Issuu

2026 IMF PATIENT AND FAMILY SEMINAR BOCA RATON, FL MARCH 13 & 14, 2026

THANK YOU TO OUR SPONSORS!

SCAN THIS QR CODE FOR KEY IMF RESOURCES Helpful Links to: • Slides from Friday & Saturday Programming • Evaluations for Friday & Saturday Programming • SparkCures Search Engine specific for the Florida region • Ways to Give 2

The International Myeloma Foundation is the global leader in multiple myeloma OUR MISSION:

OUR VISION:

To improve the quality of life of myeloma patients while working toward prevention & a cure

A world where every myeloma patient can live life to the fullest, unburdened by the disease

IMF LEADS THE WAY Together, we are turning hope into action: one meeting, one conversation, one connection at a time. 4

MORE THAN THREE DECADES OF COMMUNITY 180

Active Myeloma Support Groups 160

140

120

100

2025 2024 2023 2022 2021 2020 2019 2018 2017 2016 2015 2014 2013 2012 2011 2010 2009 2008 2007 2006 2005 2004 2003 2002 2001 2000 1999 1998 1997 1996 1995 1994 1991

THE IMF SUPPORT GROUP TEAM IS HERE FOR YOU Shared Experiences Become Shared Strength! Support Groups empower patients & care partners with information, insight & hope The IMF provides educational support to a network of over 155 myeloma specific groups

155+ US Support Groups Over 200 Support Group Visits/year SGTeam@myeloma.org 6

EDUCATE, ENGAGE, AND EMPOWER Your IMF Support Group Team is more than a group of professionals — we are nurses, social workers, public health advocates, survivors, and care partners united by a shared goal: Educate, Engage and Empower everyone affected by myeloma. Together, we bring decades of experience, deep compassion, and a steadfast belief in the power of connection.

Our Commitment Together, your Team offers an unmatched depth of clinical knowledge, personal insight, and supportive care. We don’t just serve the myeloma community—we are part of it . Whether you’re looking for resources, emotional support, group leadership guidance, or simply someone who understands, we’re here.

We are united in our passion: to ensure that no one faces myeloma alone. 7

MEET THE SUPPORT GROUP TEAM!

Jenn Wieworka

Robin Tuohy

Director, Support Groups

Vice President, Patient Support 25+ Year Care Partner

•

Advocate

•

Support Group Leader

Clinical Nurse Specialist

•

Support Group Leader

•

Becky Bosley

DoctoratePrepared Nurse

Yara William

Director, Support Groups

Associate Director, Support Groups

Katie Atkins

Associate Director, Support Groups

Cecilia Romero

Project & Technology Manager, Support Groups

•

Oncology Nurse

•

Breast & Ovarian Cancer Survivor

Oncology Social Worker

•

Doctor of Public Health

Public Health Advocate

•

Support Group Leader

Resource Navigator

•

Community Engager

Technology Educator

•

Patient Advocate

•

Support Group Leader

•

Project Management Expert

SPECIAL INTEREST GROUPS Special interest groups are designed as a supplemental support for specific populations of patients, in addition to their local Support Groups  MM Families  Smolder Bolder  Founded in 2021  Founded in 2023  For patients & care  For smoldering myeloma partners with young patients & care partners children  Las Voces de Mieloma  Founded in 2022  For Spanish speaking patients & care partners  Living Solo & Strong  Founded in 2022  For patients without a care partner

 Veterans SIG  Founded in 2025  For those who served our country  MM in the Middle  Founded in 2026  For those diagnosed before age 50

 Living with High-Risk Multiple Myeloma  Founded in 2023  For high-risk myeloma patients & care partners  Care Partners Only  Founded in 2024  For myeloma care partners only 9

2026 DIRECTOR PRESENTATION LIBRARY  Stronger Together: The IMF’s Commitment

 Emotional Health: The Unseen Impact of Myeloma

 The Myeloma Treatment Landscape

 Understanding Clinical Trials

 Guided Member Roundtable

 Hope and Healing When the Future Is Uncertain

 Myeloma.org website walkthrough

 Palliative Care & Hospice

 ASH/ASCO Research Updates

 Emergency Planning for Peace of Mind

MYELO

INFOLINE 800-452-2873 (CURE) Promoting Knowledge, Empowerment, & Hope Patient-Reported Needs Include: • Understanding lab results, terminology and disease state • Preparing for medical visits • Access to medical providers, specialty care (ASCT, CAR T) • Access to specialty medications • Financial resources

CLINICAL TRIAL MATCHING ENGINE Powered by SparkCures

2026 LIVE IN THE US - PATIENT EDUCATION

EDUCATION – AWARENESS - MAM

This year’s theme, #MoreThanMyeloma, reminds us that every patient is more than their diagnosis. And together, we will make the world take notice by lighting landmarks red across the globe. Light a Landmark in Your Community Help shine a light on multiple myeloma by asking your city to light up a local landmark in red this March. From bridges and buildings to monuments and city halls, every illuminated landmark sparks curiosity and inspires conversation.

MYELOMA ACTION MONTH PROGRAMS

EDUCATION – ENDURING

Videos, Webinars, Podcasts, and More!

EDUCATION- WRITTEN Understanding Booklets Tip Cards Myeloma Minute Weekly Updates Myeloma Today Quarterly News

Hot Topics in Myeloma Joseph Mikhael, MD, MEd, FRCPC, FACP, FASCO Chief Medical Officer, International Myeloma Foundation

Myeloma 101: The Big Picture Perspective with Q&A Joseph Mikhael, MD, MEd, FRCPC, FACP, FASCO, Chief Medical Officer, International Myeloma Foundation

Patient and Family Seminars

How common is Myeloma in the US? Estimated New Cases in 2025

36,500

% of All New Cancer Cases

1.8%

Median Age At Diagnosis

69 years

How common is Myeloma?

Percent of New Cases by Age

Rate of New Cases per 100,000 Persons by Race/Ethnicity & Sex https://seer.cancer.gov/statfacts/html/mulmy.html dated 4.18.2025

Environmental Factors: • Exposure to some chemicals • Radiation exposure

Examples:  Agent Orange  Burn pits  Pesticides, Herbicides  Firefighter/First Responder exposures

Individual Factors: • Age • Family History of related disorders • Personal History of MGUS or SMM • Obesity

VA Study Documents Health Risks for Burn Pit Exposures Leukemia and Multiple Myeloma Set to Be Added to List of Conditions Linked to Burn Pits

In most cases, the honest truth ….. WE DON’T KNOW

Hematopoietic stem cell

Red Blood Cells

White Blood cell

Platelets

Carry Oxygen

Fight Infection

Prevent Bleeding

Photo Credit

This Photo by Unknown Author is licensed under CC BY

Graphic Credit: Teresa Miceli

Heavy Chain = M-Spike    

65% IgG – most common 20% IgA – associated with AL Amyloid 5% to 10% light chain-only (kappa, lambda) Less common: IgD, IgE, IgM

eGFR = estimated glomerular filtration rate; M-spike = monoclonal spike; Ig = Immunoglobulin

Image Credit: IMF Patient Handbook

Heavy Chain: G, A, M, D, E

• • • • • •

AL-Amyloid POEMS Light or Heavy Chain Deposition Disease MGCS = Clinical MGRS = Renal MGNS = Neuro

(Monoclonal Gammopathy of Undetermined Significance)

SMM1-5,8

(Smoldering Multiple Myeloma)

Active Multiple Myeloma6-8

Clonal plasma cells in bone marrow

<10%

10%-60%

>10%

Presence of Myeloma Defining Events

None

Yes

Likelihood of progression

~1% per year

~10% per year

Not Applicable

Treatment

No; observation

Yes for high risk*; No for others

Yes

MGUS1-4

Condition

* In clinical trial MGCS = clinical significance; MGRS = Renal significance; MGNS = Neuro significance

Clonal Bone Marrow ≥ 10% Or Bony/Extramedullary Plasmacytoma AND any one or more Myeloma Defining Events (MDE)

SLiM CRAB

S Clonal BMPC ≥ 60% Li FLC ratio >100

M >1 focal lesion* by MRI BMPC = Bone marrow plasma cells FLC = serum free light chain * >5 mm

Rajkumar SV, et al. Lancet Oncology. 2014; 15:e538-e548. Kyle RA, et al. Leukemia. 2010; 24(6):1121–1127.

