M-power Atlanta Community Workshop

Page 1


Welcome and Speaker Introductions Joseph Mikhael MD, MEd, FRCPC, FACP Chief Medical Officer, IMF


Today’s Presenters

Dr. Joseph Mikhael Chief Medical Officer International Myeloma Foundation

Dr. Ajay Nooka Winship Cancer Institute Atlanta, GA

Dr. Brandon Blue Charise Gleason Jameca Barrett Moffitt Cancer Center MSN, NP-BC, AOCNP® Patient Advocate Tampa, FL Winship Cancer Institute Atlanta, GA


AGENDA Welcome and Speaker Introductions Race Matters in Myeloma Care & Survival Myeloma for Patients Just Getting Started

Dr. Mikhael Dr. Mikhael Dr. Mikhael

Connecting with the Community: Better Myeloma Care An interview with Dr. Blue When Myeloma Comes Back

Dr. Nooka

Audience Questions

Panel

Break


AFTER BREAK Changing the Course of Myeloma Myeloma Research & African Americans Tools for Changing Myeloma Navigating the Multiple Myeloma Transit System

Dr. Mikhael An interview with Dr. Nooka Charise Gleason Jameca Barrett

Audience Questions & Survey

Panel

Closing and Thanks

Dr. Mikhael


Thank you to our Sponsors!



Race Matters in Myeloma Care and Survival Joseph Mikhael MD, MEd, FRCPC, FACP Chief Medical Officer, IMF


1. Myeloma is the most common hematologic cancer in African Americans Currently, African Americans comprise 14% of the total population of the USA and nearly 20% of myeloma patients… By 2034 it is estimated that African Americans will make up roughly 24% of the newly diagnosed MM population1


2. MGUS and Myeloma is TWICE as common in African Americans

African Americans have >2x the incidence rate of MM compared to white Americans1

1. American Cancer Society. Cancer Facts and Figures for African Americans 2019-2021.


3. African Americans are younger at diagnosis by about 5 years

Hispanic

African American

Asian

White

65

66

69

71

YEARS

YEARS

YEARS

The median age at diagnosis for all patients is 69 years

YEARS


4. Survival improvements in myeloma have not been as pronounced in African Americans


5. There is a longer time to diagnosis from the onset of symptoms Studies have shown the delay in diagnosis is on average 6 months LONGER in African Americans


6. Africans Americans are less likely to receive TRIPLET therapies

1. NecampJ, et al. Blood. 2016;128:4502. 2. Chehab S, et al. Cancer. 2018;124(8):4358-43651


7. African Americans are less likely to receive Stem Cell Transplants


8. Although African Americans comprise nearly 20% of all MM patients, they only represent 8% of patients on clinical trials


9. There are biologic differences in African Americans with MM that may lead to lower risk disease African ancestry associated with less aggressive disease Higher prevalence of [a]: t(11;14) t(14;16) t(14;20)

Lower prevalence[c]: 13q deletion 17p deletion •

Absence of 17p deletion associated with better survival among younger African Americans vs White counterparts[d]

a. Baughn LB, et al. Blood Cancer J. 2018;8:96; b. Badar T, et al. Cancer. 2020;127:82-92; c. Kazandjian D, et al. Blood Cancer J. 2019;9:15; d. Munjuluri A, et al. Blood. 2019;134:4388.


10. When African Americans receive equal access to care, their survival outcomes are equal, and at times, better than Whites

.

Fillmore NR, et al. Blood. 2019;133:2615-2618


So what can we do about this? • It is a complex problem and requires a complex solution • Key themes of Success:

• Awareness, Education, Advocacy and Empowerment in the lay community • Education, Cultural Competence, Access in the medical community • Policy, Expectations, Commitment in the regulatory and corporate community

• This is impossible without genuine collaboration between ALL stakeholders • We believe the IMF is uniquely poised to address this issue and bring many of these key stakeholders together…


So what can we do about this? • It is a complex problem and requires a complex solution • Key themes of Success:

• Awareness, Education, Advocacy and Empowerment in the lay community • Education, Cultural Competence, Access in the medical community • Policy, Expectations, Commitment in the regulatory and corporate community

• This is impossible without genuine collaboration between ALL stakeholders • We believe the IMF is uniquely poised to address this issue and bring many of these key stakeholders together…


The International Myeloma Foundation African American Initiative 

The core vision of this initiative is to improve the short- and long-term outcomes of African American patients with myeloma.

