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Multiple Myeloma

Understanding

REVLIMID (lenalidomide)

September 2026 Edition

HAVE QUESTIONS? WE CAN HELP The IMF team is here to support you and your loved ones with the most up-to-date information about myeloma 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 myeloma experience 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

Understanding myeloma vocabulary

What you will learn from this booklet

Who can be treated with Revlimid

How Revlimid works

How Revlimid is taken

Newly diagnosed multiple myeloma (NDMM)

Relapsed/refractory multiple myeloma (RRMM)

Maintenance therapy after ASCT

Dose and schedule

Clinical trial experience with Revlimid

Special precautions

Possible common side effects

Patient assistance program

In closing

You are not alone

The International Myeloma Foundation (IMF) has a mission: Accelerating the prevention and cure of myeloma and improving the quality of life for patients and families. The IMF gives information and support for people with multiple myeloma (also known as “myeloma”) and their care partners, friends, and family members. We do this on our website, myeloma.org, and through many programs and services like booklets, tip cards, classes, webinars, workshops, support groups, and much more.

Have questions? We can help

Myeloma is a cancer that many people have not heard of at the time of their diagnosis. The IMF can help you learn more about myeloma, understand what resources are available, and help you live well with this disease. The IMF can give you current information so you can work with your doctor 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. Myelo will help you find the right information and resources 24/7.

IMF publications

The IMF’s Patient Handbook explains what myeloma is, how doctors test for it, and how it affects the body. The Patient Handbook also introduces you to the many ways to treat myeloma and to manage its symptoms. The Patient Handbook also directs you to many helpful resources. The IMF’s Understanding-series booklets offer more information about different myeloma-specific topics, such as symptoms, 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.

Understanding myeloma vocabulary

Myeloma is a complicated disease, but the language that describes it doesn’t have to be hard to understand. Getting comfortable with the language of myeloma will help you learn more about this disease and have better communication with your healthcare team. Words in bold+blue in this booklet are explained in the IMF’s companion publication, Understanding Myeloma Vocabulary, which is located at glossary.myeloma.org. 4

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What you will learn from this booklet

This booklet discusses Revlimid® (also known by its generic drug name, lenalidomide). In the United States, this medication is available both as a brand-name and as a generic medication. Generic versions are manufactured by several companies. Research studies comparing the use of brand-name Revlimid vs. generic lenalidomide in myeloma show that both versions have very similar response rates. For the purposes of this booklet, we will continue to refer to this medication as Revlimid. Please continue reading to learn who can be treated with Revlimid, how it works, and its dose and schedule. You will also learn about support programs for patients who are prescribed Revlimid, and the possible side effects for you to discuss with your doctor.

Who can be treated with Revlimid

The U.S. Food and Drug Administration (FDA) first approved Revlimid for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) in 2006, then expanded the approval to treat myeloma throughout the disease course in 2015. The use of Revlimid has been studied in countless clinical trials over more than two decades. Currently, Revlimid is used to treat myeloma in a number of therapeutic regimens, including: ¡ As combination therapy with the steroid dexamethasone, with or without additional anti-myeloma drugs. ¡ As maintenance therapy following autologous hematopoietic stem cell transplant (ASCT).  Revlimid alone as a single agent. This is called monotherapy.  Revlimid in combination with another drug. This 2-drug regimen is sometimes called a doublet. The combination therapy usually adds another medication from the drug class of proteasome inhibitors or monoclonal antibodies.

How Revlimid works

Revlimid is in the drug class of immunomodulatory agents. These are drugs that can modify, enhance, or suppress the functioning of the immune system. Revlimid attacks myeloma in several ways: ¡ Revlimid targets and kills myeloma cells directly. It binds to cereblon (CRBN), the primary molecular target of all immunomodulatory agents. Binding cereblon triggers a protein degradation pathway that can kill myeloma cells. myeloma.org

¡ Revlimid enhances the function of the human immune system. It activates T cells (T lymphocytes) and natural killer (NK) cells that recognize and destroy myeloma cells. ¡ Revlimid prevents the growth of new myeloma cells by inhibiting vascular endothelial growth factor (VEGF). Revlimid can alter the levels of growth factors called cytokines and interleukins.

