Minneapolis PFS Friday Slides by International Myeloma Foundation

Welcome and Introduction

Teresa Miceli, RN, BSN, OCN IMF InfoLine Advisor, Nurse Leadership Board Member; Mayo ClinicRochester

Yelak Biru President and CEO

28 Year Myeloma Patient

2024 Minneapolis Patient and Family Seminar

July 19-20, 2024

THANK YOU TO OUR SPONSORS!

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 Patient

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

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

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

Becky Bosley, RN, BSN - Director, Support Groups

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

Laura Bielke, 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 W/ Panel 4:50 – 5:00 PM Day 1 Recap, Day 2 Announcements & Evaluations 5:00 – 7:00 PM Welcome Reception & Networking Diamond Ballroom FGH

Parking Reimbursement

Hotel Guests: Please put parking on your room, and the IMF will cover this directly with the hotel.

Meeting Attendees: Please See Lauren at the registration desk for a voucher.

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

Local Support Groups: You Are Not Alone!

 Multiple Myeloma Sharing SessionsRochester

 Meets virtually the 3rd Saturday of each month at 10am Central

The Twin Cities Multiple Myeloma Education & Networking Group

Meets in a hybrid fashion the 2nd Saturday of each month at 10am Central

 The Stillwater Multiple Myeloma Support Group

 The Central Minnesota Multiple Myeloma Support Group

 Meets in-person the 2nd Saturday of each month at 10am Central

 Meets in a hybrid fashion the 2nd Wednesday of each month at 1pm Central

 The Eastern South Dakota Multiple Myeloma Support Group

 Meets in-person the 2nd Tuesday of each month at 6pm Central

IMF – 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

 Designed for Spanish speaking patients only

 Living Solo & Strong with Myeloma

 Designed for patients without a care partner

 New!

Care Partners Only

 Designed to address the needs of care partners only

 High Risk Multiple Myeloma

 Designed to address the needs of the high-risk MM population

 Smolder Bolder

 Created for people living with Smoldering Multiple Myeloma

 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

Shared Decision Making

Teresa Miceli, RN, BSN, OCN

InfoLine Advisor, International Myeloma Foundation Nurse Leadership Board, Mayo Clinic-Rochester

Shared

Decision Making: Be An Active Member Of Your Health Care Team

Teresa Miceli, RN BSN OCN

International Myeloma Foundation - InfoLine Advisor, NLB Member, Support Group Leader (MMSS, Smolder Bolder)

Mayo Clinic – Myeloma Nurse Navigator

Goals

 Review Share Decision Making (SDM) Concepts

 Identify Influencing Factors To Treatment Decision Making

 Discuss Strategies To Enhance Patient Empowerment & Promote Shared Decision Making

Individual Beliefs & Preference s

Transplant

Eligible Patients

Individual Care Partner

Family

Initial Therapy

A Person With `

Treating Myeloma

Transplant (ASCT) Maintenance

Transplant

Ineligible Patients

Everyone

Social Network & Obligations

Treatment of Relapsed Disease

Consolidation / Maintenance Continued therapy

Myeloma Symptom s & Treatment

Options

Supportive Care

Employme nt & Finances

beyond the clinical-trial setting: understanding the balance between efficacy, safety and tolerability,

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-improvin g/communication/strategy6i-shared-decisionmaking.html#6i1

Steps in Shared Decision-Making

 Identify 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).

 Understand the options:

The HCP explains the evidence-based options and their pros and cons. The patient expresses their preferences, and the HCP supports the patient in decision-making (Option talk).

 Come to a decision:

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).

Follow-up: Review and evaluate the decision, adjust as needed

Advantages to Partaking in SDM

People 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 and continuation on therapy

“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. Terpos, et al.

https://www.ahrq.gov/cahps/quality-improvement/improvement-guid e/6-strategies-for-improving/communication/strategy6i-shared-decisi onmaking.html#6i1

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,

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

 Consider your priorities

 Consider your goals/values/preferences

 Include your care partner/network in the discussion

 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 together

 Arrange follow up to review and adjust the plan, if needed

Strategies for Patient Empowerment

Know the members of your care teamUnderstand 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)

Subspecialists

Allied Health Staff

Strategies: Prepare For Medical Visits

Prepare

 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

Strategies: 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) selfserve blood pressure cuff is available at many pharmacies and for purchase

Include a care partner, especially for pivotal appointments

Create a Care Network

 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

 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 self-care

Care Partner Tip Card https://www.myeloma.org/resource-library/tipcard-care-partners

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

Key Take-Aways

- Think About It ….