 Increase awareness  Increase education  Increase support  Increase research 21



Myeloma for Patients Who Are Just Getting Started

Joseph Mikhael, MD, MEd, FRCPC, FACP Chief Medical Officer, International Myeloma Foundation Professor, Translational Genomics Research Institute (TGen) City of Hope Cancer Center


The Basics of Blood • The blood is an “organ” made up of both cells and liquid “plasma” • Think of wine (red/white/rose) 1. Red Cells – carry Oxygen…trucks 2. White Cells – immune system…army 3. Platelets – help with clotting…ambulance

All produced in the blood factory = Bone Marrow

24


What is Cancer? • Simple definition: –

Identical, uncontrolled growth

• The body usually has a balance to allow cells to grow in the right

place for the right period of time – When that system is unbalanced, cancers grow – Ie, solid tissue (breast, colon…) or blood cells

• The “double whammy” of blood cancers is that they are the cells

meant to protect you

25


What is Multiple Myeloma? Multiple Myeloma* is a blood cancer that starts in plasma cells of the spongy center of bones (bone marrow). – This is where stem cells mature into red blood cells, white blood cells, and platelets. – Myeloma cells are abnormal plasma cells that make an abnormal antibody called “M protein”. * Myeloma is NOT a bone cancer or skin cancer (melanoma), it is a type of blood cancer.

26


Multiple Myeloma Snapshot National MM Statistics 34,920 Estimated New Cases in 2021

12,410 Estimated Deaths in 2021

Trends in MM Natural History by Race MM Incidence

 Higher incidence in AA vs White patients: • 15.9 vs 7.5 cases per 100,000 per year

MM  Higher mortality in AA vs White patients: Mortality • 5.6 vs 2.4 MM deaths per 100,000

The Average Survival of patients with myeloma is IMPROVING! The expected survival is nearly 10 years for all patients, but still less than 5 years in patients with high risk disease

 5-year relative survival evolution from 1973 to 2005 MM • Survival for White patients increased Survival significantly from 26.3% to 35% • Survival for AA patients increased from 31% to 34.1%

27


Myeloma Is a Cancer of Plasma Cells • • •

Cancer of plasma cells Healthy plasma cells produce immunoglobulins G, A, M, D, and E Myeloma cells produce abnormal immunoglobulin “paraprotein” or monoclonal protein

FAST STATS 1.8% of all cancers; 17% of hematologic malignancies in the United States

Most frequently diagnosed in ages 65 to 74 years (median, 69 years)

Bone marrow of patient with multiple myeloma

The average age of diagnosis of 4-5 years younger in African American and Hispanic patients

Image courtesy of American Society of Hematology Kyle et al. Mayo Clin Proc. 2003;78:21-33;

28


Multiple Myeloma Diagnosis Can Be Challenging

Fatigue

Bone Pain Kyle RA. Mayo Clin Proc. 2003;78:21-33.

Anemia 29


Multiple Myeloma Typically Preceded by Premalignant Conditions Premalignant

Condition

(Monoclonal Gammopathy of Undetermined Significance)

SMM1-5,8

(Smoldering Multiple Myeloma)

Active Multiple Myeloma6-8

<10%

10%-60%

>10%

None

None

Yes

~1% per year

~10% per year

Not Applicable

No; observation

Yes for high risk*; No for others

Yes

MGUS1-4

Clonal plasma cells in bone marrow Presence of Myeloma Defining Events Likelihood of progression Treatment

Malignant

* In clinical trial (preferred)

or offer treatment for those likely to progress within 2 years

1. Kyle RA, et al. N Engl J Med. 2007;356:2582-90. 2. International Myeloma Working Group. Br J Haematol. 2003;121:749-57. 3. Jagannath S, et al. Clin Lymphoma Myeloma Leuk. 2010;10(1):28-43.

4. Kyle RA, et al. Curr Hematol Malig Rep. 2010;5(2):62-69. 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. 8. Rajkumar SV, et al. Lancet Oncology 2014; 15:e538e548.

30


2014 IMWG Active Myeloma Criteria: Myeloma-Defining Events Clonal bone marrow ≥10% or bony/extramedullary plasmacytoma AND any one or more Myeloma-Defining Events

Calcium elevation R enal complications A nemia B one disease

BM

Clonal bone marrow ≥60%

FLC

sFLC ratio >100

MRI

>1 focal lesion by MRI

BM, bone marrow; FLC, free light chain; MRI, magnetic resonance imaging; sFLC, serum free light chain. Rajkumar et al. Lancet Oncol. 2014;15:e538-e548. Kyle et al. Leukemia 2010;24:1121-1127.