C alcium elevation R enal complications A nemia B one disease 28

Test Name

What it means

CBC + differential Complete metabolic panel

Hemoglobin, WBC, Platelets Creatinine, Calcium, Albumin, Liver function

Beta-2 Microglobulin (B2M) Lactate Dehydrogenase (LDH)

Part of staging and risk stratification

Serum Immunofixation and Protein electrophoresis (SPEP+IFE) Immunoglobulins (G, A, M, D, E) Free light chain assay with kappa/lambda ratio

Measures the level of normal and clonal protein Identifies the type of clonal protein

Urine immunofixation & protein electrophoresis (UPEP+IFE)

Measures the level of normal and clonal protein Identifies the type of clonal protein

Rajkumar SV, et al. Lancet Oncol. 2014;15:e538-3548. Ghobrial IM, et al. Blood. 2014;124:3380-3388; mSMART.org; NCCN.org

C R A B

This Photo by Unknown Author is licensed under CC BYSA-NC

S Li M

CBC= Complete Blood Count; WBC = White Blood Cell

Imaging: – Skeletal survey: Series of X-rays; less sensitive than other techniques

– Whole body low dose (CTWB-LD CT ) – Positron Emission Tomography (PET/CT) – Magnetic Resonance Imaging (MRI)

S L i M

Healthy bone versus myeloma bone disease

C R A B

This Photo by Unknown Author is licensed under CC BY-NC-ND

Rajkumar SV, et al. Lancet Oncol. 2014;15:e538-3548. Ghobrial IM, et al. Blood. 2014;124:3380-3388; mSMART.org; NCCN.org

This Photo by Unknown Author is licensed under CC BY-SA

Bone marrow genetics • Cytogenetics • Fluorescence in situ hybridization (FISH) • Next generation sequencing (NGS) High Risk FISH Results* Image Credit: IMF Patient Handbook

Bone marrow biopsy & aspirate • Bone marrow plasma cells (%) • Congo Red staining if concern for AL-Amyloid Rajkumar SV, et al. Lancet Oncol. 2014;15:e538-3548. Ghobrial IM, et al. Blood. 2014;124:3380-3388; mSMART.org; NCCN.org

Deletions

Translocations

Gain

1p17p- (p53del)

t(4;14) t(14;16) t(14;20)

1q+

*15-20% of people with NDMM

IMS/IMWG consensus on high risk myeloma definition Del17p

in more than 20% of sorted plasma cells

Biallelic Del(1p32)

TP53 mut (no threshold VAF)

t(4;14) or t(14;16) or t(14;20) 2 among

β2M ≥5.5mg/L

Gain/amp 1q

(if creat <1.2mg/dL)

Monoallelic del(1p32) Avet-Loiseau et al. J Clin Oncol 2025

What is the Myeloma Treatment Landscape? L O T # 1

Initial Therapy (a.k.a. Frontline, Induction) Quad Therapy (ex. CD38+ MoAb + VRd) HD-Melphalan + Stem Cell Transplant (ASCT)

Consolidation Therapy

Maintenance LOT #2

Treatment for Relapse

LOT #3

Treatment for Relapse

LOT #4

Treatment for Relapse

LOT #5

Treatment for Relapse

LOT #6

Treatment for Relapse ASCT = Autologous Stem Cell Transplant; MoAb=monoclonal antibody; VRd=Velcade, Revlimid, dexamethasone

Supportive Care and Living Well

Class

Drug Name

Abbreviation

IMiD immunomodulatory drug

Thalomid (thalidomide)

T or Thal

Revlimid (lenalidomide)

R, Rev, Len

Pomalyst (pomalidomide)

P or Pom

Velcade (bortezomib)

V or Vel or B

SC/SQ or IV

Kyprolis (carfilzomib)

C or K or Car

Ninlaro (ixazomib)

N or I

Oral

Cytoxan (cyclophosphamide)

C, CTX

Alkeran or Evomela (melphalan)

M or Mel

Oral IV

Decadron (dexamethasone)

Dex or D or d

Prednisone

P or Pred

Oral IV

Monoclonal Antibodies

Darzalex (daratumumab) Sarclisa (isatuximab) Empliciti (elotuzumab)

Dara Isa Elo

IV or SQ IV IV

XPO1 Inhibitors

Xpovio (selinexor)

X or Sel

Oral

Proteasome inhibitor

Chemotherapy Steroids

SC or SQ = Subcutaneous, Under the skin; IV = Intravenous

Administration Oral (PO)

Class

Drug Name

Abbreviation

Administration

Peptide Drug Conjugate*

Pepaxto (Melphalan Flufenamide)

Melflufen

BCMA Targeted Antibody Drug Conjugate (ADC)

Blenrep (belantamab mafodotinblmf)

Bela, Belamaf, or B

Abecma (idecabtagene vicleucel)

Ide-cel

CAR T Cell therapy

Bispecific Antibodies

Pipeline

IV Carvykti (ciltacabtagene vicleucel)

Cilta-cel

Tecvayli (teclistimab) Talvey (Talquetamab) Elrexfio (Elranatamab) Lynozyfic (Linvoseltamab

Tec Talq Elra Linvo

Cevostamab, Iberdomide, Mezigdomide, Anito-cel, Venetoclax AZD0120, Etentamig, KLN-1010, Trispecifics ……………………………

SC/IV

MORE TO COME!

* This agents is currently off the market in the US but available through special programs

SC or SQ = Subcutaneous, Under the skin; IV = Intravenous

Measuring Disease Response: IMWG Response Criteria

sCR Molecular CR

Response

Myeloma Cells & Protein

Flow MRD negative*

VGPR PR MR SD PD

Negative by next generation flow (NGF) (minimum sensitivity 1 in 10-5 nucleated cells or higher)* mCR AND normal Free Light Chain ratio, Bone Marrow negative by flow, 2 measures CR AND negative PCR Complete Response: Negative immunofixation (IFE); no more than 5% plasma cells in BM; 2 measures Very Good Partial Response: 90% reduction in myeloma protein Partial Response: at least 50% reduction in myeloma protein Minimal Response Stable Disease: Not meeting above criteria Progressive Disease: At least 25% increase in identified myeloma protein from lowest level

MRD = Minimal Residual Disease sCR = Stringent Complete Response; BM = Bone Marrow

Kumar, S., Paiva, B., Anderson, K. C., Durie, B., Landgren, O., Moreau, P., ... & Dimopoulos, M. (2016). International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. The lancet oncology, 17(8), e328-e346.

