Issuu

Understanding

MGUS and Smoldering Multiple Myeloma

September 21, 2026

HAVE QUESTIONS? WE CAN HELP The IMF team is here to support you and your loved ones with the most up-to-date information Call the IMF at 1.818.487.7455 (and press 1) or visit the web page at mmsm.link/infoline to schedule a time to talk with us about your medical condition or if you wish to discuss the contents of this booklet.

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Contents You are not alone

Have questions? We can help

IMF publications

The importance of consulting with an expert

What is MGUS

What is SMM

Active myeloma

How MGUS and SMM are diagnosed

Monitoring and management

Risk of progression

The iStopMM screening study of MGUS and SMM

FDA approves treatment of HR-SMM

In closing

The information in this booklet is not a substitute for and does not constitute medical advice, diagnosis, or treatment. The IMF intends only to provide information that will help you in discussions with your healthcare team. Always seek advice from qualified medical professionals. Call 911 if you think you may be having a medical emergency.

You are not alone

The International Myeloma Foundation (IMF) provides information about multiple myeloma and its two precursor conditions: monoclonal gammopathy of undetermined significance (MGUS, pronounced EM-gus) and smoldering multiple myeloma (SMM, pronounced by spelling out each letter S-M-M). The IMF offers support to patients and their care partners, friends, and family members. We do this on our website, myeloma.org, and through many programs and services.

Have questions? We can help

The IMF can help you learn more about your diagnosis, understand what resources are available, and help you to live well with your condition. The IMF can assist you in preparing for conversations with your healthcare team, so that you are ready to make the best decisions for your health. ¡ For information and support, call the IMF at 1.818.487.7455 (and press 1) or visit mmsm.link/infoline to schedule a time to talk with us. ¡ Want answers and don’t want to wait? Ask Myelo®, your AI assistant at myeloma.org, that will help you find resources 24/7.

IMF publications

The IMF’s Understanding-series booklets offer more information about specific topics, such as tests, treatments, and possible side effects. All IMF publications are free and can be read online, downloaded, or mailed to you. If you would like to read IMF publications digitally, just click on the light blue links in this booklet or go to publications.myeloma.org.

The importance of consulting with an expert

Medical specialists at large treatment centers or academic institutions care for hundreds of people with MGUS, SMM, and myeloma. If it is suspected that you have MGUS, SMM, or myeloma, it is essential that you consult with an experienced hematologist, a doctor who specializes in the problems of blood and bone marrow (the soft and spongy tissue in the center of bones). Hematology specialists develop the expertise needed to help guide the optimal strategies for MGUS, SMM, and myeloma. The IMF can help you to identify one or more such specialists. If an in-person visit cannot be arranged, you or your local doctor may be able to schedule a remote (video) consultation. This is a common practice. Your goal is to gain a clear understanding of your condition so you can make decisions with confidence. 4

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What is MGUS

Monoclonal gammopathy of undetermined significance (MGUS) is a benign condition, which means it is not cancerous (malignant). People with MGUS have relatively low levels of an abnormal monoclonal protein (also called myeloma protein or M-protein) in their blood or urine. M-protein can accumulate in and eventually damage bone and bone marrow. All people who eventually develop active myeloma have previously had MGUS followed by SMM. However, not everyone with MGUS or SMM will develop active myeloma. The risks of progression are discussed later in this booklet. The earliest precursor condition to myeloma is MGUS. The causes of MGUS are mostly unknown.