31


More About the Common “CRAB” Symptoms Low Blood Counts • May lead to anemia and infection • Anemia is present in 60% at diagnosis Decreased Kidney Function • Occurs in over half of myeloma patients Bone Damage • Affects 85% of patients • Leads to fractures Bone Turnover • Leads to high levels of calcium in blood (hypercalcemia)

Weakness Fatigue Infection Weakness Bone pain Loss of Appetite & Weight loss

About 10% to 20% of patients with newly diagnosed myeloma will not have any symptoms. 32


How to Choose a Treatment Plan

Age

Lifestyle Goals of Therapy

Patient Preference

Myeloma Symptoms

33


Second/Expert Opinion • You have the right to get a second opinion. Insurance providers may require second opinions. • A second opinion can help you: – Confirm your diagnosis – Give you more information about options – Talk to other experts – Introduce you to clinical trials – Help you learn which health care team you’d like to work with, and which facility 34


Tools of the Trade for Frontline Therapy Standard Drug Overview

Class

Drug Name

IMiD immunomodulatory drug

Revlimid (lenalidomide)

R or Rev

Thalomid (thalidomide)

T or Thal

Chemotherapy Steroids Monoclonal Antibodies

V or Vel or B

Administration Oral

Kyprolis (carfilzomib)

C or K or Car

Intravenous (IV) or subcutaneous injection (under the skin)

Ninlaro (ixazomib)

N or I

Oral

Cytoxan (cyclophosphamide)

C

Alkeran or Evomela (melphalan)

M or Mel

Decadron (dexamethasone)

Dex or D or d

Prednisone

P

Daratumumab (Darzalex)

Dara

Velcade (bortezomib) Proteasome inhibitor

Abbreviation

Oral or intravenous Oral or intravenous Intravenous (IV)

35


Pillars of Myeloma Treatments • Doxorubicin, Panobinostat, Steroids

New Immune Drugs

Proteasome Inhibitors Bortezomib Carfilzomib Ixazomib

Belantamab mafodotin

• Others?

• Steroids • Elotuzumab

Immunomodulatory Thalidomide Lenalidomide Pomalidomide

Selinexor Monoclonal Antibodies Daratumumab Elotuzumab Isatuximab

Alkylators Melphalan, Cyclophospha-mide Melflufen • Other Conventional

Chemo (Bendamustine, DPACE…)

CAR T Cell Therapy?

36


General Principles of Initial Therapy 1. Frontline therapy has a significant impact on long term survival 2. We don’t “save the best for last” but use the best we have early on 3. We leverage combinations of drugs to best control the myeloma 4. We seek a DEEP and DURABLE response 5. We mix and match from the 3 major classes of drugs and add steroids: Proteasome Inhibitors Immunomodulatory Drugs Monoclonal Antibodies 6. We decide early on whether or not someone will have a stem cell transplant

37


Personalized Approach to Frontline Therapy Newly Diagnosed MM and Risk Stratified

Factors to be considered for ASCT Age, performance status (PS), comorbidities (R-MCI score, HCT-Cl) and organ function

ASCT Eligible

ASCT Ineligible

38


Treatment Algorithm in Frontline Newly Diagnosed MM

Not Transplant Candidate

VRd x 8-12 cycles followed by Len

Transplant Candidate VRd x 4 cycles

DRd

Early Auto SCT followed by Maintenance

Collect & store Continue VRd x4 Maintenance Delayed Transplant

*Based on CALGB 100104, S0777, IFM-2009, MAIA ¶ VTd/VCd if VRd not available RAJKUMAR SV. 2020 39


Transplant Eligible Key Questions: 1. Is Transplant still necessary?