When Do I Need A New Treatment? • Not every relapse requires immediate therapy • Each case is different

Asymptomatic biochemical relapse on 2 consecutive assessments

Consider Observation Monitor Carefully

Kumar et al. NCCN Guidelines. Multiple myeloma. V4.2018.

Asymptomatic high-risk disease or rapid doubling time or extensive marrow involvement Consider Treatment Patient-/Disease-Specific Monitor Carefully

Symptomatic or extramedullary disease

Initiate Treatment

Targets on the Myeloma Cell Surface and Therapeutic Antibodies Bi-Specific Antibodies Talvey (Talquetamab) CAR-T

Bi-Specific Antibodies CAR-T GPRC5D

FcRH5

SLAMF7

CD38 Monoclonal Antibodies Daratumumab and Darzalex Faspro Sarclisa (Isatuximab) TAK-079 MOR202

Antibody Drug Empliciti (Elotuzumab) Bi-Specific Antibodies

BCMA

Immune Therapies Abecma (Ide-cel CAR-T) Carvykti (Cilta-cel CAR-T) Tecvayli (Teclistamab) Elrexfio (Elranatamab) Lynozyfic (Linvoseltamab) Other CAR-Ts Other Bi-Specific Antibodies

Antibody Drug Conjugates

How it works: An antibody directed at a target (BCMA) combined with a cytotoxic agent (chemotherapy)

ADC = Antibody-Drug Conjugate BCMA = B-Cell Maturation Antigen ADCP/ADCC = Antibody-Dependent Cellular Cytotoxicity & Phagocytosis Image Credit: https://creativecommons.org/licenses/by-nc/3.0/

Bispecific Antibodies: Mechanism of Action • Incorporates 2 antibody fragments to target and bind both tumor cells and T cells • Brings target-expressing MM cells and T cells into close proximity, enabling T cells to induce tumor-cell death

Targets of Bispecific Molecule Vary Agent

Tumor Cell Target

T-Cell Target

Teclistamab Elranatamab Linvoseltamab

BCMA

CD3

Talquetamab

GPRC5D

CD3

Cevostamab

FcRH5

CD3

“Off the Shelf” Advantage • No manufacturing process, unlike CAR T-cell therapy (but like ADC/belantamab therapy) • Thus, no delay between decision to treat and administration of drug ADC = Antibody-Drug Conjugate; BCMA = B-Cell Maturation Antigen; CD3 = Cluster of Differentiation 3; FcRH5 = Fc receptor-homolog 5; GPRC5D = G-protein coupled receptor family C group 5 member D Image Source: Shah N, et al. Leukemia. 2020;34:985–1005. Creative Commons License: CC BY 4.0. Barilà G, et al. Pharmaceuticals (Basel). 2021;14(1):40.

The Process of CAR T Cell Therapy 2a

1 CAR T therapy recommended. Insurance approved and ready to move forward.

Apheresis to collect T Cells

Bridging therapy, if needed; Lymphodepleting therapy when CAR T cells are ready

CAR T= Chimeric Antigen Receptor T Cell; LOT = Lines of Therapy

Hucks G, Rheingold SR. Blood Cancer J. 2019;doi:10.1038/s41408-018-0164-6.

Close monitoring and Management of side effects

What about Cure in Myeloma?  We have historically called myeloma “incurable” as such a small fraction of patients remained in long term remission

Defining “Cure” has many considerations:  Elimination of disease, down to Minimal Residual Disease Negative (MRD-)  Prolonged deep response Off Therapy  A recent DRAFT definition is being considered:

 Survival continues to improve in MM with an average over 10 years now!

https://seer.cancer.gov/statfacts/html/mulmy.html dated 4.18.2025

The Evolution of Myeloma Therapy

Now

VD Rev/Dex CyBorD VTD VRD KRD D-VMP DRD

ASCT Tandem ASCT (?)

Front line treatment

Induction

New

D-VRD Isa-VRD D-KRD Isa-VRD

Consolidation

“More” induction?

Nothing Thalidomide? Bortezomib Ixazomib Lenalidomide Combinations

Bortezomib Panobinostat Lenalidomide Daratumumab Carfilzomib Ixazomib Pomalidomide Elotuzumab Selinexor Isatuximab Belantamab mafodotin* Melphalan flufenamide* Idecabtagene autoleucel Ciltacabtagene autoleucel Teclistamab, Talquetamab Elranatamab, Linvoseltamab

Maintenance

Relapsed

Post Consolidation

Rescue

Daratumumab? Carfilzomib? Lenalidomide + PI

ASCT, autologous stem cell transplant; CAR, chimeric antigen receptor; Cy, cyclophosphamide; d- daratumumab; D/dex, dexamethasone; isa, isatuximab; K, carfilzomib; M, melphalan; PD-L1, programmed death ligand-1; PI, proteasome inhibitor; Rev, lenalidomide; V, bortezomib. Speaker’s own opinions.

CAR T Cell Therapy Bispecific/Tri-specific Antibodies Cell Modifying Agents Venetoclax PD/PDL-1 Inhibition? Small Molecules

* These agents are currently off the market but available through special programs

Anito-cel Cevostomab Iberdomide, Mezigdomide Sonrotoclax KLN-1010 AZD0120

Second/Expert Opinion • You have the right to get a second opinion. Insurance providers may require second opinions. • A second opinion can help you: – Confirm your diagnosis – Give you more information about options – Talk to other experts – Introduce you to clinical trials – Help you learn which health care team you’d like to work with, and which facility

Where can I learn more? Myeloma.org

Thank you https://seer.cancer.gov/statfacts/html/mulmy.html; dated 6.15.2024

The Unseen Impact of Myeloma: Taking Care of your Emotional Health Katie Atkins, LCSW, LCAS, CCS, OSW-C Associate Director, Support Groups, International Myeloma Foundation

THE UNSEEN IMPACT OF MYELOMA: TAKING CARE OF YOUR EMOTIONAL HEALTH IMF Support Group Directors

. .0.2 . .0.2

Disclaimer

The International Myeloma Foundation Support Group Team presents this information to support learning and conversations with your healthcare team. This presentation is for informational purposes only and is not intended to provide medical advice or replace guidance from your medical providers.

AGENDA

COMMON EMOTIONAL RESPONSES

Myeloma is often seen through the lens of physical symptoms, treatments, and survival rates.

Beneath the surface of this medical battle lies a profound emotional journey that affects not only the person diagnosed but also their loved ones.

Initial Feelings

https://opentextbc.ca/introductiontopsychology/chapter/10-1-the-experience-of-emotion/

Shock & Disbelief Some patients describe a feeling of numbness or surrealism after a cancer diagnosis; unable to fully grasp the weight of the news. •

Confusion

•

Disconnection

•

Denial

Anger It is completely normal to experience anger towards: •

Doctors

•

Healthcare team

•

Yourself

•

God

Fear & Worry Patients describe many fears after a myeloma diagnosis, including: •

Fear of death and dying

•

Fear of pain or treatment

•

Fear of rejection/loneliness

•

Fear about the future

•

Practical worries (finances, housing, career, etc.) 55

Grieving Shifts in Identity •

Side effects like fatigue, hair loss, nausea, and cognitive changes can strip away one’s sense of normalcy and identity.

•

Some people feel isolated as they withdraw from social activities, work, or relationships due to physical limitations or emotional distress.

•

The loss of independence and routine can be demoralizing and defeating. 56

Relationship Challenges •

Cancer can significantly impact relationships with partners, family, friends, and coworkers.

