Chemoprevention Therapy in Treating Patients at High Risk of Developing Multiple Myeloma - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00006219

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Drug: clarithromycin Drug: prasterone	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Prevention
Official Title:	A Phase II Clinical Trial of Dehydroepiandrosterone and Biaxin in Monoclonal Gammopathy of Undetermined and Borderline Significance

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Prasterone Clarithromycin Dehydroepiandrosterone sulfate

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Study Start Date:	August 2000
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006219

Locations

United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Study Chair:

John A. Lust, MD, PhD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	John A. Lust, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier:	NCT00006219 History of Changes
Other Study ID Numbers:	CDR0000068084, P30CA015083, 979202
Study First Received:	September 11, 2000
Last Updated:	August 2, 2011
Health Authority:	United States: Federal Government

Keywords provided by Mayo Clinic:

multiple myeloma

Additional relevant MeSH terms:

Neoplasms
Paraproteinemias
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Blood Protein Disorders
Hematologic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders

Lymphoproliferative Disorders
Dehydroepiandrosterone
Clarithromycin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012