Myeloma Today - Winter 2023

Brian G.M Durie, MD International Myeloma Foundation

Linda Huguelet Patient Advocate Nick Lenoir Patient Advocate

Brian G.M Durie, MD M.-V. Mateos, MD, PhD Tom Martin, MD

A Message from the IMF Chairman & Chief Scientific Officer

Dear Reader,

Founded in 1990, the IMF is the first and largest organization focusing specifically on myeloma. Our reach extends to more than 525,000 members in 140 countries. The IMF works to improve the quality of life of myeloma patients while working toward prevention and a cure through our four founding principles: Research, Education, Support, and Advocacy.

This edition of Myeloma Today includes a report about the top myeloma research (see page 5) presented in December 2022 at the 64th Annual Meeting & Exposition of the American Society of Hematology (ASH). I would like to briefly touch on the work of the IMF in the area of myeloma research.

The IMF continues to have an impact in a complex myeloma landscape by addressing unmet needs. One of the many ways we do this is through the numerous guidelines produced by the IMF’s International Myeloma Working Group (IMWG). How is it possible to assess if one treatment is better than another unless you have standardized an accepted response? The IMWG response criteria was first published more than a decade ago, and it has since been updated to include the minimal residual disease (MRD) testing, which is now recognized as essential to assessing outcomes.

The IMWG has also published the diagnostic criteria for myeloma. All IMWG criteria are accepted by the U.S. Food and Drug Administration (FDA) and provide a standardized template to work with. If everyone is using different criteria, it’s very hard to compare each other’s data. The criteria are a foundation for collaboration in myeloma research. The IMF is actively collaborating on myeloma research throughout the world, such as with global clinical trials in the United States, Europe, and Asia.

An initial idea born in the spring of 2012 led to a scientific brainstorming meeting linked to the IMWG Summit held in June of that year, which focused on the question: “How Can We CURE Myeloma?” The answer: “Establish a new research project focused on both finding a cure and preventing myeloma in the first place.” The key concept of the Black Swan Research Initiative® (BSRI®) is to standardize precise and reproducible methods for assessment of the lowest levels of myeloma after best treatment.

The BSRI’s collaborative CURE clinical trials are bearing fruit. The CESAR clinical trial in Spain has been completed. The ASCENT clinical trial in the U.S. has completed enrollment. Understanding the onset of myeloma and early intervention are key to achieve best results and, eventually, a CURE.

The Iceland Screens Treats or Prevents Multiple Myeloma (iStopMM) screening study has now examined blood samples from more than 85,000 adults over the age of 40 in Iceland for the earliest signs of

myeloma. Please see page 5 of this edition of Myeloma Today for the iStopMM abstracts presented recently at ASH 2022. Screening is safe, cost effective, and can become a new standard of care to decisively improve patient outcomes.

The BSRI is providing the scientific roadmap for the next steps, studying molecular and immune testing, best frontline therapy, MRD-positivity and biochemical relapse, and immunotherapy combinations. And the IMF is pursuing multiple research projects at once. Our International Independent Team for Endpoint Approval of Minimal Residual Disease in Myeloma (i2TEAMM) has been active since 2016 and holds the investigational new drug application (IND) with the FDA. The European Medicines Agency (EMA) is also proceeding with follow-up.

Every year since 1994, the IMF has funded new myeloma research through our Brian D. Novis Research Grant program, named in honor of the IMF’s co-founder. The IMF has supported more than 150 of the most promising projects by talented investigators from leading institutions around the world.

The quest for a cure demands constant innovation. The IMF has been pioneering the way for discovery since 1990. Throughout the years, we have been a leading voice in the fight against myeloma. Working creatively and collaboratively with the world’s foremost experts, we are improving outcomes for patients. Achieving a cure for myeloma is closer than ever.

Dr. Brian G.M.

Durie IMF Chairman Chief Scientific Officer

Susie Durie and Dr. Brian G.M. Durie receive a joint 2019 Honorary Doctorate for Scientific Excellence from the Vrije Universiteit Brussel

IMF’s global platform for Black Swan Research Initiative® collaborations

Letter from the IMF President & Chief Executive Officer

Dear Friends,

The December 2022 Annual Meeting & Exposition of the American Society of Hematology (ASH) served as confirmation that the pace of science, accelerated by technological developments, has gone from evolution to revolution. More than 1,000 myeloma-related abstracts were presented! The unprecedented volume and scope of myeloma research being performed all over the world made it emphatically clear that the word “cure” is no longer used merely in contemplation of a far-fetched dream. In 2023, a cure of myeloma feels tangible; it is nearly in sight.

While myeloma research is bringing us closer to a cure, there is no question that it has already delivered innovative treatment options that make it possible for many patients to live better and to live longer. Currently, there more than a dozen drugs approved by the U.S. Food and Drug Administration (FDA) for use in myeloma, with dozens more being tested in clinical trials. But it must be said that as more myeloma therapies become available both in the standard-of-care setting and in well-designed clinical trials, the ever-expanding menu of treatment options requires careful navigation by the patient.

Working with a myeloma specialist at an academic institution or myeloma center of excellence will help formulate your overall treatment strategy based on the latest data for your particular disease. Which therapeutic approach to use, when to use it, how to best sequence the treatment of your myeloma? Your needs, challenges, and preferences are essential considerations in making such determinations. YOU are the leader of your team, and it is more important than ever to be informed about YOUR myeloma in order to make informed choices.

While your doctor may be the one to administer your myeloma therapy, your healthcare team will include more members, and your care partners will also help support your personal strategy for living well with myeloma. Optimal care occurs when there is effective communication within your team and your voice is heard. Living well with myeloma is as much about your mental and spiritual resilience as it is about your physical well-being. In a larger sense, the researcher you’ve never met in a lab you’ve never visited is also on your team. Certainly, we at the IMF are always on your team.

