A publication of the International Myeloma Foundation
International Myeloma Working Group
2024 IMWG Summit brings together top myeloma experts to advance myeloma diagnosis and treatment
ALSO IN THIS EDITION:
2024 ASCO & EHA Key Abstracts in Myeloma
Exciting data presented from clinical trials of myeloma drugs, combination therapies, and much more! PAGE 4
IMF Honors Dr. Shaji Kumar and Dr. Francesca Gay
Two distinguished myeloma researchers receive the Robert A. Kyle Lifetime Achievement Award and the Brian G.M. Durie Outstanding Achievement Award PAGE 10
Transition
of
Care for Patients with Myeloma
Members of the IMF’s Nurse Leadership Board share their experiences with collaborative patient care PAGE 14
Myeloma Made Simple:
Go to videos.myeloma.org and click on the tab Myeloma Made Simple
Bispecific Antibodies Made Simple
Learn about bispecific antibodies, a cutting-edge class of drugs that heralds a new era in myeloma treatment, providing hope for patients with limited therapeutic options. In this video, Dr. Joseph Mikhael delves into the fundamentals of bispecific T-cell engagers designed to harness the patient’s own immune system to effectively combat myeloma, as well as the crucial management of side effects to ensure patient well-being and treatment success. Stay informed and empowered! Watch now
2024 IMWG Conference Series Making Sense of Treatment
WATCH THE REPLAY myeloma.org/videos/imwg-conference-series-2024-making-sense-treatment
Be on the forefront of the latest myeloma research with myeloma experts Drs. Brian G.M. Durie (former IMF Chief Scientific Officer), María-Victoria Mateos (University of Salamanca, Spain), and Thomas Martin (University of California, San Francisco). Don’t miss the lively discussion about current challenges in myeloma, MGUS and SMM, future directions of frontline therapy, CAR T-cell and bispecific immunotherapies, new myeloma drugs and endpoints, and IMWG Working Committee reports. Watch now
Hot off the Press: The Lancet publishes new guidelines by the IMWG Immunotherapy Committee
Consensus guidelines and recommendations for the management and response assessment of CAR T-cell therapy for relapsed and refractory multiple myeloma (RRMM)
CAR T-cell immunotherapies that target BCMA have demonstrated promising results in improving overall response rates and extending the survival of patients with RRMM. However, the unique toxicities of CAR T-cell therapy necessitate optimized management strategies. The guidelines by the International Myeloma Working Group (IMWG) Immunotherapy Committee offer comprehensive recommendations, from the selection of patients through toxicity management. Published in May 2024 with Dr. Li Yin as lead author.
Consensus guidelines and recommendations for optimal use of T-cell-engaging bispecific antibodies in multiple myeloma
Cytokine release syndrome (CRS) and neurological complications are associated with bispecific antibody therapies in myeloma. The guidelines by the International Myeloma Working Group (IMWG) Immunotherapy Committee offer comprehensive recommendations for the assessment and management of CRS and neurological toxicities by employing diagnostic investigations, step-up doses, pre-medications, route of administration, and scoring system. Published in May 2024 with Dr. Paula Rodriguez-Otero as lead author
To read the full manuscripts, visit myeloma.org/imwg-publications
Contact the IMF InfoLine with your myeloma-related questions and concerns infoline.myeloma.org
Email the IMF at sgteam@myeloma.org for help with finding or starting a myeloma support group support.myeloma.org
Learn about the growing number of FDA-approved therapies for myeloma medications.myeloma.org
Take advantage of the hyperlinks in Myeloma Today by signing up for the digital edition at subscribe.myeloma.org, where you can also sign up to receive alerts about IMF events, webinars, teleconferences, and advocacy actions, as well as our e-newsletter Myeloma Minute And engage with us on social media! /myeloma @imfmyeloma @imfmyeloma IMFMyeloma
Paula Rodriguez-Otero, PhD
Yi Lin, MD, PhD
Message from the IMF President & Chief Executive Officer
Dear Friends,
For many of you reading this, the International Myeloma Foundation (IMF) is more than just an organization. The IMF is a beacon of hope, a source of support, and a community united by a shared vision: a world where every myeloma patient can live life to the fullest, unburdened by the disease.
Hope and possibility
The IMF vision is shared by the Board of Directors, the Executive Team, and the Staff. This vision reflects our unwavering commitment to your wellbeing. This is a future we strive for every day, upholding our founding mission of “Improving the quality of life of myeloma patients while working toward prevention and a cure!”
Ever since my myeloma diagnosis in 1995, I have known myeloma to be a relentless opponent. Ever since my earliest engagement with the IMF, I have known this organization to be relentless and strategic in its pursuit of a better future. Our calling is clear: to fight alongside you in every battle, starting with your myeloma diagnosis.
The patient-centric approach
In 2020, an estimated 176,404 people worldwide were diagnosed with myeloma, the second-most common type of blood cancer after lymphoma. Every 15 minutes, a new myeloma patient is diagnosed. Statistics aside, each and every myeloma patient we encounter is a unique story. You are a parent, a child, a partner, a friend. You are an individual with dreams, ambitions, and a right to live your life to the fullest. This is why a cure alone isn’t enough.
At the IMF, we believe in the patient-centric approach. This means focusing on the whole person, not just on the person’s disease. We provide you with the information and resources you need to make educated decisions about your treatment options in partnership with your doctors. We have built the support systems to help you navigate the emotional and practical challenges of living with myeloma.
What the IMF is doing
The IMF has made huge strides in empowering patients. We arm you with clear information about myeloma and its treatment options. We connect you with supportive networks and we share management strategies while furthering a sense of community. We advocate relentlessly on your behalf, both locally and on the global stage. We simultaneously conduct important clinical research as well as fund scientific and clinical studies that advance the frontiers of treatment efficacy and accelerate finding a cure.
Is the IMF doing A LOT? Yes, absolutely. Is it enough? Beyond finding a cure for myeloma, each and every patient must have access to the curative treatment that supports living a full life unburdened by myeloma.
Three core principles
Myeloma shouldn’t dictate your quality of life. We envision a future where you thrive, not just survive. You shouldn’t have to choose between effective treatment and debilitating side effects. You should be free to pursue and enjoy your life to the fullest. This is where the importance of the IMF’s support for groundbreaking scientific and clinical research comes in. The IMF is also building a global network of funders and partners who share our ambitions to make paradigm-changing discoveries that will improve the lives of all people affected by myeloma.
The IMF’s actions are guided by three core principles:
1. Each action must be purpose-driven, meaningful, and effective.
2. Each action must address an unmet patient need and expand our reach to diverse and underserved populations.
3. Each action must provide those who need it most with what they need the most.
Four founding pillars
Our unwavering commitment to the Research pillar fuels discoveries through funding and collaboration. The Education pillar empowers you with high-quality, patient-friendly information about myeloma and its treatment options so you can make the best decisions about your care in partnership with your doctor. The Support pillar connects you with tools and resources to help you navigate your myeloma journey. The Advocacy pillar ensures that your voice is heard in policy discussions on the global stage. Together, these pillars are a comprehensive support system that fosters hope and builds a brighter future for each person affected by myeloma.
The IMF is building a world of hope for every person with myeloma. This is a world we can create together. Join us in the fight for a brighter future, one where myeloma no longer holds you back.
Yelak Biru Myeloma Patient IMF President & CEO
Yelak Biru at the IMF 15th Annual Gala
2024 ASCO and EHA Meetings Feature
By Dr. Joseph Mikhael IMF Chief Medical Officer
Two very important annual medical meetings are held every spring, back-to-back, by the American Society of Clinical Oncology (ASCO) and the European Hematology Association (EHA). The 2024 annual meetings did not disappoint! During my more than 20 years working in myeloma, I don’t recall ever seeing FOUR large phase III clinical trials reporting their first data at ASCO and EHA. This speaks to the incredible progress made in myeloma over the past year. It is my pleasure to summarize for you these four studies as well as several other abstracts presented at ASCO and/or EHA in five major areas.
Newly diagnosed multiple myeloma (NDMM)
Two of the phase III clinical trials presented were designed to evaluate the benefit of a quadruplet (4-drug) combination therapy in patients with NDMM who did not intend to proceed to an autologous stem cell transplant (ASCT).
ASCO abstract #7500 IMROZ clinical trial (Facon) of Sarclisa® (isatuximab) in combination with Velcade® (bortezomib) + Revlimid® (lenalidomide) + dexamethasone [Isa-VRd] was compared to the triplet (3-drug) therapy with VRd. An impressive improvement in progression free survival (PFS) was demonstrated in the Isa-VRd arm, with 63% of study patients still in remission at 4 years vs. 45% of patients in the VRd arm.