Plasma cell types of MGUS

Plasma cells are an important part of the human immune system, which is a complex network of multiple mechanisms. The immune system works to protect and defend the body from external threats (e.g., bacteria, viruses, toxins) and from internal threats (e.g., cancer), while protecting healthy cells. Plasma cells produce antibodies (also known as immunoglobulins or “Ig” for short) that protect us from infections. The types of MGUS are based on the type of immunoglobulin made. The most common are IgG and IgA. In rare cases, MGUS can also involve IgD, IgE, or IgM. MGUS is actually very common. It affects about 3% to 5% of the population in the United States over the age of 50. The chance of an MGUS diagnosis goes up with age: it affects less than 1% of young adults and up to 10% of adults age 80 and older. MGUS is more common in men than in women. People of African ancestry have double the risk of developing MGUS compared to white individuals. People with MGUS that originated from plasma cells have an overall 1% per year risk of progression to: ¡ Myeloma, a cancer of bone marrow plasma cells. ¡ Amyloid light-chain (AL) amyloidosis, a rare disorder where abnormal proteins form fibrils (fibers) that are deposited in tissues and organs. ¡ Light chain deposition disease (LCDD), a rare disorder where abnormal proteins cause granular deposits (not fibrils) to build up in organs, most often in the kidneys.

Lymphoid cell type of MGUS

Lymphoid cells are a type of white blood cell that begin their development in the bone marrow. They can also lead to the production of IgM type MGUS, which can progress to IgM myeloma, Waldenström myeloma.org

macroglobulinemia (a slow-growing type of non-Hodgkin lymphoma also called lymphoplasmacytic lymphoma), or other slow-growing lymphomas. IgM MGUS is less common than plasma cell types of MGUS.

What is SMM

Smoldering multiple myeloma (SMM) is an asymptomatic (no signs or symptoms) precursor condition of active myeloma. The M-protein is present in people with SMM, but typically at a higher amount than in people with MGUS. SMM may be diagnosed during a routine medical exam, or in a person who is being monitored for MGUS, or when an individual receives medical care for another condition. SMM affects approximately 0.53% of people age 40 or older, with 0.67% males and 0.39% females. The incidence increases with age. A person with SMM may remain at the smoldering stage for many years, without developing active myeloma. Each person’s situation has its own distinct characteristics, so do not compare yourself to other patients.

Active myeloma

If you are diagnosed with myeloma, read the IMF’s Patient Handbook. It explains what myeloma is, how it affects the body, and introduces you to the many highly effective ways that myeloma is treated and managed. People with myeloma can lead full and productive lives for years, even decades, after diagnosis. Survival and quality of life of myeloma patients are improving steadily.

How MGUS and SMM are diagnosed

Generally, MGUS and SMM do not have symptoms. MGUS and SMM are usually discovered through laboratory testing performed during routine appointments or evaluations for other conditions. Table 1. Differences between MGUS, SMM, and active myeloma

MGUS

SMM

Active Myeloma

Monoclonal plasma cells in bone marrow

< 10%

10%–60%

≥ 10%

M-protein in the serum (blood)

less than 3 g/dL

3 g/dL or more

Myeloma defining events (MDE)

yes

Likelihood of progression

~1% per year

~5% to 10% per year

not applicable

Management

observation

observation, clinical trials, or potential treatment if high-risk SMM (HR-SMM)

treatment

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Figure 1. Structures of immunoglobulins heavy chain

light chain

IgG, IgE, IgD

IgA

IgM

An introduction to immunoglobulins

An immunoglobulin (Ig) is another term for an antibody. Each type of immunoglobulin has a different function in the body. Your plasma cells can produce one of 5 classes (isotypes) of immunoglobulin: IgG, IgA, IgD, IgE, and IgM. An immunoglobulin is formed by heavy chains and light chains that are linked together. The light chains are chemically attached to the ends of the heavy chains. The light chains are smaller than the heavy chains. During the creation of antibodies, healthy plasma cells produce a small excess of free (unbound) light chains than what is needed for pairing with the heavy chains. Abnormal plasma cells produce an unusually large amount of immunoglobulin – heavy chains, light chains, or both that are all the same (monoclonal). The heavy chains are typically measured in the blood by a test called the serum protein electrophoresis (SPEP). Sometimes they are measured in a urine sample collected over a period of 24 hours. The abnormal amount is often called the “M-spike” due to its spiked appearance on the SPEP test. The free light chains circulate in the blood. They are small enough to enter the kidneys, where they may be filtered out into the urine or they may stick together, blocking the kidney’s tubules. Free light chains are typically measured in the blood by a test called the serum free light chain (FLC) assay, which measures both types of light chains (kappa and lambda) and calculates the light chain ratio (kappa over lambda). Below, you will find more details on testing. In about 1% to 3% of myeloma cases, abnormal plasma cells do not produce M-protein that is measurable in the blood or urine. Known as non-secretory myeloma, it is diagnosed through bone marrow testing. myeloma.org

Blood tests to diagnose MGUS The most convenient way to diagnose MGUS is through blood tests. These tests are simple and not invasive. The following blood tests are usually part of routine medical care.