How Revlimid is taken

Revlimid is taken by mouth (orally) in capsule form. Both brand-name and generic capsules come in the following dosages: ¡ 2.5 mg ¡ 5 mg ¡ 10 mg ¡ 1 5 mg ¡ 20 m ¡ 25 mg A capsule of 7.5 mg strength is available only as brand-name Revlimid, not as a generic version. You do not need to be at a doctor’s office or in a clinic or hospital to receive Revlimid. This makes it your responsibility to take Revlimid as directed by your doctor. Before you begin taking Revlimid, read the IMF tip card Adherence to an Oral Treatment Plan. You must read and understand the written materials your doctor gives you. Please also review the notes below: ¡ Do not open, break, or chew your capsules. ¡ Do not handle the capsules any more than needed. ¡ Swallow capsules whole. ¡ Take capsules with water, with or without food. ¡ Take capsules at about the same time each day. ¡ If you touch a broken capsule or the medicine inside, immediately wash the contact area of your skin with soap and water. ¡ If you miss a dose, and it has been less than 12 hours since your regular time to take this medication, take it as soon as possible. ¡ If you miss a dose, and it has been more than 12 hours since your regular time to take this medication, contact your myeloma doctor for instructions. NOTE: If you have renal (kidney) disease, your dosage of Revlimid may be adjusted in accordance with your level of kidney function. The drug manufacturer’s prescribing information includes the recommended dosage for patients with kidney disease, which your doctor must follow.

Newly diagnosed multiple myeloma (NDMM) Revlimid is part of many FDA-approved frontline regimens, the initial treatments used in a patient with newly diagnosed multiple myeloma (NDMM). Importantly, Revlimid is part of the two 4-drug (quadruplet)

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therapies currently considered the standard of care (SOC) for the newly diagnosed: ¡ DVRd: Darzalex Faspro® (daratumumab + hyaluronidase-fihj) + Velcade® (bortezomib) + Revlimid + dexamethasone. ¡ Isa-VRd: Sarclisa® (isatuximab) + Velcade + Revlimid + dexamethasone. Currently, Isa-VRd is FDA-approved only for patients who are not eligible for an autologous stem cell transplant (ASCT). For patients who do not have access to the quadruplet SOC therapies listed above, Revlimid is part of several 3-drug (triplet) regimens: ¡ VRd: Velcade + Revlimid + dexamethasone. ¡ DRd: Darzalex Faspro + Revlimid + dexamethasone for patients who are not eligible for ASCT. For more information about frontline therapies that include Revlimid, read the following IMF booklets, listed in alphabetical order: ¡ Understanding DARZALEX® (daratumumab) and DARZALEX FASPRO® (daratumumab + hyaluronidase-fihj) ¡ Understanding Dexamethasone in the Treatment of Myeloma ¡ Understanding SARCLISA® (isatuximab-irfc) ¡ Understanding Stem Cell Transplant in Myeloma ¡ Understanding VELCADE® (bortezomib) ¡ Understanding the VRd Regimen for Newly Diagnosed Myeloma

Relapsed/refractory multiple myeloma (RRMM) Revlimid is part of many FDA-approved regimens for the treatment of patients with myeloma whose disease was treated previously. Regimens for patients with RRMM include the following:

¡ DRd: Darzalex + Revlimid + dexamethasone for patients who have received at least 1 prior myeloma therapy. ¡ IRd: Ninlaro® (ixazomib) + Revlimid + dexamethasone for patients who have had at least 1 prior myeloma therapy. ¡ ERd: Empliciti® (elotuzumab) + Revlimid + dexamethasone for patients who have had from 1 to 3 prior myeloma therapies. ¡ KRd: Kyprolis® (carfilzomib) + Revlimid + dexamethasone for patients who have received 1 to 3 prior lines of therapy. For more information about Revlimid-containing therapies for patients with RRMM, read the following IMF booklets, listed in alphabetical order: ¡ Understanding EMPLICITI® (elotuzumab) ¡ Understanding KYPROLIS® (carfilzomib) ¡ Understanding NINLARO® (ixazomib) myeloma.org

Maintenance therapy after ASCT

To prolong remission, some patients receive maintenance therapy after their ASCT. Studies show that maintenance therapy with Revlimid received after ASCT significantly increases both progression-free survival (PFS) and overall survival (OS). This is also true for patients who have high-risk multiple myeloma (HRMM). The proportion of patients who achieve MRD-negative status with Revlimid maintenance is also increased. ¡ PFS: This is the length of time during and after the treatment that a patient lives with myeloma, but it does not get worse. In a clinical trial, PFS is one way to measure how well the treatment is working. ¡ OS: This is the amount of time measured from diagnosis or start of treatment until death from any cause. In past clinical trials, OS was used to assess if a treatment extended a patient’s life. However, the length of OS duration has increased significantly as myeloma therapies have become more effective; current clinical trials use faster endpoints to validate their outcomes. ¡ HRMM: Approximately 20% of myeloma patients have a more aggressive form of myeloma that is more likely to be resistant to treatment, to relapse more quickly, and to feature specific genetic chromosomal abnormalities. ¡ Minimal residual disease (MRD): The presence of residual tumor cells after treatment has been completed. ¡ MRD-negative: Highly sensitive testing methods are able to detect 1 myeloma cell among 1,000,000 sampled cells in blood or bone marrow. MRD-negativity is associated with significantly prolonged PFS and OS, including in patients with HRMM. For more information, read the IMF booklet Understanding Stem Cell Transplant in Myeloma.