•

Some people may not know how to respond or offer support, leading to awkwardness, discomfort, or distance.

•

Care partners can also experience emotional exhaustion, guilt, and helplessness as they witness their loved one's suffering.

Anxiety Symptoms of anxiety include: • ruminating about a specific fear • sleep disturbance • feeling restless or edgy • irritability • being easily fatigued or overstimulated • difficulty concentrating or forgetfulness

Depression Symptoms of depression include: 

Sleep disturbance



Loss of interest/pleasure in activities that used to feel exciting (anhedonia)

•

Feelings of guilt or worthlessness

•

Changes in energy or excessive fatigue Appetite/weight changes

•

Psychomotor disturbance

•

Suicidal thoughts

•

Depressed mood

Prevalence of Depression •

In the US, 23.1% of the general population meet criteria for a diagnosis of a mental health disorder.

•

Over 56% of patients living with blood cancers experience anxiety and depression

Depression is Serious Please take these symptoms seriously AND seek help as you need it! PLEASE call 988 if you ever have thoughts that you may want to hurt yourself.

There is a professional available 24/7 to talk with you! 61

THE SPECTRUM OF EMOTIONS

Finding Value in the Challenge •

This is never about suggesting the illness itself is “good” or that someone should suffer.

•

Rather, it’s about recognizing that within extremely difficult or unwanted experiences, people sometimes discover forms of meaning, strength, connection, or clarity.

Emotional and Spiritual Growth Research in psycho-oncology shows that post-traumatic growth is surprisingly common. People sometimes describe: •

A greater appreciation for life’s small moments

•

New or deepened spiritual beliefs

•

A sense of inner strength they didn’t know they had

•

Increased empathy or patience

Suffering forces confrontation with vulnerability and uncertainty, and some individuals emerge with a transformed worldview.

Healing Versus A Cure •

We may not yet have a cure for myeloma, and the reality is our physical bodies are never perfect, but we can experience emotional or spiritual healing in the midst of this journey.

•

Consider for yourself what it would mean to engage in “healing.”

Hope & Empowerment Cancer strips away control, but in that loss, people often find a different kind of agency: •

Choosing how to spend meaningful time

•

Choosing how to speak about their experience

•

Choosing how they meet uncertainty emotionally and spiritually

The struggle becomes a teacher of resilience and presence. 66

Purpose Through Helping Others A powerful source of meaning comes from turning personal suffering into support for others: •

Advocating

•

Volunteering

•

Leading a support group

•

Sharing one’s story

•

Helping someone newly diagnosed

The idea of “I can use what I’ve been through” gives suffering a sense of direction. 67

COPING WITH YOUR EMOTIONS

Coping with Heavy Emotions • Awareness • Identify • Accept • Recognize • Stay Curious • Let go

Coping with Heavy Emotions Don’t feel that you have to be “strong.” If you feel tired, lonely, anxious, depressed, angry, etc., acknowledge your feelings and talk about them. If all you want to do is cry, then go ahead. Crying is a natural catharsis.

Grief & Gratitude “The work of the mature person is to carry grief in one hand and gratitude in the other and to be stretched large by them. How much sorrow can I hold? That’s how much gratitude I can give. If I carry only grief, I’ll bend toward cynicism and despair. If I have only gratitude, I’ll become saccharine and won’t develop much compassion for other people’s suffering. Grief keeps the heart fluid and soft, which helps make compassion possible.” -Francis Ward Weller

GROUNDING TECHNIQUES

Emotional Grounding Techniques 5-4-3-2-1 Grounding Exercise The “Pretzel” or other bilateral stimulation exercises Mindful Walking 4 Square breathing Categories (i.e. Colors, college football teams, etc.) Aromatherapy Hold a piece of ice Eat a small bite of food with intention and mindfulness 73

WHEN & WHERE TO SEEK HELP

Practical Help Think about what you need. Lots of people will want to help but don’t know how. •

Practical needs

•

Financial help

•

Emotional support

When to Seek Professional Help Your mental health is as important as your physical health! Tell your healthcare team or another medical professional if you need support. Ask if your hematology/oncology clinic employs a clinical social worker or counselor. Emotional support and therapy services are available at many clinics.

WELLNESS TIPS & RESOURCES FOR SUPPORT

Support Groups Provide a Sense of Belonging • • • • • • • • • •

Included Welcomed Connected Accepted Involved Supported Heard Valued Seen Hopeful

Wellness Tips  Talk to friends and family, and others you trust  Ask for help and be specific about what you need  Join a support group  Get education and information only from reliable/reputable sources  Take time for yourself  Spend time with supportive friends  Celebrate every victory! 79

Resources Talk with your doctor to determine what plan of action works best for you. Medications could potentially be part of a treatment plan that you and your doctor work on together. If you think therapy/counseling could be beneficial, ask for a referral or check out websites/platforms such as: •

Headway

•

Better Help

•

Talkspace

•

CaringBridge

•

Psychology Today

Follow up Questions or Discussion? Please feel free to reach out to us! IMF Support Group Team: SGTeam@myeloma.org

Navigating Insurance & Medical Bills Laura Beilke, Esq. Triage Cancer

Navigating Insurance & Medical Bills Laura Beilke, Esq. Staff Attorney, Triage Cancer This presentation provides general information on the topics presented. The authors and presenters are not engaged in rendering any legal, medical, or professional services by its presentation or distribution. Although this content was reviewed by a professional, it should not be used as a substitute for professional services. No part of this presentation may be reproduced, distributed, or transmitted in any form or by any means, without the prior written permission of the author, except properly attributed, noncommercial uses permitted by copyright law. For permission requests, contact the authors at info@triagecancer.org © 2026 Triage Cancer®

About Triage Cancer

Triage Cancer is a national, nonprofit organization that provides free education on the legal and practical issues that may impact individuals diagnosed with cancer and their caregivers. © 2026 Triage Cancer®

Triage Cancer’s Free Resources

• TriageCancer.org • Educational Events • •

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Don’t Understand Health Insurance? You Are Not Alone.

Terms: Costs Cost to Have Health Insurance • Premium: each month (fixed $ amount)

Costs When You Use Health Insurance • Deductible: each year (fixed $ amount) • Co-Payment: each time you get care (fixed $ amount) • Co-Insurance / Cost-Share: each time you get care (%) • Out-of-Pocket Maximum (fixed $ amount): deductible + co-payments + co-insurance

Meet Michael Michael’s Marketplace Plan:

Deductible = $2,000 Co-insurance = 70/30 plan OOP Max = $8,000

If Michael has a $72,000 hospital bill, what does he pay? 1. His deductible of $2,000 $72,000-$2,000 = $70,000 left 2. His co-insurance amount of 30% 30% of $70,000 = $21,000 But OOP max is $8,000. So, he would pay the $2,000 deductible + $6,000 of the $21,000 co-insurance amount, for a total of $8,000. © 2026 Triage Cancer®

Out-of-Pocket Maximums Details . . . There may be a separate out-of-pocket maximum for out-of-network services Individual vs. Family Plans • e.g., Individual $5,000 and Family $10,000 Marketplace Plans • Out-of-pocket max = deductible + co-payments + co-insurance (medical care & drugs) Some Employer Plans • Doesn’t include deductibles • Out-of-pocket max = co-payments + co-insurance • Doesn’t include deductibles or co-payments • Out-of-pocket max = co-insurance • Doesn’t include prescription drugs

