Understanding TALVEY™ (talquetamab-tgvs) by International Myeloma Foundation

Multiple Myeloma | Cancer of the Bone Marrow

Understanding

TALVEY

™

(talquetamab-tgvs)

November 2023 Edition A publication of the International Myeloma Foundation

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.

RESEARCH 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 nearly 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.

EDUCATION 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.

SUPPORT 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.

ADVOCACY 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

What you will learn from this booklet

Who is a candidate for Talvey

How Talvey works

Clinical trial experience with Talvey

Important safety information

Possible common side effects of Talvey

In closing

Terms and definitions

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 Figure 1. Myeloma cells doctor, it is important and helpful to learn in the bone marrow about myeloma, as well as its treatment options and supportive care measures. The information in this booklet can guide you in your discussions with your doctor. It is not intended to be a substitute for medical advice. Your doctor is best able to answer questions about your specific healthcare management plan. The IMF’s Understanding-series publications address treatments and supportive care measures for myeloma. 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. The IMF’s publication Understanding Myeloma Vocabulary, a more complete myeloma-related compilation, is located online at glossary.myeloma.org. All IMF publications are free-of-charge and can be downloaded or requested in printed form at publications.myeloma.org. If you are reading this booklet in electronic format, the light blue links will take you to the corresponding resources. 4

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Who is a candidate for Talvey Talvey™ (also known as talquetamab-tgvs, the generic drug name) was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on August 9, 2023. Talvey is indicated for 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.

How Talvey works Talvey employs a patient’s own immune system to fight their myeloma. Talvey is a bispecific antibody, an artificial antibody that binds to two (“bi”) targeted cells. Talvey is the first bispecific antibody approved by the FDA that targets G protein–coupled receptor, class C, group 5, member D (GPRC5D) and cluster of differentiation 3 (CD3) protein complex. Talvey has two “arms,” one arm attaching to the myeloma cell through the GPRC5D on the cell surface and one arm attaching to CD3 on the surface of a local T cell (T lymphocyte) and activating that T cell to destroy the myeloma cell. GPRC5D has been identified as an immunotherapeutic target in myeloma treatment; it is overexpressed on myeloma cells but has limited expression on normal hematopoietic cells, such as B cells (B lymphocytes) and bone marrow progenitor cells (which can differentiate into specific cell types). The CD3 protein complex is involved in activating the T cell to release cytotoxic granules that kill the myeloma cell. Figure 2. Talvey mechanism of action

Talvey binds to CD3 on the surface of the T cell

TALVEYTM (talquetamab-tgvs)

CD3

Talvey binds to GPRC5D on the myeloma cell surface GPRC5D tumor-specific surface antigens

T cell myeloma cell

Talvey activates the T cell to release cytotoxic granules that kill the myeloma cell

myeloma.org

Clinical trial experience with Talvey

Talvey received accelerated approval from the FDA based on the response rate and durability of response data from the open-label, single-arm, phase I/II MonumenTAL-1 clinical trial of Talvey in patients with RRMM. The goal of conducting myeloma clinical trials is to improve patient care by determining if a new drug or treatment is more effective and/or has fewer or less harmful side effects than existing treatments. A clinical trial is a medical research study undertaken only after laboratory studies have demonstrated the potential of a new drug to work better than existing methods, and also have outlined the potential safety. Clinical trial participants are people who volunteer to test scientific approaches to a new treatment or a new combination therapy. The MonumenTAL-1 study demonstrated an overall response rate (ORR) of more than 71% with weekly and every-other-week dosing of Talvey in patients with RRMM. Nearly 75% of patients were refractory to 5 drugs prior to being treated with Talvey. However, at this time, it is too early to estimate the duration of response (DOR). Myeloma patients treated with Talvey report sustained clinically meaningful improvements in quality of life, consistent with outcomes in the MonumenTAL-1 study.

Important safety information

Your doctor will decide how many treatments with Talvey you will receive, the number of days between your doses of Talvey, as well as any medicines you may receive to help reduce your risk of side effects. Due to the potential risks of Talvey, you may be hospitalized for 48 hours after all doses that are part of your “step-up dosing schedule” (when you receive the first 2 or 3 smaller “step-up” doses), and also the first full treatment dose. Step-up doses are used to mitigate risk of potential side effects. 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), and Grade 4 (symptoms requiring urgent intervention). In the MonumenTAL-1 study, GPRC5D-associated side effects were shown to be clinically manageable with appropriate identification, monitoring, and treatment.

Cytokine Release Syndrome (CRS) CRS is a potentially severe or fatal uncontrolled immune reaction in which cytokines become highly elevated and trigger an overwhelming immune system response that can damage body tissues and organs. 6

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In the MonumenTAL-1 study, CRS occurred in 76% of patients who received Talvey at the recommended dosages, with Grade 1 CRS occurring in 57% of patients, Grade 2 in 17%, and Grade 3 in 1.5%. Recurrent CRS occurred in 30% of patients. Most events occurred following step-up dose 1 (29%) or step-up dose 2 (44%) at the recommended dosages. CRS occurred in 33% of patients with step-up dose 3 in the biweekly dosing schedule. CRS occurred in 30% of patients with the first 0.4 mg/kg treatment dose and in 12% of patients treated with the first 0.8 mg/kg treatment dose. The CRS rate for both dosing schedules combined was less than 3% for each of the remaining doses in Cycle 1 and less than 3% cumulatively from Cycle 2 onward. The median time to onset of CRS was 27 hours from the last dose, and the median duration was 17 hours.