ASCO abstract #7501 BENEFIT clinical trial (Leleu) compared IsaVRd to Sarclisa + Revlimid + dexamethasone [Isa-Rd]. Interestingly, the primary endpoint in this study was not PFS but depth of response (DpR) as measured by minimal residual disease (MRD). The quadruplet of Isa-VRd demonstrated an impressive MRDnegativity rate of 18 months. The Velcade in this trial was given weekly for one year, then every other week for 6 additional months.
Previously, at the December 2023 meeting of the American Society of Hematology (ASH), the PERSEUS clinical trial of quadruplet therapy with Darzalex® (daratumumab) in combination with VRd [D-VRd] was shown to be superior to the triplet therapy with VRd in myeloma patients who were intending to proceed to ASCT.
Takeaway: Both IMROZ and BENEFIT studies demonstrate that in patients (under the age of 80) who do not intend to proceed to transplant, Isa-VRd is both feasible and effective, with deep and durable responses that will clearly move us to greater use of 4-drug combinations in this patient population. We still have to sort out the optimal dosing strategy for VRd, as we tend to use a “VRd-lite” approach in these patients, with less frequent administration of Velcade, lower doses of Revlimid, and more rapid dose-tapering of dexamethasone.
Early-line relapsed myeloma
There have been many important clinical trials that have guided our use of therapies when myeloma relapses. We are learning that it is particularly important to choose the individual patient’s optimal therapy early on in the myeloma disease course, that is if the therapy is accessible, rather than “saving it for later.”
In April 2024, the FDA expanded the approval of Carvykti® (ciltacabtagene autoleucel or “cilta-cel” for short) CAR T-cell therapy for the treatment of patients with relapsed refractory multiple myeloma (RRMM) who have received at least 1 prior line of therapy; this was based on data from the CARTITUDE-4 clinical trial. One day earlier, the FDA expanded its approval of Abecma® (idecabtagene vicleucel or “ide-cel” for short) for the treatment of RRMM after 2 or more prior lines of therapy; this was based on data from the KarMMa-3 clinical trial.
At ASCO and EHA, it was particularly encouraging to see data from studies with patients who have “functional” high-risk multiple myeloma (HRMM) – those who relapsed within 18 months of their initial response – and how CAR T-cell therapy can benefit them. For more information, read ASCO abstract #7504 CARTITUDE-4 (Costa) and the EHA abstract #S208 KarMMa-2 (Leleu).
In addition, two important phase III clinical trials with the antibody-drug conjugate (ADC) Blenrep® (belantamab-mafodotin), which was approved by the FDA for myeloma in 2020 but withdrawn from the market in the U.S. when the confirmatory phase III clinical trial was not positive. However, we now have two clinical trials that clearly show the benefit of Blenrep in early-line relapse.
ASCO abstract #7503 DREAMM-7 (Mateos) of Blenrep in combination with Velcade + dexamethasone [BVd] vs. Darzalex in combination with Velcade + dexamethasone [DVd] demonstrated the median PFS (mPFS) for the BVd arm was an impressive 36 months vs. 14 months for the DVd arm. There was even a trend to an overall survival (OS) advantage in the Blenrep arm.
ASCO abstract #LBA103 DREAMM-8 (Trudel) of Blenrep added to Pomalyst® (pomalidomide) + dexamethasone [BPd] vs. Velcade + Pomalyst + dexamethasone [VPd] demonstrated a significantly
IMROZ clinical trial at a median follow-up (5 years or 59.7 months): Isa-VRd followed by Isa-Rd led to a statistically significant reduction in the risk of progression or death by 40.4%
Four Phase III Clinical Trials and More!
longer median PFS in the Blenrep arm, which had not been reached at the time of presentation vs. PFS of 13 months in the VPd arm. Blenrep was added to Pomalyst® (pomalidomide) + dexamethasone [Pd] vs. Velcade + Pomalyst + dexamethasone [VPd]. The median PFS was significantly longer in the Blenrep arm and it had not yet been reached at the time of presentation vs. PFS of 13 months in the Velcade arm. At one year, 71% of patients in the Blenrep arm were still in remission vs. 51% in the Velcade arm. There were still a considerable number of patients who experienced eye symptoms like blurriness of vision, although it could be reversed with dose frequency reductions.
Takeaway: More CAR T-cell therapy will likely be used in early relapse, especially in patients whose myeloma relapses quickly after initial therapy. Also, we also expect to have Blenrep back in the clinic over the next year, as it is an easily delivered and highly effective treatment. However, we have more work to do on the optimal dosing of Blenrep to minimize the side effects.
CAR T-cell therapy
It was very exciting to see a whole series of new CAR T-cell therapies being developed. Although these are not yet ready to be used in the clinic, they have many features that would make them very attractive. “Fast” CARs feature a reduced manufacturing time so patients have a shorter wait for their T cells to be returned to them. Other features include lower risk of cytokine release syndrome (CRS) and other neurological side effects.
Takeaway: A newer generation of CAR T-cell therapies may result in even more effective outcomes with fewer side effects.
Bispecific antibodies
Bispecific antibodies have become an important part of late-line relapse therapy in myeloma. We have three FDA-approved agents in Tecvayli® (teclistamab-cqyv), Talvey® (talquetamab-tgvs), and Elrexfio® (elranatamab-bcmm). Updates to the original clinical trials were presented at both ASCO and EHA with encouraging results of ongoing response, even with less frequent dosing. It is becoming common practice to increase the interval between doses for all three bispecifics, from weekly to every other week or monthly.
Several clinical trials are evaluating ways to provide bispecifics more easily and safely.
ASCO abstract #7517 (van de Donk) showed a dramatic drop in CRS from 72% to 25% with the use of prophylactic tocilizumab in patients treated with Tecvayli. There are many more new bispecific antibodies on the way, bringing the promise of reducing side effects (linvoseltamab), leveraging a new target of FcRH5 (cevostamab), or a treatment interval of every 4 weeks with no step-up dosing (ABBV-383).
Takeaway: New therapies in myeloma go through an “evolution” to make them more effective with lesser side effects. In addition, we will likely see an emphasis on more outpatient managment, reducing dose intensity, and even stopping therapy at a defined period.
Sequencing of immunotherapies
Newer myeloma therapies like CAR T-cell therapies and bispecific antibodies raise the issue of the order in which they should be given. Several ASCO and EHA abstracts presented real-world data sets to sequence treatments of relapsing myeloma. At this time, there isn’t a “perfect” sequence, but certain themes have emerged. The BCMA target on the surface of the myeloma cell that we use for CAR T-cell therapy and for two of the bispecifics (Tecvayli and Elrexfio) is not easily lost when treatment is given. The target can likely be leveraged more than once, going from one treatment to another, but the order is important. It may be preferable to go from CAR T to a bispecific, allowing a “break” for T cells between treatments. Lastly, short duration of response to one modality may encourage using a different target or approach, like switching to the GPRC5D target with Talvey.
Takeaway: As researchers continue to explore optimal sequencing of myeloma therapies, this topic should be part of the shared decision-making discussion that patients have with their healthcare team.
These are truly remarkable times in myeloma as we gain knowledge about the optimal use of the expanding array of effective tools to tackle this disease. I encourage you to visit myeloma.org/webcasts/ASCO-EHA to view IMF videos with myeloma key opinion leaders (KOLs) from ASCO and EHA. MT
Stay informed about the key developments in the field of myeloma! Sign up at subscribe.myeloma.org for our quarterly journal Myeloma Today and weekly e-newsletter Myeloma Minute, 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 Thursday and 9 a.m. to 2 p.m. on Friday at 1.800.452.CURE in the U.S. and Canada and 1.818.487.7455 worldwide. To submit your query electronically, email InfoLine@myeloma.org
15th Annual IMWG Summit Brings Researchers from around the world generate
By S. Vincent Rajkumar, MD IMF Chairperson of the Board IMWG Summit Co-Chair
The International Myeloma Working Group (IMWG) is comprised of more than 300 global experts in myeloma research and clinical care. Members of the IMWG conduct collaborative basic, clinical, and translational research to improve outcomes for myeloma patients while providing scientifically validated, critically appraised consensus guidelines that are followed around the world. The work of the IMWG has greatly advanced the understanding of myeloma and its treatments, advancing patient care and outcomes.
