Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Prevention	Completed	18 and over	NCI	MAYO-979202 NCI-P00-0163, NCT00006219

Objectives

1. 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.
2. 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.
3. 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.
4. Determine the effects of these treatment regimens on the quality of life of these patients.

Entry 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

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

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

Expected Enrollment

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.

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.

Trial Contact Information

Trial Lead Organizations

Mayo Clinic Cancer Center

John Lust, MD, PhD, Protocol chair		Ph: 507-284-2511 Email: lust.john@mayo.edu

Registry Information
Official Title		A Phase II Clinical Trial of Dehydroepiandrosterone and Biaxin in Monoclonal Gammopathy of Undetermined and Borderline Significance
Trial Start Date		2000-08-07
Trial Completion Date		2006-12-28
Registered in ClinicalTrials.gov		NCT00006219
Date Submitted to PDQ		2000-06-12
Information Last Verified		2004-07-16
NCI Grant/Contract Number		N01-CN55121, CA15083

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