Understanding POMALYST ®
The IMF InfoLine team is here to support you and your loved ones with the most up-to-date information about myeloma
Call the IMF InfoLine at 1.800.452.CURE (toll-free in the U.S. & Canada) or 1.818.487.7455 (worldwide), or email InfoLine@myeloma.org with your questions, or if you wish to discuss the contents of this booklet.
Want answers and don’t want to wait?
Get the answers you need anytime from Myelo® , your 24/7 generative AI assistant that is designed to support you on your journey with myeloma. Ask Myelo your questions at myeloma.org.
Join the Myeloma Knowledge Platform
Visit myprofile.myeloma.org and create your personal online IMF account to receive the most helpful content recommendations tailored to support your unique myeloma journey.
You are not alone
The International Myeloma Foundation (IMF) is here to help you. The IMF is committed to providing information and support for patients with multiple myeloma (which we refer to simply as “myeloma”) and their care partners, friends, and family members.
The IMF supports the myeloma community with a broad range of resources available on our website myeloma.org, and through numerous programs and services such as seminars, webinars, workshops, and the IMF InfoLine.
Contact the IMF InfoLine with your myeloma-related questions and concerns, and receive the most up-to-date information in a compassionate and caring manner. Call 1.818.487.7455, email InfoLine@myeloma.org, or visit mmsm.link/infoline to schedule a convenient time to talk with an IMF InfoLine Coordinator.
What you will learn from this booklet
Myeloma is a cancer that is not known to most patients at the time of diagnosis. To play an active role in your own medical care and to make good decisions about your care in partnership with your doctor, it is important and helpful to learn about myeloma, as well as its treatment options and supportive care measures.
If you are a patient with myeloma, we suggest that you read the IMF’s publication, Patient Handbook for Multiple Myeloma, which presents an overview of the disease and its treatment options. In addition, this booklet will direct you to resources that may be relevant in your particular case.
The IMF’s Understanding-series publications address specific drugs, drug classes, combination therapies, and supportive care measures that may help you manage the symptoms and side effects of myeloma and its treatments.
Words in bold+blue are explained in the IMF’s companion publication, Understanding Myeloma Vocabulary, which you can access directly at glossary.myeloma.org. If you prefer to read any of the IMF’s publications in electronic format, the light blue links will take you to the corresponding resources. All IMF publications are free-of-charge and can be read, downloaded, or requested in printed format at publications.myeloma.org.
This booklet discusses Pomalyst® (also known as pomalidomide, its generic drug name). Pomalyst is an agent in the drug class known as immunomodulatory agents. Pomalyst is the third immunomodulatory agent to receive approval from the U.S. Food and Drug Administration (FDA) for use in myeloma: thalidomide was approved in 2003, Revlimid® (lenalidomide) was approved in 2006, and Pomalyst was approved in 2013.
How Pomalyst works
An immunomodulatory agent is a drug that can modify, enhance, or suppress the functioning of the immune system. Immunomodulatory agents have multiple actions. They have both anti-cancer and anti- inflammatory effects. Immunomodulatory agents are vascular endothelial growth factor (VEGF) inhibitors that interfere with angiogenesis, the formation of blood vessels that usually accompanies the growth of tumor cells.
Immunomodulatory agents also reduce the levels of cytokines and interleukins, which can promote the growth of cancer cells. Research shows that interleukin-6 (IL-6) stimulates and supports the growth of myeloma cells, and that Pomalyst “down-regulates” (reduces) the amount of IL-6. Down-regulation is the process by which a cell decreases the quantity of a cellular component.
In addition, immunomodulatory agents enhance the activation of specialized white blood cells (WBC), both the T cells (T lymphocytes) and “natural killer ” (NK) cells.
Indication for treatment with Pomalyst
Pomalyst is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least 2 prior therapies, including the immunomodulatory agent Revlimid and a proteasome inhibitor, and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Pomalyst is used in many regimens for previously treated myeloma, including the following combination therapies:
¡ Pomalyst + the steroid dexamethasone [Pd].
¡ Darzalex® (daratumumab) intravenous (IV) infusion + Pomalyst + dexamethasone [DPd].
¡ Darzalex Faspro® (daratumumab + hyaluronidase-fihj) subcutaneous (SQ) injection + Pomalyst + dexamethasone [DPd].
¡ Empliciti® (elotuzumab) + Pomalyst + dexamethasone [EPd].
¡ Ninlaro® (ixazomib) + Pomalyst + dexamethasone [IPd].
¡ Pomalyst + cyclophosphamide + dexamethasone [PCd].
¡ Pomalyst + Velcade® (bortezomib) + dexamethasone [PVd].
