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Understanding Blenrep

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Understanding BLENREP®

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 living well with myeloma. Ask Myelo your questions at myeloma.org.

Join the Myeloma Knowledge Platform Visit myprofile.myeloma.org and create your online IMF account to receive the most helpful content recommendations tailored to support your personal myeloma experience.

You are not alone

The International Myeloma Foundation (IMF) is here to help you. We are 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 publications, seminars, webinars, workshops, and the IMF InfoLine.

The IMF InfoLine

The IMF InfoLine responds to your myeloma-related questions and concerns in a compassionate and caring manner. To receive the most up-to-date information about myeloma, call 1.818.487.7455, email InfoLine@myeloma.org, or schedule a convenient time to talk with an IMF InfoLine Coordinator at mmsm.link/infoline.

IMF publications

Myeloma is a cancer that is not known to most patients at the time of diagnosis. If you have been diagnosed with myeloma or if you suspect that you might have myeloma, the IMF can help you become well-informed about this disease so that you can have an active role in your own medical care and make good decisions about it in partnership with your doctor. We suggest that you read the IMF’s Patient Handbook, an introductory overview of myeloma diagnosis, effects on the body, risk stratification, treatment options, and key supportive care measures. The Patient Handbook will also direct you to other resources that may be helpful to you.

The IMF’s Understanding-series publications are intended to offer more detailed information about a broad range of myeloma-specific topics, including drugs and drug regimens, and the symptoms and side effects that can result from the myeloma itself and from its treatments.

All IMF publications are free-of-charge and can be read, downloaded, or requested in printed format at publications.myeloma.org. If you prefer to access any of the IMF’s publications or resources in electronic format, the light blue links will take you there.

Understanding myeloma vocabulary

Words in bold+blue in IMF publications are explained in a companion booklet, Understanding Myeloma Vocabulary. Myeloma is a complicated disease, but the language that describes it doesn’t have to be hard to understand. Being comfortable with myeloma-related terms is helpful to reading educational materials and to your discussions with your doctor. To read or download the electronic edition of Understanding Myeloma Vocabulary, visit glossary.myeloma.org.

What you will learn from this booklet

This booklet discusses Blenrep® (belantamab mafodotin-blmf), an antibodydrug conjugate (ADC) that is a combination of a monoclonal antibody and a chemotherapy agent. Blenrep is the first and only medication in the ADC drug class that has been approved by the FDA to treat myeloma.

You will learn how Blenrep works, who can be treated with Blenrep, clinical trial experience with Blenrep, how it is given, how to prevent or minimize potential side effects, and what assistance is available to patients who are receiving Blenrep.

How Blenrep works

Monoclonal antibodies are a type of immunotherapy. Manufactured in a lab rather than produced in the human body, the monoclonal antibody part of Blenrep is designed specifically to find and bind to the B-cell maturation antigen (BCMA) protein on the surface of myeloma cells.

Monoclonal antibodies can be used alone to treat myeloma. However, what is unique to Blenrep is that its monoclonal antibody is used to deliver a cytotoxic agent called monomethyl auristatin F (MMAF) directly to the myeloma cells, thereby killing the cancer cells.

Who can be treated with Blenrep

In October 2025, Blenrep received approval from the FDA for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least 2 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent .

Blenrep is indicated in combination with the proteasome inhibitor Velcade® (bortezomib) + the steroid dexamethasone. This treatment regimen is known

Figure 1. Blenrep (belantamab mafodotin-blmf) mechanism of action chemotherapy drug (mafodotin) monoclonal antibody (belantamab)

as BVd for short. For a more comprehensive discussion of the other two drugs that are part of this combination therapy, read these IMF publications:

¡ Understanding Dexamethasone in the Treatment of Myeloma

¡ Understanding VELCADE® (bortezomib)

Clinical trial experience with Blenrep

A clinical trial is a medical research study with people who volunteer to test scientific approaches for preventing, detecting, diagnosing, or treating cancer, or to answer scientific questions. A clinical trial is launched only after laboratory studies have demonstrated the potential of a treatment or procedure to be more effective and/or less harmful than previously existing methods. The goal of clinical trials is to improve patient care.

BVd vs. DVd

The DREAMM-7 study evaluated the efficacy of the BVd regimen in adult patients with RRMM who had received at least 1 prior line of therapy. Interestingly, the DREAMM-7 study compared two different triplet (3-drug) combination therapies: Blenrep vs. the monoclonal antibody Darzalex® (daratumumab) with the combination of Velcade + dexamethasone ( Vd) as the backbone. The study excluded patients who were refractory or intolerant of Velcade or Darzalex or had received prior BCMA-directed therapy.