In November 2021, I joined the IMF’s leadership team because the IMF team has been there for me. I was diagnosed with stage III myeloma in 1995 at age 25, embarking on a grueling course of high-dose chemotherapy that came everywhere with me in a wheeled suitcase. It was then that I walked into my first IMF support group meeting and an atmosphere filled with strength, hope, and information. I am thankful that my new community quickly helped me realize the importance of being my own advocate and making sure that my voice is heard. I am thankful for my myeloma doctors, past and present, who possess not only clinical excellence and empathy, but also embrace shared decision-making.

For more than 27 years, I have worked to advocate for our global community. I have closely observed the astonishing progress in myeloma research since the FDA approved the very first novel therapy nearly a decade after my diagnosis. The recent meeting of ASH was yet another opportunity to be energized by the future, to gain insights into the challenges of the present, and to be humbled by our history. Yes, the science itself is exhilarating, but its potential benefit for the survival and quality of life of patients with myeloma is no less so.

Yelak Biru Myeloma Patient IMF President & CEO

Yelak receiving 96-hour continuous IV chemotherapy in 1995

Yelak Biru

Yelak with his myeloma doctors, past and present

Dr. Shaji Kumar

Dr. Murali Janakiram Dr. Larry Anderson

Key Takeaways from ASH 2022 What myeloma patients and family and friends need to know

By Dr. Brian G.M. Durie IMF Chairman & Chief Scientific Officer

I am pleased to share with readers of Myeloma Today an overview of the top abstracts of interest presented during myeloma sessions at the 64th Annual Meeting & Exposition of the American Society of Hematology (ASH) in December 2022. Impressively, more than 1,000 abstracts presented at ASH were related to myeloma, demonstrating important developments for the myeloma community. Each year, different patterns of importance emerge, with bispecific antibodies becoming an area of great excitement at ASH 2022, with results from many clinical trials reported.

Bispecifics

Talquetamab

Talquetamab is an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody. It targets both GPRC5D (a novel target on myeloma cells) and CD3 (a target on T cells), activating the body’s immune system to fight myeloma. Abstract #157 oral presentation drew such interest that attendees spilled over to five extra rooms. The overall results clearly impressed the ASH participants. Talquetamab demonstrated robust efficacy and manageable safety in patients with heavily pretreated relapsed refractory multiple myeloma (RRMM). A video presentation by Dr. Ajai Chari is available on the IMF website. To view any of the IMF’s videos from ASH 2022, follow these steps: go to videos.myeloma.org and click on the “ASH” tab, then enter the abstract number or presenter name into the “search” bar.

Teclistamab

Teclistamab, the bispecific monoclonal antibody recently approved by the U.S. Food and Drug Administration (FDA) and branded as Tecvayli™ was the focus of correlative analyses in Abstract #97. Abstract #160 discussed the results of the MajesTEC-2 clinical trial of Tecvayli in combination with SQ Darzalex® (daratumumab) + Revlimid® (lenalidomide). A video presentation by Dr. Emma Searle is available on the IMF website.

Other results with bispecific antibodies

Abstract #1919 presented a first-in-human study of Abbv-383 as monotherapy in patients with RRMM. Abstract #4555 updated safety and efficacy of REGN5458 in a first-in-human study in patients with RRMM. Abstract #158 demonstrated that elranatamab induces durable clinical and molecular responses for patients with RRMM – a video presentation by Dr. Noopur Raje is available on the IMF website.

Abstract #162 presented results from a first-in-human study of alnuctamab in patients with RRMM. Abstract #567 presented data that pretreatment with tocilizumab prior to the bispecific cevostamab in patients with RRMM showed a reduction in cytokine release syndrome (CRS) incidence and severity. Abstract #161 discussed the T-cell engaging bispecific antibody RG6234 as being highly effective in patients with RRMM – a video presentation by Dr. Carmelo Carlo-Stella is available on the IMF website.

CAR T-cell therapy in the frontline setting

A new approach to CAR T-cell therapy in the frontline setting became notable. Abstract #366 was presented by Dr. Juan Du. This phase I study for transplant-eligible, newly diagnosed highrisk myeloma found the BCMA-CD19 dual FasTCAR-T therapy (GC012F) to have a safe profile and high efficacy, with a 100% overall response rate (ORR) and 100% negativity for minimal residual disease (MRD). The manufacturing time for GC012F is 22–36 hours, much faster than the standard approaches, while producing a good quality T-cell product. A video presentation by Dr. Juan Du is available on the IMF website.

iStopMM abstracts

The IMF’s iStopMM (Iceland Screens Treats or Prevents Multiple Myeloma) project is a population-based screening study for monoclonal gammopathy of undetermined significance (MGUS) led by Dr. Sigurður Kristinsson (University of Iceland, Reykjavík). iStopMM is looking at the population of Iceland, where everyone over the age of 40 was invited to participate in the study and more than half of this population volunteered. The many diverse outcomes from iStopMM will benefit not only Iceland but the myeloma community around the world. A total of 10 abstracts were invited for presentation at ASH 2022.

Four oral iStopMM abstracts

Abstract #103 demonstrates that while prevalence of MGUS is high in the iStopMM study, the prevalence of IgA MGUS does not increase with age in the way other immunoglobulin subtypes do. Abstract #105 showed that SARS-Cov-2 vaccinations do not lead to progression of MGUS – a video presentation by Dr. Róbert Pálmason is available on the IMF website.

Abstract #967 looks at the epidemiology, causes, and the impact of using mass spectrometry in the detection and identification of M-proteins. The notion that the development of a new M-protein can be either temporary or transient was assessed as related to low-level proteins detected using mass spectrometry. This video presentation by Dr. Róbert Pálmason is also available on the IMF website.

