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
18 Years
N/A
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Hildegard Frichtel, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Medsearch
Authority:
United States: Federal Government
Study ID:
CDR0000068535
NCT ID:
NCT00014339
Start Date:
March 2000
Completion Date:
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- stage II multiple myeloma
- stage III multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|---|
| Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
| Comprehensive Cancer Centers of the Desert | Palm Springs, California 92262 |
| Medcenter One Health System | Bismarck, North Dakota 58501 |
| Cancer Care Specialists of Central Illinois, S.C. | Decatur, Illinois 62526 |
| Florida Cancer Specialists | Fort Myers, Florida 33901 |
| Maine Center for Cancer Medicine and Blood Disorders | Scarborough, Maine 04074 |
| Alta Bates Comprehensive Cancer Center | Berkeley, California 94704 |
| Mid Dakota Clinic, P.C. | Bismarck, North Dakota 58501 |
| Comprehensive Blood and Cancer Center | Bakersfield, California 93309 |
| HemOnCare, P.C. | Brooklyn, New York 11235 |
| Arizona Clinical Research Center | Tucson, Arizona 85712 |
| Southwest Cancer Care | Poway, California 92064 |
| West Clinic, P.C. | Memphis, Tennessee 38117 |
| Hematology Oncology Northwest, P.C. | Tacoma, Washington 98405 |
| Indiana Community Cancer Care, Inc. | Indianapolis, Indiana 46202 |
| Southwest Clinical Research, Incorporated | Phoenix, Arizona 85032 |
| Oncology Radiation Associates | Miami, Florida 33133 |
| Oncology-Hematology Associates, P.A. | Clinton, Maryland 20735 |
| Oncology Hematology Associates of Kansas City | Kansas City, Missouri 64131 |
