IMF Los Angeles PFS 2023 - Friday Deck

Los Angeles Patient and Family Seminar

Friday, August 18, 2023

Thank you to our Sponsors!

1:00 – 1:05PM

Friday Agenda

Introduction and Housekeeping

Robin Tuohy, Vice President, Support Groups, International Myeloma Foundation

1:05– 1:20 PM

Welcome Announcements

Yelak Biru, MSc., Myeloma Patient, President and CEO of International Myeloma Foundation

1:20 – 2:35 PM

Ask-the-Experts - Open Forum Discussion with

Brian Durie, MD, Chairman of the Board & Chief Scientific Officer of International Myeloma Foundation & Robert Vescio, MD, Cedars Sinai, Samuel Oschin Cancer Center

2:35 – 3:00 PM

3:00 – 3:45 PM

BREAK

Taking the Reins of Your Multiple Myeloma Care – includes Q&A

Donna Catamero, ANP-BC, OCN, CCRC, Icahn School of Medicine at Mount Sinai

3:45 – 4:00 PM

4:00 – 4:45 PM

Q&A

Next Generation Testing and Decision Making

Brian Durie, MD, Chairman of the Board & Chief Scientific Officer of International Myeloma Foundation

4:45 – 5:00 PM

5:00 – 5:15PM

Q&A

How You Can Make a Positive Impact in Our Myeloma Community

Ilana Kenville, Director of Development, Events

Miles for Myeloma Producer, International Myeloma Foundation

5:15 – 6:45 PM

Welcome Reception

Welcome Announcements

Yelak Biru

Patient, President & CEO of the International Myeloma Foundation

Myeloma

Ask-The-Experts

Open Forum Discussion

Cedars-Sinai, Samuel Oschin Cancer Center

Brian G.M. Durie, MD

Chairman of the Board & Chief Scientific Officer of International Myeloma Foundation

Robert Vescio, MD

BREAK

Thank you to our Sponsors!

Taking The Reins of Your Multiple Myeloma Care

Mount Sinai Hospital New York, NY

Donna D. Catamero, ANP-BC, OCN, CCRC

IMF Nurse Leadership Board Member

Today’s Topics

STABLE OF TREATMENT

FINDING YOUR GAIT

GOING THE DISTANCE

STABLE OF TREATMENT

Myeloma and treatment options, side effects, symptom management, & supportive care

FINDING YOUR GAIT

Know your care team, telehealth & meeting prep, & shared decision making

GOING THE DISTANCE

Healthful living, infection prevention, renal and bone health

Stable of Treatment

Treatment options, side effects, symptom management, and supportive care

Treatment Goals

Myeloma Therapies

• Rapid and effective disease control

• Durable disease control

• Improved overall survival

• Minimize side effects

• Allow good quality of life

Supportive Treatment

• Prevent disease- and treatmentrelated side effects

• Optimize symptom management

• Allow good quality of life

Discuss goals and priorities with your healthcare team.

Stable of Treatment Options

-Mibs -MAbs -Mides Steroids Alkylators

FRONTLINE Velcade® (bortezomib)

Darzalex® (daratumumab)

Thalomid® (thalidomide)

Revlimid® (lenalidomide)

ImmunoTherapy Others

Cellular Therapies

Dexamethasone

Prednisone

Prednisolone

SoluMedrol

Melphalan

Cyclophosphamide

MAINTENANCE

Velcade® (bortezomib)

Ninlaro® (ixazomib)

Darzalex® (daratumumab)

- ECOG clinical trial

Revlimid® (lenalidomide)

RELAPSE

PENDING FDA APPROVAL

Kyprolis® (carfilzomib)

Ninlaro® (ixazomib)

Darzalex® (daratumumab)

Empliciti® (elotuzumab)

Sarclissa® (Isatuximab)

Thalomid® (thalidomide)

Revlimid® (lenalidomide)

