IMF Virtual Regional Community Workshop (RCW) - Midwest

Welcome and Announcements Kelly Cox

Director Support Groups & Senior Director Regional Community Workshops 1

Thank you to our sponsors!

2

We want to hear from you!

Feedback Survey At the close of the meeting a feedback survey will pop up.

This will also be emailed to you shortly after the workshop.

Please take a moment to complete this survey.

IMF REGIONAL COMMUNITY WORKSHOP Saturday May 21,2022 - Agenda 10:00 AM - Welcome and Announcements Kelly Cox, Director Support Groups & Senior Director of Regional Community Workshops 10:05 AM - Myeloma 101 and Frontline Therapy Morie Gertz, MD, Mayo Clinic, Rochester, MN 10:40 AM - Q & A with Panel 10:55 AM – Meditation and Stretch Break 11:05 AM - Relapsed Therapy and Clinical Trials Al-Ola Abdallah, MD, University of Kansas Medical Center 11:45 AM - How to Manage Myeloma Symptoms and Side Effects Teresa Miceli, RN, BSN, OCN, Mayo Clinic, Rochester, MN , IMF Nurse Leadership Board 12:05 PM - Q&A with Panel

4

Myeloma 101 and Frontline Therapy Morie Gertz, MD, Mayo Clinic, Rochester, MN 5

6

Audience Q&A with Panel

• Open the Q&A window, allowing you to ask questions to the host and panelists. They can either reply to you via text in the Q&A window or answer your question live.

• If the host answers live, you may see a notification in the Q&A window.

• If the host replies via the Q&A box – you will see a reply in the Q&A window.

7

IMF REGIONAL COMMUNITY WORKSHOP – Tri-State Agenda After Break

11:05 AM - Relapsed Therapy and Clinical Trials Al-Ola Abdallah, MD, University of Kansas Medical Center 11:45 AM - How to Manage Myeloma Symptoms and Side Effects Teresa Miceli, RN, BSN, OCN, Mayo Clinic, Rochester, MN , IMF Nurse Leadership Board 12:05 PM - Q&A with Panel

8

Relapsed Therapy and Clinical Trials Al-Ola Abdallah, MD, University of Kansas Medical Center 9

Relapse Multiple Myeloma Al-Ola A. Abdallah, MD

Associate Professor of Medicine Director, Plasma Cell Disorder Clinic Division of Hematologic Malignancies and Cellular Therapeutics Department of Internal Medicine The University of Kansas Cancer Center May 21, 2022

10

Disclosure Information

I have NO financial relationships to disclose

First Randomized Trial in MM • “A controlled trial of urethane treatment in multiple myeloma.”

•

•

Holland JR, Hosley H, Scharlau C, Carbone PP, Frei E 3rd, Brindley CO, Hall TC, Shnider BI, Gold GL, Lasagna L, Owens AH Jr, Miller SP Randomized 83 patients with treated or untreated multiple myeloma to receive urethane or a placebo consisting of a cherry- and cola flavoured syrup.

No difference was seen in objective improvement or in survival in the two treatment groups. In fact, the urethane-treated patients died earlier.

Blood 1966; 27: 328-342

13

Types of Relapse • Pattern of relapse: 1.

Insidious form: Increase in myeloma markers in serum or urine without other clinical manifestation 18%

2.

Classical form: Progressive increase in myeloma markers, classic myeloma symptoms and new osteolytic lesions 66%

3.

Plasmacytoma form: Extramedullary disease 14%

4.

