San Francisco PFS - Friday Slide Deck

2024 San Francisco Patient and Family Seminar

April 12 & 13, 2024

What do the dots mean?

More than 1 year since diagnosis

Stem cell transplant recipient

Less than 1 year diagnosed

Care Partner for someone with Myeloma

Friday Agenda

12:00 – 1:00 PM Registration

1:00 – 1:15 PM Welcome and Agenda Review

Yelak Biru President, Chief Executive Officer and 28-year Myeloma Survivor Patient

Robin Tuohy, Vice President, Patient Support

1:15 – 1:30 PM Hot Topics in Myeloma

Joseph Mikhael, MD, MEd, FRCPC, FACP - Chief Medical Officer; Translational Genomics Research Institute, City of Hope Cancer

Center

1:30 – 1:50 PM Shared Decision Making

Teresa Miceli, RN, BSN, OCN - InfoLine Advisor, Nurse Leadership Board; Mayo Clinic-Rochester

1:50 – 2:10 PM Advanced Care Planning

Wendy Thomas, RN, MSN, CHPN – Palliative Care Nurse Specialist, Kansas University Medical Center; Support Group Leader

2:10 – 2:25 PM Myeloma.org: Resource Review

Robin Tuohy

2:25 – 2:45 PM BREAK

2:45 – 3:25 PM Myeloma 101 & Understanding Your Labs

Joseph Mikhael, MD, MEd, FRCPC, FACP & Teresa Miceli, RN, BSN, OCN

3:25 – 4:05 PM Financial Considerations in Myeloma

Erin Bair, Esq., Triage Cancer

4:05 – 4:35 PM Clinical Trials

Joseph Mikhael, MD, MEd, FRCPC, FACP & Yelak Biru

4:35 – 4:50 PM Q & A with Panel

4:50 – 5:00 PM Day 1 Recap, Day 2 Announcements & Evaluations

Robin Tuohy 5:00 – 7:00 PM Welcome Reception & Networking

Foyer A/B

The IMF Support Group Team is Here For You!

Shared Experiences Help to Better Understand the Myeloma Journey

• Support Groups Empower Patients & Care Partners with information, insight, & hope

• The IMF provides educational support to a network of over 150 myeloma specific groups

We are happy to help connect you with an existing support group or help form a new one!

We assist with virtual, in-person, and hybrid options for meetings.

Local Support Groups: You Are Not Alone!

 Myeloma Stompers

(Napa/Sonoma)

Meets virtually the 2nd Friday of each month at 10AM

 San Gabriel Valley

Myeloma Support Group

Meets in-person the 1st Monday of each month at 6:30PM

 Upland, CA

Myeloma Support Group

Meets hybrid the 1st Friday of each month at 10AM

 San Francisco Bay Area

Myeloma Support Group

Meets virtually the 3rd Saturday of each month at 10AM

 Westlake Myeloma Support Group

Meets virtually the 2nd Saturday of each month at 11AM

 San Fernando Valley Myeloma Support Group

Meets in-person the 3rd Wednesday of each month at 7PM

 Sacramento Area

Myeloma Support Group

Meets virtually the 1st Saturday of each month at 10AM

Local Support Groups: You Are Not Alone!

 San Diego Multiple Myeloma Support Group

Meets hybrid the 2nd Monday of each month at 6:30PM

 Inland Empire, CA

Myeloma Support Group

Meets hybrid the 3rd Saturday of each month at 10:30AM

 Orange County

Myeloma Support Group

Meets in-person every other month & virtually the alternate months on the 1st Thursday of each month

 Los Angeles Multiple

Myeloma Support Group

Meets virtually on the 3rd Saturday of each month at 10:30AM

 Santa Cruz Multiple Myeloma Support Group

Meets virtually the 1st Monday of each month at 4:30PM

 Rancho Mirage, CA

Myeloma Support Group

Meets virtually on the 1st Thursday of each month at 3PM

Special Interest Virtual Groups

Special interest groups are designed as a supplemental support for specific populations of patients, in addition to their local Support Groups

 Las Voces de Mieloma Spanish speaking

patients & care partners

 Living Solo & Strong with Myeloma

For patients without a care partner

 High Risk Multiple Myeloma

For high-risk myeloma

Patients & care partners

Coming Soon!