(continues on next page)

IMF International Myeloma Working Group (IMWG) meeting at ASH 2022

ASH 2022 HIGHLIGHTS – CONTINUED FROM PAGE 5

Abstract #107 discusses the development of a multivariable model to predict the risk of ≥ 10% bone marrow plasma cells, which changes the diagnosis from MGUS to SMM, which in turn carries a greater risk of progression to myeloma. This received some of the greatest attention from ASH attendees. The need for upfront bone marrow sampling in individuals with MGUS was based on four predictors: MGUS isotype (IgG, IgA, biclonal), M-protein concentration, free light chain ratio, and total concentrations of IgG, IgA, and IgM. Using this risk model, it became possible to avoid bone marrow sampling in 36.1% percent of patients. From a screened cohort of 75,422 persons age ≥ 40 years (51% of the Icelandic population), MGUS has been identified in 3,358 cases, of which 2,542 were randomized to active follow-up. A calculator app has been developed and can be accessed at istopmm.com/riskmodel. Patients’ laboratory results can be entered to obtain an output of the predicted percent of plasma cells in the bone marrow. Patients and treating doctors can use these results to decide the best approach for each individual patient while considering factors such as age, cost, and preference.

Six poster iStopMM abstracts

Abstract #3188 investigates determining hemodilution in diagnostic bone marrow samples in myeloma and its precursors by next-generation flow (NGF) cytometry. Abstract #4455 looks at circulating tumor plasma cells in the screened smoldering multiple myeloma (SMM) cohort of iStopMM with the aim of giving clinical care and treatments to those who benefit the most from them, while limiting interventions in those who do not need them. Abstract #4504 looks at MGUS with multiple paraproteins.

Abstract #4507 found that for screened individuals who had no known illness prior to testing, there is no correlation between

underlying autoimmune diseases and MGUS. This calls into question prior linkage of M-proteins as possible causes of autoimmune problems. Abstract #4537 presents that hypercalcemia, particularly isolated hypercalcemia, is not a strong indicator of MGUS progression. Lastly, Abstract #4541 finds no association between MGUS and chronic kidney disease.

Icelandic screening datasets

I recommended that you review all abstracts from the iStopMM study. Collectively, these abstracts point to many new paradigms in the evaluation and management of M-protein disorders, and many more new observations are forthcoming. This is the beginning of a new era in the study of early disease entities which can be precursors to myeloma or other lymphoproliferative disorders. Visit myeloma.org/black-swan-research-initiative/istopmm to learn more about the iStopMM study.

Potential curative approaches

The IMF Black Swan Research Initiative® (BSRI®) is funding CURE clinical trials in the U.S. and abroad. The ASCENT and the CESAR studies use a curative strategy that aims to treat myeloma early and aggressively. The curative approach is at the heart of the BSRI pathway to a cure for myeloma. Effective new multiple myeloma therapies are driving longer remissions, and “cure” is coming into focus in three different ways:

 Functional cure is when a patient is in a prolonged remission, while testing can still detect that a small amount of myeloma is present.

 Normal relative survival is when a patient is in a prolonged remission and has reached a point where their survival is equal to or better than another person of the same sex and age.

 True cure is the goal of the CURE trials. It is the most difficult to confirm, no matter how sensitive the testing.

CURE trials presented at ASH 2022

Abstract #757 presented data from the ASCENT clinical trial of fixed-duration aggressive induction therapy for high-risk SMM with the combination of Darzalex + Kyprolis® (carfilzomib) + Revlimid + dexamethasone (D-KRd) for two years of therapy. Eighty-seven patients were enrolled in the study, with 31% still receiving active treatment at this time. Best ORR thus far is 97%, with only 3 patients progressing. Bone marrow MRD negativity was achieved by 84% of patients. The median time for MRD negativity was 6.6 months with 53 cases occurring at the end of induction, 16 at the end of consolidation, and 4 at the end of maintenance. This means that more MRD negativity will be achieved as patients complete the planned therapy. Therapy was well-tolerated with no unexpected toxicity signals. There is great optimism about the potential for long-term MRD negativity, with the possibility of “cure” for some patients.

Abstract #118 presented the post-hoc analysis of sustained undetectable MRD in the GEM-CESAR clinical trial of high-risk SMM, the longer-term follow-up from the companion study of Kyprolis + Revlimid + dexamethasone (KRd) with an autologous stem cell transplant (ASCT) rather than Darzalex. The results were similar to the ASCENT study – 63% of patients achieving MRD negativity after maintenance. After 70.1 months of follow-up, 94% of patients are still in remission, with 6 patients having progressive disease. Thus far, 7 patients have died, meaning a 6-year survival rate that’s also in the 90% range. A video presentation by Dr. María-Victoria Mateos is available on the IMF website.

Longer follow-up is required for both ASCENT and CESAR trials, but it is reasonable to anticipate excellent long-term benefits.

MRD testing approaches

Abstract #865 presents ultrasensitive assessment of MRD in peripheral blood used to enhance the NGF method to increase sensitivity to a level of 10 -7 or 10 -8 by the “BloodFlow” method,

which shows great promise to reduce the need for bone marrow sampling. A video presentation by Dr. Laura Notarfranchi is available on the IMF website.

Abstract #866 discusses the clinical impact of NGF in bone marrow vs. mass spectrometry in peripheral blood to assess MRD. Bone marrow NGF and blood mass spectrometry testing gave similar predictive information. It seems that newer blood testing approaches have the potential to substantially reduce the need for bone marrow sampling. This is a very promising trend both for patients and for the efficiency of clinical trials. Longer follow-up is required for both trials, but it is reasonable to anticipate excellent long-term benefits. A video presentation by Dr. Noemí Puig is available on the IMF website.

Dexamethasone-sparing approach

Abstract #569 presented an efficacy and safety analysis of the IFM2017-03 phase III clinical trial. This became a point of considerable interest for its non-aggressive approach in frail or elderly patients with newly diagnosed myeloma. The Revlimid + dexamethasone (Rd) regimen was compared to the dexamethasone-sparing Darzalex + Revlimid (DR) regimen. Although more deep responses occurred with the Rd regimen, the DR regimen had excellent results without long-term dexamethasone and was well-tolerated, becoming an option for frail or elderly patients.

In closing

Important work in myeloma research is continuing. The reports presented at ASH 2022 are very exciting, with numerous new observations and great hope for the immediate future. For more detailed discussions, I invite you to view the many IMF video recordings with ASH 2022 abstract presenters at videos.myeloma.org, as well as to replay two archived IMF webinars, “Top Myeloma Research Presented at ASH 2022” and “Making Sense of Treatment.”