• Separate out-of-pocket max for prescription drugs = co-payments + co-insurance

Where We Get Health Insurance

Know Your Health Insurance Options

Health Insurance Resources TriageCancer.org/HealthInsurance • Quick Guide to Health Insurance Options • Quick Guide to Health Insurance Basics • Quick Guide to Health Insurance Marketplaces • CancerFinances.org  Health Insurance • Triage Cancer Blog – Health Insurance • Recorded Webinar: Understanding Medicare • Recorded Webinar: How to Choose & Use Your Health Insurance …and many more! © 2024 Triage Cancer®

Comparing Plan Options Marketplace Plan 1

Employer Plan 1

Marketplace Plan 2

Employer Plan 2

Marketplace Plan

Medicare Advantage Plan 1

Medicare Advantage Plan 2 93

Total Annual Cost

Bronze: Monthly Premium

Deductible

Out-of-pocket Maximum

$200

$6,000

$8,000

Silver: Monthly Premium

Deductible

Out-of-pocket Maximum

$275

$2,500

$6,000

Platinum: Monthly Premium

Deductible

Out-of-pocket Maximum

$400

$2,000 94

Do the Math! Total costs for year = (monthly premium x 12) + OOP max Bronze: Monthly Premium

Deductible

Out-of-pocket Maximum

$200

$6,000

$8,000

$200 x 12 = $2,400 + $8,000 = $10,400 Silver: Monthly Premium

Deductible

Out-of-pocket Maximum

$275

$2,500

$6,000

$275 x 12 = $3,300 + $6,000 = $9,300 Platinum: Monthly Premium

Deductible

Out-of-pocket Maximum

$400

$2,000

Note: for in-network providers only 95

Key Considerations • Cost • Premiums, co-payments, deductibles, co-insurance, out-ofpocket maximums

• Network of providers and facilities • Check if your providers and facilities (hospitals, labs, imaging centers, etc.) are covered

Picking a Health Insurance Plan TriageCancer.org/video-pickingaplan

TriageCancer.org/Worksheet-Medicare

When to Enroll? • Employer plans: varies (often in the Fall) • Medicaid: accepted year round • Medicare: Oct. 15 – Dec. 7* • 2026 Marketplace: Nov. 1 – Jan. 15* • Enroll by Dec. 15 for coverage that starts Jan. 1 • Some states may have longer open enrollment periods • 2027 Marketplace OEP: Nov. 1 – Dec. 31 *Plans are for a calendar year © 2026 Triage Cancer®

Where Are There Opportunities to Lower Costs? Insurance Company Government: Medicare, Medicaid, Military, State & Local Programs, etc.

Employer

100

Help With COBRA Costs

• Health Insurance Premium Payment Program (HIPP) • Medicaid-eligible recipients with group health insurance • Medicaid pays premium for group health insurance (e.g., COBRA) • Don’t have to change providers; employer coverage may be better • 31 states have this program, including: CA, GA, IA, IL, MA, PA, RI, TX, VA TriageCancer.org/StateLaws

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Enhanced Premium Tax Credits “Four in five customers are able to find a plan for $10 or less a month.”

Will continue through 2025 under IRA

Household Size

100%

138%

150%

250%

400%

400% +

$15,960

$22,025

$23,475

$39,125

$62,600

21,640

29,863

31,725

52,875

84,600

27,320

37,702

39,975

66,625

106,600

33,000

45,540

48,225

80,375

128,600

$ help  reduce monthly premiums to 8.5% of household income

38,680

53,378

56,475

94,125

150,600

44,360

61,217

64,725

107,875

172,600

(2026)

(2025)

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Medicare Part D – 2026

• $2,100 out-of-pocket maximum for Part D drug costs • Applies to: • Part D plans • Part C plans with drug coverage

• Does not apply to drugs covered by Part B!!! • If plan has a drug deductible, that counts towards the out-of-pocket maximum • Cap will continue to increase over time

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Medicare Prescription Payment Plan • Out-of-pocket costs can be spread out through the calendar year (aka “smoothing”) • There is no interest charged on the payments • Run by your Part D drug plan • Voluntary program • You have to choose to sign up • You can cancel at any time, but you must pay your balance

• You pay nothing at the pharmacy • Instead, your plan will send you monthly bills for your out-of-pocket drug costs • This is different than your Part D plan monthly premium bill; and • Your Part D Explanation of Benefits document

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Medicare Prescription Drug Exceptions Ask your HCP for supporting statement about why a drug is medically necessary for you •

Alternatives aren’t as effective, and/or

•

Alternatives would cause adverse effects

Timing • Can ask to expedite the request if you can show the standard timeframe will jeopardize life, health, or ability to regain maximum function • After receiving supporting statement, drug plan must provide written notice of decision within 72 hours (24 hours, if expedited request) Appeals • If your request for an exception is denied, appeal! TriageCancer.org/Checklist-MedicarePrescriptionRequest © 2026 Triage Cancer®

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Help Paying for Medicare Parts A & B Medicare savings programs (MSPs) • Helps pay for premiums; and sometimes deductibles, co-payments, & cost-share • Four types of MSPs: 1.

Qualified Medicare Beneficiary (QMB – “Quimby”) Program helps eligible individuals pay for Part A and Part B premiums, as well as deductibles, coinsurance, and co-payments

Specified Low-Income Medicare Beneficiary (SLMB – “Slimby”) Program helps eligible individuals pay for Part B premiums.

Qualifying Individual (QI) Program helps pay the Part B premiums for certain individuals who are not eligible for Medicaid.

Qualified Disabled and Working Individuals (QDWI) Program helps eligible individuals pay their Part A premiums.

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Help Paying for Medicare Part D - 2026 • Low-Income Subsidy (aka Extra Help): most people will pay no premium or deductible & have lower co-payments and cost-share • May be automatically enrolled, but can also apply • Income limit = 150% FPL; Resource limit = $16,590 (individual), $33,100 (married)* • Pay no more than $5.10 for each generic/$12.65 for each brand-name covered drug • www.ssa.gov/benefits/medicare/prescriptionhelp

• State Pharmaceutical Assistance Programs (SPAP): pays some premiums or drug costs • Programs not available in every state: www.medicare.gov/plancompare/#/pharmaceutical-assistance-program/states/ © 2026 Triage Cancer®

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Consumer Protections: Appeals • Denials of coverage (aka “adverse benefit determination” (ABD)) • Internal appeals • External appeals (individual and employer plans) • AKA: Independent or External Medical Review • Conducted by an independent medical review organization (IRMO) or independent review entity (IRE) • State Health Insurance Agency: Triagecancer.org/StateResources • Cost: $0 if HHS process. Up to $25 if issuer contracts with IRO or uses state process • Is it worth it?

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Hurdle: Knowledge

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Hurdle: Staying Organized

• Keep track of: • Dates, times, and method of any contact (phone, email, etc.) • Names of people you talk to • Summaries of your conversations • Any documents you send or receive • Important dates

TriageCancer.org/AppealTrackingForm

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Appeals Checklist  Understand why your claim was denied  Gather your evidence  Submit necessary paperwork  Pay attention to deadlines  Remember the Golden Rule  File external appeal if needed  Expedite appeal if appropriate  Stay organized  Don’t give up! © 2026 Triage Cancer®

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Health Insurance Appeals Resources TriageCancer.org/HealthInsurance

• Quick Guide to Appeals for Employer-Sponsored & Individual Health Insurance • Quick Guide to Access to Medical Records • Health Insurance Appeals Tracking Form • CancerFinances.org – Health Insurance Appeals Module • Recorded Webinar: Health Insurance Appeals • Animated Video: When an Insurance Company Says No

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Managing Medical Bills • From your insurance company: We have received a claim

We are processing your claim

Explanation of Benefits

113

114

Managing Medical Bills

• From your provider: • The bill

• Doesn’t always happen in this order! • • • • •

Wait for the EOB before paying any bills Compare EOB & Bills – check for errors! Ask questions of providers and insurance Was coverage denied? Appeal! Do you qualify for hospital charity care?