¡ Kyprolis® (carfilzomib) + Pomalyst + dexamethasone [KPd].
¡ Sarclisa® (isatuximab-irfc) + Pomalyst + dexamethasone [Isa-Pd].
Dose and schedule of Pomalyst
Pomalyst capsules are given orally at 4 mg per day on days 1 through 21 of repeated 28-day cycles until disease progression. Pomalyst was approved in combination with dexamethasone. The recommended dose of dexamethasone is 40 mg per day on days 1, 8, 15, and 22 of each 28-day cycle.
If you are experiencing an unwanted or unexpected side effect or reaction, your doctor will determine if it is appropriate to adjust your dose of Pomalyst and/or dexamethasone. You must promptly report any and all new problems to your doctor.
How Pomalyst is taken
¡ Pomalyst is taken orally (by mouth) in capsule form.
¡ On the days that Pomalyst is taken, it should be taken at the same time of the day.
¡ Swallow Pomalyst with water. Pomalyst may be taken with or without food.
¡ Do not break, chew, or open the capsules.
¡ Do not handle the capsules more than needed.
¡ If you touch a broken Pomalyst capsule, wash the area of your body that came in contact with the medicine immediately and thoroughly with soap and water.
¡ If you miss a dose of Pomalyst, and it has been less than 12 hours since your regular time to take it, you should take it as soon as possible. If it has been more than 12 hours since your regular time, just skip your missed dose. Do NOT take two doses at the same time.
¡ If you take either too much or too little Pomalyst instead of your prescribed dose, promptly alert your doctor or poison control center.
¡ Store Pomalyst at room temperature.
¡ Keep Pomalyst and all medications out of the reach of children.
Warnings and precautions with Pomalyst
Most of the side effects associated with Pomalyst are manageable and predictable. However, there are certain potential side effects that are serious enough to require a “Boxed Warning,” the highest safety-related warning that a medication can have assigned by the FDA. A Boxed Warning is intended to bring the patient’s attention to the risks of a drug.
Before starting treatment with Pomalyst, discuss the warnings, precautions, and side effects with the doctor treating your myeloma. After starting treatment with Pomalyst, promptly report to your doctor any problems or changes in your health so that appropriate steps can be taken. No problem is too small to report.
Pomalyst REMS
Pomalyst is available only through a restricted program called “Risk Evaluation and Mitigation Strategy (REMS).” The FDA requires a REMS program if a specific drug or treatment has serious safety concerns. REMS programs support the use of such drugs or treatments and help ensure that the potential benefits outweigh the risks. Prescribers and pharmacists must be certified with the REMS program, and patients must sign an agreement and comply with its requirements.
Females of reproductive potential
Pomalyst is contraindicated in pregnancy. Pomalyst is a chemical analog of thalidomide, which is known to cause severe birth defects and embryofetal death.
Females of reproductive potential must have pregnancy tests weekly for 4 weeks, then every 4 weeks (if your menstrual cycle is regular) or every 2 weeks (if your menstrual cycle is irregular).
Patients must agree to use 2 acceptable forms of effective birth control at the same time for at least 4 weeks before starting Pomalyst, while taking Pomalyst or during any interruptions in treatment, and for at least 4 weeks after stopping treatment with Pomalyst.
If you become pregnant while taking Pomalyst, stop taking it and contact your doctor immediately. If your doctor is not available, contact FDA MedWatch at 1.800.FDA.1088.
Male patients
Pomalyst is present in the semen of male patients who take it, so they must also comply with mandatory contraceptive measures. If your female partner becomes pregnant, alert your doctor right away. In addition, do not donate blood because if a pregnant female gets your donated blood, her baby may be born with birth defects.
Nursing mothers
Because many drugs are excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Blood clots
Deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as myocardial infarction (heart attack) and stroke can occur in myeloma patients treated with Pomalyst. In the clinical trial data submitted to the FDA for approval of Pomalyst, all study patients were required to receive antithrombotic medication to reduce the risk of blood clots forming and growing. Your doctor will assess your individual risk factors to determine which medication is most appropriate for you.
Before starting Pomalyst, tell your doctor about all the medicines you take, and if you have had a blood clot in the past, if you smoke, have high blood pressure, or have hyperlipidemia (high level of fat in your blood).
Get emergency medical help if you experience any of the following:
¡ Swelling of your lips, mouth, tongue, or throat,
¡ Trouble breathing or swallowing,
¡ Skin hives (raised red areas on your skin),
¡ A very fast heartbeat,
¡ Dizziness or fainting,
¡ Severe headache or confusion,
¡ Problems with vision, speech, or balance,
¡ A red skin rash or peeling of your skin or blisters,
¡ Chest pain (that may or may not spread to the arms, neck, jaw, back, or abdomen),
¡ Sudden numbness or weakness (especially if on one side of the body).