MT

1. Cesar Rodriguez, MD

2. Alfred Garfall, MD

3. Bruno Paiva, PhD

4. Joseph Mikhael, MD

5. Suzanne Lentzsch, MD, PhD

6. Philippe Moreau, MD

7. Sonja Zweegman, MD, PhD

8. Paul Richardson, MD

9. Meletios Dimopoulos, MD

10. Noopur Raje, MD

11. Thomas Martin, MD

12. Sundar Jagannath, MD

13. Sigurður Kristinsson, MD, PhD

14. Ruben Niesvizky, MD

15. Elena Zamagni, MD, PhD

16. Ajai Chari, MD

17. Jesús San Miguel, MD, Phd

18. María-Victoria Mateos, MD, PhD

19. Drs. Shaji Kumar, Kenneth Anderson, and S. Vincent Rajkumar, with Lisa Paik (IMF)

20. Sikander Ailawadhi, MD

21. Solomon Manier, MD, PhD

22. Noemí Puig, MD, PhD

23. Sæmundur Rögnvaldsson, MD, PhD

24. Dan Vogl, MD

25. Kwee Yong, PhD

26. Dan Navid (IMF) opens an auxiliary meeting of the Asian Myeloma Network (AMN) at ASH

#WHEREISDRJOE

Research on Myeloma Disparities Key myeloma research abstracts presented at ASH 2022

By Dr. Joseph R. Mikhael IMF Chief Medical Officer

The Annual Meeting & Exposition of the American Society of Hematology (ASH) is an important platform for presenting groundbreaking research in myeloma. This overview of the December 2022 meeting is focused specifically on health disparities. For a broader summary of myeloma research presented at ASH 2022, please read Dr. Durie’s article on page 5 of this edition of Myeloma Today

.

Myeloma incidence

Myeloma is considered to be a rare disease, but the precursor states of myeloma can be very common. Myeloma accounts for about 2% of all cancers, but it’s twice as common in the African American community. Indeed, 20% of all myeloma patients in the United States are of African descent. Being of African descent myself, this is both personally and professionally important to me.

Health disparities include the differences in the incidence of a disease but, ultimately, it is about how people survive and live with the disease. Although African Americans are twice as likely to have myeloma, their survival is roughly only half that of white Americans. The mortality of African American myeloma patients is nearly twice that of white Americans. It’s not acceptable that there’s such a difference in survival.

Similarly, within the Hispanic community, myeloma patients also have a reduced survival. In addition, Hispanics are on average the youngest patients diagnosed with myeloma. The average age of myeloma diagnosis is around 69–70 overall, 65–66 in African Americans, and 64–65 in Hispanic Americans.

Discrepancy in survival

African Americans and Hispanic Americans are less likely to obtain an early and accurate diagnosis of myeloma. There is also a disparity in access to the treatments that I call the Big Four Ts: triplet (3-drug) combination therapy, autologous stem cell transplant (ASCT), clinical trials, and CAR T-cell therapy (one of the newest available treatments). It’s not acceptable that many in our community don’t have access to the best of available therapies.

Research presented at ASH 2022

More than 1,000 abstracts relevant to myeloma were presented at ASH 2022. ASH meetings cover all blood diseases, and for myeloma to have such a large footprint this year is truly exciting. Approximately 25 abstracts focused on health disparities in the seven categories outlined below, and three abstracts were selected for the high distinction of oral presentations.

1. Social determinants of health

Health is not just a function of interacting with a healthcare professional. It also includes housing, education, nutrition, and the influence that these systems have on our lives overall. Several

ASH abstracts looked at how outcomes are influenced by racism and by issues of trust within the healthcare system. For social determinants of health, we see a significant impact not just in general health, but specifically in myeloma.

Abstract 4907 looked at the impact of social vulnerability index (SVI) on survival following ASCT for myeloma. Areas where there is a significant SVI should be guiding part of the work that we’re doing in myeloma. Abstract 2266 looked at how patients of lower socioeconomic status were less likely to obtain an ASCT. Abstract 4522 demonstrated that socioeconomic status was not associated with adherence to treatment, nor with progression-free survival (PFS) or overall survival (OS). We know that adherence leads to better outcomes.

2. Insurance coverage

Abstract 2309 looked at racial differences in Medicare Part D enrollment and survival among older patients with myeloma. While patients who are enrolled in Part D may have better access to certain myeloma therapies, race and ethnicity create an issue with access. A study of over 56,000 people in the National Cancer Database showed that African American patients were less likely to have private insurance and more likely to have Medicaid or to be uninsured, which led to inferior outcomes in survival. A suggestion made in several abstracts was for clinics to have trained “navigators” to assist patients with enrolling into insurance and other helpful programs.

3. Access to treatment

What is the biggest health disparity in myeloma? Access to treatment. Abstract 172 offered perspectives on myeloma-related healthcare access barriers. To address all the pragmatic challenges of getting a patient to the clinic, multi-level intervention necessitates the engagement of the community, including help with transportation, financial navigation, and appointment scheduling. The study concluded that community outreach was most important to educating both patients and non-specialists in the healthcare community. It’s gratifying to see a prominent ASH abstract focusing on the importance of community engagement and education of the primary care world for reducing health disparities.

4. Difference in biology

Prior studies have demonstrated that African Americans have differences in the biology of myeloma, with higher incidence of standard-risk cytogenetic abnormality “t(11;14)” and lower incidence of high-risk cytogenetic abnormality “deletion 17p.” African Americans are more likely to respond well to myeloma therapies because they have less high-risk disease biologically. Given equal access to treatment, the disparity in mortality between white and African American patients disappears.

Abstract 3582 noted the impact of Hispanic ethnicity on myeloma characteristics. Hispanics have a greater likelihood of extramedullary myeloma and of chromosomal abnormality “del 1p” when compared to white Americans. Abstract 4495 looked at renal function and race in individuals who

were screened for MGUS. Abstract 252 (also mentioned in the two categories below) presented racial and ethnic differences in clinical outcomes among myeloma patients treated with CAR T-cell therapy.

