This guide, which will be published as a series of articles over the next couple of weeks, is intended to help clarify the clinical trial process and to answer common questions so that you can decide whether a clinical trial is the right option for you. The guide will explain the different types of clinical trials, address common concerns, provide answers from physicians to common questions, describe patients’ clinical trial experiences, and provide resources for finding a clinical trial.

If you have decided to participate in a clinical trial, then you will need to select a clinical trial that is right for you. This process may be very easy if your physician has already recommended a specific trial, or this process may require research and careful consideration if you are trying to find a trial on your own. This article provides a list of resources for finding a clinical trial as well as describes the things you will want to consider and questions you will want to ask when deciding between several trials.

How To Search For Myeloma Clinical Trials In Your Area

Fortunately, there are many ways to find myeloma clinical trials. One of the easiest ways is often by word of mouth. Ask your doctor about clinical trials that are currently recruiting participants. Your doctor is familiar with your case and can recommend a clinical trial that will be right for you. Also, you can inquire at your cancer treatment center about ongoing trials.

If you want to search on your own for clinical trial options, there are a number of websites and organizations that can help you find suitable trials based on your stage of myeloma, your location, and treatments that you are interested in trying.

The United States National Institutes of Health’s website, www.ClinicalTrials.gov, allows you to search by disease or treatment and also allows you to refine your search by location, clinical phase, enrollment status, and much more. The entry for each trial also provides information about the purpose of the trial, eligibility criteria, and who is sponsoring and conducting the trial.

The U.S. National Cancer Institute also maintains a website, www.cancer.gov/clinicaltrials, for searching clinical trials based on disease, location, treatment type, clinical phase, and trial sponsors or investigators. The entry for each trial also provides detailed information about eligibility criteria. Additionally, if you have questions about clinical trials, you can call their toll-free hotline at 1-800-4-CANCER (1-800-422-6237).

The clinical trial matching service, found on the Multiple Myeloma Research Foundation website, is also another online tool for finding clinical trials. It enables you to view all myeloma trials or to build a personal profile and to narrow down your search for a trial based on your specific case. Their registry provides detailed information about eligibility and the treatment protocol but does not provide information about the locations where the trial is being conducted or who the sponsor or investigator is. They also have a toll-free hotline at 1-866-603-MMCT.

You can also find a treatment center near you by using The Myeloma Beacon’s treatment center directory. You may wish to check with local treatment centers if they are conducting any ongoing clinical trials.

Criteria For Joining

Once you have found a few clinical trials that you are interested in, you will also need to determine whether you are eligible to participate in any of those trials.

Because each trial has a specific purpose, only certain patients are eligible to participate. Each clinical trial protocol clearly states who can or cannot join the trial. These criteria reduce variability in the study so that the results can be accurately analyzed to determine whether the treatment being studied is effective.

Common criteria for entering a trial include:

• Having a certain type or stage of cancer
• Having received a certain kind of therapy in the past
• Other health problems
• Current medications
• Being in a certain age group

For myeloma patients, criteria for entering a trial include:

• Newly diagnosed myeloma
• Refractory/relapsed myeloma
• Patients with a certain treatment history

For more information about eligibility criteria, see the eligibility sections of Part 3 in this series.

These criteria help ensure safety as well as accurate and meaningful study results. Some people have health problems besides cancer that could be made worse by the treatments in a study. If you are interested in joining a trial, you will receive medical tests to assure that you are healthy enough to participate.

You may not be able to join certain clinical trials if you already have had another kind of treatment for your cancer. There are a number of reasons for this type of restriction: the purpose of the trial may be to investigate the drug in newly diagnosed patients, it may already be known that the drug is not effective if you relapsed or are refractory to a certain drug, or the researchers may want to be sure that your response to the new treatment is not being affected by a previous treatment.

Also, it is wise to discuss with your physician all medications that you take, including any you may not take on an ongoing basis. Some medications may interfere with the protocol being studied and, therefore, may need to be stopped. Clinical trials often require a washout period of two to six weeks before the start of the trial in which you are not allowed to take any medications. The purpose is to allow all current drugs to leave your system, so that the researchers can accurately determine whether the new drug is effective.

If you are required to stop any of your medications, please discuss this carefully with your physician to determine the risks and to make sure this would be safe for you.

Important Questions To Ask

While you are deciding which clinical trial in which to participate, there are a number of questions that you want to ask about each trial. Many of the questions can be answered by the entry for the trial in a clinical trials database, such as www.ClinicalTrials.gov.

Once you have selected a clinical trial in which you most likely want to participate, you will begin the informed consent process in which you will meet with the principle investigator of the study as well as the research coordinator at your treatment center to discuss the trial. This is an opportunity to find out all of the details of the trial, to ask the remaining questions you have about the trial, and to make your final decision about whether you want to participate in the trial.

It is important to communicate with your physician and your research coordinator, both while you are deciding whether to participate in a clinical trial and also during your participation in the trial. If you have questions, do not be afraid to ask them.

It can be useful to write down and take your questions with you when you go to visit the doctor. It is also helpful to take a writing pad with you to jot down notes during your conversation. This way, if you get nervous or flustered, you have your questions right in front of you.

It also helps to bring along a family member or a friend for moral support and as a second set of ears. Some people prefer to bring an audio recorder with them to record the conversation so they can replay it later.

During the day of the appointment, it will be helpful to clear your schedule for a couple of hours or even the whole day. The informative process itself takes a while, and you do not want to have to rush through it. For some people, a day is needed to fully process the information as it sinks in.

Here are some questions to keep in mind as you consider your clinical trial options:

About this trial:

• Why is this trial being done?
• Why do the doctors who designed the trial believe that the treatment being studied may be better than the standard treatments? Why might it not be better?
• How long will I be in the trial?
• What kinds of tests and treatments are involved?
• What are the possible short and long-term side effects or risks of the new treatment?
• What side effects have been seen in patients who took this treatment previously?
• What are the possible benefits?
• How will the doctor know if the treatment is working?
• What happens if the treatment is found to be ineffective or harmful?

Costs:

• Will I have to pay for any of the treatments or tests?
• What costs will my health insurance cover?
• Are there any other costs that I need to worry about such as travel expenses, overnight stays, hospital parking, etc.?

Daily life:

• How might the trial affect my daily life?
• How often will I have to come to the hospital or clinic?
• How often do I have to make appointments with my doctor/research coordinator?
• How often do I have to be tested during the trial?
• Will I have to travel long distances?

Comparing choices:

• What are my other treatment choices, including standard treatments?
• Have I exhausted all other options?
• How does the treatment I would receive in this trial compare with the other treatment choices?

To learn more about clinical trials, please read the previous articles in the series and check The Myeloma Beacon in the coming weeks for subsequent articles.