Get medical help right away if you experience any of the following:
¡ Arm or leg swelling,
¡ Shortness of breath, ¡ Feeling sweaty, ¡ Severe itching, ¡ Vomiting, ¡ Fever.
Neutropenia
Neutropenia is a reduced level of neutrophils, a type of white blood cell necessary to combat bacterial infection. Having too few neutrophils can lead to infection. Fever is the most common sign of neutropenia and indicates that you need immediate medical attention.
Neutropenia of any Grade was reported in 50% of clinical trial patients and was the most frequently reported serious side effect. Other common symptoms associated with a low neutrophil count include sore throat and mouth sores.
When patients with relapsed myeloma begin therapy with Pomalyst, neutropenia is often a problem that results from the combined effects of myeloma infiltration of the bone marrow, the impact of prior therapy, and the impact of the Pomalyst.
During the first 2–3 months of therapy, it is especially important to try to maintain the full dose of Pomalyst. As your neutrophils recover, your tolerance for the full dose of Pomalyst should improve. Your doctor may prescribe a colony-stimulating factor (CSF) to stimulate the development and growth of your blood cells.
For the first 8 weeks of treatment, patients should be monitored with a weekly complete blood count (CBC), and with a monthly CBC thereafter. Treatment can be modified if blood counts are too low. Tell your doctor if you have any cold- or flu-like symptoms, because neutropenia accompanying a viral infection may resolve quickly after the infection has cleared.
With ongoing Pomalyst therapy beyond the initial cycles, support for white blood cell production may be an ongoing concern. Mild neutropenia generally has no symptoms and may not need treatment.
Renal and hepatic impairment
Pomalyst is metabolized in the liver. Pomalyst and its metabolites are excreted by the kidneys. The influence of renal (kidney) and hepatic (liver) impairment on the safety, efficacy, and pharmacokinetics (PK) of Pomalyst has not been evaluated. Pomalyst should not be taken by the following patients:
¡ Patients whose serum creatinine is > 3.0 mg/dL.
¡ Patients whose serum bilirubin is > 2.0 mg/dL.
¡ Patients whose AST/ALT liver enzymes ratio in the blood is > 3.0 x ULN (upper limit of normal).
Hypersensitivity reactions
Patients with a prior history of serious sensitivity to thalidomide or Revlimid were excluded from studies with Pomalyst and may be at higher risk of allergic reactions to Pomalyst. Drug hypersensitivity results from the interaction of a drug and the immune system. Risk factors for drug hypersensitivity reactions include age, female gender, concurrent illnesses, and previous hypersensitivity to related drugs. Symptoms may include difficulty breathing, rash, hives, fever, swelling, vomiting, or diarrhea.
Treatment for hypersensitivity reactions is largely supportive and includes discontinuation of the medication and treatment of the symptoms. Contact your healthcare provider immediately if you experience any symptoms after taking Pomalyst.
Drug interactions
No formal drug interaction studies have been conducted with Pomalyst, but patients should not take Pomalyst with drugs that are strong inhibitors of CYP1A2, CYP3A, or P-gp. Cigarette smoking may reduce the efficacy of Pomalyst due to CYP1A2 activation. Any concerns or questions about possible drug interactions or smoking should be discussed with your doctor.
Age
Safety and effectiveness of Pomalyst in patients under the age of 18 have not been established. No dosage adjustment is required for Pomalyst based on age. However, clinical trial patients aged 65 years or older were more likely to experience pneumonia than patients younger than age 65.
Second primary malignancy
Cases of acute myelogenous leukemia (AML) have been reported in patients receiving Pomalyst in clinical trials, although none of these were patients in myeloma trials.
Other potential side effects of Pomalyst
In a clinical trial of 219 patients who received Pomalyst alone or the Pd combination therapy, all patients experienced at least one side effect. The most common side effects occurring in 30% or more of patients included asthenia, neutropenia, anemia, constipation, nausea, diarrhea, difficulty breathing, upper respiratory tract infection, back pain, and fever.
The most common serious side effects were low blood counts and pneumonia. Your doctor may decide to interrupt your treatment with Pomalyst until your side effect resolves, then restart it at a lower dose.
Dizziness and confusion
In the clinical trial that led to FDA approval of Pomalyst, 18% of patients experienced dizziness and 12% of patients experienced some mental confusion.
