Chemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm
- Registration Number
- NCT00014339
- Lead Sponsor
- Medsearch
- Brief Summary
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.
- Detailed Description
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.
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Southwest Cancer Care
🇺🇸Poway, California, United States
West Clinic, P.C.
🇺🇸Memphis, Tennessee, United States
Oncology-Hematology Associates, P.A.
🇺🇸Clinton, Maryland, United States
Southwest Clinical Research, Incorporated
🇺🇸Phoenix, Arizona, United States
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Cancer Care Specialists of Central Illinois, S.C.
🇺🇸Decatur, Illinois, United States
Comprehensive Cancer Centers of the Desert
🇺🇸Palm Springs, California, 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
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
Oncology Radiation Associates
🇺🇸Miami, Florida, United States
Indiana Community Cancer Care, Inc.
🇺🇸Indianapolis, Indiana, United States
Maine Center for Cancer Medicine and Blood Disorders
🇺🇸Scarborough, Maine, United States
Medcenter One Health System
🇺🇸Bismarck, North Dakota, United States
Mid Dakota Clinic, P.C.
🇺🇸Bismarck, North Dakota, United States
Oncology Hematology Associates of Kansas City
🇺🇸Kansas City, Missouri, United States
Hematology Oncology Northwest, P.C.
🇺🇸Tacoma, Washington, United States
HemOnCare, P.C.
🇺🇸Brooklyn, New York, United States