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VELCADE® (bortezomib) for Injection is indicated for the treatment of patients with multiple myeloma. The UPFRONT clinical trial is a study evaluating the use of VELCADE in patients with newly diagnosed multiple myeloma. The trial will study the addition of VELCADE to 3 active drug therapies presently being used to treat multiple myeloma. Each of the 3 drug therapies are either approved by the FDA or considered standard therapies for the treatment of multiple myeloma. The purpose of the UPFRONT clinical trial is to help doctors understand the potential benefit and assess the safety profile of adding VELCADE to each of these three drug therapies.
ABOUT MULTIPLE MYELOMA
Multiple myeloma is the second most common cancer of the blood, with an
estimated 19,900 new cases in the United States in 2007.* It is a cancer of
the blood and bone marrow where plasma cells produce antibodies to fight infection. Patients with myeloma have cancerous plasma cells that build up, forming tumors in many bones and soft tissues of the body. These tumors may prevent the bone marrow from making enough normal blood cells and limit the plasma cells from making disease-fighting antibodies. The myeloma may spread to many parts of your body, which is why it is called multiple myeloma.
WHAT IS A CLINICAL TRIAL
A clinical trial is a study. Some clinical trials help doctors find the most appropriate treatment for their patients. Before a clinical trial can begin, a study plan is created. In general, the study plan is designed to help doctors find answers to medical research questions
The results of this trial may one day help other people with multiple myeloma. As with
all clinical trials, study participants can stop participating at any time, for any reason. To learn more about clinical trials in general, visit www.clinicaltrials.gov/ct/info/resources.
TALK TO YOUR DOCTOR
Before deciding whether to participate in a clinical trial, you should talk with your doctor about your treatment options and ask any questions you may have. If you are interested in this study, find out as much as possible about it. For example, what are the potential benefits and risks of participating in this study? What study drugs are used in the study? Have they been investigated before? How long will the trial last? How will I know if the investigational therapy I receive is working? What will your participation in the study cost? Most of these questions are answered below or can be answered by your doctor. As part of your consideration of the trial, you will receive an informed consent document from your doctor that will explain details about the trial including its purpose, duration, required procedures, key contacts, risks and potential benefits. A participant may withdraw from a trial at any time.
THE UPFRONT CLINICAL TRIAL
The purpose of the UPFRONT clinical trial is to help doctors understand the potential benefit and assess the safety profile of adding VELCADE to 3 active drug therapies presently being used to treat multiple myeloma. VELCADE is currently approved for use in treating patients with multiple myeloma who have received at least 1 prior therapy. The 3 active drug therapies are either approved by the FDA or considered standard therapies for the treatment of multiple myeloma. To participate in the UPFRONT trial, eligible patients must have newly diagnosed multiple myeloma and cannot have received treatment for their myeloma. Patients also cannot be considered candidates for high-dose chemotherapy and stem cell transplantation. Eligible patients in this study will receive VELCADE in combination with other study drugs. Each patient will be randomly assigned a study group, with an equal chance of being assigned to any one of the 3 groups. Patients in all 3 groups will receive study drugs that are intended to treat their myeloma. You will receive more details about the other drugs used in this study if you are eligible to participate in this trial.
HOW WILL THE TRIAL WORK?
The trial has 3 parts:
- A screening period of up to 21 days
- A treatment period of up to 1 year
- A follow-up period of up to 3 years after the treatment is completed
The screening period can last up to 21 days. During the screening
period patients will answer questionnaires, have medical tests, and x-rays
to see if he or she is eligible to participate in the study. If eligible, each patient will
have an opportunity to ask questions and discuss the risks and
benefits of participating in this clinical trial. The study drugs used in this study involve risks, some of which may be serious. It is not possible to predict what side effects any one person will have. As part of this process, each patient will also be required to give his or her written consent to participate in this trial. As with any trial, a patient can stop participating at any time, for any reason.
During the main treatment period, each patient will go to their treatment center
2 times per week for 2 consecutive weeks to receive a VELCADE injection followed by 1 week without VELCADE therapy. The patient's doctor will
review the patient's response to the study treatment and monitor side-effects associated with the treatment throughout the course of the study and make changes to the doses of study drugs if necessary. If a patient's doctor determines that the study drugs are not working and the patient's disease is progressing, or he or she is not tolerating the study treatment, he or she will be taken off the study drugs. If a patient completes treatment or ends treatment early, he or she will be asked to complete an End of Study Visit after his or her last dose of study drugs and move on to the follow-up period.
After a patient has finished his or her treatment, the patient will visit the treatment
center for a check-up every 3 months, for up to 3 years. Each patient will
be asked for blood and urine samples, and to fill out a questionnaire.
If a patient's multiple myeloma gets worse during this time, the patient's doctor
will help him or her decide what to do next.
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