2. What is the triplet combination? (VRD or KRD)

3. Should we switch to quadruplet combinations? (D-VRD, D-KRD or I-VRD, I-KRD)

40


Transplant Eligible Key Questions: 1. Is Transplant still necessary? YES, it seems that it still helps with DEPTH and DURATION of response 2. What is the triplet combination? (VRD or KRD) Both are legitimate, we tend to use VRD more but KRD in certain patients 3. Should we switch to quadruplet combinations? (D-VRD, D-KRD or I-VRD, I-KRD) It is still early, but is clearly promising and will come soon…

41


Frontline Therapy and Transplant - Conclusions • We will likely be transitioning to quadruplets in frontline eligible patients

in the near future • Transplant still has a role in MM even with long term use of novel agents • It is still unclear if we should routinely give consolidation therapy after transplant • We can likely improve on current maintenance strategies of lenalidomide alone by adding daratumumab or carfilzomib

42


Transplant Ineligible Key Questions: 1. Are triplets better than Doublets? (VRD vs RD and DRD vs RD)

2. How long should patients be treated?

3. How can we make these combinations more tolerable?

43


Transplant Ineligible Key Questions: 1. Are triplets better than Doublets? (VRD vs RD and DRD vs RD) YES, this has been a consistent trend, but it has to be matched to the patient as some may still receive a doublet 2. How long should patients be treated? In general, the longer the better – but hopefully we will develop stopping rules in the future 3. How can we make these combinations more tolerable? Using drugs that impair quality life LESS is critical… 44


Conclusions in Transplant Ineligible Patients • There is more overlap than ever between therapies for transplant eligible and transplant ineligible patients • Although ASCT remains the standard of care, use is likely to decline in patients who are 65-75 or with significant comorbidities • Continuous therapy has resulted in better outcomes • The balance of toxicity and efficacy is particularly important in this population • My approach is to select 2 agents from the 3 Novel Classes (PIs, IMiDs and MoAbs) – I favor DRD in standard risk patients – I favor VRD in high risk patients

• DRD is more easily delivered and feasible • D-VRD may well be a future standard of care

45


The Evolution of Myeloma Therapy

Now

VD Rev/Dex CyBorD VTD VRD SCT KRD Tandem ASCT (?) D-VMP DRD Front line treatment

Induction

New

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

Nothing Thalidomide? Bortezomib Ixazomib Lenalidomide Combinations

Bortezomib Panobinostat Lenalidomide Daratumumab Ixazomib Carfilzomib Pomalidomide Elotuzumab Isatuximab Selinexor Belantamab mafodotin Melphalan flufenamide

Maintenance

Relapsed

Consolidation

Post consolidation

“more” induction

Daratumumab? Lenalidomide + PI

Rescue

CAR T Cell Therapy Bispecific/Trispecific Antibodies Cell Modifying Agents Venetoclax? PD/PDL-1 Inhibition Multiple small molecules ++++++++

46


THANK YOU! Joseph Mikhael, MD, MEd, FRCPC, FACP Chief Medical Officer, International Myeloma Foundation Professor, Translational Genomics Research Institute (TGen) City of Hope Cancer Center Director of Myeloma Research and Consultant Hematologist, HonorHealth Research Institute jmikhael@myeloma.org

47



Connecting with the Community: Better Myeloma Care An Interview with Dr. Brandon Blue Moffitt Institute Tampa, FL



When myeloma comes back Ajay K. Nooka, MD, MPH, FACP Associate Professor Medical Director, Data and Technology Applications Shared Resource Department of Hematology and Oncology Winship Cancer Institute of Emory University Emory University School of Medicine Winship Cancer Institute | Emory University

51


Biochemical vs Clinical Progression • Biochemical progression:

• Progression of disease based on M-protein parameter increase only • Timing of therapy institution/escalation dependent on numerous factors • Pace of progression • Original clinical presentation • Standard- vs high-risk disease biology • Patient/physician comfort level

• Clinical relapse:

• “Direct indicators of increasing disease and/or end organ dysfunction (CRAB features) related to the underlying clonal plasma cell proliferative disorder” • Mandates immediate institution/escalation of therapy

Kumar S, et al. Lancet Oncol. 2016;17:328-346.

IMWG Consensus Criteria for Response in MM Biochemical Progression ↑ of ≥25% from nadir response value in one or more of the following: 1) Serum M-protein (absolute increase ≥0.5 g/dL, ≥1 g/dL if nadir ≥5 g/dL) 2) Urine M-protein (absolute increase ≥200 mg/ 24 hours) 3) Measurable by serum FLC testing only: difference between involved and uninvolved FLCs (absolute increase ≥10 mg/dL) 4) Non-secretory: bone marrow PC % (absolute increase ≥10%)

Clinical Relapse 1)

2)

3) 4) 5) 6)

