SARCLISA: Uses, Dosage & Side Effects
An anti-CD38 monoclonal antibody for the treatment of multiple myeloma in combination with other anticancer agents
SARCLISA (isatuximab) is a monoclonal antibody that targets the CD38 protein on the surface of myeloma cells. It is used in combination with other anticancer agents for the treatment of multiple myeloma – a cancer of plasma cells in the bone marrow. SARCLISA works by binding to CD38 and activating the body’s immune system to identify and destroy the cancer cells through multiple mechanisms. It is administered as an intravenous infusion in a hospital or clinic setting and requires a prescription. SARCLISA is approved for use in both previously treated and newly diagnosed patients with multiple myeloma.
Quick Facts: SARCLISA
Key Takeaways
- SARCLISA (isatuximab) is an anti-CD38 monoclonal antibody that helps the immune system recognize and destroy myeloma cells through multiple mechanisms including ADCC, CDC, ADCP, and direct apoptosis.
- It is approved for multiple myeloma in combination with pomalidomide and dexamethasone (Isa-Pd), carfilzomib and dexamethasone (Isa-Kd), or bortezomib, lenalidomide, and dexamethasone (Isa-VRd) for both previously treated and newly diagnosed patients.
- Infusion-related reactions are common, especially with the first dose; pre-medication with antihistamines, corticosteroids, and antipyretics is always required before each infusion.
- SARCLISA can interfere with blood typing and cross-matching tests for up to 6 months after the last dose; inform all healthcare providers including blood bank personnel that you are receiving this treatment.
- Women of childbearing potential must use effective contraception during treatment and for 5 months after the last dose; the companion drugs (pomalidomide, lenalidomide) have additional strict pregnancy prevention requirements.
What Is SARCLISA and What Is It Used For?
SARCLISA contains the active substance isatuximab, a monoclonal antibody belonging to the immunoglobulin G1 (IgG1) subclass. Monoclonal antibodies are laboratory-engineered proteins designed to recognize and bind to specific targets on cells. In the case of SARCLISA, the target is CD38 – a protein found in high amounts on the surface of myeloma cells. By binding to a specific region (epitope) on CD38, SARCLISA triggers the body’s natural immune defenses to identify and eliminate the cancer cells.
The mechanism of action of SARCLISA is multifaceted and involves several distinct immune-mediated processes. First, it induces antibody-dependent cellular cytotoxicity (ADCC), in which natural killer cells are recruited to attack and kill the antibody-coated myeloma cells. Second, it activates complement-dependent cytotoxicity (CDC), where proteins in the blood known as complement cascade are triggered to destroy the targeted cells. Third, SARCLISA promotes antibody-dependent cellular phagocytosis (ADCP), in which macrophages engulf and digest the cancer cells. Uniquely, isatuximab also has the ability to directly induce programmed cell death (apoptosis) in myeloma cells without requiring additional cross-linking, which distinguishes it from some other anti-CD38 antibodies.
Beyond its direct anticancer effects, SARCLISA may also modulate the immune environment within the tumor. CD38 is expressed not only on myeloma cells but also on certain immunosuppressive cells, including regulatory T cells (Tregs) and regulatory B cells (Bregs). By depleting these immunosuppressive cell populations, isatuximab may help restore and enhance the overall anti-tumor immune response, potentially contributing to more durable treatment outcomes.
Multiple myeloma is a cancer of the plasma cells, a type of white blood cell normally responsible for producing antibodies that fight infection. In myeloma, abnormal plasma cells accumulate in the bone marrow and produce excessive amounts of an abnormal protein (M protein or paraprotein). This can lead to bone destruction, kidney damage, anemia, and increased susceptibility to infections. Multiple myeloma is the second most common blood cancer worldwide, accounting for approximately 10% of all hematologic malignancies, with an estimated 176,000 new cases diagnosed globally each year.
SARCLISA is approved by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and regulatory authorities in numerous other countries for the following indications:
- Relapsed/refractory multiple myeloma with pomalidomide and dexamethasone (Isa-Pd): For adult patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. The pivotal ICARIA-MM trial demonstrated that adding SARCLISA to pomalidomide-dexamethasone significantly improved progression-free survival compared with pomalidomide-dexamethasone alone.