¡ Complete blood count (CBC) of red blood cells, white blood cells, and platelets can detect or rule out abnormalities. ¡ Comprehensive metabolic albumin (CMP) measures many panel different substances to assess your metabolism and organ function. Importantly, CMP measures the amount of serum calcium and creatinine, which would show if alpha-1 alpha-2 beta-1 beta-2 gamma there is bone-calcium leakage or kidney dysfunction. The guidelines by the IMF International Myeloma Working Group (IMWG) albumin recommend the following 3-test beta-2 panel. ALL three of these low-cost and accurate tests must be used together. These are the same tests used for MGUS, SMM, and active myeloma. alpha-1 alpha-2 beta-1

gamma

¡ Serum protein electrophoresis (SPEP) separates blood proteins to detect and measure the presence and amount of M-protein.

Figure 2. SPEP test results albumin

alpha-1 alpha-2 beta-1 beta-2 gamma

Normal SPEP result albumin beta-2

alpha-1 alpha-2 beta-1

gamma

Abnormal result with myeloma cells producing the M-protein, creating an M-spike in the beta-2 zone albumin

gamma

alpha-1 alpha-2 beta-1 beta-2

Abnormal result with myeloma cells producing the M-protein, creating an M-spike in the gamma zone

¡ Serum immunofixation electrophoresis (IFE) identifies the heavy and light chain subtype of the M-protein. ¡ Serum free light chain (FLC) test measures kappa and lambda free (unbound) light chains in the blood to identify light-chain variants.

Urine tests to diagnose MGUS

Urine tests can help assess whether the M-protein is causing organ stress or damage. Urine tests can help identify MGUS subtypes or rule out more advanced conditions. 8

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¡ 24-Hour Urine Protein Electrophoresis (UPEP) test uses a urine sample collected over 24 hours to measure the amount of M-protein or light chains filtered by the kidneys. Ask your doctor if the 3-test panel of SPEP, serum IFE, and serum FLC may eliminate the need for a 24-hour urine collection.. ¡ Urine immunofixation electrophoresis (IFE) test uses the same 24-hour urine sample to identify the heavy or light chain subtype of the M-protein.

Bone marrow tests

For low-risk MGUS patients with M-protein of less than 1.5 g/dL and a normal FLC ratio, clinical guidelines state that bone marrow testing and full-body imaging can often be avoided. If higher-risk markers or unexplained symptoms are present, the following testing is recommended: ¡ For a bone marrow aspiration, a needle is used to remove a sample of fluid and cells from the bone marrow for examination. ¡ For a bone marrow biopsy, a hollow needle is used to remove a sample of tissue from the bone. Bone marrow biopsy is usually done at the same time as bone marrow aspiration. ¡ For imaging, the tests used to assess possible bone, organ, and tissue damage are:  Low-dose skeletal computed axial tomography (LDCT) scan uses much less radiation than conventional CT, plus it does not use contrast agents to detect early bone disease.  Whole-body low-dose computed axial tomography (WBLDCT) has all the benefits of LDCT, plus it can scan the entire body .  Positron emission tomography (PET) and PET/CT scans can focus on a part of the body or can provide whole-body imaging that shows bones, organs, and soft tissues. This type of imaging can distinguish precursor conditions (MGUS and SMM) from active myeloma.

