Understanding Elrexfio

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April 2024 Edition A publication of the International Myeloma Foundation Multiple Myeloma | Cancer of the Bone Marrow
Understanding ELREXFIO™ (elranatamab-bcmm)

Founded in 1990, the International Myeloma Foundation (IMF) is the first and largest organization focusing specifically on myeloma. The IMF’s reach extends to more than 525,000 members in 140 countries. The IMF is dedicated to improving the quality of life of myeloma patients while working toward prevention and a cure through our four founding principles: Research, Education, Support, and Advocacy.


The IMF is dedicated to finding a cure for myeloma, and we have a range of initiatives to make this happen. The International Myeloma Working Group, which emerged from the IMF’s Scientific Advisory Board established in 1995, is the most prestigious organization with more than 300 myeloma researchers conducting collaborative research to improve outcomes for patients while providing critically appraised consensus guidelines that are followed around the world. Our Black Swan Research Initiative® is bridging the gap from long-term remission to cure. Our annual Brian D. Novis Research Grant Program is supporting the most promising projects by junior and senior investigators. Our Nurse Leadership Board, comprised of nurses from leading myeloma treatment centers, develops recommendations for the nursing care of myeloma patients.


The IMF’s webinars, seminars, and workshops provide up-to-date information presented by leading myeloma scientists and clinicians directly to patients and their families. We have a library of more than 100 publications for patients, care partners, and healthcare professionals. IMF publications are always free-of-charge, and available in English and select other languages.


The IMF InfoLine responds to your myeloma-related questions and concerns via phone and email, providing the most accurate information in a caring and compassionate manner. We also sustain a network of myeloma support groups, training hundreds of dedicated patients, care partners, and nurses who volunteer to lead these groups in their communities.


We empower thousands of individuals who make a positive impact each year on issues critical to the myeloma community. In the U.S., we lead coalitions to represent the interests of the myeloma community at both federal and state levels. Outside the U.S., the IMF’s Global Myeloma Action Network works to help patients gain access to treatment.

Learn more about the ways the IMF is helping to improve the quality of life of myeloma patients while working toward prevention and a cure. Call us at 1.818.487.7455 or 1.800.452.CURE, or visit myeloma.org .

Contents You are not alone 4 What you will learn from this booklet 4 How Elrexfio works 5 Indications for treatment with Elrexfio 6 Clinical trial experience with Elrexfio 6 Elrexfio administration, dosing, and schedule 6 Warnings and precautions 7 Other potential side effects of Elrexfio 10 Access and support 10 In closing 10 Terms and definitions 10

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.

We achieve this through 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, which consistently provides the most up-to-date and accurate information about myeloma in a caring and compassionate manner. Contact the IMF InfoLine at 1.818.487.7455 or InfoLine@myeloma.org.

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 with your doctor, it is important and helpful to learn about myeloma, as well as its treatment options and supportive care measures.

The IMF’s Understanding-series publications address treatments for myeloma, supportive care measures, and the tests that are used to diagnose, monitor, and assess disease status throughout its course.

This booklet discusses Elrexfio™ (elranatamab-bcmm), a B-cell maturation antigen (BCMA) -directed CD3 T-cell engager. On August 14, 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Elrexfio for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent , and an anti-CD38 monoclonal antibody.

If you are newly diagnosed with myeloma, we suggest that you read the IMF’s publication Patient Handbook for the Newly Diagnosed, which will help you to better understand this complex disease.

To learn about myeloma in later disease settings, read the IMF’s publication Concise Review of Relapsed and Refractory Myeloma.

Words in bold+blue type are explained in the “Terms and definitions” section at the end of this booklet. A more comprehensive glossary can be found in the IMF’s publication Understanding Myeloma Vocabulary located online at glossary.myeloma.org.

If you are reading this booklet in electronic format, the light blue links will take you to the corresponding resources. All IMF publications are free-of-charge and can be downloaded or requested in printed format at publications.myeloma.org.

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How Elrexfio works

Elrexfio is an immunotherapy that employs a patient’s own immune system to attack their myeloma cells. Elrexfio is a bispecific antibody, an artificial antibody that binds to two (“bi”) targeted cells. The term “bispecific” means that the drug has 2 “arms,” with one arm attaching to the myeloma cell through the BCMA tumor-specific antigen on the cell surface and the other arm attaching to and activating a local T cell (T lymphocyte) by its CD3 antigen.