 Care Partners Only

Designed to address the needs of care partners only

 Smolder Bolder

Created for people living with Smoldering Myeloma

 MGUS 4 Us

Created for people living with MGUS

 MM Families

For patients & care partners with young children

EVALUATION

Please be sure to complete your program evaluation today.

Questions 1 – 5 can be completed before the program begins.

Questions 7 & 8 can be answered after each presentation.

If you are attending Friday program only, we ask that you turn the survey in at the end of the day.

If you are coming back for the Saturday sessions, please hold onto your survey, bring it back tomorrow and turn it in at the end of the program.

We greatly appreciate your time and feedback!

Hot Topics in Myeloma

Joseph Mikhael, MD, MEd, FRCPC, FACP

Chief Medical Officer, International Myeloma Foundation

Professor, Translational Genomics Research Institute City of Hope Cancer Center

Teresa Miceli, RN BSN OCN

International Myeloma Foundation - InfoLine Advisor, NLB Member, Support Group Leader (MMSS, Smolder Bolder) Mayo Clinic – Myeloma Nurse Navigator

National Cancer Institute - Myeloma Patient Advocate

Goals



Review Share Decision Making (SDM)



Identify influencing factors to Treatment Decision Making



Discuss strategies to enhance patient empowerment & promote Shared Decision Making

Ineligible Patients Consolidation / Maintenance Continued therapy

Supportive Care Initial Therap y Transplant (ASCT) Maintenance Treatment of Relapsed disease Transplant Eligible Patients Transplant

Individual Care Partner Family Employme nt & Finances Social Network & Obligations

Individual Beliefs & Preference s Quality of Life (QOL) Satisfaction and Adherence

Terpos E, Mikhael J, Hajek R, Chari A, et. al. Management of patients with multiple myeloma beyond the clinical-trial setting: understanding the balance between efficacy, safety and

SDM: Patient-Centered Care

“The aim of shared decision making is to ensure that:

- Patients understand their options and the pros and cons of those options.

- Patient's goals and treatment preferences are used to guide

https://www.ahrq.gov/cahps/quality-improvement/improvement-guide/6-strategies-for-improving/co mmunication/strategy6i-shared-decisionmaking.html#6i1

Steps in Shared Decision-Making

HCP=Health Care Provider

https://www.ahrq.gov/health-literacy/professi

onal-training/shared-decision/index.html

Recognizing and acknowledging that a decision is needed:

The HCP informs the patient that a decision is to be made and that the patient's opinion is important (Choice talk).

Knowing and understanding the best available evidence-based options:

The HCP explains the options and their pros and cons. The patient expresses their preferences, and the HCP supports the patient in deliberation (Option talk).

The HCP and patient discuss the patient's wish to take part in the decision making and incorporate the patient's values and preferences into the decision (Decision talk).

The HCP and patient follow-up:

Stiggelbout AM, Pieterse AH, De Haes JC. Shared decision making: Concepts, evidence, and practice. Patient Educ Couns. 2015 Oct;98(10):1172-9

Review and evaluate the decision, adjust as needed

Advantages to Partaking in SDM

Patients, regardless of age, want to be a part of treatment decision-making

 Requires staying informed

 Reduces uncertainty and alleviates concerns

 Decisions reflect personal and family values

 Promotes patient and care partner engagement and sense of empowerment

 Positive impact on QOL

 Lower demand on health care resources

“The 'efficacy' of treatment means different things to different patients, and treatment decision-making in the context of personalized medicine must be guided by an individual's composite definition of what constitutes the best treatment choice.”

Terpos, et al.

Influencing Factors to Treatment Decision-Making

Disease-derived

 Time: Stage, risk stratification, Urgent intervention needed vs time to consider options

 Treatment: Availability/access, effectiveness, toxicity, current research

Choon-Quinones, Mimi, Hose D, Kaló Z, Zelei T, Harousseau JL, Durie B, Keown P, Barnett M, Jakab I. Patient and Caregiver Experience Decision Factors in Treatment Decision Making: Results of a Systematic Literature Review of Multiple Myeloma Decision Aids. Value Health. 2023 Jan;26(1):39-49. doi: 10.1016/j.jval.2022.04.003. Epub 2022 May 22. PMID: 35613958.