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Charity Care

• Nonprofit hospitals are required to offer free or discounted health care to patients with certain incomes • A/K/A financial assistance or ability to pay programs • Can include inpatient and emergency room services • Bill shouldn’t go to collections while application under review • Apply for help from Dollar For: DollarFor.org/TriageCancer

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Negotiate! • Contact providers if having trouble paying your bills • When: • Before unpaid bills sent to collections agencies

• What: • Ask for more time • Check to see if they would be willing to: • Write off a portion of your bill; • Negotiate a payment plan; or • Accept a lower lump sum payment Note: can work with other creditors, too! © 2026 Triage Cancer®

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Medical Bill Tracker TriageCancer.org/Worksheet-BillTracker

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Benefits to Keeping Track . . .

• Paying co-pays & co-insurance when you visit a provider • What to do if you have already met your OOP maximum? • What to do when a provider asks you to pre-pay your co-insurance?

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Keep Records Of…  Medical bills from all healthcare providers:  Hospital admissions, clinic visits, lab work, diagnostic tests, procedures, treatments  Drugs given & prescriptions ordered  Claims filed

 Payments from insurance companies and explanations of benefits  Any pre-authorizations  Dates, names, and outcomes of any correspondence with insurance companies or providers  Non-reimbursed or outstanding medical and related costs  Meals, lodging, and travel expenses (including gas, parking, and tolls)  Your medical records *Some of these may be tax-deductible! © 2026 Triage Cancer®

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Triage Cancer Conference Educational event for: • Individuals diagnosed with chronic or serious medical conditions • Caregivers Online 2026: • Health care teams • May 15-16 • Advocates & others Topics: • November 6-7 • Being an Advocate TriageCancer.org/Conferences • Health Insurance • Finances “Absolutely amazing. Triage Cancer Conference supplied me with a lot of details on information that I thought I • Being Prepared knew....I was wrong. However, I do feel more confident in • Employment each of the topics that were discussed.” –Virtual Attendee • Disability Insurance *Free CEs/Contact Hours for nurses, social workers, & patient advocates *Free PDCs for HR professionals © 2026 Triage Cancer®

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Webinar Series

Upcoming Topics: • March 24 ~ Steps to Navigate Common Insurance Hurdles • April 22 ~ Medicare Made Simple: A Guide for First-Time Enrollees • May 27 ~ Coping with Stress Full Schedule & Registration: TriageCancer.org/Webinars Recordings of Past Webinars: TriageCancer.org/Past-Webinars *Free Contact Hour/CE for nurses, social workers, & patient advocates *Free PDCs for HR professionals © 2026 Triage Cancer®

“It is helpful to know this info at the beginning of a cancer diagnosis or at the VERY LEAST to know it exists, as you do not know what you do not know!” –Attendee

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Legal & Financial Navigation Program Free, one-on-one help for: • Individuals diagnosed with cancer • Caregivers • Health care professionals

Health Insurance, Employment, Disability Insurance, Finances, Estate Planning, & More Our Navigation services: • Explain options • Provide accurate information • Empower you to take next steps

Start Online: TriageCancer.org/GetHelp For Spanish: TriageCancer.org/ConsigueAyuda 124

2026 Myeloma Advocacy Priorities & How You Can Get Involved Danielle Doheny Director of Public Policy & Advocacy, International Myeloma Foundation

2026 MYELOMA ADVOCACY PRIORITIES & HOW YOU CAN GET INVOLVED Danielle Doheny IMF, Director of U.S. Policy & Advocacy

Introduction | Advocacy at the IMF The IMF Advocacy Team collaborates with multiple stakeholders to inform and influence decision-making on the critical healthcare issues that directly impact myeloma patients.

The U.S. Advocacy Team advocates for equitable access to timely diagnosis, innovative treatments and research funding on Capitol Hill and with key regulatory agencies. The team advocates both alongside of and on behalf of the patient community that we serve.

Advocacy play a critical role to educate policymakers about the issues important to our community and motivate them to act.

What Do We Advocate For? The following policy principles are the foundation on which we prioritize our advocacy work.

Ensure Access to Care: We advocate for policies that ensure all myeloma patients have equitable, comprehensive, patientcentered care without insurance barriers that limit options or delay treatment initiation.

2. Eliminate Financial Barriers: We advocate for policies that allow myeloma patients access to treatments and supportive care interventions without facing financial hardships. 3. Advance Myeloma Research: We advocate for annual appropriations funding for myeloma research and the advancement of clinical trial eligibility and research protocols that ensure representation from diverse populations.

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2026 U.S. Advocacy Priorities Snapshot 1. ENSURE ACCESS TO CARE

INSURANCE REFORM: DRUG ACCESS INSURANCE REFORM: DRUG ACCESS MEDICARE REFORM: PHYSICIAN ACCESS

Step Therapy Protocols Safe Step Act

PBM Reform PBM Reform Act

2. ELIMINATE FINANCIAL BARRIERS

INSURANCE REFORM: COINSURANCE

INSURANCE REFORM:

MEDICARE REFORM: ANNUAL COST LIMITS

Annual Appropriations

Oral Parity Cancer Drug Parity Act FEDERAL FUNDING

Copay Accumulators HELP Copays Act

COPAYS

Tele-Health/Medicine Telehealth Modern. Act

3. ADVANCE MYELOMA RESEARCH

Inflation Reduction Act implementation Cap & Smoothing (MPPP), Drug Pricing, Drug Formularies

ANNUAL APPROPS

NIH: National Cancer Institute, National Institute on Minority Health, ARPA-H CDC: Comprehensive Cancer Control Initiative DoD: Congressionally Directed Medical Research Program (CDMRP) for Myeloma.

Primary care education, Focus on underserved, CLINICAL TRIAL ACCESS POC, rural settings and socioeconomically disadvantaged groups

How You Can Get Involved

Patients and caregivers are the most powerful voices in health policy. 130

Your Voice Matters in Washington, D.C. WHAT THIS IS: Each year, the International Myeloma Foundation brings myeloma patients and caregivers to Capitol Hill to meet with members of Congress. Together, we advocate for: • Better access to treatment • Stronger support for cancer research • Policies that improve the lives of people living with myeloma

HOW YOU CAN GET INVOLVED: No policy experience is needed. Just a willingness to share your experience. IMF provides: • Advocacy training • Policy briefings • Guidance every step of the way Email us to join the IMF Advocacy Master Class and prepare for the next Hill Day.

Advocacy Works: Protecting Cancer Research Funding

Program

President’s FY26 Budget Proposal

Final FY26 Funding Outcome

NIH

-$18 billion cut proposed

+$415 million increase

NCI

-$2.7 billion cut proposed

+$128 million increase

ARPA-H

-$545 million cut proposed

Level funding

CDC Cancer Programs

Program eliminated

+$3 million increase

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Addressing healthcare barriers for multiple myeloma patients depends on winning over the hearts and minds of policymakers. It is not enough to just identify an issue and have data-driven evidence/research to back it up. It is not even enough to work with coalition partners that agree with our point of view. We must convince policymakers to prioritize our issues, draft legislation and vote it into law. Email us at advocacy@myeloma.org Join Us! Join the Advocacy Team and share Your Story.