Prevention of dizziness and confusion
Patients should be aware that dizziness and confusion are potential side effects and should avoid situations where this would pose a risk to, or problem for, themselves or others. You must discuss all your medications with your doctor because dizziness and confusion may be caused by other medications you are taking.
Neuropathy
Symptoms of neuropathy that affect the sensory and motor nerves include numbness, tingling, and pain in the hands or feet, which 18% of patients experienced in the clinical trial of Pomalyst. Symptoms of neuropathy that affect the autonomic nervous system include dizziness and fainting. There were no cases of serious neuropathic side effects.
Prevention and treatment of neuropathy
We strongly urge you to contact your doctor if you experience new or worsening symptoms of this condition. Many myeloma patients have underlying neuropathy from their disease before they are diagnosed and treated for myeloma. Early detection and dose modification can prevent progression of neuropathy. For more information, read the IMF’s publication Understanding Peripheral Neuropathy in Myeloma.
Fatigue
Fatigue caused by cancer or cancer treatment is a distressing, persistent, subjective sense of tiredness or exhaustion that is not proportional to recent activity and interferes with usual functioning. Although many of the patients in clinical trials with Pomalyst felt fatigued, very few had severe fatigue that prevented them from performing the activities of daily living. As a general rule, any patient suffering from fatigue should exercise caution if operating machinery, including automobiles.
Prevention and treatment of fatigue
If your fatigue is severe, your doctor may have to intervene with appropriate supportive care measures. There are medications to treat this problem. The effects of fatigue may be minimized by maintaining:
¡ A moderate level of activity (because inactivity breeds greater fatigue).
¡ A healthy diet and proper fluid intake.
¡ A consistent sleeping schedule with enough rest.
¡ Regularly scheduled visits with your healthcare providers to discuss your fatigue issues.
For more information, read the IMF’s publication Understanding Fatigue.
Asthenia
Asthenia is a condition in which the body lacks or has lost strength either as a whole or in any of its parts. It is a common complication of a number of drugs that are used to treat myeloma, and of cancer treatments in general.
Prevention and treatment of asthenia
First and easiest, try taking your Pomalyst at night before you go to bed in order to limit the side effects to the hours when you’re asleep. If you are still experiencing asthenia during your waking hours, your doctor may reduce your dose of Pomalyst or may prescribe medication to be taken in the mornings that may help you be more active during the day. Finally, asthenia may improve by itself with prolonged therapy or may improve as your myeloma disease burden is decreased.
Thrombocytopenia
Thrombocytopenia is a low number of platelets in the blood. 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. For example, at Mayo Clinic the “normal” level is 150,000 or more platelets per microliter of circulating blood. If the platelet count is less than 50,000, bleeding problems could occur. Major bleeding is usually associated with a reduction to less than 10,000.
Prevention and treatment of thrombocytopenia
You should inform your doctor if you experience excessive bruising or bleeding. Management may include platelet transfusions at the discretion of your doctor.
Anemia
Red blood cells contain hemoglobin, a protein that carries oxygen to the body’s tissues and organs. Anemia is usually defined as a decrease in hemoglobin < 10 g/dL or as a decrease of ≥ 2 g/dL from the normal level for an individual. More than 13–14 g/dL is considered normal. Low levels of oxygen in the body may cause shortness of breath and feelings of exhaustion. Many newly diagnosed myeloma patients have anemia.
Prevention and treatment of anemia
In addition to lowering the dose of Pomalyst, if this is deemed appropriate, your doctor may determine that a treatment regimen for anemia may be best suited and safest for you.
The following are options for treatment of anemia:
¡ Adjusting medications.
¡ Blood transfusions.
¡ Erythropoietic (red blood cell-making) agents.
Pomalyst access and support
Bristol Myers Squibb, the company that makes Pomalyst, has a program to help patients access their prescribed BMS medications. For eligible patients, BMS Access Support® can offer coverage and access assistance, co-pay and financial support, help identifying local resources, and more. To learn if you are eligible to receive BMS support, schedule a call with a BMS access specialist at bmsaccesssupport.com/patient/co-pay-financial-support .
Clinical trials with Pomalyst
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 specific condition, and to answer scientific questions.
If you have an interest in participating in a clinical trial, be sure to discuss with your myeloma doctor all the potential risks and benefits that may apply to your particular case. For general information about what’s involved in study participation, read the IMF’s publication Understanding Clinical Trials in Myeloma.
At this time, there are numerous ongoing clinical trials for patients with myeloma, including studies with Pomalyst, and some of these clinical trials may be enrolling patients. To help myeloma patients with personalized support for identifying and exploring clinical trial options, the IMF has partnered with SparkCures. Visit myeloma.org/sparkcures or contact the IMF InfoLine for more information.