T cells are a type of white blood cell (WBC) that play a central role in the immune system. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on the cell surface. The CD3 protein complex is involved in activating the T cell to release cytotoxic granules that kill the myeloma cell. Elrexfio bridges the myeloma cell and the T cell, bringing them together so that the T cell can be activated to engage the myeloma cell and destroy it.

A similar strategy is already used in myeloma, known as chimeric antigen receptor (CAR) T-cell therapy, for which T cells are collected from a patient and then altered in a laboratory to express a receptor on their surface that can attach to BCMA on the surface of a myeloma cell. These engineered cells are multiplied in a laboratory and then reinfused into the patient to attack their myeloma cells.

The difference with Elrexfio is that there is no need to collect the patient’s T cells, which are instead engaged directly by infusing the Elrexfio into the patient. Not having to collect, engineer, and manufacture T cells over the course of several weeks shortens the time to treatment for the myeloma patient. This facilitates easier access to treatment as bispecific antibodies are given “off-the-shelf.”

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Figure 1. Elrexfio mechanism of action

Indications for treatment with Elrexfio

Elrexfio is used to treat myeloma patients who have already received at least 4 treatment regimens and their myeloma has come back or did not respond to prior treatment. This indication has received accelerated approval by the FDA based on clinical trial response rate and duration of response (DoR).

Clinical trial experience with Elrexfio

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.

In August 2023, the journal Nature Medicine published a manuscript with the clinical trial results from the phase II MagnetisMM-3 study. Elrexfio was shown to induce deep and durable responses with a manageable safety profile.

Heavily pretreated patients with relapsed or refractory myeloma, a high number of whom had poor prognostic features at baseline, were treated with Elrexfio by subcutaneous (SQ) injections at a dose of 76 mg once-weekly after a step-up priming dose regimen of 12 mg followed by 32 mg during the first week of treatment. After 6 cycles, persistent responders were switched to biweekly dosing (every 2 weeks). Patients in cohort A, who had not received prior BCMA-directed therapy, had an overall response rate (ORR) of 61%.

A complete response (CR) was achieved by 35% or more of patients, 50 patients were switched to biweekly dosing, and 40 patients improved or maintained their response for at least 6 months. With extended median follow-up of 17.6 months, which was presented at the annual meeting of the American Society of Hematology (ASH) in December 2023, median progression-free survival (PFS) was 17.2 months. Median DoR had not been reached; 18-month rate of DoR was 68.8% and duration of CR was 89.1%. The results reported from the phase II study are consistent with results reported from the MagnetisMM-1 phase I study.


administration, dosing, and schedule

Elrexfio is intended for SQ injections by a healthcare provider only.

The Elrexfio dosing schedule begins with 2 step-up doses in Week 1.

Approximately 1 hour prior to receiving Elrexfio, patients are premedicated for both step-up doses on Days 1 and 4, as well as for the first treatment dose on Day 8. Premedication includes:

¡ acetaminophen (or comparable) 650 mg by mouth,

¡ dexamethasone (or comparable) 20 mg by mouth or by intravenous (IV) infusion, and

¡ diphenhydramine (or comparable) 25 mg by mouth.

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*Patients are premedicated for step-up doses on Days 1 and 4, as well as for the first treatment dose on Day 8.

Elrexfio step-up dosing schedule is as follows:

¡ Day 1, step-up dose = 12 mg of Elrexfio

¡ Day 4, step-up dose = 32 mg of Elrexfio

¡ Day 8, first treatment dose = 76 mg of Elrexfio

Elrexfio is administered at the dose of 76 mg once weekly for 24 weeks, then once every 2 weeks at the same dose in patients who respond to treatment. Elrexfio is continued at 76 mg until disease progression or unacceptable toxicity.

Due to the risk of a potential side effect called cytokine release syndrome (CRS), which is discussed below, patients may be hospitalized for 48 hours after administration of the first step-up dose of Elrexfio on Day 1, and for 24 hours after administration of the second step-up dose of Elrexfio on Day 4. Alternatively, your doctor may decide to treat you on an outpatient basis.

Warnings and precautions

Elrexfio is available only through a Risk Evaluation and Mitigation Strategy (REMS) restricted program. 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.

All patients treated with Elrexfio will receive a Patient Wallet Card to remind them of the signs and symptoms of CRS and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and when to seek immediate medical attention. Patients should share this card with any healthcare provider who provides care to them to inform them of receipt of Elrexfio treatment and when to contact the patient’s myeloma doctor.

