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

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title: A Phase II Clinical Trial of Dehydroepiandrosterone and Biaxin in Monoclonal Gammopathy of Undetermined and Borderline Significance

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

• NCT number: NCT00006219
• Study type: Interventional
• Source: Mayo Clinic
• Status: Completed
• Phase: Phase 2
• Start date: August 2000
• Completion date: December 2006