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

2014-07-23 21:56:00 | BioPortfolio


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.


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 Design

Primary Purpose: Treatment


Multiple Myeloma and Plasma Cell Neoplasm


Wobe-Mugos E, melphalan, prednisone, quality-of-life assessment


Southwest Clinical Research, Incorporated
United States


Active, not recruiting


National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:56:00-0400

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Medical and Biotech [MESH] Definitions

An alkylating nitrogen mustard that is used as an antineoplastic in the form of the levo isomer - MELPHALAN, the racemic mixture - MERPHALAN, and the dextro isomer - MEDPHALAN; toxic to bone marrow, but little vesicant action; potential carcinogen.

A measurement index derived from a modification of standard life-table procedures and designed to take account of the quality as well as the duration of survival. This index can be used in assessing the outcome of health care procedures or services. (BIOETHICS Thesaurus, 1994)

Activities and programs intended to assure or improve the quality of care in either a defined medical setting or a program. The concept includes the assessment or evaluation of the quality of care; identification of problems or shortcomings in the delivery of care; designing activities to overcome these deficiencies; and follow-up monitoring to ensure effectiveness of corrective steps.

A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral and social environment; the overall condition of a human life.

A measure of the quality of health care by assessment of unsuccessful results of management and procedures used in combating disease, in individual cases or series.

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