5. Side effects

Abstract 252 demonstrated that African American and Hispanic American patients were more likely to experience cytokine release syndrome (CRS) after CAR T-cell therapy, and were more likely to stay in the hospital longer. Abstract 3173 noted that newly diagnosed African Americans were more likely to develop peripheral neuropathy from Velcade® (bortezomib). Abstract 4560, a subgroup analysis of newly diagnosed transplant-eligible Black patients receiving 4-drug combination therapy found that more African Americans were more likely to need a dose reduction due to side effects, and more likely to discontinue therapy, but had fewer deaths.

6. Outcomes

Several studies looked at the differences between what clinical trials show and what we see in the real world. These studies often draw from large databases like the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute (NCI). Abstract 4904 looked at key trends over time in OS of myeloma patients by race and ethnicity, and by comorbidity status. OS in myeloma continues to improve. Unfortunately, improvement has not been seen to the same degree in both African American and Hispanic patients. However, there is hope as the gap is starting to be bridged. We also saw that there was reduced survival independent of race and ethnicity in patients that have diabetes and hypertension. As a myeloma doctor, I treat the individual patient, not just their plasma cells. I look at their whole social context and their whole medical care.

Abstract 252 noted that Hispanic patients seemed to have a reduced response rate and PFS after CAR T-cell therapy when compared to white patients. This needs to be understood further, but helps us appreciate the impact of race and ethnicity even with these newer and highly effective therapies. Abstract 4948 looked at factors associated with early mortality of myeloma patients who die within two years of diagnosis. Early death in myeloma is more common in African Americans and Hispanics. There is clearly much more work to do to reduce these disparities.

7. Communication

Abstract 2235, which I presented, reported on the experiences and expectations of doctors and patients and how they thought they were doing in their treatment, to see if there was a difference in perspective. What we learned is that often there is a difference between white patients and African American patients in how comfortable they were with their treatment plan, how confident they were in their treatment team, and how they feel that issues were communicated to them. One of the most important points I can share is that the relationship and the communication between patients and their healthcare providers is of critical importance. Do not prejudge your patient before you walk into that room. Listen to them. What are their desires and expectations? Why might there be hesitancy? Do they need support with decision-making? It is a very positive sign that many doctors who participated in this study were keen to implement strategies to improve communication with their patients, including taking courses on unconscious bias and shared decision-making.

In closing

It’s a privilege to share with you some of the latest research in health disparities in myeloma. Disparities extend beyond delayed diagnosis and access to treatment. They include the systemic racism in our healthcare system and the way providers communicate with patients and care partners.

The IMF is deeply committed not only to better understand the disparities but also to drive solutions. The IMF’s M-Power initiative was launched to empower patients and communities to change the course of myeloma. We’re partnering with local medical and non-medical groups to raise awareness of myeloma, enhance early and accurate diagnosis, and improve access to treatment. Visit mpower.myeloma.org to learn about our program and to access the resources that the IMF makes accessible to all. If we work together, we can make a difference in the lives of patients with myeloma. MT

Stay tuned for Dr. Mikhael’s next #WHEREISDRJOE column and contact the IMF InfoLine with your myeloma-related questions and concerns. Phone lines are open 9 a.m. to 4 p.m. (Pacific) Monday through Friday at 1.800.452.CURE in the US and Canada and 1.818.487.7455 worldwide. To submit your query electronically, email InfoLine@myeloma.org .

Black community. Learn the risks and symptoms of myeloma, and how to get the best care. Watch Now Race Matters in Myeloma Care and Survival

Patient Advocates Attend ASH 2022

Leaders of myeloma support groups share their takeaways

By Robin Tuohy IMF Vice President, Support Groups

Each December, the IMF brings a team of myeloma support group leaders and patient advocates to the Annual Meeting & Exposition of the American Society of Hematology (ASH). In many ways, the 2022 meeting of ASH was the most exciting to date: more than 1,000 myeloma-related abstracts, presentations by key opinion leaders, auxiliary meetings of the IMF’s International Myeloma Working Group (IMWG) and the IMF’s Black Swan Research Initiative® (BSRI®), and the camaraderie among members of our team who made the most of this unique opportunity both virtually and in-person!

To learn about research presented at ASH 2022, read the overviews by Dr. Brian G.M. Durie (see page 5) and Dr. Joseph R. Mikhael (see page 8). In this column, I would like to highlight some of the insights by members of the support group leaders team shared during ASH via blogs at ash2022blogs.myeloma.org, Twitter hashtag #IMFASH22, Facebook, and videos:

“This was my 17th year attending ASH. The 2022 ASH meeting continued to amaze me with so many studies in all stages of myeloma, with tremendous advances being made.”

– Jack Aiello, 28-year myeloma survivor

“I witnessed first-hand the commitment of the myeloma doctors who are working to find better treatments and a cure. Their research gives me hope, which I can bring back to my support group.”

– Sheri Baker, 11-year myeloma survivor

“ASH attendance by patients, care partners, advocates, and nurses means that important medical information is reaching and empowering tons of myeloma patients around the world! When patients and researchers meet each other, it opens an opportunity for a dialogue. They learn as much from us as we learn from them!”

– Becky Bosley, OCN

“Those of us with SMM live with our own set of questions and unknowns, and our own anxieties. By sharing what I learned with other SMM patients, I hope to give them useful information about our diagnosis and possible journey ahead.”

– Jessie Daw, smoldering multiple myeloma (SMM)

“I so appreciate the IMF and its tireless staff that made it possible for me to observe outstanding myeloma experts who are doing groundbreaking research, and to strengthen our sense of community and reassurance as we make our way through this difficult journey.”

– Dr. John DeFlice, 10-year myeloma survivor, retired gastroenterologist

“In 2013, I attended ASH for my first time. Over the last 10 years, myeloma research has advanced immeasurably, bringing great promise and hope to myeloma patients like me.”

– Linda Huguelet, panelist in Dr. Durie’s webinar

“The synergy in myeloma research at ASH was profound. The calls for diversity, equity, and inclusion in healthcare for people of color are being heard. Now I’m better equipped to effectively advocate and support patients and care partners. I am grateful to the IMF for investing in me, and I will look to pay it forward.”