Cytokine release syndrome (CRS)

Cytokines are proteins secreted by cells which can stimulate or inhibit the growth or activity in other cells. In patients with myeloma, cytokines are

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Day Dose Step-up* 1 Dose 1 12 mg 4 Dose 2 32 mg 8 First treatment dose 76 mg Weekly One week after first treatment dose and weekly thereafter Subsequent treatment doses 76 mg
Table 1. Elrexfio dosing schedule

produced in the bone marrow and circulate in the bloodstream. Cytokines are normally released in response to hematologic-related events (low blood counts) and infection.

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. CRS is the most frequent side effect observed with T-cell therapies, but the incidence and severity of CRS are lower with bispecific antibodies than with CAR T-cell therapy.

Prevention and treatment of CRS

To reduce the risk of CRS, patients receive pretreatment medications. In addition, therapy with Elrexfio is started with the step-up dosing schedule. Patients are monitored following the administration of Elrexfio. At the first sign of CRS, immediate evaluation must be made to consider the patient for hospitalization. Supportive care is administered based on severity of CRS. Further management should follow current practice guidelines. Elrexfio administration may be interrupted or discontinued, depending on severity of CRS.

Neurologic toxicities

Immune effector cell-associated neurotoxicity syndrome (ICANS) has occurred in patients following treatment with Elrexfio. ICANS often correlates with CRS, but it can also occur in the absence of CRS. After treatment with Elrexfio, ICANS can occur before, during, or after CRS onset, or after CRS resolution. ICANS may be severe, life-threatening, or fatal. Symptoms of neurologic side effects include but are not limited to confusion, disorientation, loss of consciousness, seizures, tremor, slower movements, changes in personality, depression, tingling and numbness of hands and feet, leg and arm weakness, facial numbness, and difficulty speaking, reading, or writing.

Prevention and treatment of neurologic toxicities

Patients must be monitored for signs and symptoms of neurologic toxicity during treatment with Elrexfio. At the first sign of neurologic toxicity, including ICANS, patients are provided supportive therapy based on severity, and Elrexfio treatment may also be withheld.

Patients are advised to refrain from driving or operating heavy or potentially dangerous machinery during and for 48 hours after completion of Elrexfio step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until neurologic toxicity resolves.

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Elrexfio can cause severe, life-threatening, or fatal infections. Do not start treatment with Elrexfio if you have an active infection.

Prevention and treatment of infections

You must be monitored for signs and symptoms of infection prior to and during treatment with Elrexfio. It is essential that you promptly report any infection to your doctor. Anti-infectives (e.g., antibiotics, antivirals) may be instituted, and Elrexfio may be withheld or discontinued based on severity. Your immunoglobulin (Ig) levels should also be monitored to assess if you may need intravenous immunoglobulin (IVIG).


Elrexfio can cause neutropenia and febrile 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. Febrile neutropenia is the development of fever, often with signs of infection, in a patient with neutropenia. Febrile neutropenia is usually treated with antibiotics even if an infectious source can’t be identified.

Prevention and treatment of neutropenia

Complete blood counts (CBC) should be measured at baseline and monitored periodically during treatment. Fever is the most common sign of neutropenia. If you have a fever, you must get immediate medical attention.


Elrexfio can cause hepatotoxicity (liver damage). Elrexfio may elevate liver enzyme aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin. Liver enzyme elevation can occur with or without concurrent CRS.

Prevention and treatment of hepatotoxicity

Your doctor will measure your liver enzymes and bilirubin at baseline and monitor during treatment as clinically indicated. Elrexfio may be withheld or discontinued if necessary.

Embryo-fetal toxicity

Embryo-fetal toxicity is the exposure of an embryo or a fetus to a toxic substance. Elrexfio may cause fetal harm.

Prevention and treatment of embryo-fetal toxicity

Females of reproductive potential and males with female partners of reproductive potential should use effective contraception during treatment with Elrexfio. Ask your doctor if it is also necessary to use effective contraception before treatment begins and after the last dose of treatment is administered.

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Other potential side effects of Elrexfio

Other common side effects that occurred during treatment with Elrexfio in the MagnetisMM-3 clinical trial, having been absent before treatment, or side effects that worsened relative to the pretreatment state that were reported in the study were fatigue, injection site reaction, diarrhea, upper respiratory tract infection, musculoskeletal pain, pneumonia, decreased appetite, rash, cough, nausea, and fever.

In the MagnetisMM-3 clinical trial, the most common Grade 3 to 4 laboratory abnormalities that occurred in 30% or more of study patients were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased white blood cells, and decreased platelets.

