Understanding ABECMA® (idecabtagene vicleucel)
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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 the drug Abecma® (also known by its generic drug name, idecabtagene vicleucel or “ide-cel” for short). Abecma was approved by the U.S. Food and Drug Administration (FDA) in March 2021 for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM).
Immunotherapy
The immune system is comprised of a complex network of cells, tissues, organs, and the substances they make. The immune system involves multiple mechanisms that work together to protect and defend the human body from external threats (e.g., bacteria, viruses, toxins) and from internal threats such as cancer. The immune system helps to destroy infected and diseased cells and to remove cellular debris while protecting healthy cells.
Myeloma interferes with the normal function of the body’s immune system. Designed to protect us from harm, the immune system is very complex. To learn more about the immune system in the context of myeloma, read the IMF’s publication Understanding the Immune System in Myeloma.
Immunotherapy is treatment that enhances the body’s natural defenses to protect us from harm. Abecma is a type of immunotherapy, a personalized chimeric antigen receptor (CAR) T-cell therapy that is manufactured for each individual patient using the patient’s own T cells, and is delivered as a one-time infusion.
T cells (T lymphocytes) are a type of white blood cell. T cells are an important part of our immune system by helping the body fight infection and disease. T cells can be distinguished from other white blood cells by the presence of a T-cell receptor (TCR) on the cell surface. T cells can recognize and bind to specific antigens, thereby triggering an immune response.
T cells can recognize myeloma cells as foreign and cancerous. However, as myeloma grows, the number of T cells is significantly reduced and their function blocked, thus allowing the myeloma to continue to grow. What is needed are T cells which recognize myeloma cells as foreign and are capable of destroying them.
Indications for the use of Abecma
In March 2021, Abecma became the first-in-class B-cell maturation antigen (BCMA) -directed CAR T-cell therapy approved by the FDA for the treatment of adult patients with RRMM after 4 or more prior lines of therapy, including an immunomodulatory agent , a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Abecma is the first CAR T-cell therapy for myeloma to be approved by the FDA, and it is the first to target BCMA.
In April 2024, the FDA approved Abecma for the treatment of RRMM after 2 or more prior lines of therapy. This approval is based on data from the KarMMa-3 phase III clinical trial, which demonstrated a progression-free survival (PFS) of roughly 13 months in the Abecma arm of the study vs. 4 months in the control arm with standard regimens. This new FDA approval expands the previous indication, making this important CAR T-cell therapy available to patients earlier in their treatment journey.
How Abecma works
CAR T-cell therapy with Abecma takes the patient’s own T cells and engineers them to identify the B-cell maturation antigen (BCMA) receptor on the surface of myeloma cells, bind to this receptor, and destroy the myeloma cells.
BCMA is a protein involved in myeloma cell growth and survival. BCMA is found on the surface of nearly all cells in patients with myeloma, both on myeloma cells and on healthy cells as well. BCMA is also known as tumor necrosis factor receptor superfamily member 17 (TNFRSF17).
Collection
The patient’s own T cells are collected by a procedure called apheresis, sometimes also called leukapheresis. Apheresis is a procedure whereby whole blood is taken from the patient, then passed through a machine that separates the blood into its individual components so that one particular component can be collected. The remaining blood components are then immediately re-infused back into the bloodstream of the patient. This is similar to how a patient’s own stem cells may be collected for an autologous transplant.
Manufacturing
The harvested T cells are sent to a highly specialized manufacturing laboratory to be engineered to attack the myeloma. The laboratory inserts a gene into the patient’s T cells, genetically modifying the T-cells to recognize and attach to BCMA. This creates the Abecma BCMA T-cell product that is unique to the patient.
The patient’s genetically engineered T cells are grown in the lab until millions of cells have multiplied, enough active T cells for the therapy to be effective. This process usually takes approximately 4 weeks.
Preparation
Approximately 5 days before the CAR T cells are reinfused, the patient begins a 3-day, low-dose chemotherapy regimen in order to prepare the body to more easily receive the CAR T cells.
Infusion
Approximately 4 weeks after the initial T-cell collection, the Abecma BCMA T-cell product is administered to the patient by way of an infusion through an intravenous (IV) catheter. The Abecma dose can be administered in one or more infusion bags, with up to 30 minutes for each infusion bag.
The infused CAR T cells immediately begin to seek out the myeloma cells in the body and attack them. As a precaution, due to the specialized nature of T-cell therapy and the possibility of side effects during this process, many
patients are admitted to the hospital for about a week. Abecma must be administered at a certified treatment center.