- Relapsed/refractory multiple myeloma with carfilzomib and dexamethasone (Isa-Kd): For adult patients who have received one to three prior lines of therapy. The IKEMA trial showed that the addition of SARCLISA to carfilzomib-dexamethasone significantly improved progression-free survival, with a deeper response rate including higher rates of minimal residual disease (MRD) negativity.
- Newly diagnosed multiple myeloma with bortezomib, lenalidomide, and dexamethasone (Isa-VRd): For adult patients who are not eligible for autologous stem cell transplantation, or for those who are eligible for transplantation. The IMROZ trial demonstrated that the four-drug combination of Isa-VRd significantly improved progression-free survival compared with VRd alone in transplant-ineligible patients. The GMMG-HD7 trial evaluated Isa-VRd induction in transplant-eligible patients.
SARCLISA represents a class of targeted immunotherapy that harnesses the patient’s own immune system to fight cancer. Unlike traditional chemotherapy, which attacks rapidly dividing cells indiscriminately, SARCLISA specifically targets cells bearing the CD38 protein. This targeted approach aims to maximize effectiveness against myeloma cells while reducing collateral damage to healthy tissues, although side effects can still occur due to CD38 expression on some normal cell populations.
What Should You Know Before Receiving SARCLISA?
Contraindications
SARCLISA must not be given if you have a known severe hypersensitivity (allergic reaction) to isatuximab or any of the other ingredients in the formulation (sucrose, histidine hydrochloride monohydrate, histidine, polysorbate 80, and water for injections). If you have experienced an anaphylactic reaction to a previous dose of SARCLISA, treatment must be permanently discontinued.
Warnings and Precautions
Infusion-related reactions are very common with SARCLISA and can be serious. They occur most frequently during the first infusion. Symptoms may include shortness of breath, cough, chills, nausea, high blood pressure, and in rare cases, severe anaphylactic reactions with difficulty breathing and swelling of the face, mouth, throat, lips, or tongue. Pre-medication is mandatory before every infusion. If a reaction occurs, the infusion may be slowed, paused, or stopped entirely.
Before and during treatment with SARCLISA, inform your doctor if any of the following apply to you:
- Infections and low white blood cell count: SARCLISA can decrease the number of white blood cells (particularly neutrophils), which are essential for fighting infections. Tell your doctor immediately if you develop a fever, as this may indicate an infection. Your doctor will monitor your blood counts regularly and may prescribe antibiotics or antiviral medications (such as those for herpes zoster/shingles) to prevent infections, or medications to help increase your white blood cell count.
- Heart problems: If you are receiving SARCLISA in combination with carfilzomib and dexamethasone, inform your doctor about any current or past heart conditions or medications for heart problems. Contact your doctor immediately if you develop difficulty breathing, cough, or swollen legs during treatment.
- Risk of new cancers (second primary malignancies): New cancers have been observed in patients receiving SARCLISA in combination with its partner drugs. Your doctor will monitor you for the development of new cancers during and after treatment.
- Tumor lysis syndrome: Rapid breakdown of cancer cells can release large amounts of substances into the blood, potentially causing irregular heartbeat, seizures, confusion, muscle cramps, or decreased urine output. Tell your doctor immediately if you experience any of these symptoms.
- Blood transfusion interference: If you need a blood transfusion, you will have a blood test to determine your blood type. SARCLISA binds to CD38 on red blood cells, which can interfere with blood compatibility testing (indirect antiglobulin test/indirect Coombs test) and produce false-positive results. Inform the person performing the blood test that you are being treated with SARCLISA. This interference can persist for at least 6 months after your last dose.
Pregnancy and Breastfeeding
SARCLISA is not recommended during pregnancy. Although there are no human data on the effects of isatuximab during pregnancy, IgG1 antibodies are known to cross the placental barrier, and CD38 is known to play a role in early embryonic development. The potential risk to the fetus cannot be excluded. If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before receiving SARCLISA.
It is not known whether isatuximab passes into breast milk. Since human IgG antibodies are excreted in breast milk, a risk to the breastfed infant cannot be excluded. You and your doctor should decide together whether the benefits of breastfeeding outweigh the potential risks to the child.
Women of childbearing potential must use effective contraception during treatment with SARCLISA and for 5 months after the last dose. It is important to note that the companion drugs used with SARCLISA – pomalidomide and lenalidomide – are known teratogens (can cause birth defects) and have their own strict pregnancy prevention programs requiring two reliable methods of contraception and regular pregnancy testing. Refer to the prescribing information of these companion drugs for their specific contraception requirements.