Patient-derived

Provider-derived

 Time limitations

 Support for patient involvement

 Provider bias and preference

 Understanding complex treatment options

 Physical and emotional wellness

 Comfort in speaking up “Doctor knows best”

 Financial, Cultural and Religious factors

 Care partner & social network, transportation

https://www.ahrq.gov/sites/de fault/files/wysiwyg/cahps/qua lity-improvement/improveme nt-guide/6-strategies-for-impr oving/communication/cahps-s trategy-section-6-i.pdf

Strategies for Patient Empowerment

 Stay informed, understand options

 Use reliable and current sources of information

 Use caution considering stories of personal experiences

 Consider your priorities

 Discuss with your care partner

 Consider your goals/values/preferences

 Be a part of the conversation, create a dialog

 Ask questions & Express your goals/values/preferences

 Ask for time to consider options, if needed

 Arrive at a treatment decision

Know the Members of Your Care Team

Understand their different roles

 Myeloma specialist and General Heme/Onc

 Primary care: for health screening, general check ups, vaccinations

 Sub-specialists: specialty needs

 Keep a contact list of your providers

Primary Care Provider (PCP)

Family/Support Network

Subspecialists

You & Your Care Partner

Allied Health Staff

General Hem/Onc

Myeloma Specialist

Prepare

Prepare For Medical Visits

 Medications: Bring a current list of prescribed and over-thecounter

 Questions: Prioritize questions & concerns including financial issues

 Paperwork needing medical signature (ex. FMLA, prior authorizations)

Inform

 Updates: Medical or life changes since your last visit

 Symptoms: How have they changed (improved, worsened, stable)?

Keep a symptom diary. Bring it along

 Communicate effectively so your health care team can help

Follow Up

 “Next Steps”: Future appointments, medication changes, plan of care. Ask for the information in writing or on your patient portal

Include a care partner, especially for pivotal appointments

Consider Telemedicine

Prepare For Tele-Med Visits

Check with your healthcare team –

 Is telemedicine an option?

 What is the process and what technology is needed?

 Are labs needed in advance? Do you need an order?

Preparation is similar for “in-person” appointment

PLUS:





Location: quiet, well-lit location with strong Wi-Fi is best

Yourself: Do you need to show a body part - wear accessible clothing

 Vital signs (blood pressure, temp, heart rate, weight)

self-serve blood pressure cuff is available at many pharmacies and for purchase

Include a care partner, especially for pivotal appointments

Create a Care Partner Network

Myeloma causes the highest burden of symptoms, most commonly effecting people of older age with other medical issues. Care partner support is valuable in SDM

Care partners assist in many ways

• Attending medical appointments, being present to learn and discuss possible treatment options and alert the medical team of side effects to treatment

• Some treatment options available only if care partner support exists

Care partners can be one person or a rotation of many people (Care Network)

Building a partnership is based in good communication

• Finding the balance:

- helping the patient with needed activities while maintaining a sense of independence

- allowing the care partner to have time for good selfcare Care Partner Tip Card https://www.myeloma.org/resource-library/tip-cardcare-partners

Terpos, et al. 2021; Soong, et al., 2023 Image Credit: https://www.mmtoldtrue.com/community/care-partner-corner

Resource List

Bylund CL, Eggly S, LeBlanc TW, Kurtin S, Gandee M, Medhekar R, Fu A, Khurana M, Delaney K, Divita A, McNamara M, Baile WF. Survey of patients and physicians on shared decision-making in treatment selection in relapsed/refractory multiple myeloma. Transl Behav Med. 2023 Apr 15;13(4):255-267. doi: 10.1093/tbm/ibac099. PMID: 36688466.

Chari A, Romanus D, DasMahapatra P, Hoole M, Lowe M, Curran C, Campbell S, Bell JA. Patient-Reported Factors in Treatment Satisfaction in Patients with Relapsed/Refractory Multiple Myeloma (RRMM). Oncologist. 2019 Nov;24(11):1479-1487. doi: 10.1634/theoncologist.2018-0724. Epub 2019 Aug 1. PMID: 31371520; PMCID: PMC6853123.

