Pomalyst (pomalidomide)

POMALYST® (also known as pomalidomide, its generic drug name) is an immunomodulatory agent taken by mouth in capsule form. It 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 Does Pomalyst Work?

Pomalyst is an immunomodulatory agent, a drug that can change, increase, or decrease the functioning of the human immune system. The human immune system works to protect and defend the body from external threats (e.g., bacteria, viruses, toxins) as well as from internal threats (e.g., cancer). 

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 was approved in 2006, and Pomalyst was approved in 2013.

Immunomodulatory agents have both anti-cancer and anti-inflammatory effects. Immunomodulatory agents are vascular endothelial growth factor (VEGF) inhibitors that interfere with 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 stimulate and support the growth of myeloma cells. 

In addition, immunomodulatory agents increase the activation of specialized white blood cells (WBC), the T cells (T lymphocytes) that can help the body fight infection and disease, as well as “natural killer” (NK) cells that can recognize cells transformed by cancer and can induce a strong response against them through the release of cytokines. 

What Are Some Myeloma Clinical Trials That Use Pomalyst?

DREAMM-8 clinical trial 

An important ongoing study with Pomalyst is the DREAMM-8 clinical trial (https://www.myeloma.org/videos/dreamm-8-study-belantamab-mafodotin-plus-pomalidomide-dexamethasone-shows-improved-outcomes), which is treating patients with RRMM who have received between 1 and 3 prior lines of therapy, including patients with high-risk cytogenetic abnormalities (HRCA). The DREAMM-8 study compares the combination of Blenrep® (belantamab mafodotin-blmf), Pomalyst, and dexamethasone [BPd] in 155 patients to the FDA-approved combination of Pomalyst, Velcade, and dexamethasone [PVd] in 147 patients. 

Data shared at the annual meeting of the American Society of Clinical Oncology (ASCO) in May 2025 showed greater progression-free survival (PFS) 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. 

The BPd combination therapy was approved in July 2025 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. 

The AMN003 clinical trial

The IMF sponsored the AMN003 study (https://www.myeloma.org/news-events/multiple-myeloma-news/amn-publishes-amn003-study-results) by its Asian Myeloma Network (AMN). It was conducted in compliance with the requirements of local regulatory authorities in Hong Kong, Japan, Malaysia, Singapore, South Korea, and Taiwan. The AMN003 study compared the efficacy (how well it works in clinical trials) and toxicity (if it causes side effects) of Pomalyst, cyclophosphamide, and  dexamethasone [PCd] vs. Pomalyst and dexamethasone [Pd] in patients with RRMM who had received an average of 3 prior lines of therapy. The study patients who received PCd had significantly longer PFS vs. study patients who received Pd (10.9 months vs. 5.8 months). 

Due to limited access to new myeloma therapies outside the U.S., the AMN003 study shows that combining Pomalyst with conventional, cost-effective treatment options in a triplet (3-drug) PCd regimen improved PFS without a significant increase in side effects when compared to treatment with a doublet (2-drug) Pd regimen. PCd represents a realistic and effective treatment option for patients with RRMM in Asia and across the world, especially in countries where resources may be limited.

The IRAKLIA clinical trial 

At the 2025 annual meeting of the American Society of Clinical Oncology (ASCO), results were reported from the multicenter IRAKLIA study (https://www.myeloma.org/videos/subcutaneous-vs-iv-isatuximab-pomalidomidedexamethasone-rr-mm-iraklia-phase-3-study) that compared the FDA-approved intravenous (IV) infusion Sarclisa® (isatuximab-irfc) to the subcutaneous (SQ) injection of Sarclisa using an on-body injector (OBI) as part of the Sarclisa and Pd [Isa-Pd] combination therapy. 