As published in the New England Journal of Medicine in August 2024, a total of 494 participants in the DREAMM-7 study were randomly assigned to receive either BVd (243 patients) or DVd (251 patients). At a median follow-up of 28.2 months (range, 0.1 to 40.0), median progression-free survival (PFS) was 36.6 months in the BVd group and 13.4 months in the DVd group. Overall survival (OS) at 18 months was 84% in the BVd group and 73% in the DVd group. Remarkably, the data demonstrates a benefit for both PFS and OS.

Dose and schedule of Blenrep

Blenrep is given through an intravenous (IV) infusion on an outpatient basis at your doctor’s office or at a certified outpatient clinic. The length of time for the IV infusion varies from patient to patient and can be as short as 30 minutes. The recommended initial dosage of Blenrep is 2.5 mg/kg.

Blenrep is given every 3 weeks or on a schedule set by your doctor. The frequency of the dosing is often lengthened to reduce the risk of side effects, especially the risk of eye problems.

For the first 8 treatment Cycles, you will receive Blenrep in combination with Velcade and dexamethasone. After 8 Cycles, you will receive Blenrep alone, without Velcade and dexamethasone, until disease progression or unacceptable side effects.

Special precautions with Blenrep REMS

Blenrep is available only through a Risk Evaluation and Mitigation Strategy (REMS) restricted program because of the risk of eye problems. 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.

Before you can receive Blenrep, you must enroll in the Blenrep REMS program by completing the Patient Enrollment Form with your doctor. Ask your doctor about the risk of eye problems and the need for eye exams before and during treatment with Blenrep. Your doctor will give you the REMS Patient Guide that describes the risk of eye problems. For more information, visit blenreprems.com.

Eye problems

Eye problems are common during treatment with Blenrep, which can cause changes to the surface of the eye (cornea). Promptly report to your doctor if you experience worsening vision, blurred vision, dry eyes, sensitivity to light, eye irritation, eye pain, or eye infection. Cataract of the eye may also occur.

Prevention and treatment of eye problems

You will be required to have your eyes checked before you start treatment with Blenrep and before you receive each dose of Blenrep. Some eye problems can occur without you experiencing any symptoms, and some eye problems may be detectable only during an eye exam by an eye specialist (e.g., optometrist or ophthalmologist).

Your myeloma doctor may refer you to an eye specialist or you can find a qualified eye doctor in your area on the Blenrep website at blenrep.com/ find-eye-doctor/.

It is helpful to use “preservative-free” artificial tears, starting with your first infusion of Blenrep and continuing through your last infusion of Blenrep.

If you use contact lenses, ask the eye doctor if you need to switch to wearing glasses during treatment with Blenrep.

Potential vision changes mean that you must exercise caution if you need to drive a vehicle or operate machinery during treatment with Blenrep.

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 varies from laboratory to laboratory.

For example, at Mayo Clinic the “normal” level is at least 150,000 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. Blenrep may cause thrombocytopenia.

Prevention and treatment of thrombocytopenia

Promptly report to your doctor any bleeding or bruising that you may experience. Decrease in platelets with Blenrep can be severe. Your doctor will monitor your platelet counts at baseline and during treatment. Management of low platelet counts may include platelet transfusions or medication to stimulate the production of platelets.

Embryo-fetal toxicity

Females of reproductive potential and males with female partners of reproductive potential must use effective contraception during treatment with Blenrep, and for 6 months after the last dose of treatment. Ask your doctor which birth control methods to use. Due to the potential for harm in the breastfed child, lactating women should not breastfeed during treatment with Blenrep and for 3 months after the last dose of treatment.

Possible common side effects of Blenrep or BVd

A side effect is an unwanted or unexpected adverse reaction or adverse event (AE) caused by a drug. Common side effects are events that are experienced by 20% or more patients in a clinical trial. Side effects can be managed by your doctor with supportive care, dose reductions or interruptions, or permanent discontinuation of a drug or combination therapy.

It is always better to deal with a problem immediately rather than let it get worse. Promptly report to your doctor any new or worsening signs or symptoms. Good communication with your doctor is extremely important while you are receiving treatment for myeloma.

Upper respiratory tract infection

An upper respiratory tract infection may be a bacterial or a viral infection of the nose, throat, sinuses, or larynx. Possible respiratory infections include lung problems such as pneumonia (an infection in one or both lungs).