– Diane Hunter, first-time ASH attendee

“I was diagnosed in 2016 at age 32. In the years since then, I have fought myeloma as hard as I could, and have tried to live a life not controlled by cancer. I’ve had an allogeneic transplant, CAR T-cell therapy, and other lines of treatment all while living my life to the fullest. Now I have 3 children and I co-lead a local myeloma support group. I hope to inspire other myeloma patients to live life fully.”

– Nick Lenoir, panelist

in Dr. Durie’s webinar

“Attending ASH with the IMF is an immersion into the best of international myeloma research with expert navigation by Dr. Durie and Dr. Mikhael. Thanks to Robin and her team, we had an optimal learning experience. I am humbled to be a part of this team.”

– Gail G. McCray, 15-year myeloma survivor, Community Health Educator

“Attending ASH brought home how far the myeloma research landscape has come since I became a nurse in 1991. But with new treatments come new challenges. What to use when? Whose myeloma will respond to what drugs? Clinical trials are the best objective measure of how to answer these questions.”

– Teresa Miceli, RN, BSN, OCN

“I was diagnosed in 2000 at age 36 and have attended ASH every year since the IMF made it possible. The myeloma treatment landscape is continuously evolving. Living well with myeloma entails learning

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The IMF team at ASH 2022: Nick Lenoir, Diane Hunter, Robin Tuohy, Linda Huguelet, Teresa Miceli, and Michael Tuohy

Jessie Daw Becky Bosley Sheri Baker Jack Aiello Jill Zitzewitz, PhD

Gail G. McCray John DeFlice, MD

GMAN Members Reflect & Plan for 2023

By Serdar Erdoğan IMF Director, GMAN and European & Middle Eastern Patient Programs

On December 15, 2022, more than 30 members of the IMF’s Global Myeloma Action Network (GMAN) came together for a virtual meeting to review the key research outputs from the 64th Annual Meeting and Exposition of the American Society of Hematology (ASH), which was held December 10–13 in New Orleans, LA.

Key research abstracts from ASH 2022

Dr. Brian G. M. Durie, IMF Chairman & Chief Scientific Officer, presented what he described as a “flavor” of the ASH conference, conveying the areas of greatest interest and importance for the myeloma community. For Dr. Durie’s comprehensive overview of ASH 2022, please turn to page 5 of this edition of Myeloma Today.

New GMAN committee and subgroups

Yelak Biru, IMF President & Chief Executive Officer, spoke about the three key objectives of the IMF’s GMAN network: bringing support and education to patients and their care partners, raising awareness of myeloma, and improving access to diagnosis and treatment. In service of these objectives, GMAN has formed a steering committee co-chaired by Yelak and Martine Elias (Executive Director, Myeloma Canada). Other members of the steering committee include myself, Mira Armour (CEO, Mijelom CRO, Croatia), and Hayley Beer (Myeloma Clinical Nurse Consultant, Myeloma Australia). The committee’s four subgroups will focus on access to care, health policy, clinical research, and capacity building. The committee and subgroups will report on their topics at the next GMAN Summit, which will be held in June 2023 in Frankfurt, Germany.

Reflections on successes of 2022

During the past year, GMAN held 13 Patient & Family Seminars in 10 countries and in a variety of formats: in person, online, and as hybrid sessions. The IMF’s groundbreaking educational seminar program was brought to Austria, Croatia, Czechia, Denmark, Iceland, Norway, Poland, Portugal, Spain, and Turkey. In addition, GMAN hosted three successful workshops for doctors.

PATIENT ADVOCATES AT ASH 2022 – CONTINUED

The combined participation of nearly 9,000 meeting attendees demonstrates GMAN’s success in driving its objectives forward. Several representatives of GMAN’s member organizations reported on their work during 2022, including Viorica Cursaru (President, Myeloma Euronet România), who described the support being offered to Ukrainian war refugees with myeloma who have crossed into Romania. Printed information about available support and services for patients and care partners is distributed in Ukrainian, English, and Romanian.

GMAN is working across European organizations to further assist myeloma patients affected by the war in Ukraine. For example, to help safeguard continuity of care for this population, GMAN is working closely with call centers and support groups in Poland, which has a high number of Ukrainian refugees.

In closing

The closing session of the GMAN meeting was a reminder from Dr. Durie that myeloma patients should remain vigilant in protecting themselves from the potential risks of COVID-19 infection by being vaccinated and boosted, and wearing high-quality masks during group gatherings, especially indoors. Dr. Durie expressed his thanks to the members of GMAN for their involvement in the network and their valuable contributions to their local myeloma communities. We also thank our industry partners from across the globe for supporting the important work of GMAN and its member organizations. MT

In 2013, the IMF led the development of the Global Myeloma Alliance, a group of myeloma patient organizations from around the world, which became the Global Myeloma Action Network (GMAN) in 2014. GMAN’s global mission is to improve the lives of myeloma patients, raise myeloma awareness, enhance the capabilities of patient advocacy groups, build the capacity of local myeloma organizations, and increase worldwide access to medicine and treatment.

FROM PREVIOUS PAGE

about your disease, appreciating the importance of having an informed dialogue about your myeloma with your healthcare team, and maintaining hope for the future.”

– Michael Tuohy, 23-year myeloma survivor

“Attending ASH these past two years as a patient advocate has been one of the silver linings of having myeloma, helping me think of more ways to use my science skills and educational focus to help other patients. I’m so incredibly grateful for all the IMF does!”

– Jill Zitzewitz, PhD

Each year, it is my honor and privilege to lead a team of support group leaders at ASH. This year, Jessie Daw called us a #FaMMily and I couldn’t agree more. We are all in this together, supporting each other. On behalf of the IMF, I would like to express my thanks

to our team of ASH 2022 patient advocates for their commitment to the myeloma community, and together we all would like to express our thanks to the IMF’s industry partners who supported our ASH attendance: Amgen, Karyopharm Therapeutics, and Takeda Oncology. MT

For information about joining a local myeloma support group, or launching one in your area, please contact Robin Tuohy at rtuohy@myeloma.org or visit myeloma.org/support-groups

Join Us and Become an Advocate for the Myeloma Community!