Development of new soft tissue plasmacytomas or bone lesions (osteoporotic fractures do not constitute progression) Definite increase in the size of existing plasmacytomas or bone lesions. A definite increase is defined as a 50% (and ≥1 cm) increase as measured serially by the SPD of the measurable lesion Hypercalcemia (>11 mg/dL); Decrease in hemoglobin of ≥2 g/dL not related to therapy or other non-myelomarelated conditions Rise in serum creatinine by 2 mg/dL or more from the start of the therapy and attributable to myeloma Hyperviscosity related to serum paraprotein

≥50% increase in circulating plasma cells (minimum 200 cells/mcL) if this is the only disease measure available

Winship Cancer Institute | Emory University

53


• NOT EVERY RELAPSE NEEDS TO BE TREATED WITH THE SAME UNRGENCY • WE CAN GAIN SOME MORE MILEAGE WITH THE SAME TREATMENT AS LONG AS THERE IS NO CLINICAL RELAPSE • UNDERSTANDING THE RELPASE IS THE KEY • KNEE JERK REACTIONS – RELPASE ≠ CHANGE IN TREATMENT

Winship Cancer Institute | Emory University

54


Winship Cancer Institute | Emory University

55


Winship Cancer Institute | Emory University

56


• ONE SIZE DOES NOT FIT ALL • KNOWING ABOUT YOUR PRIOR TREATMENTS WILL HELP FORMULATE THE NEW PLAN • YOUR MYELOMA MAY BE MORE SENSITIVE TO A SPECIFIC THERAPY • IT WILL ALSO ALLOW FOR NOT CHOOSING TREATMENTS THAT YOU DID NOT TOLERATE WELL BEFORE Winship Cancer Institute | Emory University

57


Winship Cancer Institute | Emory University

58


• NOT EVERY PATIENT IS THE SAME • AGE, OTHER EXISTING ILLNESSES WILL ALLOW FOR CHOOSING OR ‘NOT CHOOSING’ CERTAIN TREATMENTS • SOME TREATMENTS MAY NOT BE SAFE FOR PATIENTS WITH HEART DISEASE, KIDNEY DISEASE ETC • DYNAMIC SCENARIO – MAY BE ABLE TO ADD OR PEEL OFF TREATMENTS BASED ON SPECIFIC PATIENT • PATIENT PREFERENCES – ORAL MEDICATIONS VS INTRAVENOUS OR SUBCUTANEOUS MEDICATIONS Winship Cancer Institute | Emory University

59


Winship Cancer Institute | Emory University

60


• MYELOMA IS NOT A SINGLE DISEASE • HIGH RISK MYELOMAS NEED TO BE DEALT WITH AGGRESSIVELY WITH COMBINATION THERAPIES • CERTAIN GENETIC ALTERATIONS MAY ALLOW FOR USING OFFLABEL TREATMENTS • SOME TREATMENTS WITH URGENT CHEMOTHERAPY ARE NECESSARY TO ‘PUT OUT THE FIRE’ AND TO PREVENT ORGAN DAMAGE FROM MYELOMA Winship Cancer Institute | Emory University

61


Available Approved Multiple Myeloma Therapies in 2021 IMIDs

PIs

Naked antibodies

XPO inhibitors

ADCs

CART

Thalidomide

Bortezomib

Daratumumab (anti-CD38)

Selinexor

Belantamab (anti-BCMA+MMAF)

Idecel (anti-BCMA)

Lenalidomide

Carfilzomib

Isatuximab (anti-CD38)

Pomalidomide

Ixazomib

Elotuzumab (anti-SLAMF7)

HDACis: Panobinostat Steroids: prednisone, dexamethasone Conventional chemotherapeutic agents: melphalan, cyclophosphamide, doxorubicin, bendamustine, combos (DCEP, VDT-PACE)

Winship Cancer Institute | Emory University

62


Mechanism of action of IMiDs Ikaros/Aiolos

IMiD Agent Cereblon E3 Ubiquitin Ligase Complex

Enhances the immune system (Immunomodulatory effects)

Directly kills myeloma cells (Tumouricidal effects)

Myeloma Cells

IRF4 c-MYC

↑ ↑

Stromal Cell Inhibition

NK

NK

NK NK

NK Apoptotic Myeloma Cells

T

↑IFN-γ

↑IL-2 T

NK

T TT

T

T

T Immune Cell Activation NKT

NKT

IFN, interferon; IL, interleukin; NK, natural killer; NKT, natural killer T cell; T, T cell. 1. Hayashi T, et al. Br J Haematol 2004;128:192–203; 2. Brissot E, et al. Leukemia 2015;29:2098–100; 3. Görgün G, et al. Blood 2010;116:3227–37; 3. Lu G, et al. Science 2014;343:305–9

