Back to resultsChemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma
Primary Purpose
Multiple Myeloma and Plasma Cell Neoplasm
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Wobe-Mugos E
melphalan
prednisone
quality-of-life assessment
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage II multiple myeloma, stage III multiple myeloma
Eligibility 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 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
Sites / Locations
- Southwest Clinical Research, Incorporated
- Arizona Clinical Research Center
- Comprehensive Blood and Cancer Center
- Alta Bates Comprehensive Cancer Center
- Providence Saint Joseph Medical Center - Burbank
- Comprehensive Cancer Centers of the Desert
- Southwest Cancer Care
- Florida Cancer Specialists
- Oncology Radiation Associates
- Cancer Care Specialists of Central Illinois, S.C.
- Indiana Community Cancer Care, Inc.
- Maine Center for Cancer Medicine and Blood Disorders
- Oncology-Hematology Associates, P.A.
- Oncology Hematology Associates of Kansas City
- HemOnCare, P.C.
- Medcenter One Health System
- Mid Dakota Clinic, P.C.
- West Clinic, P.C.
- Hematology Oncology Northwest, P.C.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00014339
Brief Title
Chemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma
Official Title
A Randomized, Phase III, Placebo-Controlled Multicenter Study to Demonstrate the Effectiveness and Safety of the Combination Enzyme Tablet (Wobe-Mugos E) as Adjuvant Therapy to Standard of Care Treatment in Patients With Stages II or III Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Medsearch
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
stage II multiple myeloma, stage III multiple myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Wobe-Mugos E
Intervention Type
Drug
Intervention Name(s)
melphalan
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hildegard Frichtel, MD
Organizational Affiliation
Medsearch
Official's Role
Study Chair
Facility Information:
Facility Name
Southwest Clinical Research, Incorporated
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Providence Saint Joseph Medical Center - Burbank
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Comprehensive Cancer Centers of the Desert
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Southwest Cancer Care
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Oncology Radiation Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Cancer Care Specialists of Central Illinois, S.C.
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Indiana Community Cancer Care, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Maine Center for Cancer Medicine and Blood Disorders
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Oncology-Hematology Associates, P.A.
City
Clinton
State/Province
Maryland
ZIP/Postal Code
20735
Country
United States
Facility Name
Oncology Hematology Associates of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
HemOnCare, P.C.
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Medcenter One Health System
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Mid Dakota Clinic, P.C.
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
West Clinic, P.C.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38117
Country
United States
Facility Name
Hematology Oncology Northwest, P.C.
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Chemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma
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