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

NCT00006219 | Completed Phase 2 DMC

• 3 other identifiers: CDR0000068084P30CA015083979202
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

multiple myeloma

Interventions

clarithromycin DRUG

prasterone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Clarithromycin; Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• John A. Lust, MD, PhD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2000
• First Posted: January 27, 2003
• Study Start: August 1, 2000
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: August 4, 2011

Record last verified: 2011-08

Locations

US (3)