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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006219 |
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 |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: clarithromycin Drug: therapeutic dehydroepiandrosterone |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Official Title: | A Phase II Clinical Trial of Dehydroepiandrosterone and Biaxin in Monoclonal Gammopathy of Undetermined and Borderline Significance |
Study Start Date: | August 2000 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
New or prior diagnosis of 1 of the following:
Monoclonal gammopathy of undetermined significance
Monoclonal gammopathy of borderline significance
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Arizona | |
Mayo Clinic Scottsdale | |
Scottsdale, Arizona, United States, 85259 | |
United States, Florida | |
Mayo Clinic - Jacksonville | |
Jacksonville, Florida, United States, 32224 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 |
Study Chair: | John A. Lust, MD, PhD | Mayo Clinic |
Study ID Numbers: | CDR0000068084, MAYO-979202, NCI-P00-0163 |
Study First Received: | September 11, 2000 |
Last Updated: | February 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00006219 History of Changes |
Health Authority: | United States: Federal Government |
multiple myeloma |
Immunoproliferative Disorders Immunologic Factors Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Adjuvants, Immunologic Vascular Diseases Dehydroepiandrosterone Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Anti-Bacterial Agents Clarithromycin Hemorrhagic Disorders Monoclonal Gammopathy of Undetermined Significance Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Hemostatic Disorders Clarithromycin Anti-Bacterial Agents Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Hematologic Diseases Vascular Diseases Adjuvants, Immunologic Dehydroepiandrosterone Enzyme Inhibitors Pharmacologic Actions Multiple Myeloma Protein Synthesis Inhibitors Neoplasms Lymphoproliferative Disorders Neoplasms, Plasma Cell |