Saturday, February 12, 2005 1:18:45 PM
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A Study of the Efficacy and Safety of 2-Methoxyestradiol to Treat Multiple Myeloma
IRB Number : 2191-00
Trial Status : Open for Enrollment
Why is this study being done?
This study is being done to see if 2-Methoxyestradiol (2ME2), swallowed twice daily, can stop multiple myeloma from progressing. Researchers also expect to learn about the side effects of giving the drug twice a day and to learn how the human body processes 2ME2.
Who is Eligible to Participate in the Study?
Patients with plateau phase or relapsed multiple myeloma may be eligible for this study.
What is Involved With this Study?
To make sure that you can safely take part in this study, there will be two screening visits. At the first one, researchers take your medical history and give you a complete physical exam. You will have a bone marrow aspirate and biopsy, bone survey, and blood tests. At the second, you will have an electrocardiogram, more blood tests, and a urinalysis to make sure you are still eligible for this study.
Before you actually begin taking the study drug, you may have to repeat some of these tests for safety purposes. You will take the 2ME2 twice day for as long as you are on the study.
Before the first dose of drug, and once a month for the first 6 months, special tests will measure the levels of 2ME2 in your blood. The special tests will be repeated at months 9, 12, and 18, then once a year until the study is over -- or until your disease progresses or your doctor decides it is in your best interest to leave the study.
You will have a physical exam, medical history, and the special blood tests once a month for the first six months; at month(s) 9, 12, 18; and then once a year.
How long will the Study run?
You could be in the study as long as the disease does not progress and you have no bad side effects from the study drug.
Who can I Contact for Additional Information on this Trial?
For more information about this study or other cancer studies please email:
Mayo Clinic Comprehensive Cancer Center.
What is/are the Locations of this Clinical Trial?
Rochester, MN
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