Winship Cancer Institute | Emory University

63


IBERDOMIDE Mechanism of Action • IBER enhances in vitro immune stimulatory activity versus LEN and POM1 1,500

120

LEN POM IBER Live Cells (% DSMO)

IBER2 Secreted IL-2 (ng/mL)

LEN2

IL-2 Secretion by Treated PBMCs1

1,000

500

0

100 80 60 40 20

Compound Concentration (nM)

CRBN binding IC50 • • •

CC-220: Pomalidomide: Lenalidomide:

0.06 uM 1.20 uM 1.50 uM

Aiolos degradation (5 hrs) EC50 • • •

CC-220: Pomalidomide: Lenalidomide:

DSMO, dimethylsulfoxide; EC50, half maximal effective concentration; IL, interleukin; PBMC, peripheral blood mononuclear cell.

0.5 nM 22.0 nM 87.0 nM

MM Cell Survival in Co-Culture With Treated PBMCs1

LEN POM IBER

Compound Concentration (nM)

Ikaros degradation (5 hrs) EC50 • • •

CC-220: Pomalidomide: Lenalidomide:

1.0 nM 24.0 nM 67.0 nM

1. Bjorklund CC, et al. Unpublished data. 2. Adapted with permission from Matyskiela ME, et al. J Med Chem. 2018;61:535-542. © 2018 American Chemical Society.

Winship Cancer Institute | Emory University

64


Mechanism of action of PIs

Winship Cancer Institute | Emory University

65


Mechanism of action of daratumumab

Winship Cancer Institute | Emory University

66


Survival Outcomes of Patients Refractory to CD38-Antibodies •

Retrospective studies of patients with MM refractory to CD38 antibodies 1.0

0.8

N=275

N=130

0.6

OS

Median OS: 8.6 mos (95% CI: 7.2-9.9)

0.4

Not triple refractory: 11.2 mos

0.2

0 Nooka ASH 2018; Gandhi UH, Cornell RF, Lakshman A, et al. Leukemia. 2019;33(9):2266-2275. doi:10.1038/s41375-019-0435-7

Triple and quad-refractory: 9.2 mos

P = .002 0

10

Penta-refractory: 5.6 mos 20

30

Mos

40

67 50


Selinexor Inhibits Nuclear Transport

Nooka et al unpublished



Slide 3

NC Munshi et al. N Engl J Med 2021;384:705-716.


Mechanism of action of belantamab

Winship Cancer Institute | Emory University

71


Recent FDA Approved Agents/ Combinations Treatment

Number of Lines of prior Therapy

Carfilzomib monotherapy (PX-171–00311; FOCUS12)

≥1

Carfilzomib + lenalidomide + dexamethasone (ASPIRE trial1)

1-3

Carfilzomib(56), dexamethasone (Endeavor trial8)

1-3

Daratumumab + either lenalidomide or bortezomib + dex (Pollux5 & Castor6 trials)

≥1

Daratumumab + pomalidomide + dexamethasone7

≥2

Daratumumab monotherapy (Sirius trial9)

≥3

Ixazomib + lenalidomide + dexamethasone (Tourmaline-MM1 trial3 )

≥1

Elotuzumab + lenalidomide + dexamethasone (ELOQUENT- 2 trial2 )

1-3

Elotuzumab + pomalidomide + dexamethasone (ELOQUENT-313)

≥2

Isatuximab-irfc + pomalidomide + dexamethasone (ICARIA-MM14)

≥2

Pomalidomide + dexamethasone

≥2

Panobinostat + bortezomib + dexamethasone (Panorama-14)

≥2

Selinexor + dexamethasone (STORM10)

≥4

Belantamab mafodotin-blmf (DREAMM-215)

≥4

References in notes

72


Approach to Relapse Determine early vs late relapse Clinical trials Len sensitive - IRd - DRd - KRd - ERd

*increase

dose of lenalidomide to 25 mg

Len refractory - DPd - IsaPd - PVd - EPd - IPd - KPd - DKd - IsaKd - PanoKd - DVd - PanoVd - SeliVd - KCd - PCd - Vd - Kd

Len and bort refractory - DPd - IsaPd - KPd - EPd - DKd - IsaKd - PanoKd - Kd - KCd - PCd

Len/bort/CD38mab refr

1) Patient characteristics (comorbidities, frailty, patient preferences) 2) Tumor characteristics (cytogenetic risk, rapid increase in Mprotein)

