Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

OBJECTIVES:

• Determine whether dehydroepiandrosterone (DHEA) or clarithromycin causes a significant reduction in bone marrow plasmacytosis, serum and/or urine M protein or Bence Jones protein, and surrogate endpoint biomarkers in patients with monoclonal gammopathy of undetermined or borderline significance.

• Determine whether differences in interleukin-1-beta (IL-1-beta) expression and IL-1-beta dependent biomarkers (adhesion molecule expression and serum interleukin-6 levels) are useful surrogate endpoint biomarkers in these patients.

• Determine whether differences in ploidy, proliferative index, nuclear pleomorphism index, circulating monoclonal plasma cells, Th1/Th2 ratios, serum s-interleukin-6R (SIL-6R) levels, interleukin-6 and SIL-6R expression, or plasma cell apoptosis assay are useful surrogate endpoint biomarkers in these patients.

• Determine the effects of these treatment regimens on the quality of life of these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to disease (monoclonal gammopathy of undetermined significance vs monoclonal gammopathy of borderline significance) and monoclonal protein abnormality (IgG vs IgA). Patients are randomized to 1 of 4 treatment arms.

• Arm I: Patients receive oral dehydroepiandrosterone (DHEA) once daily.

• Arm II: Patients receive oral clarithromycin once or twice daily.

• Arm III: Patients receive oral placebo once daily.

• Arm IV: Patients receive oral placebo twice daily. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, 6 months, 12 months, and then at disease progression.

Patients are followed every 3 months for 1 year and then every 6 months for 1.5 years.

PROJECTED ACCRUAL: A total of 75 patients (25 per treatment arms I and II and 25 between arms III and IV) will be accrued for this study within 2.5 years.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Mayo Clinic Cancer Center

John A. Lust

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00006219
Information obtained from ClinicalTrials.gov on December 14, 2011

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