Pomalyst® (pomalidomide)

• CelMods

‒ Iberdomide

‒ CC-92480

Dexamethasone

Prednisone

Prednisolone

SoluMedrol

Melphalan

Cyclophosphamide

Bendamustine

Tecvayli™ (Teclistamab)

• Bispecific Antibodies

‒

Xpovio® (Selinexor)

Doxil (liposomal doxorubicin)

ASCT

NOTED SIDE

EFFECTS Neuropathy

Carfilzomib: Cardiac Infusion reaction DVT/PE See steroid slide

Myelosuppression

Talquetamab

‒ Cevostamab

• Antibody Drug

Conjugates*

‒ Belantamab mafodotin

CRS and neurotoxicity; infection risk;

Blenrep: Keratopathy

Venclexta® (venetoclax)

Myelosuppression, GI

Selinexor: Low sodium

ASCT

CAR-T cell therapy

Ide-Cel

Cilta-Cel

Other CAR-T

Infection risk

CAR-T: CRS and neurotoxicity

CAR T: A New Treatment Approach

STABLE OF TREATMENT

FINDING YOUR GAIT

GOING THE DISTANCE

CAR T: Tips

• Ask for a referral to CAR T-cell therapy center before relapse

– Insurance preauthorization required (weeks, maybe longer)

– Must have sufficient blood count and organ function to be eligible

– Must be able to wait or have bridging therapy

– Manufacturing CAR T-cell therapy is limited: center-specific “wait list” processes

• In patient for ≈ 1 week when CAR T administered

• Patients need a caregiver and must stay within proximity of CAR T-cell therapy center for ≈ 1 month

• No driving for 8 weeks

• One and done…BUT will need ongoing monitoring; some patients need transfusion support

• CRS, neurotoxicity, or infection are possible side effects

Horse of Another Color:

Bispecific Antibodies also Target BCMA

• Different bispecific antibodies have differences in efficacy, side effects

– About 7 in 10 patients responded

– CRS is common

– Some had skin/nail disorders

• Tecvayli™ (teclistamab) is the first but more expected

• Off-the-shelf treatment; no waiting for engineering cells

• Route of administration and dosing schedule will vary depending on product

• CRS, neurotoxicity, or infection are possible side effects

BISPECIFIC ANTIBODIES

Cytotoxic cytokines

Bispecific antibody

MM cell death

BCMA = B-cell maturation antigen; CAR = chimeric antigen receptor; MM = multiple myeloma; scFV = single chain fragment variable.

Shah N, et al. Leukemia. 2020;34(4):985-1005. Yu B, et al. J Hematol Oncol. 2020;13:125.

BCMA CD3

CAR T and Bispecific Antibodies: Unique Side Effects

Shortness of Breath

CRS is a common but usually mild side effect

CAR T and Bi-specific Antibodies: Unique Side Effects

Neurotoxicity is a rare but serious side effect

CAR T and Bi-specific Antibodies: Unique Side Effects

 Both viral and bacterial

 Up to a 3rd of patients on clinical trials has grade 3 infections

 Increased risk of serious COVID complications despite history of vaccination

 Antibody levels monthly

 Immediate treatment once diagnosed Nirmatrelvir with Ritonavi (Paxlovid)

 Start as soon as possible; must begin within 5 days of when symptoms start

Infection Awareness & Prevention

Infection Prevention Tips

Good personal hygiene (skin, oral)

COVID: The Best Way to Prevent Illness Is

to Avoid Being Exposed to the Virus

Spread mainly through respiratory droplets that are produced by cough, sneezing and talking. More droplets with louder talking, yelling, singing

Environmental control (wash hands, avoid crowds and sick people, etc)

Growth factor (Neupogen [filgrastim])

Immunizations (NO live vaccines)

Medications (antibacterial, antiviral)

As recommended by your health care team

• Get COVID Vaccine + Booster: Excellent protection against severe disease, but vaccine effectiveness may be lower in people with compromised immune systems

• Wear a High-quality Mask: Respiratory droplets can spread disease; a high-quality mask can prevent exposure to airborne viral particles

• Avoid Crowds & Sick People

• Physical Distance & Outdoors: Close contact and indoor locations increases risk of spread

• Wash Your Hands: Less common to get from a hard surface

• Report fever of more than 100.4°F, shaking chills even without fever, dizziness, shortness of breath, low blood pressure to HCP as directed.

