day 1 of the first course of chemotherapy. Arm II: Patients receive melphalan and prednisone as in arm I. Patients also receive an oral placebo 3 times daily as in arm I. Treatment continues for a minimum of 12 months to up to 4 years in the absence of unacceptable toxicity. Patients continue on melphalan and prednisone on a 4-week course until achieving maximum response or plateau phase and then receive 2 additional courses of therapy. Quality of life is assessed at baseline; at 1, 3, and 6 months and every 6 months for up to 4 years during study; and then at end of study. Patients are followed for survival for 1 month after completing the study and all patients receive the enzyme product. PROJECTED ACCRUAL: A total of 250 patients (125 per treatment arm) will be accrued for this study within 1.5 years.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage II or III multiple myeloma by bone marrow biopsy or aspiration; Previously untreated with chemotherapy - Melphalan and prednisone as only choice of standard treatment --Prior/Concurrent Therapy-- - Biologic therapy: No prior transplantation or stem cell therapy; No concurrent interferon therapy during initial melphalan and prednisone regimen - Chemotherapy: See Disease Characteristics; Concurrent other chemotherapy allowed if disease progression on study therapy - Endocrine therapy: Not specified - Radiotherapy: No more than 6 months since prior localized radiotherapy; Concurrent localized radiotherapy allowed - Surgery: Not specified - Other: At least 30 days since prior investigational drug therapy; Concurrent bisphosphonates for bone disease required; No other concurrent enzyme preparation (including over the counter or nutraceutical preparations); No concurrent participation in other clinical study; No concurrent anticoagulant therapy unless medically indicated --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 1 year - Hematopoietic: WBC at least 2,000/mm3; Absolute neutrophil count at least 1,000/mm3; Platelet count at least 50,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; SGOT or SGPT no greater than 3 times upper limit of normal (ULN); PT or PTT no greater than 1.2 times ULN - Renal: Creatinine no greater than 2.0 mg/dL (if stage IIA or IIIA); Creatinine greater than 2.0 mg/dL (if stage IIB or IIIB) - Cardiovascular: No myocardial infarction within the past 6 months; No congestive heart failure - Other: No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell cancer or carcinoma in situ of the cervix; No other disease, psychiatric condition, or substance abuse that would preclude study; No serious non-malignant disease, including uncontrolled infection or peptic ulcer disease; HIV negative; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HildegardFrichtel, Study Chair, Medsearch
Mid Dakota Clinic, P.C.
Bismark, North Dakota, 58501
United States
Arizona Clinical Research Center
Tucson, Arizona, 85712
United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
United States
HemOnCare, P.C.
Brooklyn, New York, 11235
United States
Oncology-Hematology Associates, P.A.
Clinton, Maryland, 20735
United States
Oncology Radiation Associates
Miami, Florida, 33133
United States
Florida Cancer Specialists
Ft. Myers, Florida, 33901
United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, 04074
United States
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, 62526
United States
Providence Saint Joseph Medical Center - Burbank
Burbank, California, 91505
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
Indiana Community Cancer Care, Inc.
Indianapolis, Indiana, 46202
United States
Southwest Cancer Care
Poway, California, 92064
United States
Comprehensive Cancer Centers of the Desert
Palm Springs, California, 92262
United States
Oncology Hematology Associates of Kansas City
Kansas City, Missouri, 64131
United States
Hematology Oncology Northwest, P.C.
Tacoma, Washington, 98405
United States
Southwest Clinical Research, Incorporated
Phoenix, Arizona, 85032
United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
United States
West Clinic, P.C.
Memphis, Tennessee, 38117
United States
Additional Information:
Study ID Numbers: CDR0000068535; MUCOS-MU-699-501,MEDSEARCH-MU-699-501
Study Start Date: March 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014339
Other Quality Of Life Studies:
1. Dexamethasone With or Without Oblimersen in Treating Patients With Relapsed or Refractory Multiple Myeloma
2. Combination Chemotherapy, Peripheral Stem Cell Transplantation, Biological Therapy, Pamidronate and Thalidomide in Treating Patients With Multiple Myeloma
3. CCI-779 in Treating Patients With Relapsed or Refractory Multiple Myeloma
4. Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, or Multiple Myeloma
5. Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Related Studies:
Other Quality of Life Clinical Trials
Other North Dakota Clinical Trials
Other Bismark Clinical Trials
Chemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma
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