Possible risk of SPM

Maintenance therapy with Revlimid after ASCT can increase the risk of a second primary malignancy (SPM), a new cancer that is unrelated to the diagnosis of myeloma. Secondary cancers that are a consequence of treatment for myeloma may occur months or years later. An SPM can occur in a patient who has been exposed to both Revlimid and melphalan, which is used in the ASCT process. Studies show that second hematologic (blood) cancers occurred in 7.5% of patients who received Revlimid maintenance compared to 3.3% of patients who did not receive Revlimid maintenance. 8

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At a follow-up of almost 10 years later, the incidence of SPMs with a hematologic plus a solid tumor cancer was 14.9% compared to 8.8% patients who received no maintenance. Each patient must discuss with their myeloma doctor both the advantages and the potential risks of post-ASCT maintenance therapy with Revlimid. Be sure to discuss and evaluate your individual risk factors and your response to transplant before deciding to receive Revlimid maintenance therapy. If you decide to proceed with maintenance therapy, you must be carefully monitored.

Dose and schedule

The standard dose for Revlimid is one capsule, taken daily on Days 1 through 21 of a 28-day Cycle. It is important to follow the Revlimid dose and schedule prescribed by your myeloma doctor. Clinical trials show that if the dose of Revlimid is reduced after 12 months or longer, treatment benefit is retained. Your myeloma doctor will determine if it is appropriate to change your dose and/or schedule. Your doctor may lower your dose to a level determined to be appropriate for you, possibly down to as low as 2.5mg.

Clinical trial experience with Revlimid

A clinical trial is a medical research study with people who volunteer to test scientific approaches to a new treatment or a new combination therapy. Each clinical trial is designed to find better ways to prevent, detect, diagnose, or treat a medical condition, or to answer scientific questions. A clinical trial is launched only after laboratory studies have shown the potential of a treatment or procedure to be more effective and/or less harmful than previous methods. For patients with myeloma, 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.

The ISKIA clinical trial

The ISKIA phase III clinical trial enrolled 302 transplant-eligible patients with NDMM to assess efficacy and safety of Sarclisa + Kyprolis + Revlimid + dexamethasone [Isa-KRd] as induction therapy before ASCT and consolidation therapy after ASCT. Isa-KRd is being compared to KRd. Results published in Nature Medicine in April 2026 show significant improvement in MRD-negativity rates at 10–5 after consolidation therapy in the Isa-KRd group (77%) vs. the KRd group (67%). At the deeper threshold of 10–6, MRD-negativity was 68% with Isa-KRd vs. 48% with KRd. After one year, sustained MRD-negativity at 10–6 was higher with Isa-KRd at 52% vs. with KRd at 38%. The MRD benefit of Isa-KRd was consistent across subgroups, including patients with HRMM. myeloma.org

The MIDAS clinical trial

Published in the New England Journal of Medicine in June 2025, the MIDAS phase III clinical trial showed that a quadruplet regimen can achieve high rates of MRD-negativity and that some patients may not require ASCT when MRD-negativity is achieved. Longer follow up is still needed. In addition, the MIDAS study showed that tandem (two) ASCT procedures do not seem to provide a significant additional benefit for patients who remain MRD-positive after induction therapy.

Finding a clinical trial to match your needs

Myeloma clinical research is very exciting, with many studies enrolling patients. To help you with personalized support for identifying clinical trial options across 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 myeloma doctor if a study may be right for you and about the potential risks and benefits that may apply to you. For more information about what’s involved in study participation, read the IMF booklet Understanding Clinical Trials in Myeloma.

Special precautions

All medications come with a risk of side effects. You must promptly report to your doctor any changes in your health, including all new or worsening side effects that you experience. Most side effects associated with Revlimid are manageable. Some potential side effects of Revlimid are serious enough to require an FDA-mandated Boxed Warning, the strictest warning in the labeling of prescription drugs.

Revlimid and blood-making stem cells

Newly diagnosed patients who are eligible for ASCT should know that the collection of stem cells for use in ASCT should occur within 4 to 6 Cycles of a Revlimid-containing regimen. This is because longer use of Revlimid can affect blood-making stem cells.