The IMWG’s mission is to identify and implement the most promising research to prevent the onset of active disease, to improve treatment, and to achieve a cure. The IMWG emerged from the IMF Scientific Advisory Board, which was established in 1995. The IMWG was assembled by the IMF in 2002, publishing its first consensus guidelines in 2003. The IMF hosted its first IMWG Annual Summit in 2010 in Barcelona, Spain.
Supporting the important work of the IMWG and its members is a critical element of the IMF’s mission to expand collaborative myeloma research and to help educate the myeloma patient community globally. The IMWG Summit is an important annual activity for many of the world’s top myeloma experts who work on imperative projects throughout the year. The IMWG has become the most prestigious organization for myeloma researchers from
around the world, and the IMWG Summit is an important annual activity for top myeloma experts who work together to fulfill the patient-centric mission of the IMF.
Every year since 2010, the IMWG Summit has been both a unique and an extraordinary experience. It is different from other medical meetings in general, and from other myeloma meetings in particular. Our collective primary goal is to move the field of myeloma forward for the utmost benefit of patients. To date, the IMWG has published more than 60 consensus guidelines and research reports. These are highly regarded in the field and include fundamental papers such as the diagnostic criteria, response criteria, and staging systems.
The 2024 IMWG Summit was held from June 11–12 in Madrid, Spain. More than 100 of the world’s leading myeloma researchers gathered for intensive brainstorming and planning. I co-chaired
Dr. S. Vincent Rajkumar
Dr. Shaji Kumar
Drs. Martin Kaiser and María-Victoria Mateos
Yelak Biru and Dr. S. Vincent Rajkumar
Drs. Joseph Mikhael and Bruno Paiva
Drs. Kwee Yong and Suzanne Lentzsch
Together Top Myeloma Experts progress in myeloma diagnosis and treatment
the sessions with the IMWG Steering Committee: Drs. Brian Durie, Philippe Moreau, Nikhil Munshi, and Jesús San Miguel.
The IMWG Summit included both a variety of presentations on a multitude of topics and numerous brainstorming discussions. Each presentation was followed by panel discussions and in-depth conversations with other experts in the audience. The major scientific presentations are summarized below.
MGUS and SMM
The first session focused on monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). Dr. Thorvardur Jon Love (University of Iceland) summarized the major findings so far from the Iceland Screens, Treats, or Prevents Multiple Myeloma (iStopMM) population-screening study, which is funded in part by the IMF’s Black Swan Research
Dr. Daryl Tan
Drs. Yi Lin and Thomas Martin
Drs. Brian Durie and Nikhil Munshi
More than 200 participants attended the 2024 IMWG Summit in Madrid, Spain
Scientific & Clinical
IMWG SUMMIT – CONTINUED FROM PAGE 7
Initiative® (BSRI®). The iStopMM project has screened approximately 75,000 individuals over the age of 40 in Iceland for presence of MGUS. The iStopMM study seeks to understand whether screening for MGUS, followed by early intervention, can be beneficial to the general population.
Dr. Love presented data on prevalence of MGUS and SMM. He showed data that there was no significant increased risk of MGUS in persons with autoimmune disorders. Early results show screening can indeed detect myeloma at an early stage, but more follow-up is needed to determine if this translates to improvement in outcomes.
Dr. Shaji Kumar provided an update on SMM. He highlighted the various parameters that can be used to identify patients with high-risk SMM (HR SMM). Patients with a 50% risk of progression to myeloma at 2 years are candidates for early intervention and clinical trials. He also reviewed updated results of the CESAR and ASCENT clinical trials, which are pilot efforts to see whether early aggressive therapy in HR SMM patients can be potentially curative. Visit myelomarisk.com to see the risk stratification calculators.
Current challenges
Dr. Daryl Tan (Raffles Hospital, Singapore) reviewed challenges that patients around the world face with regard to access to new myeloma treatments. For both regulatory and financial reasons, many new myeloma drugs are not available to patients in most parts of the world. Dr. Tan discussed strategies to expand access and improve affordability.
Dr. Thomas Martin (University of California – San Francisco) discussed the role that real-world studies can have in accelerating progress. Randomized controlled clinical trials are the gold standard for new drug development, but they take a long time to complete and do not address many pressing questions. Real-world database studies can provide answers to many critical questions. Dr. Martin is leading the IMF immunotherapy real-world database initiative.
Frontline therapies
Dr. Luciano Costa (University of Alabama) reviewed current advances in frontline therapy for myeloma. Multiple studies now indicate that the addition of monoclonal antibodies to frontline therapy improves outcomes in myeloma. For many newly diagnosed patients, the use of quadruplet (4-drug) regimens is increasingly becoming standard of care. Studies show higher rates of minimal residual disease negativity (MRD-negativity) when anti-CD38 monoclonal antibodies are added to the patient’s induction regimen.
Dr. Francesca Gay (University of Torino, Italy) discussed future strategies in frontline therapy, including clinical trials that test immunotherapies with bispecific antibodies and with chimeric antigen receptor (CAR) T-cell therapy. She also discussed approaches to myeloma in a risk-adapted manner, and the incorporation of MRD in therapeutic decision-making. Autologous stem cell transplantation (ASCT) should still be considered in patients who are eligible for transplant.
Drs. Jesús San Miguel and Philippe Moreau
Dr. Ajai Chari
Dr. Pieter Sonneveld
Dr. Wee Joo Chng with Yelak Biru and Daniel Navid
Drs. Hartmut Goldschmidt and Heinz Ludwig
Drs. Surbhi Sidana and Sonja Zweegman
Immune therapies
Dr. Paula Rodríguez Otero (University of Navarra, Spain) and Dr. Ajai Chari (University of California – San Francisco) discussed updated results from clinical trials with bispecific antibodies and with CAR-T cell therapies. Both CAR T-cell therapy and bispecific antibody therapies are already approved in many countries for the treatment of advanced relapsed refractory multiple myeloma (RRMM). These therapies may be moved up to earlier-line treatment in the next few years. They also discussed patient selection and management of side effects, including cytokine release syndrome (CRS), neurotoxicity, and infections. The IMWG recently published guidelines for use of bispecific antibodies and CAR-T in myeloma.
New drugs and new endpoints
Dr. Paul Richardson (Dana-Farber Cancer Institute, Boston, Massachusetts) reviewed new drugs that are likely to soon become available for the treatment of myeloma. These include iberdomide and mezigdomide, the new and more potent cereblon E3 ligase modulators (CELMoDs) that are currently in clinical development.
Dr. Nikhil Munshi (Dana-Farber Cancer Institute, Boston, Massachusetts) reviewed the discussions that took place at a recent U.S. Food and Drug Administration (FDA) meeting organized by the International Myeloma Society (IMS). He indicated that we are working together to see if MRD and novel clinical trial designs can be utilized to bring new myeloma drugs sooner to the clinic.
Dr. Brian Durie (former IMF Chief Scientific Officer) reviewed the excellent outcome at a recent FDA Oncologic Drugs Advisory Committee (ODAC) meeting where there was a unanimous recommendation to consider MRD as a surrogate endpoint for accelerated approval in myeloma. For greater detail, please see the article about the ODAC meeting in this edition of Myeloma Today.
Committees & Working Groups
The final session of the IMWG Summit featured reports from all of the IMWG Committees. Updates and action plans were presented by committee chairs: the SMM Committee (Drs. Shaji Kumar and María-Victoria Mateos), the Bone Disease Committee (Drs. Evangelos Terpos and Jens Hillengass), the Immune Therapy Committee (Drs. Thomas Martin and Yi Lin), the Quality of Life Committee (Drs. Surbhi Sidana and Sonja Zweegman), the Mass Spectrometry Committee (Drs. David Murray and Brian Durie), and the MRD Committee (Drs. Nikhil Munshi and Bruno Paiva).
The 15th Annual IMWG Summit was the unique, highly productive, exemplary experience of collaboration in myeloma research that we have come to expect from its outstanding membership. The IMF is proud to bring together experts from around the world as part of the IMWG. MT
The IMF Bids Farewell to Dr. Brian G.M. Durie
The International Myeloma Foundation (IMF) extends its deepest gratitude to Dr. Brian G.M. Durie for his exceptional 35-year service to the IMF. His visionary leadership and scientific expertise were instrumental in shaping the IMF into the organization it is today. While Dr. Durie has transitioned from his official role as a chief scientific officer, his legacy of unwavering patient focus and scientific excellence continues to inspire us. We are fortunate to benefit from his continued service on the IMF’s Board of Directors.