- Pano Kd - KCd - PCd - Selidex - Blenrep - CART - Melflufen

3) Prior treatment (response, toxicity)

• t(11;14) pts to be considered for venetoclax • Cermods: Iberdomide / CC-92480

4)Access/availability/t ransportation issues

Winship Cancer Institute | Emory University

73


Conclusions • Several antimyeloma agents in the RRMM space • Not every relapse needs to be treated right away but will need to be monitored closely • Several factors – patient related, disease related, prior therapies need to be considered prior to choosing a plan • Several drugs and combinations that are FDA approved and available • More importantly, the new effective drugs are in pipeline and available as clinical trials – ‘a proactive patient’ always makes the best use of this option. • ‘When myeloma comes back’ there is hope and promise – don’t panic Winship Cancer Institute | Emory University

74


Questions anooka@emory.edu @AjayNookaMD

Winship Cancer Institute | Emory University

75


Webinar Q&A

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.

The host may also answer your question live. You may see a notification in the Q&A window if the host plans to do this.

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


Break



AFTER BREAK Changing the Course of Myeloma

Dr. Mikhael

Myeloma Research and African Americans

An interview with Dr. Nooka

Tools for Changing Myeloma

Charise Gleason

Navigating the Multiple Myeloma Transit System

Jameca Barrett

Audience Questions & Survey

Panel

Closing and Thanks

Dr. Mikhael



M-Power Atlanta: Changing the Course of Myeloma Dr. Joseph Mikhael MD, MEd, FRCPC, FACP IMF Chief Medical, Officer, Professor, Translational Genomics Research Institute (TGen), City of Hope Cancer Center


IMF PATIENT EMPOWERMENT MISSION

Advancing early and equitable access to myeloma information, screening and treatment in vulnerable communities worldwide

82


African American Initiative The IMF African American Initiative is one important portion of the IMF’s Patient Empowerment Mission

Many groups have sought to reach out to the African American myeloma community

SUPPORT

HOWEVER The IMF is ideally poised to make a difference due to its unique mission and presence in the community

RESEARCH

AWARENESS

EDUCATION 83


The IMF African American Initiative long-term outcomes education

actively engaging

educating

supporting

improve the short and engagement and support


Be M - Powered YOU Can Change the Course of Myeloma in Your Community

Ask if you should be screened @#$ %

#!? %^

Speak to your doctor about your risk Know the symptoms

Talk to friends & family about what you’ve learned about Multiple Myeloma


Community Outreach • Social Media Campaigns including Black History Month • M-Power Announcement & Press Release • M-Power Website with Toolkit • Patient Stories • Community Workshops • Myeloma Made Simple video • Teaming up with local organizations to provide community ed particularly in churches • Post ASH Facebook Live • Kappa Alpha Psi Black Health Matters Summit booth



88


M-Power Website

89


Education for Primary Care Providers Remember that there is typically a DELAY in diagnosis of myeloma in all patients The delay in LONGER in African American patients for many reasons Our goal is to reduce this time delay by educating the primary care communities in these cities with a focus on: * Recognizing the signs and symptoms of myeloma * Discriminating myeloma from other diagnoses such as diabetes * Proper use of testing to capture the accurate diagnosis of myeloma * Guidance as to referral to Hematology and Oncology



Current and Upcoming Geographies

M-Power Community Workshops Adjacent, targeted states States under consideration for 2022 Myeloma voices


Please reach out to us!

Website myeloma.org IMF InfoLine 800 452 CURE (2873) Website m-power.myeloma.org Website m-poweratlanta.myeloma.org

97



Myeloma Research and African Americans An Interview with Ajay K. Nooka, MD, MPH, FACP

Associate Professor Medical Director, Data and Technology Applications Shared Resource Department of Hematology and Oncology Winship Cancer Institute of Emory University Emory University School of Medicine



Tools for Taking Charge of Myeloma Charise Gleason, MSN, NP-C, AOCNP Winship Cancer Institute of Emory University


Shared Decision Making: Take Charge of Your Care Keep a contact list of your providers Understand the different roles Orchestrate your care ► Be M-Powered:

• Ask questions • Participate in decisions • Communicate effectively with

Subspecialists General Hem/Onc

Primary Care Provider (PCP)

You and Your Caregiver(s)

your entire team

Myeloma Specialist

Family/Support Network Allied Health Staff

125


Shared Decision Making: Be the Best Partner in Your Care ► 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

► Express your goals/values/preferences;

create a dialogue

► Arrive at a treatment decision together


Shared Decision Making: How and When to Discuss Priorities Ask Important Questions at Your Appointments • What Can I Expect Now? • What Can I Expect In the Future? Have these conversations… • Whenever your treatment stops working • Whenever you start a new treatment • Whenever there is a change in your life priorities • Whenever you have a question or concern

Available for download at myeloma.org


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

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

• Stop smoking • Dental care

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.