Children and Adolescents
SARCLISA is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy of isatuximab have not been established in this population, as multiple myeloma is predominantly a disease of older adults.
Other Medications
Tell your doctor, pharmacist, or nurse about all medications you are currently taking, have recently taken, or might take. This includes prescription medicines, over-the-counter medications, vitamins, and herbal or nutritional supplements. If you have heart conditions and are taking cardiac medications, inform your doctor before starting treatment with SARCLISA, especially when it is used in combination with carfilzomib and dexamethasone.
SARCLISA is always used in combination with other anticancer medications. The specific combinations approved include pomalidomide and dexamethasone; carfilzomib and dexamethasone; and bortezomib, lenalidomide, and dexamethasone. You should also read the patient information leaflets for each companion drug, as they have their own interaction profiles and precautions.
Driving and Operating Machinery
SARCLISA itself is unlikely to affect your ability to drive or operate machinery. However, it is given in combination with other drugs that may affect your ability to drive or use machines. Please refer to the patient information leaflet of your companion medications for specific guidance.
Important Information About Ingredients
SARCLISA contains polysorbate 80 (0.2 mg per mL of concentrate, corresponding to approximately 0.1 mg/kg of body weight). Polysorbates can cause allergic reactions in some individuals. Inform your doctor if you have any known allergies to polysorbate.
How Does SARCLISA Interact with Other Drugs?
As a monoclonal antibody, isatuximab is eliminated primarily through target-mediated drug disposition and catabolism (protein degradation), rather than through the cytochrome P450 (CYP) enzyme system. This means that direct pharmacokinetic drug-drug interactions are unlikely with SARCLISA itself. However, because SARCLISA is always administered in combination with other agents, the interaction profiles of its companion drugs must be considered carefully.
Combination Partner Interactions
| Interacting Drug / Factor | Effect | Clinical Significance |
|---|---|---|
| Dexamethasone (pre-medication and companion drug) | Required as pre-medication to reduce infusion reactions; also part of the treatment regimen | Mandatory – do not omit pre-medication doses |
| Live vaccines (e.g., MMR, varicella, BCG) | Risk of vaccine-strain infection due to immunosuppression from treatment | Avoid during treatment and for a period after; consult your doctor |
| Strong CYP3A4 inhibitors (relevant for carfilzomib regimen) | May increase carfilzomib exposure and toxicity | Monitor closely when co-administered with Isa-Kd |
| Blood typing reagents | SARCLISA binds CD38 on red blood cells, causing false-positive indirect antiglobulin test results | Inform blood bank; type and screen before first dose; interference persists ≥6 months after last dose |
Companion Drug-Specific Interactions
| Companion Drug | Key Interaction Concern | Recommendation |
|---|---|---|
| Pomalidomide | CYP1A2 substrate; strong CYP1A2 inhibitors (e.g., ciprofloxacin, fluvoxamine) may increase levels | Use caution with strong CYP1A2 inhibitors; refer to pomalidomide prescribing information |
| Carfilzomib | Cardiovascular toxicity risk; additive effect with cardiotoxic drugs | Monitor cardiac function closely; avoid concurrent cardiotoxic agents when possible |
| Lenalidomide | Immunosuppressive; additive immunosuppression with other immunosuppressive drugs | Monitor blood counts and infections carefully; refer to lenalidomide prescribing information |
| Bortezomib | Peripheral neuropathy risk; additive neurotoxicity with other neurotoxic agents | Monitor for neuropathy symptoms; refer to bortezomib prescribing information |
Because SARCLISA is always used in combination therapy, it is essential that your oncologist reviews all your current medications before starting treatment. The interactions listed above relate primarily to the companion drugs rather than isatuximab itself, but the overall treatment regimen requires careful consideration of potential drug interactions to optimize safety and efficacy.
Before receiving your first dose of SARCLISA, a blood typing and screening test should be performed. Always inform blood bank staff and any healthcare provider performing blood compatibility testing that you are being treated with SARCLISA. The interference with indirect antiglobulin tests (indirect Coombs test) may last for at least 6 months after your last dose, making it important to carry a treatment card or inform healthcare providers even after completing therapy.
What Is the Correct Dosage of SARCLISA?
SARCLISA is always administered by a doctor or nurse as an intravenous infusion (drip into a vein). The dose is calculated based on your body weight. Your doctor will determine the appropriate dosing schedule based on the specific combination regimen being used and your response to treatment.