Study data confirmed that both Sarclisa IV and Sarclisa OBI have similar efficacy and safety. New technology to deliver drugs, such as OBIs, are being developed to make administration of therapies simpler and improve patient experience while maintaining treatment efficacy and safety.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency’s (EMA) issued a positive opinion in March 2026 (https://www.myeloma.org/news-events/multiple-myeloma-news/chmp-ema-positive-opinion-isatuximab-on-body-injector) and recommended approval of the SQ formulation of Sarclisa, including administration via an OBI. As of May 2026, the FDA is evaluating the OBI delivery of Sarclisa, and we hope to have an answer in the near future.
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 (https://www.myeloma.org/sparkcures) or contact the IMF InfoLine (https://www.myeloma.org/infoline) 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’s publication Understanding Clinical Trials in Myeloma (https://www.myeloma.org/resource-library/understanding-clinical-trials-myeloma).
 

What Are Myeloma Treatment Regimens That Use Pomalyst?

Pomalyst is indicated for the treatment of adult patients with relapsed and refractory myeloma 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 as therapy for previously treated myeloma, including the following combination therapies:

• Pd: Pomalyst and the steroid dexamethasone  (https://www.myeloma.org/dexamethasone) 
• DPd: Darzalex® (daratumumab) (https://www.myeloma.org/darzalex-daratumumab) intravenous (IV) infusion,or Darzalex Faspro® (daratumumab plus hyaluronidase-fihj) subcutaneous (SQ) injection (https://www.myeloma.org/darzalex-faspro-daratumumab-hyaluronidase-fihj), Pomalyst, and dexamethasone 
• EPd: Empliciti® (elotuzumab) (https://www.myeloma.org/empliciti-elotuzumab), Pomalyst, and dexamethasone  
• IPd: Ninlaro® (ixazomib (https://www.myeloma.org/ninlaro-ixazomib)), Pomalyst, and dexamethasone 
• PCd: Pomalyst, Cytoxan® (cyclophosphamide (https://www.myeloma.org/cyclophosphamide)), and dexamethasone 
• PVd: Pomalyst, Velcade® (bortezomib (https://www.myeloma.org/velcade-bortezomib)), and dexamethasone 
• Kyprolis® (carfilzomib) (https://www.myeloma.org/kyprolis-carfilzomib), Pomalyst, and dexamethasone [KPd]. 
• Isa-Pd: Sarclisa® (isatuximab-irfc) (https://www.myeloma.org/sarclisa-isatuximab-irfc), Pomalyst, and dexamethasone
• XPd: Xpovio® (selinexor) (https://www.myeloma.org/xpovio-selinexor), Pomalyst, and dexamethasone 

What Is the Dose and Schedule of Pomalyst? 

Cancer is often treated at regular intervals called Cycles, which can be measured in days or weeks and may be followed by a period of rest. A Cycle is the amount of time between the start of one round of therapy and the start of the next round of therapy.

Pomalyst capsules are taken by mouth at 4 mg per day on days 1 through 21, with a rest of no Pomalyst on days 22 through 28. The Cycles repeat on this schedule until the myeloma progresses. When Pomalyst is taken 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. 

Pomalyst is also available in doses of 3 mg, 2 mg, and 1 mg. Your doctor may adjust your dose and schedule and will decide how long you should stay on this treatment.
 

How Is Pomalyst Taken?

• On the days Pomalyst is taken, it should be taken at the same time each day. To limit its possible side effects to the hours when you’re asleep, try taking your Pomalyst at bedtime.
• Pomalyst may be taken with or without food, swallowed with water.
• Do not handle the capsules more than necessary. Do not break, chew, or open the capsules. If you touch an open Pomalyst capsule, immediately wash the area of contact thoroughly with soap and water. 
• If you miss a dose of Pomalyst, contact your healthcare team for instructions. 
• If you take more Pomalyst than 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 

Before you begin treatment with Pomalyst, talk with your doctor about any special precautions and possible side effects that may apply to you. If you have already started treatment with Pomalyst, promptly report any changes in your health to your doctor, including new or worsening signs or symptoms.

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. Pomalyst is available only through a REMS program.
 

Embryo-fetal toxicity   

Pomalyst is part of the same drug class as thalidomide, a drug known to cause severe birth defects or embryo-fetal death. Women who are able to get pregnant must have 2 negative pregnancy tests before starting Pomalyst treatment, must use 2 forms of contraception or not have any heterosexual sex during treatment with Pomalyst and for 4 weeks after treatment ends. Contact your doctor immediately if you become pregnant while taking Pomalyst. If your doctor is not available, contact FDA MedWatch at 1.800.FDA.1088.