Access and support

If you’ve been prescribed Elrexfio, you can receive one-on-one support from a Pfizer Patient Access Navigator during your treatment, including help navigating your insurance coverage and what your out-of-pocket costs may be, identifying potential resources for financial assistance, and coordinating with you to confirm logistics and providing appointment reminders. Visit elrexfio.com or contact the IMF InfoLine.

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 effective treatment with good quality of life, you must play an active role in your own medical care.

We encourage you to visit myeloma.org for more information about myeloma and to contact the IMF InfoLine with your myeloma-related questions and concerns. The IMF InfoLine consistently provides the most up-to-date and accurate information about myeloma in a caring and compassionate manner. Contact the IMF InfoLine at 1.818.487.7455 or InfoLine@myeloma.org.

Terms and definitions

The following selected terms are used in this booklet, while a more complete compendium of myeloma-related terms can be found in the IMF’s publication Understanding Myeloma Vocabulary located online at glossary.myeloma.org.

Antibody: A protein produced by plasma cells in response to an antigen that enters the body. See “ Immunoglobulin (Ig).”

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Antigen: Any foreign substance that causes the immune system to produce natural antibodies. Examples of antigens include bacteria, viruses, parasites, fungi, and toxins.

B-cell maturation antigen (BCMA): A protein involved in myeloma cell growth and survival. BCMA is found on the surface of cells in all patients with myeloma. Also called “tumor necrosis factor receptor superfamily member 17 (TNFRSF17).”

Baseline: The initial known data that is gathered and used for comparison with later data.

Cancer: A term for diseases in which malignant cells divide without control. Cancer cells can invade nearby tissues and spread through the bloodstream and lymphatic system to other parts of the body.

Chimeric antigen receptor (CAR) T-cell therapy: In myeloma, this immunotherapy involves collecting the patient’s T cells, and engineering them to attack the patient’s own cancer cells.

Complete blood count (CBC): Many cases of MGUS, SMM, and myeloma are identified as the result of this routine blood test, which quantifies all the cells that make up the solid parts of blood. The CBC is usually performed as part of an annual medical exam, and it is also one of the tests needed for diagnosing and monitoring patients with myeloma.

Duration of response (DoR): The length of time from onset of response to disease progression or death.

Frontline therapy: A general term for the initial treatment used in an effort to achieve response in a newly diagnosed myeloma patient. See “Induction therapy ” and “ Response or remission.”

Grade: The toxicity criteria adopted in the United States by the National Cancer Institute (NCI) for cancer clinical trials includes:

• Grade 0 – no symptoms,

• Grade 1 – mild symptoms,

• Grade 2 – moderate symptoms,

• Grade 3 – symptoms requiring treatment,

• Grade 4 – symptoms requiring urgent intervention,

• Grade 5 – symptoms resulting in death.

Hemoglobin: A protein in red blood cells that carries oxygen.

Immune system: A complex network of cells, tissues, organs, and the substances they make. The immune system helps the body defend itself by destroying infected and diseased cells and removing cellular debris, while protecting healthy cells.

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Immunoglobulin (Ig): A protein produced by plasma cells; an essential part of the body’s immune system. Immunoglobulins attach to foreign substances (antigens) and assist in destroying them. The classes (isotypes) of immunoglobulins are IgG, IgA, IgD, IgE, and IgM. Each type of immunoglobulin has a different function in the body. See “Antibody ” and “Antigen.”

• IgG, IgA – The two most common types of myeloma. The G and A refer to the immunoglobulin heavy chain produced by the myeloma cells.

• IgD, IgE – These types of myeloma occur less frequently.

• IgM – This is a rare type of myeloma. IgM myeloma is not the same as Waldenström macroglobulinemia.

Immunomodulatory agent: A drug that can modify, enhance, or suppress the functioning of the immune system. An immunomodulatory agent is sometimes called an “immunomodulatory drug (IMiD®).”

Immunotherapy: Treatment that enhances the body’s natural defenses to fight cancer.

Induction therapy: The initial treatment given to a patient in preparation for an autologous stem cell transplant (ASCT). See “ Frontline therapy ” and “ Line of therapy.”

Intravenous immunoglobulin (IVIG): A medical product that is made up of concentrated human antibodies collected from blood donated by thousands of people.

Intravenous (IV) infusion: Administered into a vein.

Line of therapy: A term used to calculate the number of therapies a patient has received. A line of therapy is 1 or more complete cycles of a regimen that can consist of a single agent, a combination of several drugs, or a planned sequential therapy of various regimens. Also see “ Induction therapy.”

