A Phase II Clinical Trial of Dehydroepiandrosterone and Biaxin in Monoclonal Gammopathy of Undetermined and Borderline Significance
18 Years
N/A
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
A Phase II Clinical Trial of Dehydroepiandrosterone and Biaxin in Monoclonal Gammopathy of Undetermined and Borderline Significance
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Principal Investigator
John A. Lust, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000068084
NCT ID:
NCT00006219
Start Date:
August 2000
Completion Date:
December 2006
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- multiple myeloma
- Neoplasms
- Paraproteinemias
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
| Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
| Mayo Clinic in Florida | Jacksonville, Florida 32224 |