Factors in Treatment Decision Making: Results of a Systematic Literature Review of Multiple Myeloma Decision Aids. Value Health. 2023 Jan;26(1):3949. doi: 10.1016/j.jval.2022.04.003. Epub 2022 May 22. PMID: 35613958.

Rifkin RM, Bell JA, DasMahapatra P, Hoole M, Lowe M, Curran C, Campbell S, Hou P, Romanus D. Treatment Satisfaction and Burden of Illness in Patients with Newly Diagnosed Multiple Myeloma. Pharmacoecon Open. 2020 Sep;4(3):473-483. doi: 10.1007/s41669-019-00184-9. PMID: 31605300; PMCID: PMC7426337.

3718 Cytokine Release Syndrome: The Patient, Caregiver and Healthcare Professional Experience. Janelle Soong, Giuseppe De Carlo, Naziah Lasi-Tejani, Sumanjit K. Sethi, Natacha Bolaños, Martine Elias, Yelak Biru, Solène Clavreul, G. Scott Chandler, Klaus Finzler, Yann Nouet, Antonio Giuseppe Del Santo. Blood (2023) 142 (Supplement 1): 3718

Terpos E, Mikhael J, Hajek R, Chari A, Zweegman S, Lee HC, Mateos MV, Larocca A, Ramasamy K, Kaiser M, Cook G, Weisel KC, Costello CL, Elliott J, Palumbo A, Usmani SZ. Management of patients with multiple myeloma beyond the clinical-trial setting: understanding the balance between efficacy, safety and tolerability, and quality of life. Blood Cancer J. 2021 Feb 18;11(2):40. doi: 10.1038/s41408-021-00432-4. PMID: 33602913; PMCID: PMC7891472. Choon-Quinones, Mimi, Hose D, Kaló Z, Zelei T, Harousseau JL, Durie B, Keown P, Barnett M, Jakab I. Patient and Caregiver Experience Decision

https://www.ahrq.gov/health-literacy/professional-training/shared-decision/index.html

https://www.ahrq.gov/cahps/quality-improvement/improvement-guide/6-strategies-for-improving/communication/strategy6i-shared-decisionmaking.ht ml#6i1

Advanced Care Planning

Wendy Thomas, RN, MSN, CHPN

University of Kansas Cancer Center

KC Area Support Group Leader

Advance Care Planning

Wendy Thomas, RN, MSN, CHPN

Wendy Thomas, RN MSN CHPN

• Outpatient Palliative Care

Nurse Navigator

• Kansas City Area Myeloma

Support Group Leader

About me:

• Nurse 27 years

• 14 years in blood and marrow transplant

• 8 years in palliative care

• 10 years as a myeloma support group leader

• Worked for the University of Kansas

Health System for 17 years

• Based at the Bloch Cancer Care Pavilion, Westwood Kansas

Advance Care Planning

What is Advance Care Planning?

• Discussing and preparing for future medical care decisions

• Important at any stage of life

• Crucial for anyone with a serious illness

• Goes into effect ONLY when you are unable to speak for yourself

Do you have an Advance Directive?

• Who would you want to speak for you if you were unable to speak for yourself?

• Do your family/loved ones know what your wishes would be in a healthcare emergency?

• Do you know what your wishes would be?

• Are you confident they could carry out your wishes?

Advance Care Planning DPOA & Healthcare Directive

CA requires notary or two adult witnesses to signature DPOA

What are your wishes?

Code Status

• What is a Code Status?

– Cardiopulmonary Resuscitation (CPR)

• Why do they keep asking?

– Code status expires at discharge

– Out of hospital DNR

– Living will

• How aggressive do you want care to be?

– ICU

DNR = Do Not Resuscitate ICU = Intensive Care Unit

– Mechanical Ventilation

– Medically administered nutrition

Deciding about CPR CPR

• No pulse, not breathing

• One of the few treatments that patients must choose to NOT have performed

• A physician order is NOT perform CPR

• Older people and people with cancer may have quality of life after CPR

• You can CHOOSE to allow a NATURAL death if you prefer

CPR

= Cardiopulmonary Resuscitation

Level of Medical Interventions?