“We deeply appreciate Dr. Durie’s invaluable contributions, which have shaped the IMF and the myeloma community into what they are today,” said Yelak Biru (IMF President & CEO and 28-year myeloma patient). “Dr. Durie’s reputation for innovation in the field of myeloma globally has allowed the IMF to develop in ways no one could have imagined. The IMF was the first of its kind in many arenas. That pioneering mindset contributed to groundbreaking research and invaluable patient support services, offering a brighter future for those diagnosed with multiple myeloma.”
“This is a major transition point for the IMF, and we will work hard as a team to ensure that the organization continues to
grow and expand its reach in our quest to improve the lives of myeloma patients around the world through research, education, support, and advocacy. In this regard, I am glad that some of the best researchers in the myeloma field will be assisting us as members of the newly reconstituted Scientific Advisory Board,” said Dr. S. Vincent Rajkumar (IMF Chairperson of the Board).
Led by Dr. Rajkumar and Mr. Biru, the IMF’s new Scientific Advisory Board includes an esteemed group of myeloma experts who will guide the IMF’s research initiatives as well as identify areas for investment and expansion: Wee Joo Chng, MD (Singapore), Vania Hungria, MD, PhD (Brazil), Sigurður Yngvi Kristinsson, MD, PhD (Iceland), Shaji Kumar, MD (USA), Sagar Lonial, MD, FACP (USA), Thomas Martin, MD (USA), María-Victoria Mateos, MD, PhD (Spain), Joseph Mikhael, MD (USA), Philippe Moreau, MD (France), Nikhil Munshi, MD (USA), Jesús San Miguel, MD, PhD (Spain), and Saad Usmani, MD, MBA, FACP, FASCO (USA).
The IMF will continue to be inspired by the remarkable legacy of its founders – Dr. Durie, Susie Novis Durie, and Brian D. Novis –in realizing its mission of improving the quality of life of myeloma patients while working toward prevention and a cure. MT
2024 IMWG Summit Awards Honor
The International Myeloma Foundation (IMF) and the International Myeloma Working Group (IMWG) are proud to announce the 2024 recipients of the Robert A. Kyle Lifetime Achievement Award and the Brian G.M. Durie Outstanding Achievement Award. Every year during the IMWG Summit, two researchers who have made significant contributions in the field of myeloma are honored with these awards. This year’s awards ceremony was held on June 11 during the 15th annual IMWG Summit in Madrid, Spain.
Robert A. Kyle Lifetime Achievement Award
The Robert A. Kyle Lifetime Achievement Award recognizes individuals whose work has resulted in significant advances in research, treatment, and care of patients with myeloma. Dr. Kyle (Mayo Clinic, Rochester, MN) is a world-renowned myeloma expert whose groundbreaking work led to the discovery of significant hematologic entities, such as monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM).
The recipient of the 2024 Robert A. Kyle Lifetime Achievement Award is Shaji K. Kumar, MD. Dr. Kumar is Professor of Medicine and Chair of the Myeloma, Amyloid, and Dysproteinemia Group at the Mayo Clinic in Rochester, MN. Dr. Kumar has had a sustained impact on the field of myeloma and related disorders. He has led numerous phase I, II, and III clinical trials that have advanced new
treatments for patients with myeloma. He has published more than 600 peer-reviewed manuscripts. His extensive laboratory research contributions include the development of targeted therapies as well as biomarkers for response assessment and prognosis.
Dr. Kumar led the development of the IMWG response criteria in myeloma and established the currently used definitions for minimal residual disease (MRD). His work has contributed to a better understanding of the tumor microenvironment, mechanisms of disease progression, and risk stratification of plasma disorders.
“It is a great honor to be chosen for an award that bears the name of Prof. Robert A. Kyle, who is a teacher, a mentor, a colleague, and a friend to most of us in the field of plasma cell disorders and an inspiration for generations of myeloma clinicians and researchers. This recognition is, without doubt, the highlight of my career, and I am humbled by the fact that all my work has been built on the foundation laid by many individuals over decades. I am forever grateful to my mentors and colleagues at Mayo; without their help and constant encouragement, I would not have been able to succeed, and I accept this award on behalf of the entire Mayo team,” said Dr. Kumar upon accepting the award.
Yelak Biru, IMF President & CEO and 28-year myeloma survivor, extended his warmest congratulations: “As Dr. Kumar’s patient, I’m overwhelmed with joy to see him honored with the Robert A. Kyle Lifetime Achievement Award. Dr. Kumar’s impact goes far beyond groundbreaking research. His empathy and care are unparalleled. He takes the time to understand his patients truly, explains complex situations in a clear and comforting way, and is always available to address any concerns. His methodical and thoughtful approach instills confidence in his patients. Dr. Kumar’s research is prolific and highly respected by his colleagues – a testament to his collaborative spirit, which embodies the essence of Dr. Kyle’s legacy. This award is a well-deserved recognition of Dr. Kumar’s exceptional contributions that have given hope and improved the lives of countless myeloma patients, including myself.”
In 2021, Dr. Kumar was recognized by the IMF and the IMWG with the Brian G.M. Durie Outstanding Achievement Award.
Brian G.M. Durie
Outstanding Achievement Award
The Brian G.M. Durie Outstanding Achievement Award recognizes excellent achievements in myeloma research. Dr. Durie is the former IMF Chief Scientific Officer, IMWG Chairman, leader of the IMF’s Black Swan Research Initiative® (BSRI®), Professor of Medicine, Hematologist-Oncologist, and recipient of the 2019 Honorary Doctorate for Scientific Excellence from the Vrije Universiteit Brussel. The recipient of the 2024 Brian G.M. Durie Outstanding Achievement Award is Francesca Gay, MD, PhD. Dr. Gay is an Associate Professor at the University of Torino (Molecular Biotechnology and Health Sciences) and a hematologist at the SSD Clinical Trials in oncohematology and myeloma, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Italy.
Dr. Gay has more than 150 peer-reviewed publications, has led multiple phase I, II, and III clinical trials in myeloma, and has worked on international multicenter projects and data analyses.
Dr. Shaji Kumar with wife Seema and daughter Sandhya
Drs. Shaji Kumar, Brian G.M. Durie, and S. Vincent Rajkumar
Dr. Shaji Kumar and Dr. Francesca Gay
Dr. Gay’s research contributions include the use of new biological molecules, monoclonal antibodies, immunotherapeutic agents, CAR-T cells, and stem-cell transplantation techniques.
“It is a great honor for me to receive this award. Dr. Durie [has] dedicated his life to myeloma research and patient care and is a model to all researchers. It is a privilege for me to work with many colleagues to improve the outcome of myeloma patients. This award acknowledges the work we have been doing
Prof. Mario Boccadoro, the Head of Hematology at the University of Torino (Oncology Division), the founder of the Italian Myeloma Study Group, and the recipient of the 2008 Dr. Kyle Lifetime Achievement Award said: “I think this award is a recognition for all the trials Francesca was able to design. She is brilliant and able to foresee where myeloma therapy is headed, and then to plan the right clinical trial at the right moment.”
Dr. S. Vincent Rajkumar, IMF Chairperson of the Board of Directors, applauded Dr. Gay’s exceptional achievements: “Dr. Gay has had a huge impact on the field, with her enduring contributions through a series of well-designed laboratory and clinical trials. I am particularly pleased that we were able to work together on several research projects on the treatment of myeloma.”
Yelak Biru expressed his appreciation: “I am thrilled to congratulate Dr. Gay on receiving the Brian G.M. Durie Outstanding Achievement Award. Dr. Gay’s dedication to research, particularly in the area of new treatment options for newly diagnosed myeloma patients undergoing autologous stem cell transplantation, is truly inspiring. It’s especially noteworthy that Dr. Gay is the second woman to receive this prestigious award. This highlights the growing influence of female researchers in the field of myeloma, paving the way for a more inclusive and diverse future. Her collaborative spirit, evident in her work with the European Myeloma Network and
leadership roles within multiple professional organizations, reflects the essence of Dr. Durie’s legacy. The IMF is proud to recognize Dr. Gay’s achievements and to celebrate her as a role model.”
In 2019, Dr. Gay was recognized by the International Myeloma Society (IMS) with the Bart Barlogie Young Investigator Award. In 2022, she was the recipient of the COMy (Controversies in Myeloma) World Congress Achievement Award.
