Multiple Myeloma Clinical Trial
Official title:
Phase II Study to Evaluate Efficacy and Safety of Single Weekly Administration of Bortezomib in Newly Diagnosed Multiple Myeloma
This is a research study to see if a new drug called bortezomib is useful to treat multiple myeloma in people who are newly diagnosed, and have not yet received treatment for their disease. VELCADE® (bortezomib) for Injection is a drug under development by Millennium Pharmaceuticals, Inc.
This study is a multi-site study which will enroll up to 50 patients with multiple myeloma
who have not had prior treatment.
Prior to starting treatment individuals will be evaluated to determine if they are eligible
to participate in the study. There are certain prestudy test that are required: physical
exam, blood tests, ECG, chest x-ray, skeletal survey, bone marrow aspirate and biopsy to
confirm the diagnosis of multiple myeloma and to determine baseline health status.
Before beginning each treatment cycle and at the end of the study, patients will have protein
studies (including blood and urine) to see if they are responding to the treatment. Before
each weekly treatment cycle patients will also have blood tests for red and white blood cells
and platelets, and blood chemistry tests for electrolytes, kidney and liver function, calcium
and blood sugar.
Patients may receive up to 6 cycles of treatment. At the end of the study, individuals who
have responded to treatment will be seen every two months to check for disease progression.
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