SARCLISA + Pomalidomide + Dexamethasone (Isa-Pd)
28-Day Treatment Cycles
Indication: Relapsed/refractory multiple myeloma (at least 2 prior therapies)
Dose: 10 mg/kg intravenously
Cycle 1: SARCLISA is given on Days 1, 8, 15, and 22 (weekly)
Cycle 2 and beyond: SARCLISA is given on Days 1 and 15 (every 2 weeks)
Treatment continues for as long as the disease is responding and side effects remain acceptable.
SARCLISA + Carfilzomib + Dexamethasone (Isa-Kd)
28-Day Treatment Cycles
Indication: Relapsed/refractory multiple myeloma (1–3 prior therapies)
Dose: 10 mg/kg intravenously
Cycle 1: SARCLISA is given on Days 1, 8, 15, and 22 (weekly)
Cycle 2 and beyond: SARCLISA is given on Days 1 and 15 (every 2 weeks)
Treatment continues for as long as the disease is responding and side effects remain acceptable.
SARCLISA + Bortezomib + Lenalidomide + Dexamethasone (Isa-VRd)
Transplant-Ineligible Patients
Indication: Newly diagnosed multiple myeloma (not eligible for autologous stem cell transplantation)
Dose: 10 mg/kg intravenously
Cycles 1–4 (42-day cycles): SARCLISA given on Days 1, 8, 15, 22, and 29 (Cycle 1), then Days 1, 15, and 29 (Cycles 2–4)
Cycles 5–17 (28-day cycles): SARCLISA given on Days 1 and 15
Cycle 18 onward (28-day cycles): SARCLISA given on Day 1 only (every 4 weeks)
Transplant-Eligible Patients
Indication: Newly diagnosed multiple myeloma (induction before transplant)
Dose: 10 mg/kg intravenously
Cycles 1–3 (42-day cycles): SARCLISA given on Days 1, 8, 15, 22, and 29 (Cycle 1), then Days 1, 15, and 29 (Cycles 2–3)
Your doctor will determine the duration of induction therapy prior to transplantation.
Pre-Medication Before Each Infusion
Before every SARCLISA infusion, you will receive the following pre-medications to reduce the risk of infusion-related reactions:
- Antihistamines: Medications to reduce allergic reactions
- Corticosteroids: Medications to reduce inflammation (note: dexamethasone, which is part of the treatment regimen, may serve as this pre-medication)
- Antipyretics: Medications to reduce pain and fever (such as paracetamol/acetaminophen)
Missed Dose
It is very important that you attend all scheduled treatment appointments on time. If you miss an appointment, contact your doctor or nurse to reschedule as soon as possible. Your medical team will determine how to adjust your treatment schedule accordingly.
Overdose
SARCLISA is administered by healthcare professionals in a controlled clinical setting, making accidental overdose extremely unlikely. In the unlikely event that too much SARCLISA is given, your doctor will monitor you closely and treat any side effects as they arise. There is no specific antidote for isatuximab overdose.
Children
SARCLISA is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy have not been established in pediatric patients, and multiple myeloma is exceedingly rare in this age group.
SARCLISA is always prepared and administered by trained healthcare professionals in a hospital or specialized infusion center. You will not self-administer this medication at home. Each infusion is carefully calculated based on your body weight, and infusion rates are adjusted to minimize the risk of reactions.
What Are the Side Effects of SARCLISA?
Like all medicines, SARCLISA can cause side effects, although not everyone experiences them. The side effect profile depends on which combination of drugs you are receiving. Your healthcare team will monitor you closely throughout treatment and manage side effects as they arise.
Infusion-Related Reactions
Infusion-related reactions are very common with SARCLISA (occurring in more than 1 in 10 patients) and most frequently occur during the first infusion. Serious reactions include high blood pressure (hypertension), breathing difficulties, and in rare cases, severe anaphylactic reactions (occurring in up to 1 in 100 patients) with difficulty breathing and swelling of the face, mouth, throat, lips, or tongue. The most commonly reported symptoms include breathing difficulties, cough, chills, and nausea. If you feel unwell during or after the infusion, tell your doctor or nurse immediately. They may slow the infusion rate, pause it, or stop it entirely, and may administer additional medications to manage the reaction.