Plasma cell leukemia: 2%

14

Therapy Selection Considerations Disease Related

Therapy Related

Patient Related

• Place of relapse • Cytogenetics • Disease burden

• Previous Therapies • Prior treatmentrelated AE • Regimen-related toxicity • Depth and duration of previous response

• Fitness • Comorbidities • Organ Function • Preferences • Social Factors

15

Relapsed/Refractory Myeloma: Options of treatment Immunomodulatory Drugs (IMIDS)

Thalidomide (Thalomid) Lenalidomide (Revlimid) Pomalidomide (Pomalyst)

±

Proteosome Inhibitors (PIs) Bortezomib (Velcade) ± Carfilzomib (Kyprolis) Ixazomib (Ninlaro)

Newer agents MoA BCMA/CAR-T Corticosteroids ± ± Selinexor Idea-Cel Dexamethasone ± Daratumumab Belantamab Isatuximab Cita-Cel Elotuzumab

Isa/PD Dara-VD

KRD

Dara-PD

DKd

ERD 16

17

Treatment of 1st relapse RRMM

18

Treatment of 1st relapse RRMM

19

Treatment of RRMM

20

POLLUX

ICARIA-MM

IKEMA

APOLLO

CANDOR

CASTOR

22

Triple-class and Penta- class refractory MM

23

FDA APPROVED treatmentS for triple class RRMM

24

Selinexor

25

Selinexor in RRMM

26

Belantamab in RRMM

27

Triple Class- RRMM treatment

Trial

Regimen

N

STORM

Selinexor/dex

DREAMM-2 Belantamab Horizon

Melflufen/dex

Median LOT

TripleRRMM

ORR (CR)

Median PFS (months)

Comments

122 7

100%

26% (2%)

3.7

GI toxicity

97

100%

31% (3%)

3.0

Keratopathy

75%

29%(1%)

4.2

Cytopenia

7

157 5

28

29

CAR T-cell therapy

CAR T-Cell in RRMM

31

Response

32

Survival

33

Safety All grades

Grade III/IV

Neutropenia

91%

89%

Anemia

70%

60%

Thrombocytopenia

63%

52%

Leukopenia

42%

39%

Febrile Neutropenia

16%

16%

Hypogammaglobinemia

21%

<1%

CRS

84%

5%

ICANS

18%

3%

Elevated LFT

16%

2%

Tocilizumab 52% Steroids 15%

34

CARTITUDE-1: 2-year Responses •

No patient had CR or SD as best response ORR: 97.9%

100

Patients (%)

80 60

sCR: 82.5%

82.5%

≥VGPR: 94.9%

40

• Median time to first response: 1 mo (0.9-10.7) • Median time to best response: 2.6 mo (0.9-17.8)

20 0

sCR rates deepened over time – 67% at median 1-yr follow-up – 83% at median 2-yr follow-up – 92% pts achieved MRD negativity

3.1%

Best response =

12.4% sCR

• Median time to ≥CR: 2.9 mo (0.9-17.8) VGPR

PR

• Median DoR: NE (range: 21.8-NE) • 60.5% : progression-free at 2 yr

Martin. ASH 2021. Abstr 549. Reproduced with permission.

Safety Grade III/IV Neutropenia

95%

Anemia

68%

Tocilizumab 69% Steroids 22%

Thrombocytopenia 60% CRS

4%

ICANS

9%

36

37

BiTES (Bispecific T – cell engagers)

38

Efficacy

39

Safety

40

41

42

Conclusion • Daratumumab/Isatuximab based therapy in early relapse is an optimal choice • Choose wisely in relapsed myeloma based on the prior lines of therapy (PI/IMiD refractory) • Main challenges are triple/Penta- Class RRMM (NO RCT available yet) • Ide-Cel /Cita-Cel (FDA approved) treatment of triple Class-Refractory Myeloma • BCMA BiTE will be available • Need more trials for post BCMA failure Twitter : @Abdallah81MD

43

44

How to Manage Myeloma Symptoms and Side Effects Teresa Miceli, RN, BSN, OCN, Mayo Clinic, Rochester, MN , IMF Nurse Leadership Board 45

May 21, 2022 Midwest Regional Community Workshop

LIFE IS A CANVAS, YOU ARE THE ARTIST: EMPOWERING PATIENTS THROUGH EDUCATION Teresa S. Miceli RN BSN OCN IMF Nurse Leadership Board Myeloma Research Nurse Navigator Assistant Professor of Nursing and Mayo Associate

Mayo Clinic, Rochester, MN

Patient Education Slides 2021

FRAMING YOUR CARE Shared Decision Making, Reliable Resources and Know your care team

SHARED DECISION-MAKING Be empowered to be part of the treatment decision-making • Ask for time to consider options (if needed/appropriate) • Understand options; consider priorities • Use reliable sources of information • Use caution considering stories of personal

experiences • Consider your goals/values/preferences • Get a 2nd opinion, Meet with a Myeloma expert • Express your goals/values/preferences; create a

dialogue

• My top priority is [goal/value]; additional [preferences] are also important.