Risk Evaluation and Mitigation Strategy (REMS)

REMS programs are required by the FDA for treatments that may have serious safety concerns. REMS programs support the use of treatment and help ensure that the potential benefits outweigh the risks. Revlimid is available only through a REMS program.

Embryo-fetal toxicity

Revlimid may cause birth defects or embryo-fetal death. Women of reproductive potential and males with female partners of reproductive potential must use two reliable methods of contraception 10

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during treatment with Revlimid. Pregnancy must be excluded before start of treatment and prevented during treatment with Revlimid.

Thrombocytopenia

A low number of platelets (thrombocytes) in the blood is called thrombocytopenia. Platelets help blood to clot. Fewer platelets can lead to easier bruising, bleeding, and slower healing. The “normal” level of platelets varies from laboratory to laboratory but is approximately 150,000 or more platelets per microliter of circulating blood. Bleeding problems could occur if the count is less than 50,000 platelets. Major bleeding is usually associated with a reduction to less than 10,000 platelets. Promptly alert your doctor of excessive bruising or bleeding. At the discretion of your doctor, management can include platelet growthstimulating medication or transfusion.

Neutropenia

White blood cells (WBC) help to fight infection. A low level of white blood cells called neutrophils can lead to infection. Alert your doctor immediately if you have a fever, sore throat, or any other sign of an infection. Fever is often the first symptom of infection. Your doctor will determine how to best manage your infection. Treatment of neutropenia depends on its cause and severity. Neutropenia accompanying viral infections (such as influenza or flu) may go away after the infection has cleared. Mild neutropenia generally has no symptoms and may not need treatment. In some cases, treatment may include medication to stimulate the growth of neutrophils.

Venous thromboembolism (VTE)

VTE is a condition that includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). Signs or symptoms of VTE may include difficulty breathing and/or warmth, swelling, redness, and/or pain in an extremity. ¡ DVT occurs when a blood clot (thrombus) forms in one or more of the deep veins in the body, usually in the lower extremities. A blood clot from a DVT can break loose (embolize) and travel to the heart or lungs. An embolus is potentially life-threatening. DVT can occur without any symptoms or can cause leg pain or swelling. ¡ PE occurs when a blood clot in the vein breaks loose, travels through the bloodstream, and lodges in a lung, blocking blood flow. Blood clots in the arteries, veins, and lungs occur more often in people who take Revlimid than in the healthy population. The risk of blood clots is even higher for people with myeloma who take Revlimid together with dexamethasone. myeloma.org

Myocardial infarctions (heart attacks) are more frequent in people who take Revlimid together with dexamethasone. Signs or symptoms may include: ¡ Chest pain, which may spread to the arms, neck, jaw, back, or abdomen (belly area). ¡ Breaking out in a sweat. ¡ Shortness of breath. ¡ Feeling sick to your stomach or vomiting. Strokes are more frequent in people who take Revlimid together with dexamethasone. Signs or symptoms may include: ¡ Sudden numbness or weakness, especially on one side of the body. ¡ Severe headache. ¡ Confusion. ¡ Problems with vision, speech, or balance. A doctor will diagnose your condition and determine whether or not treatment is needed. Treatment depends upon both the location of the VTE and the underlying cause. Preventive therapy with a blood thinner is required. The type and dose of blood thinner you will receive is determined by your personal risk factors. Before taking Revlimid, tell your doctor: ¡ If you had a blood clot in the past. ¡ If you have high blood pressure, if you smoke, or if you have hyperlipidemia (high level of fat in your blood). ¡ About all the medicines you take, because some medications can increase the risk for blood clots. Seek urgent medical care if you experience any of the above signs or symptoms.

Liver injury (hepatotoxicity)

Revlimid may be associated with liver injury. Risk factors may include pre-existing viral liver disease, elevated baseline liver enzymes, and other medications that a patient may be taking. Liver failure, including fatal cases, has occurred in patients treated with Revlimid in combination with dexamethasone. Your doctor will monitor your liver enzymes. Your treatment with Revlimid will be stopped if your liver enzymes are higher than normal. After the enzymes return to your normal baseline levels, treatment at a lower dose may be considered. 12

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Possible common side effects Diarrhea