Because many medicines can pass into breast milk, you and your doctor should decide whether you should stop nursing or stop taking Pomalyst based on how important this treatment is for you.

Pomalyst is found in the semen of men who take it. Men with partners who can become pregnant must follow the required birth control steps.

In addition, do not donate blood while you’re taking Pomalyst. If a pregnant woman receives your donated blood, her baby will be exposed to Pomalyst.

Venous and arterial thromboembolism

In clinical trials of Pomalyst, all patients took medicine to help prevent blood clots. Your doctor will look at your health history and decide which medicine is best to lower your risk of blood clots. Before you start Pomalyst, tell your doctor about all the medicines you take and whether you have ever had a blood clot and if you smoke, have high blood pressure, or have high blood fat levels.

Deep vein thrombosis (DVT) happens when a blood clot forms in one or more deep veins in the body. The blood clot can break loose and travel to the heart or lungs. This can be life-threatening. DVT may cause leg pain or swelling, or there may be no symptoms.

Pulmonary embolism (PE) happens when a blood clot breaks loose from a vein, travels through the bloodstream, and blocks an artery in the lung. This can be life-threatening.

Myocardial infarction (heart attack) and stroke can also occur in people with myeloma treated with Pomalyst.
Get emergency medical help if you experience any of the following: 

• Swelling of your lips, mouth, tongue, or throat;
• Trouble breathing or swallowing, shortness of breath;
• Skin hives (raised red areas), red rash, peeling skin, blisters, or severe itching;
• A very fast heartbeat;
• Dizziness or fainting;
• Severe headache or confusion;
• Problems with vision, speech, or balance;
• 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);\
• Arm or leg swelling or pain;
• Feeling sweaty;
• Vomiting;
• Fever.

Drug interactions and smoking 

Pomalyst should not be taken with medicines that strongly inhibit CYP1A2, CYP3A, or P-gp. Smoking cigarettes may make Pomalyst less effective by activating CYP1A2.

Kidney and liver problems 

Pomalyst is metabolized in the liver. Pomalyst and its metabolites are excreted by the kidneys. Pomalyst should not be taken: 

• If your serum creatinine is > 3.0 mg/dL. 
• If your serum bilirubin is > 2.0 mg/dL. 
• If your AST/ALT liver enzymes ratio in the blood is > 3.0 x ULN (upper limit of normal). 

Hypersensitivity reactions 

Drug hypersensitivity is a result of the interaction between a drug and the immune system. Risk factors for drug hypersensitivity reactions include age, female gender, having more than 1 illness at a time, and previous hypersensitivity to related drugs, such as Revlimid or thalidomide. Symptoms may include difficulty breathing, rash, hives, fever, swelling, vomiting, or diarrhea.
Tumor lysis syndrome (TLS)

TLS is a disorder caused by the break-down products of dying cancer cells. TLS can occur when a patient responds very quickly and deeply to therapy. Patients who have a higher myeloma tumor burden prior to treatment with Pomalyst are at an increased risk for

TLS. This can overwhelm the kidneys and possibly lead to kidney failure. TLS is usually treated with medication used for gout.

Possible side effects with Pomalyst

In the MM-002 clinical trial that led to the FDA approval of Pomalyst, of the 219 study patients who received either Pomalyst alone (“monotherapy”), or Pomalyst and dexamethasone [Pd], all patients had at least 1 side effect. 

The most common serious side effects were low blood counts and pneumonia. Study patients 65 years or older were more likely to get pneumonia than patients younger than 65. Your blood counts will be monitored during treatment, and your doctor may decide to pause your Pomalyst until your side effect resolves, then restart Pomalyst at a lower dose.

Neutropenia 

Neutropenia is a reduced level of neutrophils, a type of white blood cell necessary to fight bacterial infection. Having too few neutrophils can lead to infection. In myeloma, neutropenia often results from the combination of the disease, Pomalyst, and the previous therapy’s effects on your system. Neutropenia of any Grade was reported in half of clinical trial patients and was the most frequently reported serious side effect.