The entire IMF team extends our profound appreciation for these two outstanding myeloma researchers, Dr. Kumar and Dr. Gay. MT
Dr. Francesca Gay with daughter Olivia and husband Luca Vogliotti
The “WoMMen of Myeloma” ranks of IMWG researchers are growing with each passing year
A musical performance by a group of myeloma researchers known as “The Plasma Cells” has become a traditional part of the annual IMWG Summit Awards celebration
Dr. Francesca Gay
Yelak Biru
Historic Turning Point in Myeloma ODAC unanimously votes in favor of MRD testing
On April 12, 2024, the U.S. Food and Drug Administration (FDA) held the Oncologic Drugs Advisory Committee (ODAC) meeting to evaluate available data to support the use of minimal residual disease (MRD) status as an early endpoint in myeloma clinical trials, including considerations regarding timing of assessment, patient populations, and design of studies that intend to use MRD to support accelerated approval of a new product or a new indication.
ODAC panelists answered the question: “Does the evidence support the use of MRD as an accelerated approval endpoint in MM trials?” with a unanimous YES: 12-0. The FDA generally follows the ODAC recommendations but is not legally bound to do so. The implementation strategies for incorporating MRD testing into ongoing and future clinical trials are now being established. MRD is a measure of tumor burden assessed in the bone marrow sample. MRD as a biomarker has multiple regulatory uses including for response assessments and as a prognostic marker in both frontline and relapse settings. MRD testing has affirmed progression free survival (PFS) results that are used as basis for several FDA approvals in phase III clinical trials.
The FDA briefing document notes that while overall response rate (ORR) has generally supported accelerated approval of myeloma therapies, the improved understanding of the impact of MRD on long-term outcomes has increased interest in evaluating it as an endpoint. Technologies that detect the presence of malignant cells at orders of magnitude below the limit of conventional ORR have allowed an assessment of MRD in myeloma.
The IMF’s International Myeloma Working Group (IMWG) has established uniform response criteria for MRD in myeloma and it has been included as an exploratory endpoint and secondary endpoint to assess response to therapies in clinical trials. Sustained MRD-negativity is an important category, which the ODAC meeting confirmed.
Several studies and meta-analyses have reported the prognostic value of MRD, and the achievement of MRD-negativity has been
associated with depth of clinical response and prolongation of PFS and overall survival (OS).
The two key applicants to the ODAC proceedings were the IMF with the collaborative International Independent Team for Endpoint Approval of Myeloma MRD (i2TEAMM) as well as a team headed by Dr. Carl Ola Landgren (Sylvester Comprehensive Cancer Center of the University of Miami – Miami, FL). Both applicants provided comprehensive presentations.
i2TEAMM representatives in attendance included Brian G.M. Durie, MD (former IMF Chief Scientific Officer), Bruno Paiva, PhD (CIMA Laboratory Diagnostics, University of Navarra –Pamplona, Spain), Qian Shi, PhD (Mayo Clinic – Rochester, MN), and Kenneth C. Anderson, MD (Dana-Farber Cancer Institute and Harvard Medical School – Boston, MA). Unfortunately, i2TEAMM members Prof. Jesús San Miguel, MD, PhD (Clinica Universidad de Navarra – Pamplona, Spain) and Nikhil Munshi, MD (Jerome Lipper Myeloma Center, Dana-Farber Cancer Institute – Boston, MA) were unable to attend.
Using strong data, the i2TEAMM affirmed that MRD-negativity can be immediately applied. ODAC members indicated that careful study design and monitoring of new therapies can be assessed to make the application of MRD-negative complete response (CR) valid and usable. The accepted early endpoints were at 9 and 12 months from start of treatment, meaning MRD can be used in the early assessment of new drugs. Because MRD can be evaluated early, it may save months or years for a randomized clinical trial to demonstrate the PFS benefit.
This is the result of nearly 10 years of research and dedication by the i2TEAMM. The IMF would also like to thank Saad Z. Usmani, MD, MBA, FACP (Memorial Sloan Kettering Cancer Center – New York, NY) and myeloma patient and advocate Linda Huguelet for their participation during the oral testimonials.
The ODAC vote is historic. MRD testing will considerably expedite the development of FDA-approved myeloma drugs and therapies and bring them to patients sooner than later. This is a turning point in myeloma clinical trials; it moves us steadily toward much improved outcomes. Expectations for new therapies and combinations are that they will produce durable long-term benefits with excellent quality of life. MT
Stay informed about the key developments in the field of myeloma! Sign up at subscribe.myeloma.org for our quarterly journal Myeloma Today and weekly e-newsletter Myeloma Minute, 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 Thursday and 9 a.m. to 2 p.m. on Friday at 1.800.452.CURE in the U.S. and Canada and 1.818.487.7455 worldwide.
To submit your query electronically, email InfoLine@myeloma.org
Dr. Nikhil Munshi, Dr. Brian Durie, Lisa Paik, Dr. Bruno Pavia, Dr. Qian Shi, Dr. Kenneth Anderson, Mimi Choon-Quinones, and Diane Moran
Coordination of Care in Myeloma
Myeloma Today in conversation with Beth Faiman and Charise Gleason
Beth and Charise, you deliver care to patients at two large institutions with specialized myeloma programs and a team approach to patient care. Please tell us about the coordination of care between your centers, local community doctors, and the myeloma patients you serve.
Beth Faiman: Some of the myeloma patients in our practice begin their journey with us from the time of diagnosis. Others are referred by their community doctors when they are newly diagnosed or after relapse. We also see patients who are “selfreferred” and come to us on their own. Our institution can offer the newer therapies and supportive care measures that may not be available at smaller clinics. Our myeloma team holds weekly meetings, and our regional colleagues are invited to present difficult cases for discussion.
Charise Gleason: Yes, that describes the work of myeloma teams at many major institutions. A myeloma patient may receive care from a different practice before or after they come to us, so our approach to patient care extends beyond the program at our center. We often partner with doctors who care for myeloma patients locally; we work together to achieve an optimal outcome for the patient. If there is a need for a transition of care for the patient, it should be seamless.
BF: The three phases of a patient’s journey are (1) before treatment, (2) during treatment, and (3) after treatment. A patient may come to our institution for a diagnosis or for a stem cell transplant, a bispecific antibody, or chimeric antigen receptor (CAR) T-cell therapy. CAR-T is available only at a limited number of clinics; it may not be available to the patient locally. The transition of care occurs when they are sent to us for treatment by their local team.
CG: After a period of post-treatment monitoring, when our myeloma team determines that a patient is ready, we transition them back to their local doctor. Our relationship with a patient does not end; the two-way communication continues. We keep an eye on their care. We want to know how the treatment is working or if there are side effects. Best practices are modeled by national guidelines, but we also take an individualized approach to each person.
BF: We build relationships both with the patient and with their local healthcare team. Side effects can be tricky with the newer therapies like bispecifics and CAR T-cell therapies. Not all local clinics are comfortable managing side effects that they rarely see.
CG: Before patients transition back to their local doctors, we equip them with the information they need about the maintenance strategy that’s recommended to keep them in remission. We make sure the patients know they can reach out to us at any time. We’re here for them.
BF: How often we communicate depends on several factors. If the local doctor starts to see changes in the patient’s numbers, even if it’s a biochemical relapse that doesn’t require immediate action, it’s time to discuss next steps. I always advise following up with the myeloma specialist within a year to capture any change, but the timing varies.
Beth Faiman, PhD, MSN, APN-BC, AOCN®, BMTCN®, FAAN, FAPO Cleveland Clinic Taussig Cancer Institute
Charise Gleason, MSN, NP-BC, AOCNP® Winship Cancer Institute of Emory University
CG: Effective coordination of care is key, and communication is a two-way street. Patients must know how to best keep in touch –online portal, phone, fax? Patients must know who’s in charge, who’s ordering or interpreting lab tests or imaging studies, who’s monitoring medications, who’s managing side effects? The biggest barrier to successful coordination is not knowing who’s in charge at any given period.
BF: Pre-plan your next therapy while you’re in remission and feeling good and in control. You may never need that next therapy, but you will be better prepared if you take the time to consider your next options. This is also a good time to continue building a relationship of trust both with your local doctors and with the myeloma specialists.
CG: We want you to get the best care that you feel comfortable with from the team you choose to manage your care at any given time. If a patient at our center wants to go elsewhere for a second opinion or for treatment, we support their decision. Sometimes it’s a matter of their ability to travel, or they may want to verify the advice they’ve received. Regardless, the patient should feel comfortable with all aspects of their care.
