Before taking part in a clinical trial, it is important to know if it is the right decision for you⁴.

Please visit Understanding Clinical Trials and Research for more information about the clinical trial process, including the different clinical steps or ‘phases’ involved.

Your healthcare team may discuss your taking part in a clinical trial with you. Like all treatment options, investigational treatments for multiple myeloma that are given to participants in clinical trials have their own potential benefits and risks^1,4, and it’s important to understand what these might be so that you can make an informed decision about your participation. Some examples of benefits and risks can be found below.

Benefits^1,4

• Potential access to an effective current treatment or an investigational treatment for multiple myeloma that might not be available outside of the trial
• Closer monitoring and follow-up by a specialist team during the trial. This team usually includes a principal investigator who directs all aspects of a clinical trial, a research nurse and data manager who manage the collection of data (information) throughout the trial, and staff doctors and nurses who help take care of the participants during the trial
• Taking part in a multiple myeloma clinical trial helps doctors and the research team learn more about the disease to improve future healthcare for people with multiple myeloma

Risks^1,4

• The investigational treatment in the clinical trial might not be better than, or may be worse than, the currently available treatments for multiple myeloma
• The investigational treatment may have unexpected and serious side effects
• Taking part in a clinical trial could require more visits to the doctor, which may take time
• The trial may require more tests such as blood tests or imaging than current treatments. These tests are important to assess how the investigational treatments work in people with multiple myeloma
• Depending on the design of the trial, the participant may receive a current treatment for multiple myeloma and/or a placebo¹, instead of the investigational treatment. In a trial known as a “double-blind” trial, neither the researchers nor the participants know who has been given the drug that is under investigation and who has not received it

Taking part in clinical trials is free for Australian citizens and residents^1,4. The cost of trial-related treatments, tests and check-ups will be paid for by the organization or company that is funding or conducting the research/clinical trial (sponsor¹). Some of these tests and treatments are part of the standard of care.

Any additional costs related to the extra care that patients need when taking part in a clinical trial, such as more doctor’s visits, more hospital stays, more tests as well as travel, housing if required, food and childcare will be covered by the sponsor. The clinical trial team will outline what expenses will be covered⁴.

Before a person with multiple myeloma can join a specific clinical trial, they must meet certain requirements. These requirements are known as inclusion and exclusion criteria¹. Please visit Understanding Clinical Trials and Research to find out more about these criteria, and the process of informed consent. If you are interested in taking part in a clinical trial, then speak to your healthcare team.

It is important to know that once enrolled in a clinical trial, participants have the right to leave the trial at any time and for any reason¹. All participants are informed of this right before they enroll. Your clinical trial team will be able to give guidance on what happens should you decide to leave the trial at any point, including any safety check-ups that would still need to take place. Your personal and health-related information collected during the trial is required to be kept private, and will not be shared with anyone who is not working on the clinical trial without your permission¹.

There are several treatments for multiple myeloma currently being investigated in clinical trials.

If you want advice on finding clinical trials, or are looking for clinical trials in people with multiple myeloma, please visit the following websites:

• Australian Clinical Trials
• Current Clinical Trials - Australasian Leukaemia and Lymphoma Group
• ClinTrial Refer
• ClinicalTrials.gov