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Answers to FAQs from our 5/5/23 webinar on Clinical Studies

When is a clinical study the best option for a patient with high-risk smoldering multiple myeloma (SMM)?

A clinical study is the only option to gain access to treatment of high-risk SMM at this time. If you have a multiple myeloma precursor condition (monoclonal gammopathy of undetermined significance [MGUS] or SMM), the standard of care is watchful waiting—that is, monitoring you closely to determine if you progress to myeloma and treating you only when progression occurs. The reason patients with MGUS or SMM are not treated is that neither condition is associated with organ damage or any of the symptoms commonly associated with myeloma. Furthermore, no more than half of SMM patients progress to myeloma within the first 5 years after diagnosis, and the number is even smaller for patients with MGUS. Additionally, administering treatments (typically the same drugs used to treat myeloma) to patients who have precursor conditions that may or may not advance to multiple myeloma could lead to unwanted side effects while also yielding no benefit.

High-risk SMM may warrant treatment rather than watchful waiting and may yield the benefits of delaying the onset of active myeloma and increasing life expectancy. Treatment, if recommended at this stage, should take place only in the context of a clinical study.

It is also important to note that not every clinical study focuses on therapeutic intervention for precursor conditions. There are several observational studies and research studies for patients with MGUS or SMM that involves the collection of bone marrow and blood samples to help clinicians better characterize the conditions and to better predict which patients are at the highest risk of progression to myeloma. Additionally, non-pharmacologic interventional studies, such as diet and lifestyle modification, are also available to determine whether these types of interventions modify the diseases at all.

Search for a clinical trial in your area access the MMRF’s Clinical Trial Finder
( or let an MMRF patient navigator help guide you through the process (1-888-841-6673 or [email protected]).

How can I join a clinical study if my doctor has not brought up the possibility of joining one?

As with any aspect of clinical care for a patient with multiple myeloma or one of its precursor conditions, open communication with the care team is important. You (and your caregivers) should always feel comfortable asking your doctors about alternative options for your care including whether or not a clinical study should be considered. All clinicians expect these questions and they want their patients to be happy with their care. You should not worry about your clinician’s feelings if you wish to seek care with a different doctor or to enroll on a clinical study.

Is there a negative impact on a patient’s relationship with their care team if he or she eventually withdraws from a clinical study due to life events or some other reason?

A withdrawal from a clinical study is never held against a patient! Of course, most clinicians would like patients to stay on a clinical study for the integrity of the data, but patients always have the right to discontinue participation for any reason. Patients will still receive quality care and respectful treatment and will in no way be punished for deciding not to participate. Clinicians understand that circumstances can change in a patient’s life that may make it difficult to continue participating.