• Compromised immune function comes from multiple myeloma and from treatment.

• Infection is serious for myeloma patients!

Infection Guidelines

Type of prophylaxis

Recommendation(s)

HSV/VZV Standard prophylaxis recommended for all patients with MM

PJP

Opportunistic infections have been noted with bispecific agents and CAR T therapy; consider PJP prophylaxis

Bacterial & Fungal Standard prophylaxis recommended for ANC < 500 cells/μL

COVID-19 Consider monoclonal antibody therapy for patients receiving BCMA -bispecifics or CAR T therapy; based on institution-specific protocols

Hypogammaglobulinemia IVIg for IgG < 400 mg/dL or recurrent infections

GCSF 2 or 3 times/wk (or as frequently as needed) to maintain ANC > 1000 cells/μL and maintain dose intensity

BCMA = B-cell maturation antigen; GCSF = granulocyte colony-stimulating factor; HSV = herpes simplex virus; IVIg = intravenous immunoglobulin; PJP = Pneumocystis jirovecii pneumonia;

VZV = varicella zoster virus

Supportive Care to Address Side Effects

Don’t change horses midstream

• It is important to stay on myeloma treatment to control myeloma cells and get the most from each treatment.

• Responses deepen over time.

• Talk to your team if side effects are bothersome. Your team may be able to help, but only if they know.

Non-medication

Symptoms of Multiple Myeloma

A meta-analysis identified the most common patient-reported symptoms and their impact on QOL. Symptoms were present at all stages of disease. Symptoms resulted from both disease and treatment, including transplant, and were in these categories:

Physical

• Fatigue

• Constipation

• Pain

• Neuropathy

• Impaired Physical Functioning

• Sexual Dysfunction

Psychological

• Depression

• Anxiety

• Sleep Disturbance

• Decreased Cognitive Function

• Decreased Role & Social Function

Financial

• Financial burden (80%)

• Financial toxicity (43%)

Ramsenthaler, et al. 2016. https://doi.org/10.1111/ejh.12790.

Steroids: The Good, The Bad, The Ugly

Steroid Synergy

• Steroids are a backbone and work in combination to enhance myeloma therapy

Managing Steroid Side

Effects

• Consistent schedule (AM vs. PM)

• Take with food

• Stomach discomfort: Over-the-counter or prescription medications

• Medications to prevent shingles, thrush, or other infections

Steroid Side Effects

• Irritability, mood swings, depression

• Difficulty sleeping (insomnia), fatigue

• Blurred vision, cataracts

• Flushing/sweating

• Increased risk of infections, heart disease

• Stomach bloating, hiccups, heartburn, ulcers, or gas

• Muscle weakness, cramping

• Increased blood pressure, water retention

• Weight gain, hair thinning/loss, skin rashes

• Increased blood sugar levels, diabetes

GI Symptoms: Prevention & Management

Diarrhea may be caused by medications and supplements

Avoid caffeinated, carbonated, or heavily sugared beverages

Take anti-diarrheal medication if recommended

Constipation may be caused by medications and supplements

Increase fiber

• Fruits, vegetables, high fiber whole grain foods

• Fiber binding agents – Metamucil®, Citrucel®,

Benefiber®

Fluid intake can help with both diarrhea and constipation and helps kidney function. Discuss GI issues with health care providers to identify causes and make adjustments to medications and supplements.