Side Effects by Frequency
Very Common
May affect more than 1 in 10 people
- Infusion-related reactions (breathing difficulty, cough, chills, nausea)
- Decreased white blood cell count (neutropenia)
- Decreased platelet count (thrombocytopenia)
- Pneumonia (lung infection)
- Upper respiratory tract infection (e.g., nose, sinuses, throat)
- Diarrhea
- Bronchitis (inflammation of the airways)
- Nausea
- Vomiting
- High blood pressure (hypertension)
- Cough
- Fatigue and tiredness
- Decreased appetite
- COVID-19
- Cataracts (clouding of the eye lens)
- Breathing difficulties (dyspnea)
Common
May affect up to 1 in 10 people
- Heart problems (may cause difficulty breathing, cough, or swollen legs) – when SARCLISA is given with carfilzomib and dexamethasone
- Febrile neutropenia (fever with severe decrease in white blood cells)
- Anemia (low red blood cell count)
- Weight loss
- Irregular heartbeat (atrial fibrillation)
- Herpes zoster (shingles)
- Decreased lymphocyte count (low white blood cells important for immune function)
Rare / Serious Reactions
May affect up to 1 in 100 people
- Anaphylactic reaction (severe allergic reaction with difficulty breathing and swelling)
Important Monitoring
Your doctor will perform regular blood tests during treatment with SARCLISA to monitor your blood cell counts (white blood cells, red blood cells, and platelets). Based on these results, your doctor may delay treatment, adjust the dose, or prescribe supportive medications such as growth factors to increase white blood cell counts or antibiotics to prevent or treat infections.
Seek immediate medical attention if you develop: fever or signs of infection; severe difficulty breathing; chest pain or irregular heartbeat; unusual bleeding or bruising; confusion, seizures, or decreased urination (possible tumor lysis syndrome); or any symptoms that concern you during or after an infusion.
If you experience any side effects, including those not listed here, tell your doctor, pharmacist, or nurse. You can also report suspected side effects to your national pharmacovigilance authority (e.g., the EMA in Europe, the FDA MedWatch program in the United States, or the MHRA Yellow Card Scheme in the United Kingdom) to contribute to the ongoing safety monitoring of SARCLISA.
How Should SARCLISA Be Stored?
SARCLISA is stored at the hospital or clinic where you receive your treatment. You will not typically need to handle storage yourself. The following storage requirements apply:
- Unopened vials: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze.
- Light protection: Keep vials in the original carton to protect from light.
- Expiry date: Do not use after the expiry date stated on the carton and vial after “EXP.” The expiry date refers to the last day of that month.
- Prepared infusion solution: Should be used immediately. If not used immediately, the diluted solution may be stored at 2°C to 8°C for up to 24 hours, provided preparation was performed under controlled aseptic conditions. The diluted solution does not need to be protected from light at room temperature.
- Disposal: Unused medicine should not be disposed of via wastewater or household waste. Your healthcare team will ensure proper disposal according to local guidelines.
Keep all medicines out of the sight and reach of children. SARCLISA vials are for single use only and must be discarded after each use.
What Does SARCLISA Contain?
Active Substance
The active substance is isatuximab. Each milliliter of concentrate contains 20 mg of isatuximab.
- 5 mL vial: Contains 100 mg of isatuximab
- 25 mL vial: Contains 500 mg of isatuximab
More than one vial may be needed for each dose, as the amount of SARCLISA required is calculated based on your body weight (10 mg/kg).
Inactive Ingredients (Excipients)
- Sucrose
- Histidine hydrochloride monohydrate
- Histidine
- Polysorbate 80
- Water for injections
Appearance and Pack Sizes
SARCLISA is a concentrate for solution for infusion. It is a colorless to slightly yellowish liquid that is essentially free from visible particles. Before administration, the concentrate must be diluted in a 250 mL infusion bag containing 0.9% sodium chloride solution or 5% glucose solution. The diluted solution is then infused intravenously through an infusion set with an in-line 0.22-micrometer filter.
- 100 mg/5 mL: Available as single vials or packs of 3 vials
- 500 mg/25 mL: Available as single vials
Not all pack sizes may be marketed in all countries.
Manufacturer
SARCLISA is manufactured by Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany. The marketing authorization holder is Sanofi Winthrop Industrie, Gentilly, France.