Activation
Abecma recognizes and binds to BCMA on myeloma cells, leading to the destruction of BCMA-expressing myeloma cells. The CAR T cells become activated and begin to directly destroy the cell and also to engage other parts of the immune system to help.
Monitoring
Monitoring ensures that the Abecma treatment is working and helps with identifying any potential side effects. For at least 7 days after receiving the infusion of Abecma, the patient is monitored daily at the certified healthcare facility where the treatment was administered.
For at least 4 weeks after the infusion of Abecma, the patient should remain within 2 hours travel to the certified healthcare facility where the treatment was administered. This is the approximate timeline of treatment with Abecma, but every patient is different and the total time it takes to complete the process may vary.
Effects on ability to drive and operate machinery
For at least 8 weeks following the Abecma infusion, you may be at risk for temporary memory and coordination problems, sleepiness, confusion, dizziness, and seizures. Don’t drive, operate heavy machinery, or engage in any activities that could be dangerous or hazardous if you are not mentally alert. Be sure to discuss with your healthcare team any potential issues that you may be experiencing.
Important safety information
Treatment with Abecma may cause side effects that are severe or lifethreatening. Immediately contact your doctor or get emergency medical help if you experience any of the following:
¡ difficulty breathing,
¡ fever of 100.4°F/38°C or higher,
¡ chills or shivering,
¡ confusion,
¡ dizziness or lightheadedness,
¡ shaking or twitching (tremors),
¡ fast or irregular heartbeat,
¡ severe fatigue,
¡ severe nausea, vomiting, or diarrhea.
If you have been treated with Abecma, do not donate blood, organs, tissues, or cells for transplantation.
Treatment with Abecma may cause a false-positive human immunodeficiency virus (HIV) test result by some commercial tests.
Patients treated with Abecma may develop secondary malignancies and should be monitored life-long.
Possible side effects of Abecma
The safety profile of Abecma is generally predictable, with side effects that are mostly low-grade, with early onset and resolution.
Tell your doctor immediately if you develop any of these or other symptoms after receiving Abecma. The side effects that occurred in 20% or more patients in the clinical trial include CRS, infections, fatigue, musculoskeletal pain, hypogammaglobulinemia, diarrhea, upper respiratory tract infection, nausea, viral infections, encephalopathy (disease in which the functioning of the brain is affected), edema, fever, cough, headache, and decreased appetite. These are the most common of the possible side effects of Abecma.
Cytokine Release Syndrome (CRS)
Cytokines are proteins that circulate in the bloodstream, usually in response to infection. Cytokines can stimulate or inhibit the growth or activity in other cells.
Cytokine release syndrome (CRS) is a potentially fatal, uncontrolled immune reaction in which cytokines become highly elevated and trigger an overwhelming immune system response. A cytokine “storm” can seriously damage body tissues and organs. The CRS toxicity is a result of the active destruction of the myeloma cells by the BCMA-targeted T cells.
Symptoms of CRS, which can be severe or fatal, may include fever, difficulty breathing, dizziness or lightheadedness, nausea, headache, fast heartbeat, low blood pressure, or fatigue. Immediately tell your doctor if you develop any of these symptoms or if you experience any other potential side effects of Abecma.
In patients treated with Abecma in the KarMMa clinical trial, CRS of any grade occurred in 85% of patients using the Lee grading system. The median time to onset of CRS was 1 day after the infusion, and the median duration of CRS was 7 days.
Other Side Effects
Abecma can lower one or more types of your blood cells, which may make you feel weak or tired, or increase your risk of severe infection or bleeding.
Abecma can increase the risk of life-threatening infections that may lead to death. Tell your doctor immediately if you develop a fever, are feeling tired, or have bruising or bleeding.
Abecma in clinical trials
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 cancer, 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.
At this time, there are numerous ongoing clinical trials for patients with myeloma, including studies with Abecma, 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.
The U.S. government maintains a database of research studies at clinicaltrials.gov. However, the government does not review the safety and science of the studies submitted to this website.
For more information about what’s involved in study participation, read the IMF’s publication Understanding Clinical Trials in Myeloma.
Access and support
If you are receiving Abecma, you can choose to enroll in the Cell Therapy 360 Patient Support Program and Copay Assistance Program. For more information, visit Abecma.com or call 1.888.805.4555. Abecma is administered only at certified treatment centers through a Risk Evaluation and Mitigation Strategy (REMS) 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 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.