Pain Prevention and Management

Pain can significantly compromise quality of life

Sources of pain include bone disease, neuropathy and medical procedures

• Management –

Prevent pain when possible

• Bone strengtheners to decrease fracture risk; anti viral to prevent shingles; sedation before procedures

–

Interventions depends on source of pain

–

May include medications, activity, surgical intervention, radiation therapy, etc

–

Complementary therapies (Mind-body, medication, yoga, supplements, acupuncture, etc)

–

Scrambler therapy for neuropathy

Tell your health care provider about any new bone pain or chronic pain that is not adequately controlled.

Peripheral Neuropathy Management

Peripheral neuropathy:

Damage to nerves in extremities (hands, feet, or limbs)

• Numbness

• Tingling

• Prickling sensations

• Sensitivity to touch

• Burning and/or cold sensation

• Muscle weakness

Prevention / management:

• Bortezomib once-weekly or subcutaneous administration

• Massage area with cocoa butter regularly

• Supplements:

– B-complex vitamins (B1, B6, B12)

– Folic acid, and/or amino acids but do not take on day of Velcade® (bortezomib) infusion

• Safe environment: rugs, furnishings, shoes

If neuropathy worsens, your provider may:

• Change your treatment

• Prescribe oral or topical pain medication

• Suggest physical therapy

Report symptoms of peripheral neuropathy early to your health care provider; nerve damage from neuropathy can be permanent if unaddressed.

Why the Long Face?

98.8%

Fatigue is the most commonly reported symptom. Sources include anemia, pain, reduced activity, insomnia, treatment toxicity, bone marrow suppression

>35% of patients

~25% of patients

Often, people do not share these symptoms with their provider. Talk to your provider about symptoms that are not well controlled or if you have thoughts of self harm. Help is available.

Rest and Relaxation Contribute to Good Health

• Adequate rest and sleep are essential to a healthful lifestyle

– Shortened and disturbed sleep increase risk of

– Heart related death

– Increase anxiety

–

Weakened immune system

–

Worsened pain

– Falls and personal injury

• Things that can interfere with sleep

–

Medications: steroids, stimulants, herbal supplements

–

Psychologic: fear, anxiety, stress

–

Physiologic: sleep apnea, heart issues, pain

Sleep hygiene is necessary for quality nighttime sleep and daytime alertness

– Engage in exercise but not too near bedtime

– Increase daytime natural light exposure

– Avoid daytime napping

– Establish a bedtime routine - warm bath, cup of warm milk or tea

• Associate your bed ONLY with sleep

• Sleep aid may be needed

– Avoid before bedtime:

• Caffeine, nicotine , alcohol and sugar

• Large meals and especially spicy, greasy foods

• Computer screen time

Rod NH et al 2014. PloS one. 9(4):e91965; Coleman et al. 2011. Cancer Nurs. 34(3):219-227.National Sleep Foundation. At: http://sleepfoundation.org/ask-the-expert/sleep-hygiene

Mustian et al. Journal of clinical Oncology. Sep 10 2013;31(26):3233-3241; Stan DL, et al. Clin J Oncol Nurs. Apr 2012;16(2):131-141; Zeng Y et al., Complementary therapies in medicine. Feb 2014;22(1):173-186.

Financial Burden

• Financial burden comes from

• Medical costs

– Premiums

–

Co-payments

–

Travel expenses

–

Medical supplies

• Prescription costs

• Loss of income

–

Time off work or loss of employment

–

Caregiver time off work

• Funding and assistance may be available

–

Federal programs

–

Pharmaceutical support

–

Non-profit organizations

– Websites:

• Medicare.gov

• SSA.gov

• LLS.org

• Rxassist.org

• NeedyMeds.com

• HealthWellFoundation.org

• Company-specific website

Finding Your Gait

Be an empowered patient; engage in your care

Don’t Ride Alone

YOU are central to the care team

Be empowered

• Ask questions, learn more

• Participate in decisions

Primary Care Provider (PCP)

