Phase II Study to Evaluate Efficacy and Safety of Single Weekly Administration of Bortezomib in Newly Diagnosed Multiple Myeloma
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the objective response rate (CR + PR) to 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.
Approximately 3 years
Nikhil C. Munshi, M.D.
Boston VA Research Institute, Inc.
United States: VA Boston Institutional Review Board
|Atlanta Va Medical Center||Decatur, Georgia 30033|
|San Francisco VA Medical Center||San Francisco, California 94110|
|Kansas City VA Medical Center||Kansas City, Missouri 64128|
|Michael E. DeBakey VA Medical Center||Houston, Texas 77030|
|VA Boston Healthcare System||Boston, Massachusetts 02130|
|Little Rock VA Medical Center||Little Rock, Arkansas 72205|
|West Los Angeles VA Medical Center||Los Angeles, California 90073|
|Eastern Colorado Health Care System||Denver, Colorado 80220|
|West Haven VA Medical Center||West Haven, Connecticut 06516|
|Tampa VA Medical Center||Tampa, Florida 33612|
|Pittsburgh VA Medical Center||Pittsburgh, Pennsylvania 15240|