Pulse present &/or still breathing

Full treatment – most aggressive

• ICU and intubation with mechanical ventilation

Midlevel treatment – less aggressive

• Antibiotics, fluids, medication to support blood pressure, transfusions

Best supportive care – least aggressive

• Treat with dignity and respect, comfort-focused medical treatment

DNR doesn’t equal non-aggressive care

Out of hospital DNR

• Patients should complete with your healthcare provider

• Requires healthcare provider signature

• Original form stays with patient

• Copy should be provided to all of your healthcare providers/health systems

• Some states have transportable DNR laws

DNR = Do Not Resuscitate

POLST

• Physician Orders for LifeSustaining Treatment (POLST)

• Provides more control over end-of-life care to seriouslyill patients

What to do with Forms & Documents?

• Make certain your family/loved ones know the location

• Give a copy to your healthcare providers/health systems

• Easy to find in case of emergency

• These documents DO NOT belong in your safe deposit box

• Fridge and beside table good locations

Other Practical issues

Planning ahead

• Eases the burden for family/loved ones

• Protects your assets

• Allows you to manage your personal effects

New Complications

• The electronic era brings new challenges

• Cellphones, computers, online accounts, social media and photos

The Most Important Part

Talking with your loved ones about your healthcare wishes brings comfort

National Healthcare Decision Day: April 16th

• Go Wish Cards

• ACP Bubble Map

• Coalition for Compassionate Care of CA

• Social Worker

Robin Tuohy Vice President, Patient Support

International Myeloma Foundation

Myeloma 101 & Understanding Your Labs

Teresa Miceli, RN, BSN, OCN

International Myeloma Foundation Nurse Leadership Board Member

Joseph Mikhael, MD, MEd, FRCPC, FACP

Chief Medical Officer, International Myeloma Foundation

Q&A with Teresa and Dr. Joe: Understanding Myeloma Basics

Joseph Mikhael, MD, MEd, FRCPC, FACP

 Professor, Applied Cancer Research and Drug Discovery, Translational Genomics Research Institute (TGen), City of Hope Cancer Center

 Chief Medical Officer, International Myeloma Foundation

 Consultant Hematologist and Director, Myeloma Research, Phase 1 Program, HonorHealth Research Institute

 Adjunct Professor, College of Health Solutions, Arizona State University

Teresa S. Miceli RN BSN OCN

Mayo Clinic, Rochester, MN

• Mayo Associate

• Assistant Professor of Nursing

• Myeloma Research RN Navigator

International Myeloma Foundation

• InfoLine Advisor

• Nurse Leadership Board

• Support Group Leader

NCI Myeloma Steering Committee

Myel0ma Statistics

Bone Marrow Cells – Good & Bad

Myeloid Progenitor Cell

Hematopoietic Stem Cell

Lymphoid Progenitor Cell

Megakaryocyte Eosinophil Basophil Erythrocytes Monocyte Neutrophil

T Cell B Cell NK Cell

Platelets Dendritic Cell Macrophage

Plasma Cell

Clonal Plasma Cells

(Mono)clonal Plasma Cells

Clonal Plasma Cells

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

Heavy Chain = M-Spike

 65% IgG – most common

 20% IgA – associated with AL Amyloid

 5% to 10% light chain-only (kappa, lambda)

 Uncommon: IgD, IgE, IgM

Normal Ranges vary between labs.