Communicate with your team

• Understand the roles of each team member and who to contact for your needs

• Participate in support network

Subspecialists

General Hem/Onc

Myeloma Specialist

You and Your Care Partner(s) Support Network

Going the Distance

Healthful living, infection prevention, renal and bone health

Healthful Living Strategies: Prevention

Maintain renal health

• Myeloma management

• Hydration

• Avoid renally-toxic medications

– Dose adjust to renal function

• Diabetes management

Protect your bones

• Nutrition, Calcium + D supplement

• Weight-bearing activity and/or walking

• Bone strengthening agents

Manage stress

• Rest, relaxation, sleep hygiene

• Mental health / social engagement

• Complementary therapy

Preventative health care

• Health screenings, vaccinations

• Prevent falls, injury, infection

• Stop smoking

• Dental care

Maintain a healthy weight

• Nutrition

• Activity / exercise

An ounce of prevention is worth a pound of cure.

Benjamin Franklin

Faiman B, et al. CJON. 2017;21(5)suppl:19-36. Dimopoulous M, et al. Leukemia. 2009;23(9):1545-56. Brigle K, et al. CJON. 2017;21(5)suppl:60-76. Faiman B, et al. CJON. 2017;21(5)suppl:19-36. Faiman B, et al. CJON. 2011;15suppl:66-76. Miceli TS, et al. CJON. 2011;15(4)suppl:9-23.

Healthful Living Strategies: Keep Active

Movement therapies can reduce stress, promote sleep

Yoga, Pilates, Tai Chi

• Shown to improve sleep and sleep

quality

• Improved quality of life & mood

Do:

• Keep a log or journal of your activity

• Notify your healthcare provider about sudden onset of pain, progressive weakness, headaches, blurred vision, numbness, and tingling

• Dehydration can lead to low blood pressure, falls

• Consider weightlifting limits

Do Not:

• Overdo it

• Force exercise

• Try things without discussing with provider Boullosa

Myeloma bone disease may affect your ability to do certain movement activities. Review your activity interests with your health care provider!

Q&A

Nurse Leadership Board

In 2006, the IMF founded the Nurse Leadership Board® as a professional partnership to represent oncology nurses who are experts in the care of multiple myeloma patients at leading medical centers. The NLB is improving the nursing care and self-care of patients with multiple myeloma via publications, symposia, multimedia, and research.

Next Generation Testing and Decision Making

Brian G.M. Durie, MD Chairman of the Board & Chief Scientific Officer of International Myeloma Foundation

Next Generation Testing and Decision Making

August 18, 2023

Brian G.M. Durie, MD

Myeloma Care in 2023 & Beyond

 Basics unchanged

 Much NEW not yet Standard of Care (SOC)

Knowledge is Power

 Still KEY Mantra

 Developed by IMF Founder & Director of Global Patient Initiatives

Susie Novis Durie

 FOCUS on IN-PERSON LEARNING

KEY TESTS

Serum Protein Electrophoresis (SPEP) Test Results

NORMAL

ABNORMAL M-PROTEIN (Spike)

KEY TESTS

Bone Marrow Myeloma Cells

Disease Impact: Documenting CRAB Criteria

C –

Calcium Increased: serum calcium

R –

Renal (Kidney) Problem: Creatinine

A –

Anemia: Hemoglobin

B –

Bone Issues – X-RAY, CT, MRI, PET

Advanced MM Emergencies

Hypercalcemia

Renal Failure

Severe Anemia

Major Bone Destruction + Severe Infections

FiSH and Imaging

 Bone marrow FiSH identifies HIGH-RISK MYELOMA

 MRI and PET/CT show BONE and SOFT TISSUE MM

Colored spots show translocations: t(11;14) FiSH – Fluorescent

ybridization F = Focal D

https://www.myeloma.org/videos/imaging-studies-or-scans-should-myeloma-patients-undergo