Immune effector cell-associated neurotoxicity syndrome (ICANS) ICANS can occur in the days or weeks after the administration of immunotherapy, especially immune effector cell (IEC) and T-cell therapies. Neurotoxicity (also known as neurologic toxicity) occurs when exposure to toxic substances changes the normal activity of the nervous system. In the MonumenTAL-1 study, neurologic toxicity occurred in 55% of patients who received Talvey at the recommended dosages, with Grade 3 or 4 neurologic toxicity occurring in 6% of patients. The most frequent neurologic toxicities were headache (20%), encephalopathy (15%), sensory neuropathy (14%), and motor dysfunction (10%). ICANS was reported in 9% of 265 patients who received Talvey at the recommended dosages in phase II of the MonumenTAL-1 study. Recurrent ICANS occurred in 3% of patients. Most patients experienced ICANS following step-up dose 1 (3%), step-up dose 2 (3%), step-up dose 3 of the biweekly dosing schedule (1.8%), or the initial treatment dose of the weekly dosing schedule (2.6%) or the biweekly dosing schedule (3.7%). The median time to onset of ICANS was 2.5 days after the most recent dose with a median duration of 2 days. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS.

Infections The incidence of severe infections was lower with Talvey when compared to treatments that target B-cell maturation antigen (BCMA). Preventive measures and management strategies are consistent with non-BCMAdirected therapies for myeloma. In the MonumenTAL-1 study, serious infections occurred in 16% of patients, with fatal infections in 1.5% of patients. Grade 3 or 4 infections occurred in 17% of patients. The most common serious infections reported were bacterial infection (8%, including sepsis), and COVID-19 (2.7%). myeloma.org

Cytopenias Talvey can cause cytopenias, including neutropenia and thrombo cytopenia. In the MonumenTAL-1 study, Grade 3 or 4 decreased neutrophils occurred in 35% of patients, and Grade 3 or 4 decreased platelets occurred in 22% of patients who received Talvey. The median time to onset for Grade 3 or 4 neutropenia was 22 days, and the median time to resolution to Grade 2 or lower was 8 days. The median time to onset for Grade 3 or 4 thrombocytopenia was 12 days, and the median time to resolution to Grade 2 or lower was 10 days.

Hepatotoxicity Talvey can cause hepatotoxicity, which is defined as injury to the liver or impairment of liver function. In the MonumenTAL-1 study, elevated alanine aminotransferase (ALT) blood test results occurred in 33% of patients, with Grade 3 or 4 ALT elevation occurring in 2.7%. Elevated aspartate aminotransferase (AST) occurred in 31% of patients, with Grade 3 or 4 AST elevation occurring in 3.3%. Grade 3 or 4 elevations of total bilirubin occurred in 0.3% of patients. Liver enzyme elevation can occur with or without concurrent CRS. Bilirubin and liver enzymes should be tested at baseline and during treatment.

Embryo-fetal toxicity Exposure of an embryo or a fetus to Talvey may cause fetal harm when administered to a pregnant woman. Females of reproductive potential and males with female partners of reproductive potential must use effective contraception during treatment with Talvey and for 3 months after the last dose.

When to seek medical help Immediately alert your doctor or seek medical help if you develop any of the symptoms listed below or if you experience any other potential side effects of Talvey: ¡ Slow or difficulty thinking, ¡ Fever (100.4°F or higher), ¡ Seizures, ¡ Feeling anxious, ¡ Trouble speaking or writing, ¡ Dizziness or lightheadedness, ¡ Muscle weakness, ¡ Headache, ¡ Shaking (tremors), ¡ Chills, ¡ Fast heartbeat, ¡ Memory loss, ¡ Difficulty breathing, ¡ Numbness and tingling (feeling “pins and needles”), ¡ Feeling very sleepy with low energy, ¡ Burning, throbbing, or stabbing pain. ¡ Feeling confused or disoriented, ¡ Being less alert or aware, 8

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Talvey is available only through a Risk Evaluation and Mitigation Strategy (REMS). You will receive a Patient Wallet Card from your healthcare provider, which lists the signs and symptoms of CRS and neurologic problems. You must have the Patient Wallet Card with you at all times – show it to all of your healthcare providers.