By Danielle Doheny IMF Director, Public Policy & Advocacy

Advocacy is one of the International Myeloma Foundation’s four founding pillars, along with Research, Education, and Support. The IMF’s Advocacy program has helped fund cancer research that has led to new treatments, expanded access to therapies, and ensured that the perspective of the myeloma patient is considered by policymakers in their decision-making process. The IMF and our team of volunteer advocates have been leaders in the patient advocacy space for many years, and in this edition of Myeloma Today, we would like to share the achievements we have attained along the way and to invite you to join our efforts.

Affordable access to care

Throughout the history of the IMF’s Advocacy program, we have maintained a commitment to help ensure affordable access to care. The IMF launched the Patients Equal Access Coalition (PEAC) and the State Patients Equal Access Coalition (SPEAC) to bring together stakeholders in the advocacy community, including organizations representing patients across all cancer types, healthcare providers, and healthcare-focused industry partners. In the early 2000s, working in coalitions was still a novel approach to advocacy that today has become commonplace. Starting with Oregon in 2008 and most recently with Arkansas in 2017, these advocates were able to get laws on the books in 43 states that protect patients who are prescribed oral drugs instead of intravenous medication.

PEAC and SPEAC have evolved since the early days. These two coalitions are now combined into one – the Coalition to Improve Access to Cancer Care (CIACC) – and the IMF is working to pass a federal law to help individuals with federally regulated insurance and to address the remaining 7 states whose residents still do not have parity in coverage of their oral drugs.

Investment in myeloma research

Promoting investment in research is another top priority for the IMF Advocacy team. The IMF has long been a leader in efforts to increase funding for government programs that support cancer research, prevention, and awareness. In 2002, the IMF’s co-founder Susie Novis Durie testified in front of the Senate Appropriations Committee to advocate for cancer research funding. Susie’s inspirational testimony described the nature of myeloma, her husband’s journey with the disease, and the sense of community they were able to form with the founding of the IMF.

For decades, the IMF’s Chairman and Chief Scientific Officer, Dr. Brian G.M. Durie, has worked toward a cure for myeloma. The IMF’s Advocacy team continues to push for robust funding

through the One Voice Against Cancer coalition, which advocates for increased funding for cancer research at the National Institutes of Health’s National Cancer Institute. Since myeloma is a service-connected illness, the IMF has also advocated for myeloma research to be included in the Department of Defense (DoD) Congressionally Directed Medical Research Program (CDMRP).

Increasing awareness of myeloma

The IMF also advocates for increased awareness of myeloma. Our efforts began with advocates working with their local governments to secure proclamations declaring March as “Myeloma Action Month,” and today we have expanded our awareness activities to include working with Congress and the Centers for Disease Control and Prevention (CDC).

Access to clinical trials

The IMF is also actively working to improve access to clinical trials, and to make the voices of myeloma patients and their care partners heard during important policy debates related to healthcare. From the passage of the Affordable Care Act, to the recently passed Inflation Reduction Act, which includes provisions that will help cap what Medicare patients pay out-ofpocket for their drugs, the IMF has been integral in influencing public policy on behalf of myeloma patients.

Join the Myeloma ACTION Team!

Together with our volunteer advocates, the IMF is committed to continuing to grow this strong legacy. The Myeloma ACTION Team – also known as “Advocates Committed to Inspiring Others Nationwide!” – works together to strengthen support for legislation, build strong grassroots networks, and raise awareness of issues that affect myeloma patients. Individuals like you have helped advocate for increases in cancer research funding, ensuring that myeloma-specific research continues, oral drug parity, access to clinical trials, healthcare parities, COVID-19-specific advocacy initiatives, and veterans’ issues. MT

To learn more about the IMF’s advocacy activities or to contact your legislators directly, visit advocacy.myeloma.org

To subscribe to the IMF Advocacy Newsletter, visit subscribe.myeloma.org . To learn more about how you can help, contact us at advocacy@myeloma.org . We welcome your engagement, questions, and ideas.

Myeloma Today in conversation with Jack Aiello

How did your journey with myeloma begin?

It began with an excruciating backache, for which I was prescribed bed rest. The back pain stopped but a blood test revealed an elevated protein level. In early 1995, I was diagnosed with myeloma. There were few treatment options. I had two autologous transplants but they didn’t work well for me.

A year and a half later, I entered the first clinical trial of thalidomide in myeloma. There hadn’t been any new drug development in myeloma for 20 years. Thalidomide didn’t work well for me either, but taking part in that clinical trial taught me a lot about the value of myeloma research and the need for more of it. Next, I had a third transplant – a full allogeneic transplant that’s hardly ever performed any longer. The “allo” made the two “auto” transplants look like a piece of cake by comparison! But I finally achieved a complete remission, and I haven’t needed any myeloma treatment since the end of 1998. However, all the side effects led to medical disability and retirement.

Why did you become an advocate?

Some people step away from the myeloma community once they or their loved ones get into remission, and that’s understandable. But I chose to stay involved and to pay it forward. I facilitate the San Francisco / Greater Bay Area Multiple Myeloma Support Group, and I talk often with newly diagnosed patients who might be feeling scared or overwhelmed. We’ve all been there, and being part of the myeloma community allows us to share with others who are on a similar journey. Together, we’re stronger.

I’m a big proponent of myeloma education, becoming your own best advocate, and then maybe even becoming an advocate for our community. Each person can find their own way of making a contribution. My special interest is myeloma research advocacy. I served on the National Cancer Institute (NCI) Myeloma Steering Committee, and currently serve on the NCI Symptom Management and Quality of Life steering committee, the Center for International Blood and Marrow Transplant Research (CIBMTR) Consumer Advocacy Committee, and as a representative of the patient community at the SWOG Cancer Research Network. I’m also happy to volunteer locally and I do so nearly daily.

For many years, you have raised funds for IMF programs and services.

