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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone.
Little Rock VA Medical Center
Little Rock, Arkansas, United States
West Los Angeles VA Medical Center
Los Angeles, California, United States
San Francisco VA Medical Center
San Francisco, California, United States
Number of Participants at Each Response Category (Stable Disease, Minimal Response, Partial Response, Very Good Partial Response, Near Complete Response/Complete Resonse)
To evaluate the response rate for weekly administered bortezomib + dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for transplant or who are eligible but wish to postpone autologous stem cell transplant.
Time frame: Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.
Number of Participants With Dose Reductions in Bortezomib, Dexamethasone or Both
To evaluate the toxicity (safety and tolerability) of weekly bortezomib + dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for transplant or who are eligible but wish to postpone autologous stem cell transplant.
Time frame: Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.
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Eastern Colorado Health Care System
Denver, Colorado, United States
West Haven VA Medical Center
West Haven, Connecticut, United States
Tampa VA Medical Center
Tampa, Florida, United States
Atlanta VA Medical Center
Atlanta, Georgia, United States
VA Boston Healthcare System
Jamaica Plain, Massachusetts, United States
Kansas City VA Medical Center
Kansas City, Missouri, United States
Pittsburgh VA Medical Center
Pittsburgh, Pennsylvania, United States
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