Note the unit of measure (mg/dL vs mg/L): Results adjusted for renal function

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

Spectrum of Monoclonal Protein Disorders

1. Kyle RA, et al. N Engl J Med. 2007;356:2582-90.

2. IMWG. Br J Haematol. 2003;121:749-57.

3. Jagannath S, et al. Clin Lymphoma Myeloma Leuk 2010;10(1):28-43.

• AL-Amyloid

• POEMS

• Light or Heavy Chain Deposition Disease

• MGRS = Renal

• MGNS = Neuro

* In clinical trial

5. Mateos M-V, et al. Blood. 2009;114:Abstract 614.

6. Durie BG, Salmon SE. Cancer. 1975;36:842-854.

7. Durie BG, et al. Leukemia. 2006;20(9):1467-1473.

4. Kyle RA, et al. Curr Hematol Malig Rep. 2010;5(2):62-69.

8. Rajkumar SV, et al. Lancet Oncology 2014; 15:e538-e548.

Testing For Myeloma: Blood & Urine

Test Name

CBC + differential

Complete metabolic panel

Beta-2 Microglobulin (B2M)

Lactate Dehydrogenase (LDH)

Serum Immunofixation and Protein

electrophoresis (SPEP+IFE)

Immunoglobulins (G, A, M, D, E)

Free light chain assay with kappa/lambda ratio

Urine immunofixation & protein

electrophoresis (UPEP+IFE)

What it means

Hemoglobin, WBC, Platelets

Creatinine, Calcium, Albumin, Liver function

Part of staging and risk stratification

Measures the level of normal and clonal protein

Identifies the type of clonal protein

Measures the level of normal and clonal protein

Identifies the type of clonal protein

Testing For Myeloma: Imaging

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)

Healthy bone versus myeloma bone disease

Testing For Myeloma: Bone Marrow

Bone marrow biopsy & aspirate

Bone marrow plasma cells (%)

Congo Red staining if concern for AL-Amyloid

Bone marrow genetics

Cytogenetics

Fluorescence in situ hybridization (FISH)

Next generation sequencing (NGS)

*15-20% of people with NDMM

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

Image Credit: IMF Patient Handbook

Staging and Risk Stratification

Revised International Staging System (RISS), adding LDH & FISH

CA = chromosomal abnormalities; LDH = Lactate Dehydrogenase; FISH = Fluorescence in situ hybridization

Myeloma Treatment Schema

Everyone

Drug Class Overview

Bispecific Antibodies

Pipeline

Tecvayli (teclistimab)

Talvey (Talquetamab)

(Elranatamab)

Cevostamab, Iberdomide, Mezigdomide, Venetoclax

Linvoseltamab, LCAR-B38M …………………………………….. MORE TO COME!

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

Measuring Disease Response: IMWG Response Criteria

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. Flow MRD negative*

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

Progressive Disease: At least 25% increase in identified myeloma protein from lowest level Stable Disease: Not meeting above criteria

MRD = Minimal Residual Disease

sCR = Stringent Complete Response; BM = Bone Marrow

When Do I Need A New Treatment?

Not every relapse requires immediate therapy

Each case is different

Asymptomatic: Biochemical relapse on two consecutive assessments

Consider Observation

Monitor Carefully

Asymptomatic with:

• High-risk disease

• Rapid doubling time

• Extensive marrow involvement

Consider Treatment

Patient-/Disease-Specific

Monitor Carefully

Symptomatic or Extramedullary Disease (EMD)

Initiate Treatment

Targets on the Myeloma Cell Surface and Therapeutic Antibodies

Bi-Specific Antibodies

Talquetamab

Antibody Drug

Elotuzumab

Bi-Specific Antibodies

Bi-Specific Antibodies CAR-T

Antibody Drug

Daratumumab and Darzalex Faspro

Isatuximab

TAK-079 MOR202

Immune Therapies

Ide-cel CAR-T

Cilta-cel CAR-T

Teclistamab

Other CAR-Ts

Other Bi-Specific Antibodies

The Evolution of Myeloma Therapy

VD

Rev/Dex

CyBorD

VTD VRD KRD

D-VMP

DRD

Nothing

Thalidomide?

Bortezomib

Ixazomib

Lenalidomide Combinations

ASCT Tandem ASCT (?)

D-VRD

Isa-VRD

D-KRD

Isa-VRD

“More” induction?

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; PDL1, programmed death ligand-1; PI, proteasome inhibitor; Rev, lenalidomide; V, bortezomib.

Speaker’s own opinions.