Thank You

Myeloma 202: Immunotherapy Made Simple Joseph Mikhael, MD, MEd, FRCPC, FACP, FASCO Chief Medical Officer, International Myeloma Foundation

Patient and Family Seminars

Objectives • Discuss the concept of immunotherapy and how it applies to myeloma • Review how we are using immunotherapy already in myeloma – – – –

Monoclonal Antibodies Antibody Drug Conjugates (ADCs) CAR (Chimeric Antigen Receptor) T Cell therapy Bispecific/Trispecific Antibodies

• Predict the future of myeloma and its reliance on immunotherapy…

The Immune System and Cancer

J Clin Invest. 2007 May 1; 117(5): 1137–1146.

Uhhhhh it’s complicated…. Myeloma Cell

Myeloma Cell

Increase in cytokine production and adhesion molecules

NFkB

Block of programmed cell death

AKT MAPK JAK–STAT

SHP2

NFkB–IkB complex

MEK

Protein kinases

IL-6 TNFα

SDF1 IGF1

Pro-caspase B

cFLIP/FADD Cell organelles

cFLIP

FAS (CD95)

FADD LFA1

FAS ligand Collagen fibers

VLA4 VCAM1

T Cells Fibronectin

MEK/MAPK

VEGF

NFkB–IkB complex

NFkB Binding Site

NFkB

BM Stromal Cells Angiogenesis Migration Growth

Dendritic Cells Bruno B et al. Lancet Oncol. 2004;5:430-442.

Natural-Killer Cells

TNFα

Monocytes

Inhibition of Anti-Myeloma Immunity

Key Immunotherapy Approaches in Myeloma • Monoclonal Antibodies

– Daratumumab, Elotuzumab, Isatuximab

• Antibody-Drug Conjugates – Belantamab

• CAR T cell therapy – Ide-cel, cilta-cel

• Bispecific Antibodies

– Teclistamab, Talquetamab, Elranatamab, Linvoseltamab

• Future Directions – MORE antibodies, novel CAR T and much more!

Targets on the Myeloma Cell Surface and Therapeutic Antibodies Bi-Specific Antibodies Talvey (Talquetamab) CAR-T

Bi-Specific Antibodies CAR-T GPRC5D

FcRH5

SLAMF7

CD38 Monoclonal Antibodies Daratumumab and Darzalex Faspro Sarclisa (Isatuximab) TAK-079 MOR202

Antibody Drug Empliciti (Elotuzumab) Bi-Specific Antibodies

BCMA

Immune Therapies Abecma (Ide-cel CAR-T) Carvykti (Cilta-cel CAR-T) Tecvayli (Teclistamab) Elrexfio (Elranatamab) Lynozyfic (Linvoseltamab) Other CAR-Ts Other Bi-Specific Antibodies

Antibody Drug Conjugates (Belantamab approved in MM)

How it works: An antibody directed at a target (BCMA) combined with a cytotoxic agent (chemotherapy)

ADC = Antibody-Drug Conjugate BCMA = B-Cell Maturation Antigen ADCP/ADCC = Antibody-Dependent Cellular Cytotoxicity & Phagocytosis Image Credit: https://creativecommons.org/licenses/by-nc/3.0/

CAR T Cell Therapy

Myeloma Cell CAR T Cell Therapy

CAR T Cell . Abecma (Idecabtagene vicleucel)

Ide-cel

Carvykti (ciltacabtagene autoleucel)

cilta-cel

Intravenous

Harnessing the Power of a Patient’s Own Immune System to Target and Kill Myeloma

Apheresis

ENGINEERED AUTOLOGOUS CELL THERAPY

Manufacturing Process

Infusion

The Process of CAR T Cell Therapy

Hucks G, Rheingold SR. Blood Cancer J. 2019;doi:10.1038/s41408-018-0164-6.

Toxicities with CAR T Cell Therapy

Toxicities with CAR T Cell Therapy Early (Days/Weeks)

Delayed (Weeks/Months)

Long-term (Years)

Cytokine Release Syndrome (CRS)

Delayed neurotoxicity (Parkinsonism, cranial nerve palsy)

Second cancers

Neurotoxicity (ICANS)

IEC-Colitis

Unknown long-term effects

IEC-HS Cytopenias and infections ICANS = immune effector cell-associated neurotoxicity syndrome IEC = immune effector cell

The Future of CAR T Cell Therapy • Novel CAR Ts with unique features

– non BCMA targets (GPRC5D, FcRH5 and others) – “fast Cars” with shorter manufacturing time – enhanced binding • •

dual targeting d-domain binding

• in vivo CAR T – without the need of T cell collection or lymphodepleting

chemotherapy

• Allo-CAR T – external T cells infused into the patient

Bispecific Antibodies – BCMA

•Incorporates 2 antibody fragments to target and bind both tumor cells and T cells •Brings target-expressing MM cells and T cells into close proximity, enabling T cells to induce tumor-cell death •BCMA = B Cell Maturation Antigen

149

Targets of Bispecific Molecule Vary Agent

Tumor Cell Target

T-Cell Target

Teclistamab Elranatamab Linvoseltamab

BCMA

CD3

Talquetamab

GPRC5D

CD3

Cevostamab

FcRH5

CD3

The Future of Bispecific Antibodies • Novel targets

– FcRH5 (Cevostamab)

• More convenient dosing – monthly (Etentamig)

• Trispecific Antibodies

– dual MM Cell targeting – potential for enhanced binding and less resistance

• Combinations with other MM agents (Teclistamab-Daratumumab)

Conclusions • Immunotherapy has completely transformed cancer care • In MM we have several forms of immunotherapy already approved and

many many more to come

• There may be a day when immunotherapy may replace traditional induction

therapy and stem cell transplant

• The next wave of immunotherapy will be likely MORE effect and have LESS

side effects

• The IMF houses the immunotherapy database so we can learn more about

this treatment even more quickly

Understanding Clinical Trials Joseph Mikhael, MD, MEd, FRCPC, FACP, FASCO, Chief Medical Officer, International Myeloma Foundation Robin Tuohy VP Patient Support, International Myeloma Foundation

Understanding Clinical Trials Joseph Mikhael MD, MEd, FRCPC, FACP, FASCO Chief Medical Officer, International Myeloma Foundation

Objectives 1. Provide The Rationale For Clinical Trials 2. Outline The Phases Of Clinical Trials 3. Discuss The Risks And Benefits Of Clinical Trials 4. Highlight the role of the IMF in Clinical Trials

155

Clinical Trials - Overview Some Of The Important Principles Of Clinical Trials: 

The drive of research has brought us to where we are



No one is expected to be a “guinea pig” with no potential benefit to them



Research is under very tight supervision and standards



Open, clear communication between the physician and the patient is fundamental

Driving research forward!

Clinical Trials – Why Me?? 

Every patient is unique and must be viewed that way



Benefits of trials are numerous and include:



Early access to “new” therapy



Delay use of standard therapy



Contribution to myeloma world – present and future



Financial access to certain agents

Must be balanced with potential risks 

“Toxicity” of side effects



Possibility of lack of efficacy

Overview of New Drug Development

Identify a target for therapy in the laboratory

Confirm the anticancer activity in laboratory and animal studies

Clinical trials (human studies) to determine safety, dosing and effectiveness

The whole process costs millions of dollars and years of effort!