• I think [treatment] may be a good choice given my priorities… What do you think?

• Arrive at a treatment decision together Publications available at Myeloma.org

48

KNOWLEDGE IS POWER USE REPUTABLE SOURCES eNewsletter: Website: http://myeloma.org Myeloma Minute

IMF TV Teleconferences

Download or order at myeloma.org

IMF InfoLine 1-800-452-CURE 9am to 4pm PST 49

You are central to the care team

Pharmacist

CARE TEAM COLLAGE General Hem/Onc Myeloma Specialist

Communicate with your team • Myeloma is a chronic disease • Understand the roles of each

team member and who to contact for your needs • Participate in support network

Be empowered • Ask questions, learn more • Participate in decisions • Know your history –

Myeloma ManagerTM Personal Care AssistantTM

Primary Care Provider (PCP)

You and Your Care Partners Support Network

Subspecialists Allied Health Staff

50

COLOR WHEEL OF TREATMENT

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

MANAGING MYELOMA: LANDSCAPE PERSPECTIVE Transplant Eligible Patients

Transplant Ineligible Patients Everyone

Transplant Consolidation

Maintenance

Initial Therapy

Treatment of Relapsed Disease Consolidation/ Maintenance/ Continued Therapy Supportive Care

52

COLOR WHEEL OF TREATMENT OPTIONS -Mibs

Frontline

Velcade® (bortezomib)

Maintenance

Velcade® (bortezomib)

Relapse

Kyprolis® (carfilzomib) Ninlaro® (ixazomib)

-MAbs

-Mides

Steroids

Darzalex® (daratumumab)

Thalomid® (thalidomide) Revlimid® (lenalidomide)

Dexamethasone Prednisone Prednisolone SoluMedrol

Others

Melphalan Cyclophosphamide

Darzalex® (daratumumab) Empliciti® (elotuzumab) Sarclissa® (Isatuximab)

Thalomid® (thalidomide) Revlimid® (lenalidomide) Pomalyst® (pomalidomide)

Dexamethasone Prednisone Prednisolone SoluMedrol

Melphalan Cyclophosphamide Bendamustine

CelMods • Iberdomide • CC-92480

Neuropathy Carfilzomib: Cardiac

ImmunoTherapy

Cellular Therapies Melphalan + ASCT

Revlimid® (lenalidomide)

Active Clinical Trials, Pending FDA Approval Noted Side effects

Alkylators

Infusion reaction

DVT/PE

Too many to list

Myelosuppression

Melphalan + ASCT Abecma® (Ide-Cel, CAR-T) Carvykti® (Cilta-Cel, CAR-T)

Blenrep® (Belantamab mafodotin) “Belamaf”

Xpovio® (Selinexor) Doxil (liposomal doxorubicin) Farydak® (panobinostat)

ADCs BSAs Ex: Teclistamab, Talquetamab Cevostamab

Venclexta® (venetoclax)

Other CAR-T • More to come!