Extramedullary Disease (EMD) on PET/CT Scanning

annning

Disappearance of EMD with double bispecific therapy (BCMA and GPRC5D)

Myeloma Defining Events (MDE)

PATIENTS WITHOUT CRAB FEATURES

 Bone Marrow Myeloma Cells >= 60%

 FREELITE ratio >= 100

 Imaging > one lesion

Myeloma Disease Evolution

BEST TESTING

SCREENING

BEST INTERVENTIONS/TREATMENTS

HR SMM Patients: 2/20/20 System

Next Generation Approaches Approaches

NEW TECHNIQUES FOR DIAGNOSIS AND MONITORING

 Mass Spectrometry

 Next Generation Flow Cytometry (NGF)

MASS SPECTROMETRY

MASS SPECTROMETRY

MASS SPECTROMETRY

NEXT GENERATION FLOW CYTOMETRY (NGF)

BloodFlow vs NGF in PB

MRD Assessment in PB Using BloodFlow

Getting to the Bottom of the Iceberg

MRD Negative cutoff

??? Start of CURE level

Goal in Current Trials/Q-TOF?

Only feasible with BloodFlow

Timeline for Next Generation Tests

Myeloma Cells

MANAGEMENT GUIDELINES REQUIRED FOR BOTH

Understanding CURE

 True CURE – Sustained Negativity at 10-8/Q-TOF Neg

 Functional CURE

NGF/NGS 10-4

–

ZERO MYELOMA BUT ?? UNDETECTED

NGF/NGS 10-5

BONE MARROW Immune Microenvironment

NGF/NGS 10-6

NOT Normal – Will ZERO be SUSTAINED at 5/10/15 YEARS?

NGF/NGS 10-7

NGF BLOOD 10-8

Treatment Decisions

 Talk to your doctor

NGF/NGS 10-4

 Get a second opinion if questions are NOT answered (Susie’s mandate)

NGF/NGS 10-5

NGF/NGS 10-6

 Work with local support group

NGF/NGS 10-7

 Involve your Personal Support Team

NGF BLOOD 10-8

Next Generation PLANS

 Most Testing & Decision Processes UNCHANGED

NGF/NGS 10-4

NGF/NGS 10-5

NGF/NGS 10-6

 New Tests and Data Searching NOT READY FOR PRIMETIME STAY

NGF/NGS 10-7

NGF BLOOD 10-8

Q&A

How You Can Make a Positive Impact in Our Myeloma Community

Ilana Kenville

Director of Development, Events

Miles For Myeloma Producer, International Myeloma Foundation

How YOU Can Make A Positive Impact In Our Myeloma Community

Pillars of the IMF

Education Support Advocacy Research

Education

You Are Here

Advocacy

Research

Improving Lives, Finding the Cure: The Fight Against Multiple Myeloma Starts Here

Innovating

Groundbreaking Cure

Cutting Edge

Research

Today, more than 50 projects are occurring to achieve the basic and translational research that is needed to move closer and closer to a cure .

San Fernando Valley Multiple Myeloma Support Group Fundraiser

Each year, the San Fernando Valley Support Group comes together to support the International Myeloma Foundation in its mission to improve the lives of multiple myeloma patients everywhere, while working towards prevention and a cure. With this support, the IMF is able to provide information and education, assist support groups, complete research and advocate for patients everywhere.

How YOU Can Make An Impact.

• One-Time

• Monthly

• Major Gifts

• Planned Giving

• Peer to Peer

• Corporate Giving

• Stock/IRA Donation

• Tributes and Memorials

• Partners in Progress

• Vehicle Donation

5th Annual Inland Empire

In Person/Virtual Walk for Myeloma Miracles

September 23, 2023

Central Park ~ Rancho Cucamonga, CA

Making An Impact

Q&A

Thank you to our Sponsors!

Welcome Reception in Hollywood Ballroom