Tests to diagnose SMM

The diagnostic process includes blood testing described above in the MGUS section: CBC, CMP, SPEP, and serum FLC. At the time of SMM diagnosis plus within 2 to 3 months after the diagnosis, a 24-hour urine collection for UPEP and IFE should be performed. Baseline bone marrow testing and imaging should also be performed. Baseline testing provides the initial data that is later used to compare against subsequent data. myeloma.org

For a diagnosis of SMM, the following criteria must be met: 1. 10% to 60% monoclonal plasma cells in the bone marrow, 2 No myeloma-defining events (MDE), 3. Absence of amyloidosis. M-protein testing can be variable with an M-spike in the serum or urine, elevated light chains, or no M-protein at all.

Monitoring and management Monitoring MGUS

In the United States, MGUS is a common condition, with approximately 5% of people over 50. The rate is higher for people of African descent. If MGUS is diagnosed, monitoring is needed typically every 6–12 months on a long-term basis. Tests include the following: ¡ CBC ¡ Serum FLC ¡ SPEP or UPEP. The vast majority of people with MGUS are monitored for many years with out the need for additional medical attention. If the M-protein level remains stable and there are no symptoms or other health changes, your doctor may extend the time between tests. Your doctor may also determine that additional tests are needed. If you experience any change in your health between doctor visits, you must promptly inform your doctor. There are no treatments for MGUS that have been approved by the U.S. Food and Drug Administration (FDA).

Monitoring SMM

After diagnosis, monitoring of SMM should be done by an experienced hematologist-oncologist, preferably by a myeloma specialist. The goal of monitoring is to catch possible progression to active myeloma early, while avoiding unnecessary treatment side effects. When monitoring begins, exams should take place every 3 to 4 months, and should include blood and urine tests, with or without imaging studies. Depending on your SMM monitoring history and the latest status of your SMM, your doctor may determine that your evaluations should take place less frequently or more frequently. The PANGEA-SMM Risk Calculator at pangeamodels.org was launched in March 2026. It is a free online calculator designed to help monitor patients 10

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with SMM. This tool tracks how lab results change over time. It helps with early detection of high-risk SMM while helping patients with low-risk SMM avoid frequent biopsies or unnecessary treatment.

Risk of progression

Risk of progression from MGUS

The risk of progression from MGUS to active myeloma is 1% per year, and only 20% of people with MGUS will ever develop myeloma. It is not yet known what triggers progression. Research is ongoing. IMWG researchers have established the following three risk factors:: 1. M-protein level is more than 1.5 g/dL (same as 15 g/L), 2. M-protein type IgA or IgM, and 3. Abnormal FLC ratio of kappa to lambda FLCs. Risk of progression from MGUS to active myeloma is categorized as follows: ¡ Low risk MGUS has 0 factors; 20-year risk of progression is 5%. ¡ Low-intermediate-risk MGUS has 1 risk factor; 20-year risk of progression is 20%. ¡ High-intermediate-risk MGUS has 2 risk factors; 20-year risk of progression is 40%. ¡ High-risk MGUS has all 3 risk factors; 20-year risk of progression is 60%. After baseline testing, if you are diagnosed with MGUS that is intermediaterisk or high-risk, you should have a bone marrow aspiration and a bone marrow biopsy.

Risk of progression from SMM

The risk of progression from SMM to active myeloma is 10% per year for the first 5 years, 3% per year for the next 5 years, and 1%–2% per year for the next 10 years. Some people with SMM never develop active myeloma. If SMM is diagnosed, clinical guidelines recommend determining the risk of progression to active myeloma. This is based on a patient having none, one, two, or all three risk factors that are most associated with progression from SMM to active myeloma. 1. Serum M-protein greater than 2 g/dL, 2. Bone marrow plasma cell (BMPC) infiltration greater than 20%, and/or 3. R atio of involved-to-uninvolved serum Free Light Chain assay greater than 20. myeloma.org

The hematologist monitoring your SMM will discuss the following imaging studies with you: ¡ WBLDCT (listed in the MGUS section), which does not require the use of contrast agents and uses much less radiation than conventional CT, is considered standard of care to detect and document early bone disease. ¡ Magnetic resonance imaging (MRI) of the spine and pelvis are highly recommended because these sensitive studies are better able to predict for more rapid progression to active myeloma. ¡ Positron emission tomography (PET) can be combined with WBLDCT or MRI to reveal areas in the body where myeloma cells can accumulate and cause damage.