Diarrhea is a common side effect of long-term Revlimid therapy. Diarrhea is defined as 3 or more loose stools per day. Severe diarrhea is defined as 7 or more loose stools per day. Revlimid activates the immune system throughout the body. This includes the immune system in the gut, which absorbs bile acids. When the intestines cannot process bile acids properly, bile acid malabsorption (BAM) can lead to diarrhea. Diarrhea can have a negative impact on quality of life. Your doctor can determine if your diarrhea is caused by BAM or by other medical problems. Treatment with intravenous (IV) fluids may be required. If not managed well, diarrhea may lead to pausing or stopping treatment with Revlimid. Revlimid-related diarrhea can be significantly improved or resolved by the following: ¡ Reducing intake of dietary fat. ¡ Taking a bile acid medication such as cholestyramine, colesevelam, or colestipol. These medications are available under several brand names. ¡ Other medications may also be used to manage diarrhea. If these medications are not sufficient to control your diarrhea, ask your doctor if a lower dose of Revlimid is acceptable in your case. In some cases, Revlimid may have to be discontinued.

Fatigue

Fatigue is associated both with cancer and with cancer therapy. Fatigue that is related to myeloma and its treatments, including Revlimid, may be severe and long-lasting, and include a feeling of overall weakness (this is called asthenia). The effects of such fatigue may be minimized by: ¡ A moderate level of activity. ¡ A healthy diet and proper fluid intake. ¡ A consistent sleeping schedule. ¡ Monitoring your red blood cell count (RBC) by your doctor. ¡ Review of the side effects of any other medications you are taking. For more information, read the IMF booklet Understanding Fatigue in Myeloma. myeloma.org

Anemia

Red blood cells contain hemoglobin. This is a protein that contains iron and transports oxygen from the lungs to the body’s organs and tissues. A low level of red blood cells results in low levels of oxygen in the body, which may cause shortness of breath and feelings of exhaustion. The following are options for treatment of anemia: ¡ Revlimid dose interruption, reduction, or discontinuation. ¡ Erythropoietic (RBC-making) medication. ¡ Blood transfusion.

Rash

Most Revlimid-related rash is mild to moderate. A rash may look like patchy, raised spots on the skin, with or without hives. The rash might be itchy. Mild rash may be treated with an oral antihistamine or steroids, either topical or by mouth. Revlimid may be paused for a period of time, then restarted at the same or lower dose. Repeated rash is not common, and this may lead to stopping treatment with Revlimid. In rare cases, Revlimid-related rashes can become severe or life-threatening.

Decreased appetite

Decreased appetite occurred in 23% of the newly diagnosed study patients. Only 3% of patients experienced decreased appetite that led to weight loss or malnutrition. The National Cancer Institute (NCI) has a booklet, Eating Hints: Before, during, and after Cancer Treatment, which you can read online or download at cancer.gov/publications/patient-education/eatinghints.pdf. It includes the following helpful suggestions to maintain body weight and meet your nutritional needs: ¡ Eat plenty of protein and calories when you can. ¡ Eat at the time of the day when you have some appetite. ¡ Eat what appeals to you, even if it’s the same thing repeatedly. ¡ Drink liquid meal replacements for extra nutrition. ¡ If you can’t eat at all some days, tell your healthcare team. ¡ Drink 8 to 12 cups of non-alcoholic liquids each day, especially on days when you cannot eat.

Other possible side effects

Other common side effects include constipation, peripheral edema (swelling of the ankles and feet), insomnia, muscle cramps and/or spasms, abdominal pain, back pain, nausea, fever, upper respiratory tract infection, gastroenteritis (“stomach flu”), and tremor (shaking or trembling). 14

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Patient assistance program

Bristol Myers Squibb helps patients who are 18 years or older and U.S. residents. Patients with commercial insurance may qualify for co-pay assistance through BMS Access Support. Call 1.800.861.0048 or go to bmsaccesssupport.com. Uninsured patients or those who are experiencing financial difficulties can apply for assistance through the BMS Patient Assistance Foundation. Call 1.800.736.0003 or go to bmspaf.org. Patients with Medicare, Medicaid, or other U.S. government insurance are not eligible for co-pay assistance but can be connected to support specialists for help identifying charitable foundations that offer grants. Teva U.S.A. has been manufacturing generic lenalidomide since 2022. For information, call 1.888.838.2872 or go to tevausa.com.

In closing

This booklet is not meant to replace the advice of your doctors and nurses who are best able to answer questions about your specific healthcare management plan. The educational information provided by the IMF is intended to guide you in your conversations with your healthcare team. You must take an active role in your own medical care to help ensure a good quality of life through effective treatment. Visit myeloma.org and join the IMF Myeloma Knowledge Platform at myprofile.myeloma.org. 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.

myeloma.org

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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. 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 impacted by myeloma 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

myeloma.org

Follow the International Myeloma Foundation on: /myeloma

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Improving Lives Accelerating the Cure

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Understanding Revlimid (lenalidomide)