A Phase II Clinical Trial of Dehydroepiandrosterone and Biaxin in Monoclonal Gammopathy of Undetermined and Borderline Significance
- 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
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
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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
John A. Lust, MD, PhD
United States: Federal Government
|Mayo Clinic||Rochester, Minnesota 55905|
|Mayo Clinic in Arizona||Scottsdale, Arizona 85259-5404|
|Mayo Clinic in Florida||Jacksonville, Florida 32224|