High-risk SMM (HR-SMM)

Using the 2018 Mayo Clinic’s “2/20/20” criteria, patients with 2 or 3 of the factors listed below are categorized as having HR-SMM, with approximately 50% risk of progression to active myeloma within 2 years. ¡ Serum M-protein: Level of 2 g/dL or greater ¡ Bone marrow plasma cells: Infiltration of 20% or greater ¡ FLC ratio: Involved/uninvolved FLC ratio of 20 or greater A new and evolving model by the IMWG includes other biomarkers with optional testing for high-risk chromosomal abnormalities. Figure 3. Chromosomal abnormalities in high-risk myeloma

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These abnormalities can be identified by the fluorescence in situ hybridization (FISH) test. The risk of progression is increased when chromosomal abnormalities are present. Patients with more than one chromosomal abnormality have a higher 2-year progression to myeloma than those who have none: ¡ Low-risk SMM without chromosomal abnormalities, 6% risk of progression. ¡ Low intermediate-risk SMM with 1 chromosomal abnormality, 23% risk of progression. ¡ Intermediate-risk SMM with 2 chromosomal abnormalities, 46% risk of progression. ¡ HR-SMM with 3 or more chromosomal abnormalities, 63% risk of progression. Patients with myeloma-defining events (MDE) are classified as having active myeloma, not SMM.

The iStopMM screening study of MGUS and SMM Launched in November 2016 with support from the IMF Black Swan Research Initiative® (BSRI®), the iStopMM® (Iceland Screens Treats or Prevents Multiple Myeloma) clinical trial is the largest-ever populationbased screening study for MGUS, SMM, and myeloma. The study invited approximately 140,000 residents of Iceland who are over age 40 to be screened for the presence of M-protein in the serum or urine.

iStopMM is the largest ever nationwide clinical trial of any cancer precursor condition. The main goal is to evaluate the impact of screening individuals for MGUS, to be able to treat them at the SMM phase, and to prevent the development of active myeloma. Several important manuscripts by the iStopMM research team reported findings that were published in 2026.

Impact of Screening – Journal of Clinical Oncology

Of the 75,422 adults who were screened for MGUS, 3,541 people were diagnosed. Being informed of an MGUS diagnosis was not associated with worse psychological well-being. After a median follow-up of 4.5 years, screening led to a 27-fold increase in the detection of SMM (8.6% vs. 0.3%). People who were identified to have active myeloma or related blood cancers were diagnosed about 1 year earlier, before myeloma-related organ damage was identified, making early treatment of myeloma myeloma.org

possible. The overall rate of active myeloma did not differ between study groups. The possible exception was a group of individuals between 40 to 70 years of age, where a sub-analysis showed a lower risk of developing active myeloma for those in active follow-up.

Defining Light Chain MGUS – European Journal of Haematology The iStopMM study has revised criteria for light chain MGUS (LC-MGUS), with the goal of improving diagnostic accuracy. According to the manuscript, standard blood FLC test ranges may diagnose too many individuals with LC-MGUS due to FLC levels naturally being higher with age, chronic kidney disease, or in people of African ancestry. New reference ranges reduced LC-MGUS diagnoses by 82%. Importantly, people who no longer met the criteria for LC-MGUS did not develop related disease during the 4.6 years of follow-up. Several studies from other countries have confirmed the updated FLC ranges.

Defining Light Chain SMM – Leukemia Journal The iStopMM researchers aimed to better define light-chain smoldering multiple myeloma (LC-SMM), a rare form of SMM. The team defined LC-SMM as having abnormal serum FLC and ratio, 10–59% plasma cells in the bone marrow, no detectable intact immunoglobulin on SPEP or IFE, and no myeloma-defining events. Figure 4. Possible evolution from MGUS to active myeloma

SLiMCRAB myeloma-defining events (MDE): Sixty percent (60%) or more plasma cells in the bone marrow. Light chains ratio of involved-to-uninvolved sFLC of 100 or more. MRI imaging of 2 or more focal lesions in bone marrow. Calcium level elevation in the blood due to myeloma. Renal (kidney) damage due to myeloma. Anemia (low hemoglobin) due to myeloma. Bone damage related to myeloma.