Over the next two days:

 Evaluate where you are at in the process (What decisions need to be made?)

 Absorb the information being presented (What are the options?)

 Consider how the information impacts you and your family (What are your preferences?)

 Create questions that will lead to better understanding (What more do I need to know before making a decision?)

 Become an active member of your health care team and be involved in

Shared Decision Making

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.

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):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.

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

Palliative Care Nurse Specialist, Kansas University Medical 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?

https://www.health.state.mn.us/facilities/regulation/infobulletins/advdir.htm

MN requires notary or two adult witnesses to signature

What are your wishes?

Code Status

• What is a Code Status?

– Cardiopulmonary Resuscitation or 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

– 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 2020 study – people with blood cancers have 2% survival

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

Physician Orders for LifeSustaining Treatment

• Transportable DNR

• Provides more control over endof-life care to seriously-ill 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

Finances

• Bank Accounts

• Bill Pay

New Complications

• The electronic era brings new challenges

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

• Property Cell Phone

• Access

• Contacts

• Photos Passwords

• Account Log-in

• Social Media

• EVERYTHING!

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

• Light the Legacy –Honoring Choices

• Social Worker

Myeloma.org: Resource Review

Becky Bosley, RN BSN Director, Support Groups

International Myeloma Foundation

BREAK

20 Minutes

THANK YOU TO OUR SPONSORS!

Myeloma 101 & Understanding Your Labs

Joseph Mikhael, MD, MEd, FRCPC, FACP

Chief Medical Officer, International Myeloma Foundation

Teresa Miceli, RN, BSN, OCN

International Myeloma Foundation Nurse Leadership

Board Member

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

How common is Myeloma?

Percent of New Cases by Age

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

What

Causes Myeloma? How/Why Did I Get This?

Biochemical or Symptomatic Progression/Relapse

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

In most cases, the honest truth

WE DON’T KNOW

Bone Marrow Cells – Good & Bad

Hematopoietic stem cell

White Blood cell

Graphic Credit: Teresa Miceli

Platelets

Red Blood Cells

Plasma cell

Photo Credit

Clonal

Plasma cells

(Mono)clonal Plasma Cells

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

Heavy Chain = M-Spike

cells

Spectrum of Monoclonal Protein Disorders

Condition MGUS1-4 (Monoclonal Gammopathy of Undetermined Significance)

1-5,8

Multiple Myeloma)

• AL-Amyloid

• POEMS

• Light or Heavy Chain Deposition Disease

• MGRS = Renal

• MGNS = Neuro

Presence of Myeloma Defining Events

Likelihood of progression

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.

* 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-

Myeloma and Myeloma Defining Events

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

This Photo by Unknown Author is licensed

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

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

Testing For Myeloma: Bone Marrow

Bone marrow genetics

• Cytogenetics

• Fluorescence in situ hybridization (FISH)

• Next generation sequencing (NGS)

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

Staging and Risk Stratification

International Staging System (ISS) (only β2M and albumin)

Result

β2M < 3.5 mg/L;

albumin ≥ 3.5 g/dL 2 β2M < 3.5 mg/L;

Myeloma Treatment Schema

Transplan t Eligible Patients

Transplan t Ineligible Patients Consolidation / Maintenance Continued therapy Everyone

Supportive

Philippe Moreau. ASH 2015.

Drug Class Overview

(thalidomide)

(lenalidomide)

Drug Class Overview

Peptide Drug Conjugate*

BCMA Targeted Antibody Drug

Conjugate (ADC)*

Bispecific Antibodies

(Melphalan Flufenamide)

Blenrep (belantamab mafodotinblmf) Bela, Belamaf, or B

Abecma (idecabtagene vicleucel)

Carvykti (ciltacabtagene vicleucel)

Tecvayli (teclistimab)

Talvey (Talquetamab)

Elrexfio (Elranatamab)

Cevostamab, Iberdomide, Mezigdomide, Venetoclax

Linvoseltamab, LCAR-B38M, ABBV-383 ……………………………

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

Measuring Disease Response: IMWG Response Criteria

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

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?