Lymphocytes: B cells (B lymphocytes), T cells (T lymphocytes), and natural killer (NK) cells that together constitute 30% of white blood cells (WBC).

Median: The mean (middle) of two central numbers in a series of numbers. For example, “median progression-free survival (mPFS)” means that half the patients had remissions that were shorter and half the patients had remissions that were longer than the mPFS.

Monoclonal antibody: An antibody manufactured in a lab rather than produced in the human body. Monoclonal antibodies are specifically

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designed to find and bind to cancer cells and/or immune system cells for diagnostic or treatment purposes. Monoclonal antibodies can be used alone, or they can be used to deliver drugs, toxins, or radioactive material directly to tumor cells.

Multiple myeloma: A cancer of the bone marrow plasma cells, white blood cells that make antibodies. Cancerous plasma cells are called myeloma cells.

Platelets: One of the three major types of blood cells, the others being red blood cells and white blood cells. Platelets plug up breaks in the blood vessel walls and release substances that stimulate blood clot formation. Platelets are the major defense against bleeding. Also called thrombocytes.

Progression-free survival (PFS): The length of time during and after the treatment of myeloma that a patient lives with the disease but the myeloma does not get worse. In a clinical trial, PFS is one way to measure how well the treatment is working. See “ Progressive disease.”

Progressive disease: Myeloma that is becoming worse or relapsing, as documented by tests. Defined as an increase of ≥ 25% from the lowest confirmed response value in the myeloma protein level and/or new evidence of disease.

Proteasome: A joined group (“complex”) of enzymes (“proteases”) that break down the damaged or unwanted proteins in both normal cells and cancer cells into smaller components. Proteasomes also carry out the regulated breakdown of undamaged proteins in the cell, a process that is necessary for the control of many critical cellular functions. These smaller protein components are then used to create new proteins required by the cell. This is important for maintaining balance within the cell and for regulating cell growth.

Proteasome inhibitor: Any drug that interferes with the normal function of the proteasome. See “ Proteasome.”

Refractory: Disease that is no longer responsive to standard treatments. Myeloma is refractory in patients who have had progressive disease either during treatment or within 60 days following treatment. Most clinical trials for advanced disease are for patients with relapsed and/or refractory myeloma.

Relapse: The reappearance of signs and symptoms of myeloma after a period of improvement. Patients with relapsed disease have been treated, then developed signs and symptoms of myeloma at least 60 days after treatment ended. Most clinical trials for advanced myeloma are for patients with relapsed and/or refractory disease.

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Response or remission: Interchangeable terms to describe the complete or partial disappearance of the signs and symptoms of cancer.

• Stringent complete response (sCR) – sCR is CR (as defined below) plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.

• Complete response (CR) – For myeloma, CR is negative immunofixation on serum (blood) and urine, and disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow. CR is not the same as a cure.

• Very good partial response (VGPR) – VGPR is less than CR. VGPR is serum M-protein and urine M-protein detectable by immunofixation but not on electrophoresis, or 90% or greater reduction in serum M-protein, plus urine M-protein less than 100 mg per 24 hours.

• Partial response (PR) – PR is a level of response in which there is at least a 50% reduction in M-protein, and reduction in 24-hour urinary M-protein by at least 90% (or to less than 200 mg per 24 hours).

Side effect: An unwanted or unexpected effect caused by a drug. Also known as adverse reaction or adverse event (AE).

Subcutaneous (SQ) injection: A method of administering medication under the skin by a short needle that injects a drug into the tissue layer between skin and muscle.

White blood cells (WBC): General term for a variety of leukocytes responsible for fighting invading germs, infections, and allergy-causing agents. These cells begin their development in bone marrow and then travel to other parts of the body. Specific white blood cells include neutrophils, basophils, eosinophils, lymphocytes, and monocytes.

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Use the hyperlinks and web addresses included in this publication for quick access to resources from the IMF.

Contact the IMF InfoLine with your myeloma-related questions and concerns infoline.myeloma.org

Learn about FDA-approved therapies for myeloma medications.myeloma.org

Diversity and inclusion are integral aspects of the myeloma community diversity.myeloma.org


The latest on myeloma research and clinical practice, as well as IMF webinars and other events


Robin Tuohy rtuohy@myeloma.org will help you find a multiple myeloma support group

IMF booklets, tip cards, guides, and periodicals –subscribe to stay in the know! publications.myeloma.org

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. And engage with us on social media! Connect. Be Informed. Take Charge.

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