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

This study is no longer recruiting patients.

Sponsored by: Medsearch
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
stage II multiple myeloma
stage III multiple myeloma
Quality of Life
 Drug: melphalan
 Drug: prednisone
 Drug: Wobe-Mugos E
Phase III

MedlinePlus related topics:  Multiple Myeloma

Study Type: Interventional
Study Design: Educational/Counseling/Training

Official Title: Phase III Randomized Study of Standard Melphalan and Prednisone With or Without Adjuvant Wobe-Mugos E in Patients With Chemotherapy-Naive Stage II or III Multiple Myeloma

Further Study Details: 

Study start: March 2000

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.

PROTOCOL 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.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

--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

Location Information


Arizona
      Arizona Clinical Research Center, Tucson,  Arizona,  85712,  United States

      Southwest Clinical Research, Incorporated, Phoenix,  Arizona,  85032,  United States

California
      Alta Bates Comprehensive Cancer Center, Berkeley,  California,  94704,  United States

      Comprehensive Blood and Cancer Center, Bakersfield,  California,  93309,  United States

      Comprehensive Cancer Centers of the Desert, Palm Springs,  California,  92262,  United States

      Providence Saint Joseph Medical Center - Burbank, Burbank,  California,  91505,  United States

      Southwest Cancer Care, Poway,  California,  92064,  United States

Florida
      Florida Cancer Specialists, Fort Myers,  Florida,  33901,  United States

      Oncology Radiation Associates, Miami,  Florida,  33133,  United States

Illinois
      Cancer Care Specialists of Central Illinois, S.C., Decatur,  Illinois,  62526,  United States

Indiana
      Indiana Community Cancer Care, Inc., Indianapolis,  Indiana,  46202,  United States

Maine
      Maine Center for Cancer Medicine and Blood Disorders, Scarborough,  Maine,  04074,  United States

Maryland
      Oncology-Hematology Associates, P.A., Clinton,  Maryland,  20735,  United States

Missouri
      Oncology Hematology Associates of Kansas City, Kansas City,  Missouri,  64131,  United States

New York
      HemOnCare, P.C., Brooklyn,  New York,  11235,  United States

North Dakota
      Medcenter One Health System, Bismarck,  North Dakota,  58501,  United States

      Mid Dakota Clinic, P.C., Bismarck,  North Dakota,  58501,  United States

Tennessee
      West Clinic, P.C., Memphis,  Tennessee,  38117,  United States

Washington
      Hematology Oncology Northwest, P.C., Tacoma,  Washington,  98405,  United States

Study chairs or principal investigators

Hildegard Frichtel,  Study Chair,  Medsearch   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068535; MEDSEARCH-MU-699-501; MUCOS-MU-699-501
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  April 10, 2001
ClinicalTrials.gov Identifier:  NCT00014339
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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