BF: The IMF InfoLine is a great resource for patients to talk with someone about their myeloma. We also recommend the educational resources and videos on the IMF website, including the IMF’s Understanding -series publications. We encourage our patients to participate in myeloma support groups.
CG: We’re happy to share the care of the patient, and they should feel comfortable flowing back and forth between all the healthcare professionals on their team MT
Stay informed about the key developments in the field of myeloma! Sign up at subscribe.myeloma.org for our quarterly journal Myeloma Today and weekly e-newsletter Myeloma Minute, 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 Thursday and 9 a.m. to 2 p.m. on Friday at 1.800.452.CURE in the U.S. and Canada and 1.818.487.7455 worldwide. To submit your query electronically, email InfoLine@myeloma.org .
Kevin Brigle, PhD, ANP VCU Massey Comprehensive Cancer Center
Donna D. Catamero, ANP-BC, OCN®, CCRC Mount Sinai Health System
Kathleen Colson, RN, BSN, BS Dana-Farber Cancer Institute
Deborah Doss, RN, OCN® Dana-Farber Cancer Institute
Beth Faiman, PhD, MSN, APNBC, AOCN®, BMTCN®, FAAN, FAPO Cleveland Clinic Taussig Cancer Institute
Elizabeth Finley-Oliver, MSN, ARNP, AGNP-BC H. Lee Moffitt Cancer Center & Research Institute
Charise Gleason, MSN, NP-BC, AOCNP® Winship Cancer Institute of Emory University
Michaela Hillengass, RN, ACSM-CPT Roswell Park Comprehensive Cancer Center
Tracy King, PhD, MN, RN Royal Prince Alfred Hospital, Australia
Rebecca Lu, MSN, FNP-C MD Anderson Cancer Center
Patricia A. Mangan, RN, MSN, APRN-BC Abramson Cancer Center
Ann McNeill, RN, MSN, APN John Theurer Cancer Center at HMH
Teresa Miceli, RN, BSN, OCN® Mayo Clinic-College of Medicine
Kimberly Noonan, DNP, ANP-BC, AOCN®, FAAN Dana-Farber Cancer Institute
Amy Pierre, RN, MSN, ANP-BC Memorial Sloan Kettering Cancer Center
Tiffany Richards, PhD, ANP-BC, AOCNP® MD Anderson Cancer Center
Sandra Rome, RN, MN, AOCN®, CNS Cedars-Sinai Medical Center
Mary Steinbach, DNP, APRN Huntsman Cancer Institute
Joseph D. Tariman, PhD, MBA, ANP-BC, FAAN Rutgers University
Daniel Verina, DNP, RN, ACNP-BC Mount Sinai Medical Center
NLB Symposium at Nurse leaders educate peers about new
By Diane Moran Senior Vice President, Strategic Planning
On April 25, the IMF Nurse Leadership Board (NLB) presented its long-standing symposium at the 49th Annual Oncology Nursing Society (ONS) Congress held in Washington, DC. “Case Studies for Nurses: New Therapies and Regimens for Patients with Multiple Myeloma” was led by a distinguished faculty of NLB members Beth Faiman, Kevin Brigle, Patricia Mangan, and Donna Catamero.
“This is the 18th year that the IMF has organized a symposium at the ONS Annual Congress,” said Beth Faiman, who chaired the symposium. “This is one of the main ways the NLB shares nursing best practices and the latest data that contributes to improved patient care.” Approximately 550 nurses from across the U.S. attended the NLB symposium at the ONS Congress.
“Carl”
Kevin Brigle began by introducing the first case: “’Carl’ is a 61-year-old male who has a history of hypertension and prostate cancer that was successfully treated with radiation therapy. He experienced back pain after helping his son build a swing set for his two grandkids.” Kevin explained that Carl visited his doctor several times for his back pain before the advanced practice nurse ordered blood tests that showed an abnormal protein. Carl was referred to a hematologist-oncologist who ordered a full myeloma workup. “Myeloma is one of the worst cancers for delayed diagnosis,” Kevin explained, since the initial symptoms of myeloma, like fatigue and pain, are non-specific.
In the context of the case, Kevin discussed disparities. Black Americans of African descent have 2–3 times the rate of myeloma and MGUS (a precancerous condition that has a low chance of progressing to myeloma). Unfortunately, Black Americans with myeloma are twice as likely to die from myeloma compared with their White counterparts, perhaps because Black patients are less likely to receive the latest treatments, an autologous stem cell transplant, or participate in clinical trials. Research, however, suggests that when treated equally, Black Americans can achieve superior outcomes compared with White patients, possibly because, as a group, they tend to have less biologically aggressive myeloma. “Nurses are crucial to reducing disparities,” said Kevin, who explained that awareness of these disparities and ensuring each patient is treated equally are essential steps.
“Margaret”
The good news is that people with myeloma are living longer than ever,” began Patricia Mangan, who introduced the second case, “Margaret.” Diagnosed with myeloma in 2016 when she was 63 years old, Margaret began to experience a biochemical relapse in 2018 when her light chains began gradually increasing. Patricia said that for many patients, the first relapse is harder psychologically than their initial diagnosis since every patient hopes they will be among the small percentage of patients with myeloma who never relapse after their first therapy. Margaret received several different therapies before her oncologist suggested CAR T-cell therapy may be a good next option.
Patricia explained that in CAR T-cell therapy, a patient’s T-cells are harvested, engineered to target myeloma, and reinfused back into the patient. “Manufacturing the CAR T cells can typically take a month or two, and some patients may need bridging therapy during this period.” She explained that to access CAR T-cell therapy, patients need to consult with a qualified center to undergo assessments to ensure they are medically able to receive the therapy and understand what their insurance will cover.” Margaret consulted with a CAR T-cell center and received a BCMA-directed CAR T-cell therapy in November 2022. Although Margaret experienced some of the typical side effects of cytokine release syndrome (CRS) and low blood counts, she attained a complete response (CR).
“It is exciting that CAR T-cell therapy is now available to more patients with myeloma,” said Beth, explaining that the two currently approved CAR T-cell products are now available after only 1 or 2 prior lines of therapy. Beth also highlighted the new guidelines for infection prevention in patients with myeloma. “Unfortunately, infection is the leading cause of death in patients with myeloma,” she said. Beth discussed several medications that can help prevent infections in patients with myeloma and when their use is recommended.
Beth Faiman, Kevin Brigle, Donna Catamero and Patricia Mangan
the 2024 ONS Congress therapies and regimens for patients with myeloma
“IVIG replacement during CAR T-cell or bispecific antibody therapy is recommended to treat or prevent infections,” said Beth, mentioning that patients on these therapies have experienced infections not commonly seen in patients receiving other myeloma therapies.
“We are very fortunate to have three bispecific antibody products available for our patients with myeloma,” began Donna Catemero, explaining that bispecific antibodies are an “off the shelf” treatment that has one side that is attracted to myeloma cells and the other side that is attracted to T cells. “The bispecific antibody leads the patient’s T cells by the hand to the myeloma cells. The T cells release cytotoxic cytokines that kill myeloma cells.” Both Donna and Beth explained that bispecific antibodies are given with step-up dosing to limit the degree of CRS a patient experiences. They explained that optimal sequencing of therapies for myeloma is an evolving process, but patients can receive CAR T and bispecific antibodies in either order. Donna continued the case of Margaret and introduced “Robert,” both of whom received bispecific antibody therapy.
“Robert”
Donna explained that clinical trials have enabled new therapies like CAR T and bispecific antibodies for patients with myeloma. She explained that some patients believe myths about clinical trials, which prevent them from considering them as a treatment option. “Some patients worry that if they participate in a clinical trial, they could receive a placebo and not active treatment. In myeloma clinical trials, a patient will never receive less than the standard of care. Many phase III trials compare a standard of care regimen to a new proposed regimen.” Donna explained that minority patients in the U.S. participate in clinical trials at half the rate of their percentage in the U.S. population, which is
problematic since drugs may interact differently in different populations. “Without sufficient participation in clinical trials by all groups, we may not understand these differences.”
Minimal residual disease (MRD)
“It is exciting that we have so many new drugs in development,” Beth said, reviewing drugs in development. “Earlier this month, an FDA committee recommended minimal residual disease (MRD) as an endpoint for myeloma clinical trials,” she continued, saying this may facilitate the development of drugs for myeloma. Attaining MRD-negativity means that, depending on the sensitivity of the test used, not even 1 myeloma cell is found in 100,000 or 1,000,000 sampled bone marrow plasma cells.