What motivates you?

My big motivation has always been to support myeloma education, and it was my work in advocacy that showed me how fundraising can help raise awareness. I have funded grants for myeloma patients to travel to educational events like seminars and summits, many of which I still attend myself. It’s important for patients to learn about their disease, and to become advocates for themselves and perhaps even for others.

But raising money for something important can still be a lot of fun. It’s like matchmaking between what you want to accomplish and what you enjoy doing. For example, one of my first fundraisers was a Texas Hold’em Poker Tournament, which I continued to run for many years because I had such a blast!

Then I started a letter campaign, but no one could read my handwriting, so now it’s an email campaign. One thing I learned is that some folks might not donate to your cause simply because you haven’t asked. An email is an easy way to ask your contacts for their support. Sometimes I have to send out reminders, but I’m always amazed at how many folks respond. It’s easy to do and very effective and rewarding.

So my advice to others is to take what they enjoy and think of ways to turn that into a fundraiser. I just love seeing the different events that people come up with!

How has your outlook evolved since 1995?

In 1995, my oncologist said that my anticipated survival was 2 to 3 years. When I told my kids that I needed to go to the hospital for treatment, my daughter asked me if I had cancer. To this day, it’s still hard for me to repeat that phrase because I really hate anything that impacts my kids negatively.

In 2022, my wife and I celebrated our 50th wedding anniversary with all of our kids and grandkids, and we had a fabulous time. I have watched my two daughters grow up and I have walked them down the aisle. I was there to see my son conduct his first orchestra concert. I have four grandkids. I consider myself extremely fortunate and I am committed to remaining as healthy as possible for as long as possible. MT

Join the fight against myeloma by supporting the IMF’s research and patient education initiatives. For more information, please contact Lynn Green at 1.334.332.0888 or lgreen@myeloma.org

Jack and Nell celebrate their 50th anniversary with family in 2022

Founder Brian D. Novis

Board of Directors

Chairman Dr. Brian G.M. Durie

Christine Battistini

Yelak Biru

Prof. Dr. Mario Boccadoro

Loraine Boyle

Susie Durie

Martine Elias

George T. Hayum

Jason Katz

Benson Klein

Founder

Susie Durie

Andrew Kuzneski, III

Dr. Robert A. Kyle

Prof. Dr. Heinz Ludwig

Dr. Edith Mitchell

Charles Newman

Dr. S. Vincent Rajkumar

Matthew Robinson

E. Michael D. Scott

IMF Executive Team

Yelak Biru

President & Chief Executive Officer

Dr. Brian G.M. Durie

Chief Scientific Officer

Jennifer Scarne

Chief Financial Officer

Diane Moran

Senior Vice President, Strategic Planning

Daniel Navid

Senior Vice President, Global Affairs

Lisa Paik

Executive Vice President, Medical Affairs

Betty Arevalo

Manager, Inventory Control

Nancy Bruno

Regional Director, Support Groups

Sarah Chambliss

Assistant Meeting Coordinator

Kelly Cox

Dr. Joseph R. Mikhael

Chief Medical Officer

Lynn K. Green, Ed.D.

Senior Vice President, Philanthropy

Mimi Choon-Quinones, PhD, MBA

Senior VP, Global Advocacy, Access, Policy & Research

Peter Anton

Vice President, Marketing

Robin Tuohy

Vice President, Support Groups

IMF Staff

Phil Lange

Accountant

Karla Lemus

Donor Relations Specialist

Jason London Manager, Marketing & Communications

Jim Needham

Director, Support Groups and Sr Dir, Regional Community Workshops

Danielle Doheny

Director, Public Policy & Advocacy

Susie Durie

Director, Global Patient Initiatives

Serdar Erdoğan

Director, GMAN and European & Middle Eastern Patient Programs

Heather Fishman Donor Relations

Jon Fitzpatrick

Technology & Coordination, Support Groups

Sherrie Guerrero

Director, Human Resources

Abigail Guzman

Manager,

Registration & Guest Relations

Paul Hewitt

Coordinator, InfoLine

Kevin Huynh Web Specialist

Marya Kazakova

Editor-in-Chief, Publications

Ilana Kenville

Associate Director, Distinguished Events

Missy Klepetar

Coordinator, InfoLine

Sapna Kumar Marketing Strategist

Publication Design

Meghan O’Connor

Coordinator, Meetings & Programs

Matthew Ohnsman

Coordinator, Audio Visual Projects

Selma Plascencia

Director, Operations

Annabel Reardon

Senior Director, Strategic Program Management

Joy Riznikove

Database Analyst

Miko Santos

Web Producer

Narmeen Shammami

Sr Research Project Coordinator

Kelley Sidorowicz

Regional Director, Support Groups

Sarah Solomon

Donor Relations

Brando Sordoni

Accounting & Distribution

Rafi Stephan

Assistant to the President & Chief Executive Officer

Daria Tabota

Coordinator, Marketing & Communications

Deborah Verla

Coordinator, InfoLine

Jonathan Weitz

Donor Relations

International Myeloma Foundation

4400 Coldwater Canyon Avenue, Suite 300 Studio City, CA 91604 USA

myeloma.org

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The IMF Returns to In-Person Patient

JOIN

&

Family Seminars in 2023!

US VIRTUALLY OR IN-PERSON

MARCH 17–18, 2023 • BOCA RATON, FLORIDA

Back in person for the first time since 2019. Attendance is limited. Register now to save your space.

LOCATION

Boca Raton Marriott at Boca Center 5150 Town Center Circle, Boca Raton, FL 33486

WHAT YOU GET WHEN YOU ATTEND A PATIENT & FAMILY SEMINAR EDUCATION

Learn about newly approved treatment options and about the latest clinical trials.

ACCESS TO EXPERTS

Ask your myeloma-related questions of the leading experts from across the globe.

CAMARADERIE

Join the conversation by networking with others in the myeloma community.

REGISTER TO ATTEND VIRTUALLY OR IN-PERSON AT THE LINK mmsm.link/3jIAMsr OR SCAN THIS QR CODE