Prevention and treatment of upper respiratory tract infection

Promptly report your symptoms to your doctor. If your infection is serious and your white blood cell count is low, the doctor may pause your treatment until you recover or support you with medications to stimulate the production of new white blood cells.

Peripheral neuropathy

Peripheral neuropathy (PN) is a serious condition that affects nerves in the hands, feet, lower legs, and/or arms. Symptoms of PN may include a

feeling of numbness, tingling, burning, and/or pain. Myeloma patients may experience PN from the effects of the disease itself or from treatments for myeloma. Velcade is known to cause PN.

Prevention and treatment of PN

Velcade administered as a subcutaneous (SQ) injection under the skin causes significantly less PN than Velcade administered as an intravenous (IV) infusion into a vein. In a French clinical trial that compared Velcade SQ to Velcade IV, only 6% of the patients who received Velcade SQ had PN of Grade 3 or 4, while 16% of the patients who received Velcade IV had Grade 3 or 4 PN.

Diarrhea

Diarrhea is defined as 3 or more loose stools per day. Severe diarrhea is defined as 7 or more loose stools per day. Dizziness, lightheadedness, or fainting may occur due to dehydration caused by either excessive or persistent diarrhea.

Prevention and treatment of diarrhea

Precautions should be taken to prevent dehydration. Ask your doctor how you can maintain an adequate level of hydration. Contact your doctor if you experience dizziness, lightheadedness, or fainting. Your doctor may administer antidiarrheal medication or intravenous fluids on an outpatient basis or may recommend hospitalization if needed.

Fatigue

Fatigue that is commonly associated with cancer or with cancer treatments is different from and more severe than normal fatigue. It tends to last longer and includes the feeling of overall weakness (the medical term for this is asthenia).

Prevention and treatment of fatigue

Let your doctor know how you feel. Your doctor may prescribe medication to minimize your fatigue. The effects of fatigue may also be minimized by maintaining a moderate level of activity, a healthy diet with proper fluid intake, and a consistent sleeping schedule. Be sure to adhere to regularly scheduled visits with your doctor to monitor your red blood cell (RBC) count and to discuss factors that may contribute to your fatigue (e.g., side effects of any other medications you are taking). For more information, read the IMF’s publication Understanding Fatigue.

Liver problems

Your liver enzymes may become elevated during treatment with Blenrep. Severe liver injury is rare. Blenrep can cause the reactivation of the hepatitis B virus (HBV), so be sure to report any history of this infection to your doctor and ask about prevention strategies.

Prevention and treatment of liver problems

Your doctor will monitor your liver function with regular blood tests. Promptly alert your doctor if you experience yellowing of the skin or eyes (jaundice), dark urine, pain in the abdomen, fatigue, or nausea. Management of liver problems by your doctor may include dose reduction, or temporarily or permanently discontinuing the medication.

Patient assistance

The “Together with BLENREP” program is designed to support patients during treatment with Blenrep. A dedicated Nurse Navigator can help you with healthcare insurance and coverage information for treatment with Blenrep and for the eye exams required for Blenrep treatment, as well as with any insurance changes that may cause treatment interruption.

The Blenrep Copay Assistance Program may help with out-of-pocket medication costs for eligible patients with commercial insurance. The Blenrep Patient Assistance Program may offer this medicine at no cost to eligible patients. The GSK ViiV Healthcare Patient Access Programs Foundation, an independent non-profit organization separate from GSK, may help with information about third-party assistance for out-of-pocket costs.

Visit blenrep.com/support-resources/ for more information and to enroll in the “Together with BLENREP” program.

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 IMF’s 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 a variety of resources. Sign up at subscribe.myeloma.org for our quarterly journal Myeloma Today and weekly e-newsletter Myeloma Minute, as well as alerts about IMF news, events, and actions.

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: improving the quality of life of myeloma patients while working toward prevention and a cure. The IMF serves people affected by myeloma at every stage of the disease.

The IMF combines world-class research, trusted education, global advocacy, and direct support. A cornerstone of this work is the IMF International Myeloma Working Group® (IMWG®), comprised of more than 350 renowned researchers and clinicians who establish the guidelines that shape how myeloma is diagnosed, treated, and managed worldwide.

The IMF ensures that scientific advances translate into better care and outcomes. Through the IMF InfoLine, educational programs, a global network of support groups, the 24/7 generative-AI myeloma assistant Myelo®, and our advocacy for healthcare access, the IMF helps people living with myeloma and their care partners navigate diagnosis and survivorship.

The IMF is driven by its vision of a world where every myeloma patient can live life to the fullest, unburdened by the disease.

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