Frequently Asked Questions About SARCLISA
SARCLISA (isatuximab) is used to treat multiple myeloma, a cancer of the plasma cells in the bone marrow. It is not used alone but always in combination with other anticancer medications. Approved combinations include isatuximab with pomalidomide and dexamethasone (for patients who have received at least two prior treatments), with carfilzomib and dexamethasone (for patients who have received one to three prior treatments), and with bortezomib, lenalidomide, and dexamethasone (for newly diagnosed patients who are not eligible for or are eligible for autologous stem cell transplantation).
SARCLISA is given as an intravenous infusion (drip) in a hospital or infusion center by a healthcare professional. The first infusion typically takes longer due to a slower starting rate and is usually administered over several hours. Subsequent infusions can generally be administered more quickly once tolerance has been established. You will be monitored during and after each infusion for potential reactions. Pre-medications are given before every infusion to reduce the risk of infusion-related reactions.
Yes, SARCLISA can interfere with blood compatibility testing. Because isatuximab binds to the CD38 protein, which is present on red blood cells, it can cause false-positive results in the indirect antiglobulin test (indirect Coombs test) used for blood cross-matching. This does not affect your actual blood type (ABO/Rh). It is essential to inform your blood bank and any healthcare provider performing blood tests that you are receiving SARCLISA. Blood typing and screening should be performed before starting treatment. The interference can persist for at least 6 months after your last dose.
Both SARCLISA (isatuximab) and daratumumab (Darzalex) are monoclonal antibodies that target the CD38 protein on myeloma cells, but they bind to different regions (epitopes) of the CD38 molecule. Isatuximab has been shown to directly induce apoptosis (programmed cell death) in myeloma cells without the need for cross-linking, which is a distinguishing feature of its mechanism. The two drugs are approved for different combination regimens and patient populations. They are generally not used interchangeably, and the choice between them depends on the specific clinical situation, prior treatments received, and the treating oncologist’s assessment.
SARCLISA has demonstrated significant clinical efficacy across multiple trials. In the ICARIA-MM trial, adding SARCLISA to pomalidomide and dexamethasone nearly doubled median progression-free survival (11.5 months vs. 6.5 months). The IKEMA trial showed that SARCLISA plus carfilzomib and dexamethasone significantly improved progression-free survival compared with carfilzomib and dexamethasone alone, with a notably higher rate of deep responses (MRD negativity). In the IMROZ trial for newly diagnosed transplant-ineligible patients, the four-drug Isa-VRd combination significantly reduced the risk of disease progression or death compared with VRd alone.
SARCLISA is not recommended during pregnancy. IgG1 antibodies are known to cross the placenta, and the potential risk to the unborn child cannot be excluded. Women of childbearing potential must use effective contraception during treatment and for 5 months after the last dose. Additionally, the companion drugs used with SARCLISA – particularly pomalidomide and lenalidomide – are known teratogens (cause birth defects) and have their own strict pregnancy prevention programs. If you are pregnant or think you may become pregnant, discuss this with your doctor before starting treatment.
References
- European Medicines Agency (EMA). SARCLISA (isatuximab) – Summary of Product Characteristics. Last updated 2025. Available from: EMA EPAR.
- U.S. Food and Drug Administration (FDA). SARCLISA (isatuximab-irfc) Prescribing Information. Revised 2024. Available from: FDA Drug Label.
- Attal M, Richardson PG, Rajkumar SV, et al. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019;394(10214):2096–2107. doi:10.1016/S0140-6736(19)32556-5.
- Moreau P, Dimopoulos MA, Mikhael J, et al. Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial. Lancet. 2021;397(10292):2361–2371. doi:10.1016/S0140-6736(21)00592-4.
- Facon T, Dimopoulos MA, Maisnar V, et al. Isatuximab plus bortezomib, lenalidomide, and dexamethasone versus bortezomib, lenalidomide, and dexamethasone in newly diagnosed multiple myeloma (IMROZ): a randomised, open-label, phase 3 study. Lancet. 2024;404(10457):1099–1113.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Multiple Myeloma. Version 3.2025.
- Dimopoulos MA, Moreau P, Terpos E, et al. Multiple myeloma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2024;35(5):446–462.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023.
- Martin T, Dimopoulos MA, Mikhael J, et al. Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma: updated results from IKEMA. Blood. 2023;141(18):2168–2179.
- Richardson PG, Perrot A, San-Miguel J, et al. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in relapsed/refractory multiple myeloma: ICARIA-MM updated overall survival analysis. Haematologica. 2023;108(8):2171–2180.
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