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


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

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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 ClinicRochester, Minnesota  55905
Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404
Mayo Clinic in FloridaJacksonville, Florida  32224