Biochemical or Symptomatic Progression/Relapse

• Not every relapse requires immediate therapy

• Each case is different

Symptomatic or extramedullary disease

Asymptomatic biochemical relapse on 2 consecutive assessments

Consider Treatment

Patient-/Disease-Specific Monitor Carefully

Asymptomatic high-risk disease or rapid doubling time or extensive marrow involvement Consider Observation Monitor Carefully

Initiate Treatment

Targets on the Myeloma Cell Surface and Therapeutic Antibodies

Bi-Specific Antibodies

Talquetamab

Antibody Drug

Elotuzumab

Bi-Specific Antibodies

Antibody Drug

Daratumumab and Darzalex Faspro Isatuximab

Immune Therapies

Ide-cel CAR-T

Cilta-cel CAR-T

Teclistamab

Other CAR-Ts

Other Bi-Specific Antibodies

The Evolution of Myeloma Therapy

Rev/Dex

CyBorD

VTD

VRD

KRD

D-VMP

DRD

Tandem ASCT (?)

Nothing

Thalidomide?

Bortezomib

Ixazomib

Lenalidomide

Combinations

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/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

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 Negative (MRD-)  Time Off Therapy

 Functional Cure

Requiring Treatment Stable or Unmeasurable Disease, Receiving Treatment

Unmeasurable Disease, Receiving No Treatment Active Disease

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

Financial Considerations in Myeloma

Laura Bielke

Esq., Triage Cancer

Financial Considerations in Myeloma

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

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.

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?

You Are Not Alone.

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 + co-insurance

Dan’s Plan: Deductible = $2,000

Co-insurance = 80/20 plan

OOP Max = $8,000

Meet Dan

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

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

• 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

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”)

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.”

400% + (2023) $ help  reduce monthly premiums to 8.5% of household income Will continue through 2025 under IRA

2024 Out-of-Pocket Maximum

Medicare Part D - 2024

Beneficiary pays max of $545

Beneficiary pays 25%

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

Beneficiary pays $0

Initial Coverage Deductible Catastrophic Coverage

Drug plan pays 5%

Drug company discounts for brand name drugs 70%

Note: patients who are taking brand name drugs, their actual OOP costs = ~$3,333

Because patients get credit for the 70% discount from drug companies on brand name drugs, which helps patients reach the total OOP drug costs of $8,000.

Medicare Part D – 2025

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, copayments, 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.

Comparing Plan Options

Do the Math!

Note: for in-network providers only

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

= $2,400 + OOP = $8,000

= $10,400

= $3,300 +

= $6,000

= $9,300

= $2,000

= $6,800

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?

Managing Medical Bills

• From your insurance company:

We have received a claim We are processing your claim Explanation of Benefits (EOB)

• From your provider:

• The bill

Managing Medical Bills

• 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

• 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:

• Individuals diagnosed with cancer • Caregivers • Health care professionals • Advocates & others Topics: • Being an Advocate

Health Insurance • Finances • Being Prepared

Employment • Disability Insurance

Upcoming Topics:

• August 27 ~ Maximizing Employee Benefits

• September 26 ~ Medicare 101

• October 29 ~ Paying for Prescription Drugs

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

Clinical Trials

Joseph Mikhael MD, MEd, FRCPC

Chief Medical Officer, International Myeloma Foundation

Yelak Biru President and CEO, International Myeloma Foundation

28 Year Myeloma Patient

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 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

• 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

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”

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

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

EVALUATION OF EFFECTIVENESS IN A CERTAIN TUMOR TYPE

• Determine short-term AEs and risks; closely monitored

• Includes up to 100 patients, typically

GATHER ADDITIONAL EFFECTIVENESS AND SAFETY INFORMATION

COMPARED TO STANDARD OF CARE

• 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

AGENTS IN NEW POPULATIONS OR NEW DOSE FORMS

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.

Importance of Participation by Diverse Populations in Clinical Trials

[P]eople 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

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 the option of 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

/webinar-template/2022/07/25/on-deman d/just-ask-increasing-diversity-in-cancer-cli nical-research

Panel Q&A

Daily Wrap Up –

• Day 1 Recap

• Welcome Reception and Networking Begins at 5:00 PM in Diamond Ballroom FGH • Day 2 Announcements

• Saturday breakfast at 7:00 – 8:00 am: Ballroom D

• Program begins at 8:00 am

• Hotel check-out is 12:00 pm

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