Bortezomib

Lenalidomide

Carfilzomib

Pomalidomide

Selinexor

Panobinostat

Daratumumab

Ixazomib

Elotuzumab

Isatuximab

Belantamab mafodotin

Melphalan flufenamide

Idecabtagene autoleucel

Ciltacabtagene autoleucel

Teclistamab, Talquetamab

Elranatamab

CAR T Cell Therapy

Bispecific/Trispecific Antibodies

Cell Modifying Agents

Venetoclax

PD/PDL-1 Inhibition?

Small Molecules

What about Disease Control and Cure in Myeloma?

Biochemical or Symptomatic Progression/Relapse



Control is the immediate priority with active disease

 Cure remains the overall goal

Defining “Cure” has many considerations:

 Minimal Residual Disease (MRD) Status

 Time Off Therapy

 Functional Cure

Active Disease

Requiring Treatment Stable or Unmeasurable Disease, Receiving Treatment

Unmeasurable Disease,

Receiving No Treatment

https://seer.cancer.gov/statfacts/html/mulmy.html; dated 2.15.2024

Financial Considerations in Myeloma

Erin Bair, 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

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.

Triage Cancer’s Free Resources

• TriageCancer.org

• Educational Events

• Triage Cancer Conference: 5/17 & 5/18

• Live & Recorded Webinars

• CancerFinances.org

• Quick Guides & Checklists

• Animated Videos

• State Resources & Chart of State Laws

• Legal & Financial Navigation Program

Contributors to Financial Toxicity

• Health Insurance Status

• Adequate coverage to minimize out-of-pocket costs

• Effective navigation of policies

• Consumer protections and medical bills

• Employment Changes

• To work or not to work - accommodations

• Disability insurance

•

Existing Financial Situation

•

Life Changes

• Marriage/divorce, moving, graduating from school, etc.

Don’t Understand Health Insurance?

Source: 2017 PolicyGenius Health Literacy Survey

Health Insurance Terms: Costs

Cost to Have Health Insurance

•Premium – each month (fixed $ amount)

Costs When You Use Your Health Insurance

•Deductible – each year (fixed $ amount)

•Co-Payment – each time you get care (fixed $ amount)

•Co-Insurance or Cost-Share – each time you get care (%)

•Out-of-Pocket Maximum (fixed $ amount) = deductible + co-payments + coinsurance

Meet Dan

Dan’s Plan:Deductible = $2,000 Co-insurance = 80/20 plan

OOP Max = $8,000

If Dan has a $102,000 hospital bill, what does he pay?

1. His deductible of $2,000

$102,000-$2,000 = $100,000 left

2. His co-insurance amount of 20%

20% of $100,000 = $20,000

But OOP max is $8,000. So, he would only pay the $2,000 deductible + $6,000 of the $20,000 co-insurance amount, for a total of $8,000.

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

Health Insurance Resources

•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! TriageCancer.org/HealthInsurance

Where Are There Opportunities to Lower Costs?

Employer-Sponsored Health Insurance

COBRA

• Keep employer-sponsored coverage

• Employers with 20+ employees

• Local and state governments

• Federal employees and church and church-related organization employees not covered by COBRA

• Federal: Temporary Continuation of Coverage (TCC) tracks with COBRA

• Cost up to 102% of applicable employee rate

= Employer amount + Employee amount + 2% fee

Help With COBRA Costs

•Health Insurance Premium Payment Program (HIPP)

• Medicaid eligible recipients with group health insurance through an employer

• Medicaid pays premium for group health insurance

• May have more doctors to choose from and other medical services may be covered through private insurance

• 31 states have this program, including: CA, GA, IA, IL, MA, PA, RI, TX, VA

TriageCancer.org/StateLaws

State Health Insurance Marketplaces

•“Exchanges” = insurance shopping mall

•Benefits:

• Cap on OOP max: $9,450 individual / $18,900 family (2024)

• Financial help

• Premium tax credits

• Cost-sharing subsidies (aka “reduction”) Ins. Co mp any

Government: Medicare, Medicaid, Military, High Risk Pools, etc.