Even Before Phase I  Most agents are tested in lab models 

Various “myeloma cell lines”, also known as “in vitro”

 Next step is animal model 

We are more like mice than you think!!

 Earliest study in Phase I is called

“First in Human” 

Often uses extremely low dose of drug to ensure safety

Phase 1 Clinical Trials 

All patients receive the experimental therapy



Phase 1 trials find the optimal dose of a new drug or drug combination



Patients get higher doses as the study continues



Determine side effects of new drugs or combinations



Explore how the drug is metabolized by the body



Important for all stages of myeloma

Phase 2 Clinical Trials 

Determine if a new drug or combination is effective against the cancer



May be added to a Phase 1 study once the ideal dose is found



Patients usually receive the experimental therapy



In some cases, the study may include two “arms” comparing either two different doses or a different treatment (another combination of drugs)

Phase 3 Clinical Trials 

Highest form of clinical evidence. Typically, a large number of patients are required…usually required for full FDA approval



Patients receive either an experimental therapy (one or more drugs) or the current standard treatment o

The patient is randomly assigned to a treatment—a process called “randomization”

Neither the physician or the patient can determine which treatment is given



May be placebo controlled, if no standard treatments are available



Very closely monitored for effectiveness and side effects

Preclinical PHASE 1

Clinical Trial Phases ANIMAL STUDIES: Examine safety and potential for efficacy FIRST INTRODUCTION OF AN INVESTIGATIONAL DRUG INTO HUMANS • Determine metabolism and PK/PD actions, MTD, and DLT • Identify AEs • Gain early evidence of efficacy, studied in many conditions; typically, 20 to 80 patients; everyone gets agent

PHASE 2

EVALUATION OF EFFECTIVENESS IN A CERTAIN TUMOR TYPE • Determine short-term AEs and risks; closely monitored • Includes up to 100 patients, typically

PHASE 3

GATHER ADDITIONAL EFFECTIVENESS AND SAFETY INFORMATION COMPARED TO STANDARD OF CARE

PHASE 4

• Placebo may be involved if no standard of care exists; hundreds to several thousand patients • Often multiple institutions; single or double blind; sometimes open label

APPROVED AGENTS IN NEW POPULATIONS OR NEW DOSE FORMS AE = adverse event; DLT = dose-limiting toxicity; MTD = maximum tolerated dose; PD = pharmacodynamics; PK = pharmacokinetics. Faiman B, et al. Adv Pract Oncol. 2016;7:17-29.

Clinical Trials: Benefits of Participation Possible Benefits: • Patients will receive, at a minimum, the best standard treatment • If the new treatment or intervention is proven to work, patients may be among the first to benefit • Patients have a chance to help others and improve cancer care

This Photo by Unknown Author is licensed under CC BY

164

Risks of Participation Possible risks: • New treatments or interventions under study are not always better than, or even as good as, standard care • Even if a new treatment has benefits, it may not work for every patient • Health insurance and managed care providers do not always cover clinical trials

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Why Do So Few Cancer Patients Participate in Trials? Patients may: • • • • • • • •

Be unaware of clinical trials Lack access to trials Fear, distrust, or be suspicious of research Have practical or personal obstacles Face insurance or cost problems Be unwilling to go against their physicians’ wishes Not have physicians who offer them trials Have a disconnect with their healthcare team

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Diversity in Clinical Trials There has been a lack of diverse representation in clinical trials in myeloma.  In the U.S., approximately 20% of all myeloma patients are of African descent, but only 5%–8% of patients in myeloma clinical trials are of African descent. This is significant for the following reasons:  All patients of all races and ethnicities should be able to benefit from clinical trials.  Diverse patient representation in clinical trials is required to ensure that the outcomes are applicable to all patients. Reasons for underrepresentation in clinical trials are complex and include:  Systemic racism, accessibility of clinical trials, sensitivity to diversity by medical professionals  Misconduct in medicine in the past, the lack of trust in the system, and more.

Diversity in Clinical Trials Program Objective: To promote trust and educate patients regarding clinical trials, particularly those from populations underserved by clinical trials, laying the groundwork for potential future trial participation

Importance of Clinical Trial Participation by Diverse Populations

“

People from racial and ethnic minorities and other diverse groups are underrepresented in clinical research. This is a concern because people of different ages, races, and ethnicities may react differently to certain medical products. – FDA

Leadership and commitment Community engagement practices

Investigator hiring, training, and mentoring practices

Patient engagement practices

FDA = US Food and Drug Administration. Regnante JM, et al. J Oncol Pract. 2019;15(4):e289-e299. FDA website. Clinical Trial Diversity. Accessed March 27, 2024. https://www.fda.gov/consumers/minority-health-and-health-equity/clinical-trial-diversity.

US Cancer Centers of Excellence: Strategies for Increased Inclusion of Racial and Ethnic Minorities in Clinical Trials

169

Is A Clinical Trial Right For Me? 

Discuss with your physician if you are eligible for a clinical trial



Work with your physician to determine the best trial for you



Meet with the clinical research nurse or trials coordinator to discuss the trial



Carefully review the provided “Informed Consent” 

Describes the study and any potential safety concerns related to the experimental medication

Clinical Trials: Myths MYTH: If I participate in a clinical trial, I might get a placebo, not active treatment MYTH: If I participate in a clinical trial, I can’t change my mind

• Phase 1 and 2, everyone gets active treatment • Phase 3 standard of care vs new regimen: often standard regimen with/without additional agent in MM trials • Patients can withdraw their consent for clinical trial participation at any time

MYTH: Clinical trials are dangerous because they have new medicines and practices

• Some risk is involved with every treatment, but medicines are used in clinical trials with people only after they have gone through testing to indicate that the drug is likely to be safe and effective for human use

MYTH: Clinical trials are expensive and not covered by insurance

PhRMA website. Accessed March 25, 2024. https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/A-C/CLINICAL-TRIALS-MYTH-FACTPRINT.pdf?hsCtaTracking=f6689b95-1626-40d9-8c87-c6b8d31600a4%7C35221aa8-d487-4db3-9416-b9c3c35e3bac.

• Research costs are typically covered by the sponsoring company • Standard patient care costs are typically covered by insurance • Check with clinical trial team/insurers; costs such as transportation, hotel, etc may not be reimbursed and are paid by patient

Resources to Find Clinical Trials

Resources to Find Clinical Trials and Avoid Bias

IMF Infoline US & Canada: 800-452 CURE (2873) Worldwide: 1-818-487-7455 infoline@myeloma.org

Clinicaltrials.gov https://clinicaltrials.gov/

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Conclusions Clinical Trials are a critical part of myeloma therapy

Every myeloma patient should at least consider participation in a trial when relevant

The IMF is deeply committed to improving access to clinical trials, especially in those who have been historically underrepresented

The IMF will continue to expand its work in clinical trials – STAY TUNED! 173

Q&A WITH GUEST PANEL

THANK YOU TO OUR SPONSORS!

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5:15 – 7:00 PM Welcome Reception Royal Palm Ballroom

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OUR MISSION:

Improving the quality of life of myeloma patients while working toward prevention and a cure.

OUR VISION:

A world where every myeloma patient can live life to the fullest, unburdened by the disease.

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Let’s Get Social:

Myeloma.org