Possible common side effects of Talvey

GPRC5D-related side effects also include oral, skin, and nail toxicities. Dentists, nutritionists, and dermatologists may be able to provide additional guidance about managing the side effects and to confirm if the side effects are related to treatment with Talvey. IMF Nurse Leadership Board (NLB) member Donna Catamero, ANP-BC, OCN®, CCRC (Mount Sinai Health System, New York) presented the poster “Practical Management of Patients with Relapsed/Refractory Multiple Myeloma Receiving Talquetamab” at the 2023 International Myeloma Society (IMS) meeting in Athens, Greece. Donna’s report is summarized below.

Oral toxicity Oral toxicity was managed with dose modifications in fewer than 9% of study patients, and treatment discontinuation in fewer than 2% of study patients. Oral side effects may persist over time, but severity was mostly Grade 1 or 2. The incidence of dysgeusia (a distortion of the sense of taste) was shown to be 71%–72%, dry mouth 27%–40%, and dysphagia (difficulty in swallowing) 24%–25%. Median time to onset of oral side effects was 15–29 days for most patients, median duration was 57–109 days for most patients, and resolution of oral side effects was achieved in 31%–73% cases.

Nutritional supportive measures and management Nutritional supportive measures and management may be required (e.g., food texture/flavor experimentation, increased hydration, artificial saliva spray, mouth rinse, dexamethasone mouthwash, anti-infection agents, and vitamin support) to restore interest in food. Patients should be monitored for weight loss, which may affect concurrent medications.

Skin-related toxicities Most skin-related toxicities can be managed with heavy moisturizers and hydration. Topical corticosteroids can be used to control inflammation, irritation, and redness. Oral corticosteroids may be used for severe events. Incidence of skin-related side effects in the study with rash and non-rash (exfoliation, dry skin, palmar-plantar erythrodysesthesia, and pruritis) was 30%–73%, and severity was mostly Grade 1 or 2. Median time to onset was 20 to 30 days for most patients, median duration was 26 to 39 days for most patients, and resolution of skin-related side effects was seen in 57%–88% of events. myeloma.org

Nail-related toxicities The incidence of nail-related side effects in the study was 54%–55% and included onycholysis, onychomadesis, onychoclasis, discoloration, disorder, dystrophy, and ridges. Severity was mostly Grade 1 or 2. Median time to onset was 68 to 69 days for most patients, median duration was 74 to 89 days for most patients, and resolution was seen in 26%–33% of events. Dose modification was needed in less than 1% of events, and there was no treatment discontinuation due to nail-related side effects. Comfortable shoes, soft socks, good hygiene, and treatment with moisturizers and/or topical corticosteroids may be considered.

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).” 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).” B cells (B lymphocytes): White blood cells that are part of the natural immune system. Some B cells develop into plasma cells in the bone marrow and are the source of antibodies. 10

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Baseline: The initial known data that is gathered and used for comparison with later data. Bone marrow: The soft, spongy tissue in the center of bones that produces white blood cells, red blood cells, and platelets. When myeloma is growing, myeloma cells build up in the bone marrow. 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. Cytokine: A protein that circulates in the bloodstream, usually in response to infection. Cytokines can stimulate or inhibit the growth or activity in other cells. Cytopenia: A condition in which there is a lower-than-normal number of red blood cells (anemia), white blood cells (leukopenia), or platelets (thrombocytopenia). Pancytopenia is a condition in which all of a person’s blood cell levels are low. 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.” Generic drug name: A brand name identifies a drug as property of the company that receives approval for it from a governmental regulatory agency, such as the U.S. Food and Drug Administration (FDA). After a drug goes “off patent,” other companies may make generic versions of the drug under a generic name that refers to the chemical makeup of a drug. 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. 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 immuno globulin 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. myeloma.org

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®).” 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.” 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.” 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 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. Neutropenia: A reduced level of neutrophils, a type of white blood cell necessary to combat bacterial infection. Having too few neutrophils can lead to infection. Fever is the most common sign of neutropenia. If you have a fever, you must get immediate medical attention. Overall response rate (ORR): In myeloma clinical trials, the percentage of patients whose monoclonal protein decreased by at least 50% in response to treatment. 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. 12

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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. 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). T cell (T lymphocyte): A type of white blood cell that plays a central role in the immune system. T cells can be distinguished from other lymphocytes, such as B cells and natural killer (NK) cells, by the presence of a T-cell receptor (TCR) on the cell surface. They are called T cells because they mature in the thymus, although some also mature in the tonsils. Thrombocytopenia: 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 of platelets varies from laboratory to laboratory. For example, at Mayo Clinic the “normal” level is 150,000 or more platelets per microliter of circulating blood. Bleeding problems could occur if the count is less than 50,000 platelets. Major bleeding is usually associated with a reduction to less than 10,000 platelets. myeloma.org

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Connect. Be Informed. Take Charge. INTERACTIVE RESOURCES AT A GLANCE Use the hyperlinks and web addresses included in this publication for quick access to resources from the IMF.

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

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

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

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

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

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

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! /myeloma

@IMFMyeloma

Telephone: 1.800.452.CURE (USA & Canada) 1.818.487.7455 (worldwide) Fax: 1.818.487.7454 TheIMF@myeloma.org myeloma.org u-talv_EN_2023_a1-01

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