Employer

More Financial Help Now Available

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

Beneficiary pays max of $545

Beneficiary pays 25%

When total out-of-pocket drug costs = $8,000

Drug

Beneficiary pays $0

Note: patients who are taking brand name drugs, get credit for the 70% discount that drug companies pay, which helps them reach the total OOP drug costs of $8,000. This means their actual OOP costs = ~$3,333

Inflation Reduction Act of 2022

2025: Caps out-of-pocket drug costs at $2,000

• Applies to both Part D plans and Part C plans with drug coverage

• If plan has a drug deductible, that will count towards the cap

• Cap could increase over time

2025: Medicare Prescription Payment Plan

• Part D plans will allow out-of-pocket costs to be spread out through the year, rather than a lump sum payment (e.g., in January)

Help Paying for Medicare Part D

•Low-Income Subsidy (aka Extra Help): pays some premiums, deductibles, co-payments, and cost-share

• May be automatically enrolled

• Income limit = 150% FPL

• Pay no more than $4.50 for each generic/$11.20 for each brand-name covered drug/no premiums or deductibles (in 2024)

• 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/pharmaceutical-assistance-program/state-programs.aspx

Help With Medicare Parts A & B Costs

Medicare savings programs (MSP)

• 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

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

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

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

TriageCancer.org/QuickGuide-MedicareSavings

Comparing Plan Options

Marketplace Plan 1

Total Annual Cost

Do the Math!

Note: for in-network providers only

Total possible costs for year = 12 months of premiums + OOP max

#1: $200x12 = $2,400 + OOP = $8,000 Total = $10,400

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

Prescription drug coverage

• Which drugs are covered (i.e., formulary)?

• Is there a separate out-of-pocket maximum for drugs?

Picking a Health Insurance Plan

TriageCancer.org/video-pickingaplan

TriageCancer.org/Worksheet-HealthInsurance

Managing Medical Bills

From your insurance company: We have received a claim We are processing your claim

Explanation of Benefits

Managing Medical Bills

From your provider:

• The bill

Doesn’t always happen in this order!

• Wait for the EOB before paying any bills

• Keep track and communicate with providers

• Ask questions

• Do you qualify for hospital charity care? Apply for help from Dollar For: https://dollarfor.org/Triage Cancer

• Appeal denials

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

Hurdle: Knowledge

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

Educational events for:

Triage Cancer Conferences

• Individuals diagnosed with cancer

• Caregivers

• Health care professionals

• Advocates & others

Topics:

• Being an Advocate

• Health Insurance

• Finances

• Being Prepared

• Employment

• Disability Insurance

Online:

May 17 & 18

October 25 & 26

TriageCancer.org/Conferences

*Free CEs/Contact Hours for nurses, social workers, & patient advocates

*Free PDCs for HR professionals

Triage Cancer Webinar Series

Upcoming Topics:

• February 27 ~ Managing Medical Bills & Getting Financial Help

• March 26 ~ Improving Access to Fertility Preservation

• April 30 ~ Estate Planning

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

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

Clinical Trials

Joseph Mikhael MD, MEd, FRCPC Chief Medical Officer, International Myeloma Foundation

Professor, Translational Genomics Research Institute, City of Hope Cancer Center

Objectives

• Provide The Rationale For Clinical Trials

• Outline The Phases Of Clinical Trials

• Discuss The Risks And Benefits Of Clinical Trials

• Listen To Patients Who Have Been On A Clinical Trial

Clinical TrialsOverview

Remember 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

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” = 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”

o 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

Clinical Trials - Phases

Phase III Tests safety Tests how well treatment works

Compares new treatment to standard treatment

Benefits of Participat ion

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

Risks of Participat ion

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

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

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.

Commonly Asked Questions

How does the study work? How often will I need to see my doctor or visit the cancer center?

Will I need to undergo additional tests?

What is currently known about the new drug or combination?

What benefits can I expect?

What side effects should I expect? Who should I notify if I have side effects?

Can I take my vitamins or other medications?

Can I get the treatment with my local doctor?

Will my insurance pay for my participation in the clinical trial?

Considering Entering a Clinical Trial?

• 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

Panel Q&A

Wrap Up

Day 1 Recap

- Welcome Reception and Networking: Foyer A/B -

Day 2 Announcements

- Saturday breakfast at 7:00 – 8:00 am: Ballroom D (Drake)

- Program begins at 8:00 am

- Hotel check-out is 12:00 pm Evaluations!