Chemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma
NCT ID: NCT00014339
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
INTERVENTIONAL
2000-03-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Wobe-Mugos E
melphalan
prednisone
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Medsearch
INDUSTRY
Principal Investigators
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Hildegard Frichtel, MD
Role: STUDY_CHAIR
Medsearch
Locations
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Southwest Clinical Research, Incorporated
Phoenix, Arizona, United States
Arizona Clinical Research Center
Tucson, Arizona, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States
Comprehensive Cancer Centers of the Desert
Palm Springs, California, United States
Southwest Cancer Care
Poway, California, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Oncology Radiation Associates
Miami, Florida, United States
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, United States
Indiana Community Cancer Care, Inc.
Indianapolis, Indiana, United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, United States
Oncology-Hematology Associates, P.A.
Clinton, Maryland, United States
Oncology Hematology Associates of Kansas City
Kansas City, Missouri, United States
HemOnCare, P.C.
Brooklyn, New York, United States
Medcenter One Health System
Bismarck, North Dakota, United States
Mid Dakota Clinic, P.C.
Bismarck, North Dakota, United States
West Clinic, P.C.
Memphis, Tennessee, United States
Hematology Oncology Northwest, P.C.
Tacoma, Washington, United States
Countries
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Other Identifiers
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MEDSEARCH-MU-699-501
Identifier Type: -
Identifier Source: secondary_id
MUCOS-MU-699-501
Identifier Type: -
Identifier Source: secondary_id
CDR0000068535
Identifier Type: -
Identifier Source: org_study_id