HR SMM

high-risk smoldering multiple myeloma

LR SMM

low-risk smoldering multiple myeloma

MGUS

monoclonal gammopathy of undetermined significance

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Approximately 19% of people with abnormal FLC test results met this definition, with about 0.08% of people over 40 years of age. The estimated risk of progressing to active myeloma was determined to be about 6% per year. The risk increased to about 9% per year in people with at least one high-risk factor (discussed earlier in this booklet). The new definition of LC-SMM can be used together with an established risk-stratification model to identify patients who need closer follow-up. Visit myeloma.org/black-swan-research-initiative/istopmm to learn more about iStopMM. The outcomes from iStopMM are important not only for the people of Iceland but for people around the world.

FDA approves treatment of HR-SMM In 2025, the FDA granted the first and only approval of a treatment for adult patients with HR-SMM. The approval of Darzalex Faspro® (daratumumab + hyaluronidase-fihj) is based on data from the AQUILA clinical trial, which compared single-agent therapy (monotherapy) with Darzalex Faspro for up to 36 months vs. monitoring (observation) in 390 patients with HR-SMM. Patients in the treatment arm of the study received Darzalex Faspro once-weekly as a subcutaneous (SQ) injection under the skin. These patients demonstrated a 63.4% overall response rate (ORR) and lowered progression to active myeloma or death by 51%. Darzalex Faspro is approved for patients with HR-SMM. It is not approved for other risk categories of SMM.

Finding a clinical trial to match your needs A clinical trial is a medical research study with people who volunteer to help answer scientific questions. Each study is designed to find better ways to prevent, detect, diagnose, or treat a medical condition. Clinical trials can be part of normal care that may provide earlier access to new drugs and therapies that are not yet available outside of a study. For personalized support with identifying clinical trial options in the U.S., the IMF has partnered with SparkCures. Visit myeloma.org/sparkcures or contact the IMF for more information. If you would like to explore possible participation in a clinical trial, ask your doctor about the potential risks and benefits that may apply to you. For information about what’s involved in study participation, read the IMF booklet Understanding Clinical Trials in Myeloma. myeloma.org

In closing

The information in this booklet is not a substitute for – and does not constitute – medical advice, diagnosis, or treatment. The IMF intends only to provide you with information that will help you in discussions with your healthcare team. Always seek advice from qualified medical professionals. To help ensure a good quality of life, you must play an active role in your own medical care. Use the hyperlinks and web addresses in this booklet for access to a variety of resources. Sign up at subscribe.myeloma.org for our quarterly journal Myeloma Today and weekly e-newsletter Myeloma Minute, as well as alerts about IMF news, events, and actions.

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myeloma.org

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Founded in 1990, the International Myeloma Foundation (IMF) is the world’s leading organization dedicated to multiple myeloma and its precursor conditions, MGUS and SMM. The IMF is steadfast in its mission: Accelerating the prevention and cure of myeloma and improving the quality of life for patients and families. The IMF serves people at every stage of the disease by combining world-class research, trusted education, global advocacy, and direct support. A cornerstone of this work is the International Myeloma Working Group® (IMWG) – a network of more than 300 internationally renowned researchers and clinicians who establish the guidelines that shape how myeloma is diagnosed, treated, and managed across the globe. Through its global network of support groups, educational programs, its 24/7 generative-AI myeloma assistant Myelo®, and its advocacy for greater healthcare access, the IMF helps people living with myeloma and their care partners navigate diagnosis, treatment, and survivorship. At the same time, the IMF ensures scientific advances translate into better care and outcomes.

Learn more at

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Follow the International Myeloma Foundation on: /myeloma

@imfmyeloma

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Understanding MGUS and Smoldering Myeloma