“Through sharing stories of our patients and highlighting the latest research, we aim to empower oncology nurses to engage and educate each patient and their care partners, reduce disparities, and enhance shared decision-making,” said Beth in closing MT
The NLB’s Certified Nurse Educator (CNE) accreditation video program will be made available online in the near future. Visit nlb.myeloma.org to learn how the NLB is improving the nursing care and self-care of patients with myeloma via publications, symposia, multimedia, and research.
The IMF Nurse Leadership Board (NLB) Symposium at the Annual Oncology Nursing Society (ONS) Congress always attracts a full-capacity crowd
The IMF Brings Together Myeloma 40 advocacy leaders from 25 countries gather at the
By Emma Hatcher IMF Global Vice President, Patient Engagement & Advocacy
The Global Myeloma Action Network (GMAN) is a coalition of myeloma patient organizations from around the world. We share a deep commitment to the mission of improving the lives of myeloma patients, enhancing the capabilities of patient advocacy groups, building the capacity of local myeloma organizations, increasing global awareness of myeloma, and improving access to timely diagnosis and critical medicines.
GMAN collaborates with patients, care partners, policymakers, industry, doctors who are key opinion leaders (KOLs) in myeloma, and other stakeholders. While each GMAN member organization pursues its own vision, GMAN works to share best practices and address mutual areas of concern.
The 2024 GMAN Annual Summit was held from June 7 through June 9 in Madrid, Spain. The event brought together 40 advocacy leaders from 25 countries and 4 continents, facilitating the exchange of information, celebrating achievements, and coordinating efforts to advance our mission.
Workshops, discussions, networking Summit participants engaged in a series of workshops, panel discussions, and networking sessions designed to foster collaboration. Key topics included advancements in myeloma research, strategies for advocacy and policy change, and innovative approaches to patient support and education.
Expert speakers included Dr. Joseph Mikhael (IMF Chief Medical Officer), who gave an overview of myeloma research in 2024,
and Dr. Brian Durie (former IMF Chief Scientific Officer), who shared an update on the IMF’s research priorities. Another highlight was a panel of GMAN members who shared their firsthand accounts of successfully gaining access to essential myeloma therapies by using innovative strategies and collaboration, including public-private partnerships, community-based initiatives, and advocacy-driven policy changes that have removed or circumvented barriers to access.
The summit also featured dedicated capacity-building breakout sessions focusing on strategies to enhance the operational effectiveness of member organizations. The breakout sessions were designed to foster an environment of growth, ensuring that all member organizations, regardless of their size or resources, could strengthen their capabilities and amplify their impact in their respective regions.
Summit participants had the opportunity to engage in group discussions and one-on-one debriefs with GMAN members, enabling them to learn directly from other advocates who have successfully navigated similar challenges. One significant component was a session focused on engaging with the European Medicines Agency (EMA) regarding the approval of MRD as a surrogate endpoint in European clinical trials. Dr. Durie, Dr. Mimi Choon-Quinones (IMF Senior VP, Global Advocacy, Access, Policy & Research), and Drs. Anja Seckinger and Dr. Dirk Hose (both of the Vrije Universiteit Brussel, Belgium) explained how utilizing MRD can accelerate the approval of new myeloma therapies in Europe. This session underscored the importance of regulatory engagement in facilitating faster access to innovative treatments for myeloma patients.
upper left: Emma Hatcher, Carsten Levin (Denmark), Mira Armour (Croatia), Viorica Cursaru (Romania), Yelak Biru, Serdar Erdoğan, Dr. Brian G.M. Durie; upper right: Emma Hatcher presents the working agenda for the 2024 GMAN Summit; lower left: Yelak Biru (IMF President & CEO) discusses the IMF’s vision for the future; lower right: Dr. Joseph Mikhael leads the session on innovations in global access through clinical trials
Advocates from Across the World 2024 Summit of the Global Myeloma Action Network
Susie Novis Durie Grants
A major highlight of the summit was the celebration of significant milestones achieved by member organizations over the past year as supported by the GMAN Susie Novis Durie Grants program. 2023 grant recipients included FAM (Argentina) for the Living Well With Myeloma radio program, APCL (Portugal) for podcasts and videos with patients, KBDCA (South Korea) for peripheral neuropathy self-care kits, and Kanser Savaşçilari (Turkey) for services provided to myeloma patients affected by the earthquake. These achievements underscore the collective power of the global myeloma community.
2024 recipients include Mijelom CRO (Croatia), Dansk Myelomatose Forening (Denmark), AMEN Organization (Israel), and Myeloma Euronet Romania (Romania). Their GMAN peers look forward to hearing about their accomplishments at the 2025 GMAN Summit.
Building upon the momentum
Looking ahead, GMAN outlined its strategic goals for the coming year, including a Global Awareness Plan for the 2025 Myeloma Action Month (MAM), quarterly Capacity Building workshops focused on fundraising, strategic planning and organizational development, along with greater collaboration with pharmaceutical industry partners focused on access to critical therapies.
By building on the momentum generated at the summit, GMAN aims to drive meaningful progress in the fight against multiple myeloma and improve outcomes for patients around the world. MT
The 2024 GMAN Summit
Myeloma advocacy leaders from across 4 continents are determined to help improve outcomes for patients with myeloma
The IMF’s 15th
Annual Gala Celebrates the
Nearly $700,000 raised to benefit the Peter Boyle Research Fund and the
By Sylvia Dsouza IMF Vice President, Development
In April 2024, the International Myeloma Foundation (IMF) held our 15th Annual Gala to benefit the Peter R. Boyle Research Fund and the IMF’s research programs. Named in honor of beloved actor who lost his battle with myeloma in 2006, the Peter Boyle Research Fund was established in 2007 to support groundbreaking, cure-focused myeloma research initiatives, such as the IMF’s Black Swan Research Initiative® (BSRI®). Peter’s wife, Loraine Alterman Boyle is a member of the IMF Board of Directors and the IMF Gala Committee Chair.
Our Gala host, the renowned actor and comedian Ray Romano (Everybody Loves Raymond ), was joined onstage by award-winning artists: comedian and singer Robert Klein and actor Tony Danza, with the special participation of actress and film producer Patricia Heaton and actress and model Alex Meneses.
The 2024 IMF Gala took the tradition of an annual fundraiser and reinvented it for a new era. It was a dynamic, forward-looking event that seamlessly blended the IMF’s long-standing commitment to funding the most promising and innovative myeloma research with the joyfully enthusiastic Comedy Celebration of years past. The 2024 Gala celebration was held at the historic Edison Ballroom in New York City.
During his opening remarks, IMF President & CEO Yelak Biru delivered a powerful message: “We are a tapestry woven from patients, caregivers, researchers, doctors, supporters, and
industry partners – all united by the same unwavering purpose –to conquer myeloma.” Yelak shared that he felt a “mix of emotions” as he recalled being diagnosed with myeloma at the age of 25 and how this diagnosis “forever altered” the course of his life. “Cancer. Incurable. Two-to-three years to live. Dead before the age of 30. These were the phrases I heard in that cold winter of 1995. By the grace of God and the innovation of science, that was 28 years ago.”
Yelak credits his survival journey to finding a “beacon of hope” in the IMF. “At the IMF, we have always placed patients at the center of everything we do. It’s more than just a mantra; it’s the very foundation upon which this organization was built. Here, patients aren’t just statistics; they’re individuals with stories, dreams, and a fierce will to live. We empower them to become active participants in their own treatment journeys. After all, it’s their lives we’re fighting for. The battle rages on and the need for continued progress is urgent!”
In 1990, the IMF was founded upon four pillars: Research, Education, Support, and Advocacy. For more than 30 years, the IMF has been the driving force to find a cure for myeloma. The IMF’s strategic partnerships are accelerating the work to find a cure for myeloma. We lead with innovation as we incorporate data and technology in sound decision-making and user-friendly interface in patient care. We reduce barriers to healthcare access and support marginalized and underrepresented communities. Yelak closed his speech with this sentiment: “This annual Gala isn’t just a fundraiser; it’s a celebration of our collective will.”