For the first 8 weeks of treatment with Pomalyst, patients should be monitored with a weekly complete blood count (CBC) test, followed with a monthly CBC test afterward. Treatment with Pomalyst can be modified if blood counts are too low. Your doctor may prescribe a colony-stimulating factor (CSF) to increase the development and growth of your blood cells. Neutropenia that happens with a viral infection may go away quickly once the infection has cleared.

Fever is the most common sign of neutropenia. If you have a fever, you must get immediate medical attention. Other common symptoms of having a low neutrophil count include sore throat and mouth sores, and cold- or flu-like symptoms.

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. What’s considered a “normal” level of platelets varies from laboratory to laboratory, so your doctor will need to explain your result to you. Bleeding problems can happen if your count is under 50,000 platelets. Major bleeding can happen when your count drops below 10,000 platelets. 

Be sure to let your doctor know if you experience excessive bruising or bleeding. Your doctor may include transfusions of platelets to manage thrombocytopenia. 

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. 
Your dose of Pomalyst may be lowered or erythropoietic (red blood cell-making) agents may be prescribed if your doctor thinks you need it. Blood transfusions may be used if necessary.

Asthenia

Asthenia is a condition where the body loses strength either as a whole or in any of its parts. This is a common complication of some drugs that are used to treat cancer, including myeloma. If you experience asthenia, your doctor may reduce your dose of Pomalyst or may prescribe medication that may help you be more active during the day. Asthenia may improve by itself or after your myeloma responds to treatment.

Dizziness and confusion 

Patients should be aware that dizziness and confusion are potential side effects of Pomalyst and should avoid situations where this would be a problem for themselves or others. Dizziness and confusion may be caused by other medications you are taking, so be sure to discuss all your medications with your doctor.

Fatigue 

Fatigue can be caused by cancer or by cancer treatment. It is an upsetting, constant, individual sense of tiredness or exhaustion that interferes with usual functioning and is not related to the person’s activity. Although many of the patients in clinical trials with Pomalyst felt fatigued, few had severe fatigue that stopped their activities of daily living. 

As a general rule, anyone suffering from fatigue should use caution if operating machinery, including driving a car. If your fatigue is severe, your doctor may add supportive care measures, such as medications to treat this problem. The effects of fatigue may be reduced by maintaining a moderate level of activity (inactivity causes greater fatigue), healthy foods and enough fluids, and a consistent sleeping schedule with enough rest. For more information, read the IMF’s publication Understanding Fatigue in Myeloma (https://www.myeloma.org/resource-library/understanding-fatigue). 

Neuropathy 

Neuropathy is caused by nerve damage. You may already have neuropathy caused by myeloma before it is diagnosed or treated. Symptoms may include a feeling of numbness, tingling, burning, and/or pain in the hands or feet, as well as dizziness and fainting. Understanding the warning signs of neuropathy and adjusting your treatment dose may help prevent neuropathy from getting worse. For more information, read the IMF’s publication Understanding Neuropathy in Myeloma. (https://www.myeloma.org/resource-library/understanding-neuropathy-myeloma)

Other possible side effects

Other side effects experienced by 30% or more of clinical trial patients included:

•  back pain
•  constipation
•  diarrhea
•  dyspnea (shortness of breath)
• nausea
• upper respiratory tract infection 
   

Pomalyst Support Programs 

U.S. residents with commercial insurance who are prescribed Pomalyst may be eligible to receive co-pay assistance from Bristol Myers Squibb Access Support. Visit bmsaccesssupport.com (https://www.bmsaccesssupport.com/) or call 1.800.861.0048. 

U.S. residents who are uninsured can receive information about an independent charitable program that provides free medication to eligible patients who are experiencing financial hardship. Visit bmspaf.org (https://www.bmspaf.org/) or call 1.800.736.0003.

Generic pomalidomide

There is a generic form of Pomalyst (pomalidomide). If you have questions about using generic pomalidomide, ask the doctor who is treating your myeloma.
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