Safety and Efficacy Study of Single Weekly 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study to Evaluate Efficacy and Safety of Single Weekly Administration of Bortezomib in Newly Diagnosed Multiple Myeloma|
- 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. [ Time Frame: Approximately 3 years ] [ Designated as safety issue: Yes ]
- 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: Approximately 3 years ] [ Designated as safety issue: Yes ]
- To evaluate time to progression and duration of response following bortezomib + dexamethasone treatment in patients with newly diagnosed multiple myeloma who are either ineligible or wish to postpone SCT. [ Time Frame: Approximately 3 years ] [ Designated as safety issue: Yes ]
- To collect blood and marrow samples for future analysis of molecular markers associated with response or resistance to bortezomib + dexamethasone in patients with newly diagnosed myeloma who are either ineligible or wish to postpone SCT. [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Drug: Bortezomib + Dexamethasone
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.
Other Name: Velcade
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.
|United States, Arkansas|
|Little Rock VA Medical Center|
|Little Rock, Arkansas, United States, 72205|
|United States, California|
|West Los Angeles VA Medical Center|
|Los Angeles, California, United States, 90073|
|San Francisco VA Medical Center|
|San Francisco, California, United States, 94121|
|United States, Colorado|
|Eastern Colorado Health Care System|
|Denver, Colorado, United States, 80220|
|United States, Connecticut|
|West Haven VA Medical Center|
|West Haven, Connecticut, United States, 06516|
|United States, Florida|
|Tampa VA Medical Center|
|Tampa, Florida, United States, 33612|
|United States, Georgia|
|Atlanta VA Medical Center|
|Atlanta, Georgia, United States, 30033|
|United States, Massachusetts|
|VA Boston Healthcare System|
|Jamaica Plain, Massachusetts, United States, 02130|
|United States, Missouri|
|Kansas City VA Medical Center|
|Kansas City, Missouri, United States, 64128|
|United States, Pennsylvania|
|Pittsburgh VA Medical Center|
|Pittsburgh, Pennsylvania, United States, 15240|
|United States, Texas|
|Michael E. DeBakey VA Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Nikhil C. Munshi, M.D.||Boston VA Research Institute, Inc.|
|Study Chair:||Saem Lee||Boston VA Research Institute, Inc.|