Infusion reaction Blenrep®: Keratopathy

Myelosuppression, GI Selinexor: Low sodium

Infection risk CAR-T: CRS and neurotoxicity

THE BRIGHT

&

DARK SIDE TO STEROIDS

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

Steroid Side Effects • Irritability, mood swings, depression • Difficulty sleeping

(insomnia), fatigue

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

Do not stop or adjust steroid doses without discussing it with your health care provider

• Increased risk of

infections, heart disease • Muscle

weakness, cramping

• Increase in blood

pressure, water retention

• Blurred vision, cataracts • Flushing/sweating • Stomach bloating,

hiccups, heartburn, ulcers, or gas

• Weight gain, hair

thinning/loss, skin rashes

• Increase in blood

sugar levels, diabetes

Rajkumar SV, Jacobus S, Callander NS, Fonseca R, Vesole DH, Williams ME, Abonour R, Siegel DS, Katz M, Greipp PR, Eastern Cooperative Oncology Group (2010) Lenalidomide plus highdose dexamethasone versus lenalidomide plus low-dose dexamethasone as initial therapy for newly diagnosed multiple myeloma: an open-label randomised controlled trial. Lancet Oncol 11(1):29–37.

King T, Faiman B. Steroid-Associated Side Effects: A Symptom Management Update on Multiple Myeloma Treatment . Clin J Oncol Nurs. 2017 Apr 1;21(2):240-249. doi: 10.1188/17.CJON.240249. PMID: 28315528.

54

SHADES OF “AUTO” STEM CELL TRANSPLANT (ASCT) • There are no black and white answers to deciding to undergo a transplant • Undergoing transplant is a commitment for both you and your care partner • Understanding the process will help bring to focus elements needed to decide if/when to undergo transplant

Data From Research

HCP Clinical Experience TREATMENT DECISION

Your Preference Philippe Moreau. ASH 2015.

TRANSPLANT BY NUMBER

•Duration: Approximately 2 weeks •Location: Transplant Center

• High Dose Chemotherapy, stem cell infusion • Supportive Care • Engraftment

• Duration: Approximately 3-4 weeks • Location: Transplant Center

POST-TRANSPLANT

PHASE 3

•Measuring treatment response •Determining Transplant Eligibility •Insurance authorization •Collecting stem cells

TRANSPLANT

PHASE 2

PHASE 1

ELIGIBILITY

• Restrengthening • Appetite recovery • “Day 100” assessment • Begin maintenance therapy • Duration: Approximately 4-6 weeks • Location: HOME!

GALLERY OF GOALS MYELOMA TREATMENT • Rapid and effective disease control • Durable disease control • Improved overall survival • Minimize side effects

SUPPORTIVE THERAPIES • Prevent disease- and treatmentrelated side effects • Optimize symptom management • Allow for good quality of life

• Allow for good quality of life

DISCUSS GOALS AND PRIORITIES WITH YOUR HEALTHCARE TEAM 57

PATIENT-REPORTED SYMPTOMS A meta-analysis identified the most common patient-reported symptoms and impact on QOL and were present at all stages of the disease.

Symptoms resulted from both myeloma disease and treatment, including transplant, and were in these categories:

Physical

Psychological

• Fatigue

• Depression

• Constipation

• Anxiety

• Pain

• Sleep Disturbance

• Neuropathy

• Decreased Cognitive Function

• Impaired Physical Functioning • Sexual Dysfunction

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

Financial • Financial burden (80%) • Financial toxicity (43%)

• Decreased Role & Social Function

58

FATIGUE, ANXIETY & DEPRESSION

Physical Psychological

Physical symptoms impact mental well being.

All can affect quality of life and relationships.

• Fatigue is the most common reported symptom (98.8%) Sources include anemia, pain, reduced activity, insomnia, treatment toxicity, bone marrow suppression

• Anxiety reported in >35% • Depression nearly 25% Financial concerns, disease progression, end-of-life, and change in social and sexual function were highlighted sources

Often, people do not share these symptoms with their provider.

Talk to your provider about symptoms that are not well controlled or thoughts of self harm. Help is available.

Ramsenthaler, et al. 2016. https://doi.org/10.1111/ejh.12790. Catamero D et al. CJON. 2017; 21(5)suppl:7-18.

