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

NCT00014339 | Unknown Phase 3

• 3 other identifiers: CDR0000068535MEDSEARCH-MU-699-501MUCOS-MU-699-501
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 19

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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage II multiple myeloma; stage III multiple myeloma

Interventions

Wobe-Mugos E DRUG

melphalan DRUG

prednisone DRUG

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medsearch: lead

Study Sites (19)

Southwest Clinical Research, Incorporated

Phoenix, Arizona, 85032, United States

Location

Arizona Clinical Research Center

Tucson, Arizona, 85712, United States

Location

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Providence Saint Joseph Medical Center - Burbank

Burbank, California, 91505, United States

Location

Comprehensive Cancer Centers of the Desert

Palm Springs, California, 92262, United States

Location

Southwest Cancer Care

Poway, California, 92064, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Oncology Radiation Associates

Miami, Florida, 33133, United States

Location

Cancer Care Specialists of Central Illinois, S.C.

Decatur, Illinois, 62526, United States

Location

Indiana Community Cancer Care, Inc.

Indianapolis, Indiana, 46202, United States

Location

Maine Center for Cancer Medicine and Blood Disorders

Scarborough, Maine, 04074, United States

Location

Oncology-Hematology Associates, P.A.

Clinton, Maryland, 20735, United States

Location

Oncology Hematology Associates of Kansas City

Kansas City, Missouri, 64131, United States

Location

HemOnCare, P.C.

Brooklyn, New York, 11235, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501, United States

Location

Mid Dakota Clinic, P.C.

Bismarck, North Dakota, 58501, United States

Location

West Clinic, P.C.

Memphis, Tennessee, 38117, United States

Location

Hematology Oncology Northwest, P.C.

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

chymotrypsin, papain, trypsin drug combination; Melphalan; Prednisone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Hildegard Frichtel, MD

  Medsearch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 10, 2001
• First Posted: February 26, 2004
• Study Start: March 1, 2000
• Last Updated: December 18, 2013

Record last verified: 2007-11

Locations

US (19)