Chemoprevention Therapy in Treating Patients at High Risk of Developing Multiple Myeloma

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Dehydroepiandrosterone and clarithromycin may be effective in preventing multiple myeloma.

PURPOSE: Randomized phase II trial to compare the effectiveness of dehydroepiandrosterone with that of clarithromycin in treating patients who may be at a high risk of developing multiple myeloma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Clarithromycin; Dehydroepiandrosterone

Criteria

DISEASE CHARACTERISTICS:

• New or prior diagnosis of 1 of the following:

• Monoclonal gammopathy of undetermined significance

• Bone marrow plasma cells of less than 10%

• Monoclonal gammopathy of borderline significance

• Bone marrow plasma cells of 10-30%

• Serum IgG or IgA at least 1.5 g/dL

• Bone marrow plasmacytosis no greater than 30%

• No multiple myeloma, amyloidosis, or B-cell neoplasm

• No evidence of bone lesions

• Prostate-specific antigen less than 4 ng/mL

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN) (unless history of Gilbert's disease)

• AST and ALT no greater than 1.5 times ULN (unless history of Gilbert's disease)

Renal:

• Creatinine no greater than 1.8 mg/dL

Cardiovascular:

• No New York Heart Association class III or IV heart disease

• No prior thromboembolic event within the past 5 years

Other:

• No prostate cancer or clinically significant benign prostatic hypertrophy

• No prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

• No malignancy suspected on mammogram

• No hypersensitivity to DHEA, clarithromycin, or any macrolide antibiotic (e.g., erythromycin)

• No insulin-dependent diabetes

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier method of contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• At least 30 days since prior DHEA or other steroids that may affect M protein

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• At least 30 days since prior clarithromycin

• At least 30 days since any other prior agents that may affect M protein

• No concurrent cisapride, terfenadine, pimozide, astemizole, or loratadine