Dr. Brian G.M. Durie, Dr. S. Vincent Rajkumar, Yelak Biru, and Dr. Joseph Mikhael
Loraine Alterman Boyle with Ray & Anna Romano
Loraine Alterman Boyle, Patricia Heaton, and Alex Meneses
Willis Steele, Sylvia Dsouza, and Dr. Tania Small
Thomas Goode with Carri Helman & Oya Gilbert
Christine Battistini and Martine Elias
Kristi Willette
Tapestry of the Myeloma Community
IMF’s robust research, education, support, and advocacy programs
One highlight of the evening was the awards ceremony, which honored the IMF’s partner organizations that have demonstrated a commitment to the myeloma community.
Innovation Awards
The IMF Innovation Award recognizes a pharmaceutical company that demonstrates exceptional dedication to developing novel therapies, advancing clinical research, and fostering patient-centric care by developing therapies and offering robust patient support programs in myeloma.
Bristol Myers Squibb and 2seventy bio were recognized for their groundbreaking research methods that led to the development of Abecma® (idecabtagene vicleucel or “ide-cel”), a life-changing third-line treatment for myeloma patients whose other options have been exhausted.
The 2024 Innovation Award were presented by Dr. S. Vincent Rajkumar (IMF Chairperson of the Board) and Tom Bellfort
(Myeloma Patient & Advocate) to Dr. Samit Hirawat (BMS Executive VP, Chief Medical Officer, Drug Development) and Chip Baird (2seventy bio CEO), who received the awards on behalf of their organizations.
Diversity, Equity, & Inclusion Award
The inaugural IMF Diversity, Equity, & Inclusion Award recognizes the critical importance of health disparities, especially in myeloma. Tyrone Brewer (Johnson & Johnson President of U.S. Hematology) accepted the award on behalf of Johnson & Johnson: “This is incredibly meaningful given my personal values, the work we are committed to every day at Johnson & Johnson, and the mission of the IMF. That’s why the work we do at Johnson & Johnson to advocate for diversity and justice, through Our Race to Health Equity initiatives, is so important. We are committed to creating a world where your identity is not a determinant of your access to care, the quality of your care, or your health outcomes. At Johnson & Johnson, we’re looking at all factors that impact quality of care,
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The Show – Ray Romano (1 & 2) hosted the IMF’s Comedy Celebration for the fifteenth year, and he performed along with comedian and singer Robert Klein (4) and actor Tony Danza (3), with the special participation of actress and film producer Patricia Heaton (2) and actress and model Alex Meneses (2)
and we’re looking to empower patients on all fronts to take charge of their health.”
The award was presented by Dr. Joseph R. Mikhael (IMF Chief Medical Officer) and Oya Gilbert (Myeloma and Patient Advocate).
Partner of the Year Award
The IMF Partner of the Year Award recognizes an organization that significantly contributes to the IMF’s vision of creating a world where every myeloma patient can live to the fullest, unburdened by the disease. Rajan Sethuraman (LatentView Analytics CEO) accepted the award: “I want to thank the IMF for this recognition. Through this collaboration, we have reduced the ‘time to hope’ for patients diagnosed with myeloma using data to reduce the time between diagnosis and choosing a treatment plan, significantly improving outcomes and lives.”
The award was presented by Sanjay Singh (IMF Board of Directors) and Kent Oliver (Myeloma Patient & Advocate).
Dr. S. Vincent Rajkumar emphasized the importance of continued innovation and collaboration: “We have made major advances in myeloma through close collaborations between researchers, pharmaceutical companies, patients, and nonprofit foundations. The IMF 15th Annual Gala was a huge success – celebrating the remarkable progress we have made and highlighting our continued commitment to research and to patients worldwide,”
The IMF 15th Annual Gala was designed with the vision of taking the organization into the next era of innovation and collaboration. The IMF exists because we help patients and care partners find their way, as they go through their own myeloma journeys. Patients and care partners turn to us at the most vulnerable
Slava Rubin and Family Tyrone Brewer, Yelak Biru, and the Johnson & Johnson team
Charlie & Laura Mooney with Scott Campbell
Andrew & Laurie Kuzneski Rachel Solomon and the Sanofi team
Rajan Sethuraman and the LatentView Analytics team
Sharon & Jason Katz
Rob Ruckman and the Pfizer team
Benson & Carol Klein
time of their lives, looking for answers. We give them HOPE and a REASON to continue to fight their battle against myeloma by showing them that it is possible to live and thrive. However, the IMF cannot do this alone.
The gala was a testament to the strong partnerships, collaborative mindset and spirit, and innovative thinking that the IMF has established with the myeloma community. We need philanthropy to help us be big and bold with research and to bring moonshot ideas to life. Science and research require money and, without funding, a cure for myeloma will remain elusive. The gala’s success brought us closer to our goals, and we are excited to continue to advance and scale in our mission!
The annual gala is our signature fundraising event to support our Research pillar. It brings together the myeloma medical and
scientific community with myeloma patients and advocates, and industry partners and entertainment luminaries. It is always an unforgettable evening of celebration.
The IMF extends its very special thanks to Gala Chair Loraine Alterman Boyle and to Ray Romano for their unwavering support of the Gala and the IMF. We also thank Gala Vice-Chairs Laurie Kuzneski, Carol Klein, and Kimberly Alexander and Honorary Chairs Anna & Ray Romano, as well as members of the Gala Honorary Committee: Joe Armstrong, Amy Boyle, Lucy Boyle, Tom Brokaw, Ebs Burnough, Judy Collins, Blythe Danner, Tom Fontana, Barbara Freitag, Brad Garrett, Mark & Marilou Hamill, Anne Hearst & Jay McInerney, Patricia Heaton, Jason Katz, Alex Meneses, Dr. S. Vincent Rajkumar, Desiree Rogers, Phil & Monica Rosenthal, Slava Rubin, Lisa Schultz & Dr. Ezriel Kornel, Stu Smiley & Lisa Doty, Otis Williams, and Alfre Woodard.
The IMF is grateful to the Gala honorees and attendees, and to our generous sponsors: Sanofi (Silver Level); Loraine Alterman Boyle, Karyopharm Therapeutics, Kite Pharma, Benson & Carol Klein, Leanne Klein, Medscape Oncology, Mount Sinai, Charles & Sharon Newman, Pfizer Inc., Rosenthal Family Foundation, and Takeda Oncology (Bronze Level). MT
Samit Hirawat and Chip Baird of BMS accept the 2024 Innovation Award from myeloma patient Tom Bellfort and Dr. S. Vincent Rajkumar
The Edison Ballroom was filled to capacity with enthusiastic supporters of the IMF and the myeloma community
Rajan Sethuraman of LatentView Analytics accepts the 2024 Partner of the Year Award from myeloma patient Kent Oliver and Sanjay Singh
Tyrone Brewer of Johnson & Johnson accepts the 2024 DEI Award from myeloma patient Oya Gilbert and Dr. Joseph Mikhael
Care Partners Only
INTERNATIONAL MYELOMA FOUNDATION
Founders
Brian D. Novis • Susie Durie • Dr. Brian G.M. Durie
Board of Directors
Chairperson Dr. S. Vincent Rajkumar
Jack Aiello
Christine Battistini
Yelak Biru
Prof. Dr. Mario Boccadoro
Loraine Alterman Boyle
Dr. Brian G.M. Durie
Martine Elias
George T. Hayum
Jason Katz
Benson Klein
Andrew Kuzneski, III
Prof. Dr. Heinz Ludwig
John O’Dwyer
Charles Newman
Poornima Parameswaran
Matthew Robinson
E. Michael D. Scott
Sanjay Singh
IMF Executive Team Yelak Biru President & Chief Executive Officer
Peter Anton Vice President, Marketing
Sylvia Dsouza Vice President, Development
Emma Hatcher Global Vice President, Patient Engagement & Advocacy
Dr. Joseph R. Mikhael Chief Medical Officer
Las Voces de Mieloma – Grupo Virtual
Un grupo de apoyo voluntario para pacientes interesados, se anima a los cuidadores, familiares y amigos a unirse a nosotros. Se trata de una excelente manera de conocer e interactuar con otros supervivientes y cuidadores para conocer los últimos avances en el tratamiento y la gestión del mieloma.
IMF Staff
Diane Moran Senior Vice President, Business Relationship Management
Lisa Paik
Executive Vice President, Research & Operations
Jennifer Scarne Chief Financial Officer
Robin Tuohy Vice President, Support Groups
Betty Arevalo Manager, Inventory Control
Becky Bosley Director, Support Groups
Brittnay Brandon Coordinator, Meetings
Matthew Broughton Assistant Director of Development, Operations
Nancy Bruno Director, Support Groups
Danielle Doheny Director, Public Policy & Advocacy
