Chemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma

December 17, 2013 updated by: Medsearch

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Southwest Clinical Research, Incorporated
      • Tucson, Arizona, United States, 85712
        • Arizona Clinical Research Center
    • California
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood and Cancer Center
      • Berkeley, California, United States, 94704
        • Alta Bates Comprehensive Cancer Center
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center - Burbank
      • Palm Springs, California, United States, 92262
        • Comprehensive Cancer Centers of the Desert
      • Poway, California, United States, 92064
        • Southwest Cancer Care
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists
      • Miami, Florida, United States, 33133
        • Oncology Radiation Associates
    • Illinois
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Central Illinois, S.C.
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Community Cancer Care, Inc.
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Center for Cancer Medicine and Blood Disorders
    • Maryland
      • Clinton, Maryland, United States, 20735
        • Oncology-Hematology Associates, P.A.
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Oncology Hematology Associates of Kansas City
    • New York
      • Brooklyn, New York, United States, 11235
        • HemOnCare, P.C.
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Medcenter One Health System
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic, P.C.
    • Tennessee
      • Memphis, Tennessee, United States, 38117
        • West Clinic, P.C.
    • Washington
      • Tacoma, Washington, United States, 98405
        • Hematology Oncology Northwest, P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medsearch

Investigators

  • Study Chair: Hildegard Frichtel, MD, MedSearch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

April 10, 2001

First Submitted That Met QC Criteria

February 25, 2004

First Posted (Estimate)

February 26, 2004

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068535
  • MEDSEARCH-MU-699-501
  • MUCOS-MU-699-501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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