59

GI SYMPTOMS: PREVENTION & MANAGEMENT Diarrhea may be caused by medications and supplements • • • •

Laxatives, antacids with magnesium Antibiotics, antidepressants, others Milk thistle, aloe, cayenne, saw palmetto, ginseng Sugar substitutes in sugar free gum

Avoid caffeinated, carbonated, or heavily sugared beverages Take anti-diarrheal medication

Physical

Constipation may be caused by • Opioid pain relievers, antidepressants, heart or blood pressure medications, others • Supplements: Calcium, Iron, vitamin D (rarely), vitamin B-12 deficiency

Increase fiber • Fruits, vegetables, high fiber whole grain foods • Fiber binding agents – Metamucil®, Citrucel®, Benefiber®

• Imodium®, Lomotil®, or Colestid if recommended • Fiber binding agents – Metamucil®, Citrucel®, Benefiber® • Welchol® if recommended

Fluid intake can help with both diarrhea and constipation, and good for kidneys.

Discuss GI issues with health care providers to identify causes and make adjustments to medications and supplements.

Smith LC, et al. CJON.2008;12(3)suppl:37-52. Faiman B. CJON. 2016;20(4):E100-E105. Miceli, T. et al. (2021). Cancer Treatment and Res Com, 100476.

60

PAIN: PREVENTION AND MANAGEMENT

Physical

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, physical therapy, surgical intervention, radiation therapy, etc

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

• Complementary therapies • Mind-body, meditation, yoga, supplements, acupuncture, activity, etc

Faiman B, et al. CJON. 2017;21(5)suppl:19-36. Miceli, T. et al. (2021). Cancer Treatment and Res Com, 100476.

61

INFECTION CAN BE SERIOUS FOR PEOPLE WITH MYELOMA Multiple myeloma

Physical

Treatment

Immune dysfunction

General Infection Prevention Tips • Good personal hygiene (skin, oral) • Environmental control (mask, wash hands, avoid crowds and sick people)

7-10 fold increased risk of bacterial and viral infections for people with myeloma Report fever of more than 100.4°F, shaking chills even without fever, dizziness, shortness of breath, low blood pressure to HCP as directed.

• Growth factor (Neupogen [filgrastim]) As recommended by your health care team

• Immunizations (NO live vaccines) • Medications (antibacterial, antiviral, IVIg) • Vaccinations (Flu, COVID, post-BMT)

Brigle K, et al. Clin J Oncol Nurs. 2017;21(5)suppl:60-76. Faiman B, et al; IMF Nurse Leadership Board. Clin J Oncol Nurs.

2011;15(Suppl):66-76. Miceli TS, et al. Clin J Oncol Nursing. 2011;15(4):9-23.

ASH Website. COVID-19 Resources. Accessed January 30, 2022. https://www.hematology.org/covid-19/covid-19-and-multiple-myeloma

62

Financial

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

Contact the Social Services department at your hospital or clinic to talk to a social worker for assistance.

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

63

HEALTHFUL LIVING STRATEGIES: PREVENTION Manage stress • Rest, relaxation, sleep hygiene • Mental health / social engagement • Complementary therapy

Maintain a healthy weight • Nutrition • Activity / exercise

Preventative health care • Health screenings, vaccinations • Prevent falls, injury, infection • Stop smoking

Physical Psychological

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 / walking • Bone strengthening agents

• Dental care

“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. Miceli, T. et al. (2021). Cancer Treatment and Res Com, 100476.

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.

64

KNOWLEDGE IS POWER USE REPUTABLE SOURCES Website: http://myeloma.org IMF InfoLine 1-800-452-CURE 9am to 4pm PST

eNewsletter: Myeloma Minute

Download or order at myeloma.org

IMF TV Teleconferences

65

YOU ARE NOT ALONE

YOU ARE NOT ALONE

73

Audience Q&A with Panel

• Open the Q&A window, allowing you to ask questions to the host and panelists. It will be sent to our moderator and panelists for discussion.

• If you have a question that does not get answered today, you can contact our Infoline at 800-452-CURE (2873) US & Canada, 1-818-4877455, or email infoline@myeloma.org.

74

We want to hear from you!

Feedback Survey At the close of the meeting a feedback survey will pop up.

This will also be emailed to you shortly after the workshop.

Please take a moment to complete this survey.

Thank you to our sponsors!

76

77