The U.S. government maintains clinicaltrials.gov, an online database of research studies. However, the government does not review the safety and science of the studies submitted to this website.
DREAMM-8 clinical trial
Novel approaches to the treatment of newly diagnosed multiple myeloma (NDMM) are producing excellent results for many patients. However, myeloma is a disease that typically relapses. An important ongoing study with Pomalyst is the DREAMM-8 clinical trial, which is treating patients with RRMM who have received 1 to 3 prior lines of therapy, including patients with high-risk cytogenetic abnormalities (HRCA). The DREAMM-8 study is comparing the novel combination of belantamab mafodotin + Pomalyst + dexamethasone [BPd] in 155 patients to the FDA-approved combination of Pomalyst + Velcade + dexamethasone [PVd] in 147 patients.
In May 2025, data reported at the annual meeting of the American Society of Clinical Oncology (ASCO) demonstrated greater progression-free survival (PFS) benefit in the BPd group across all HRCA subgroups. In patients with RRMM and one or more HRCA, the BPd combination therapy demonstrated clinically meaningful PFS benefit, higher overall response rate (ORR), and a higher rate of patients who achieved complete response (CR) or better when compared to PVd.
In July 2025, the BPd combination therapy was approved both in the European Union (EU) and in Canada for the treatment of adult patients with RRMM who have received at least 1 prior therapy including Revlimid. At this time, BPd is not approved by the FDA for use in the United States outside the setting of a clinical trial.
IRAKLIA clinical trial
At the 2025 ASCO annual meeting, results were reported from the multicenter IRAKLIA clinical trial of the Isa-Pd combination therapy. This study focused not on Pomalyst but rather compared the FDA-approved IV administration of Sarclisa to the SQ administration of Sarclisa using an on-body injector (OBI). A total of 531 patients with RRMM were randomly assigned to the two study arms (268 to IV, 263 to OBI). Data showed comparable efficacy and safety with both Sarclisa IV and Sarclisa OBI, supporting potential use of an OBI to improve patient experience.
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 IMF intends only to provide you with information that will guide you in discussions with your healthcare team.
To help ensure a good quality of life through effective treatment, you must play an active role in your own medical care. We encourage you to visit myeloma.org for more information and to join the Myeloma Knowledge Platform at myprofile.myeloma.org.
To receive the most up-to-date information about myeloma in a caring and compassionate manner, call the IMF InfoLine at 1.818.487.7455, email InfoLine@myeloma.org, or visit mmsm.link/infoline to schedule a convenient time to talk with an IMF InfoLine Coordinator.
To get answers to your questions without having to wait, ask Myelo® anytime 24/7 at myeloma.org. This generative AI assistant is designed to help you find the right resources.
Use the hyperlinks and web addresses included in this publication for quick access to resources from the IMF. 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.
The International Myeloma Foundation (IMF) is the global leader in myeloma. Our mission is to improve the quality of life of myeloma patients while working toward prevention and a cure. Since 1990, the IMF has been serving the myeloma community through the following four pillars:
RESEARCH At the IMF, finding a cure for myeloma is our top priority. The IMF Scientific Advisory Board (SAB) of leading myeloma experts identifies key opportunities to drive research forward. The IMF Black Swan Research Initiative® (BSRI®) is pushing the boundaries with early screening for a precursor condition of myeloma as well as cure-focused myeloma clinical trials. The IMF International Myeloma Working Group (IMWG) provides trusted guidelines for diagnosing, treating, and managing myeloma. We also fund innovative research through the IMF Brian D. Novis Research Grants.
EDUCATION Myeloma is a complex and unique journey for each patient. The IMF offers hundreds of videos and free publications in multiple languages to inform and empower patients and care partners to navigate their myeloma journey. All IMF seminars, webinars, and workshops are free-of-charge and designed to directly connect the patient community with expert myeloma clinicians. The IMF Nurse Leadership Board (NLB) provides recommendations for the management of myeloma. The IMF M-Power Project works to break down barriers and ensure health equity in underserved populations.
SUPPORT Studies show that social support can greatly improve the quality of life of people with cancer. The IMF offers more than 160 myeloma support groups across North America, including specialized groups for Spanish-speakers, people with smoldering myeloma, care partners of patients with myeloma, and patients who do not have care partners. The IMF InfoLine answers myeloma-related questions. Myelo®, the IMF’s generative AI assistant, is available 24/7 to help you find the right resources.
ADVOCACY In the U.S., the IMF Advocacy team represents your interests at the federal and state levels. Internationally, the IMF Global Myeloma Action Network (GMAN) works to improve patient access to treatments.
