If you have recently learned that you have multiple myeloma and have had a stem cell transplant, or are planning a stem cell transplant, the AURIGA clinical trial might be an option for you. The AURIGA clinical research study is evaluating the addition of an investigational medication to standard of care maintenance treatment for multiple myeloma.
What is a clinical research study and why is it important?
A clinical trial, also called a clinical research study, is a carefully designed scientific evaluation of an investigational medication. Clinical trials help doctors and researchers determine if an investigational medication is safe and/or effective for use in humans to potentially treat a condition, disease, or disorder. Clinical trials are completely optional and each one has a specific set of criteria a participant must meet to join. Clinical studies, conducted by doctors and researchers, often require a large number of volunteers to participate in a single study, and sometimes thousands are needed to obtain reliable information.
What can I expect if I join a clinical trial?
If you qualify and choose to join a clinical trial, you will first sign an informed consent form (ICF). “Informed Consent” is a process of information exchange before an adult agrees to participate in research. During this process you will be asked to read the ICF, and a study doctor or member of the research team will explain all the details of the study and answer your questions. By signing the ICF you agree to volunteer to take part in the study, you understand the study procedures, risks and potential side effects, and that you can leave the study at any time, for any reason. If you don’t understand what is expected of you or what is written in the document, you should continue to ask questions and talk with the study doctor, your family, or others that you trust, until you feel you understand.
What is the purpose of the AURIGA study?
The purpose of this clinical research study is to determine the safety and efficacy of the addition of an investigational medication to standard of care maintenance treatment. The investigational medication is being evaluated in people who have multiple myeloma.
Am I eligible for the AURIGA study?
You may be able to participate in this study if you:
- Are 18 to 79 years of age
- Have a diagnosis of multiple myeloma
- Have received previous treatment for multiple myeloma and a stem cell transplant, or are planning to receive a stem cell transplant
Additional eligibility criteria will be assessed by the study doctor or staff during the screening process prior to being enrolled in the study and receiving any investigational medication. Not all individuals may qualify to participate in the research.
What can I expect if I join the AURIGA study?
If you qualify and choose to join the study and sign the informed consent form (ICF), you will be asked to attend a screening visit with the study doctor. At this visit, you will undergo tests and procedures to determine if you are a good match for continuing in the study.
- If eligible, you could be in the study for 3-4 years and visit the study doctor or clinical research staff up to 46 times.
- You will be randomly assigned to one of two study groups. This means you may either receive the investigational medication plus standard of care treatment or standard of care treatment alone.
- You will know what group you are assigned.
- Qualified patients may receive an investigational medication and some study-required medical care at no cost.
What is expected during my participation in the AURIGA study?
Your study doctor and research staff will guide you throughout your participation in the study. However, you can expect the following general expectations:
- Tell the study doctor/staff about any health problems you have during the study
- Complete your study diary and bring it to all study visits
- Come to all study visit appointments
- Ask the study doctor/staff any questions you have about the study
- Tell the study doctor/staff about any new medicine you take during the study, as well as any changes to your medicines
How do I learn more about participation in the AURIGA study?
You can talk to your doctor to find out if you are a candidate for a clinical trial. You can learn more about the AURIGA study which is posted on the Sparkcures website, click here to visit the study page.
Where can I go to learn more about Multiple Myeloma?
There are several online resources available. For further information and research support groups consider visiting the following websites. Consider asking your doctor if they can recommend local support groups near you.
- American Cancer Society’s Cancer Survivors Network:Â Connect with other people with cancer and their families through discussion boards, chat rooms and private CSN email addresses.
- International Myeloma Foundation’s Smart Patients Myeloma Community: Learn about available treatments and clinical trials for Multiple myeloma. Learn about the experiences of other people living with the condition, as well as the experiences of their families and caregivers.
- Cancer Hope Network: Talk or engage in a live chat with a cancer survivor who’s faced and recovered from a situation similar to yours.
- International Myeloma Foundation: You can find more support groups by visiting this website.
- Multiple Myeloma Research Foundation: Learn more about treatments and clinical trials
- SparkCures: Learn about treatment options, multiple myeloma specialists, and find available clinical trials near you.
 This article is brought to you by Janssen.