128


Healthful Living Strategies: Can Diet Impact the Immune System? 

YES. Like gas for your car, diet provides the nutrients (fuel) your immune system needs to perform 

BUT this doesn’t mean you can load up on nutrients to “boost” your immune system

You CAN adequately fuel your immune system with your diet      

Adequate energy intake Adequate protein intake Adequate nutrient intake Minimize inflammation Feeding the gut microbiome Hydration


Healthful Living Strategies: What Should I Eat? The Western Diet • High in: sugar, trans fats, saturated fats • Low in: complex carbohydrates, fiber, micronutrients, bioactive molecules (polyphenols – anti-inflammatory), omega-3s • Risk factor for “metabolism-induced inflammation” •

High intakes of saturated fats  Chronic activation of innate immune system

Choose a plant-based diet  antioxidants, anti-inflammatory • Choose a variety of vegetables, fruits, whole grains, beans, nuts, & seeds • Mediterranean Diet: plant-based diet + fish and healthy plant-based fats/oils •

Associated with reduced risk of heart disease, cancer, Alzheimer’s disease


Healthful Living Strategies: Fatigue, Anxiety & Depression 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.

131


Healthful Living Strategies: Financial Burden Financial burden comes from: •

Medical costs o Premiums o Co-payments o Travel expenses o Medical supplies

Funding and assistance may be available… • Ask about a social worker, financial or nurse navigators at your hospital or clinic for assistance. contact the IMF Infoline for guidance at: 800-452 CURE (2873) or infoline@myeloma.org

Prescription costs

Loss of income o Time off work or loss of employment o Caregiver time off work 132


Healthful Living Strategies: Infection Prevention & Treatment Compromised immune function comes from multiple myeloma and from treatment Good personal hygiene (skin, oral) Environmental control (wash hands, avoid crowds and sick people, etc) Growth factor (Neupogen [filgrastim]) Immunizations (NO live vaccines) Medications (antibacterial, antiviral)

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.

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

Infection is serious for myeloma patients!

 Get COVID Vaccine  Wear a Mask  Avoid Crowds, Sick People, Unvaccinated  Physical Distance & Outdoors  Wash Your Hands 133

CDC website. How to Protect Yourself & Others. Accessed October 22, 2020.

ASH 2017 Abstract #903


IMF Has Many Free Resources to Help You

www.M-PowerAtlanta.myeloma.org

IMF TV

http://myeloma.org

IMF InfoLine: 1-800-452-CURE | 9am to 4pm PST 134



NAVIGATING THE MULTIPLE MYELOMA TRANSIT SYSTEM JAMECA BARRETT COMMUNITY LEADER & PATIENT ADVOCATE ATLANTA, GA

Navigating Survivorship

Navigating Disability Navigating Recovery

U

Navigating Financials


OVERVIEW •

Navigating Survivorship ‘

Navigating Disability Navigating Disability

Navigating Financials

Navigating Recovery

Navigating Survivorship

MARTA: Myeloma African-American Rapid Transit Authority

Navigating Recovery

Navigating Financials


Christmas, New Years, & Valentine’s Day ‘

What you did back then, paved the way for where you are now. Antoine


Career Development – 1999

Diagnosed with Multiple Myeloma - December 2003


MAPS ARE ESSENTIAL. PLANNING A JOURNEY WITHOUT A MAP IS LIKE BUILDING A HOUSE WITHOUT DRAWINGS. - MARK JENKINS

Unemployed

Employed

Uninsured

Insured

Dependent

Independent

Depression

Joyful

2003

2021


Key to recovery: Medical Journal Use tabs and create sections:

Examples: • Provider • Condition • Medical History • Diagnosis date • Surgery date • Track symptoms • Jot down questions & things that need to be addressed during appointment

2003


Keys to Recovery: Helping Others Getting involved in advocacy supported my own well-being while I supported others

• Get involved with card and letterwriting campaign to congress • Share during Support group meetings • Help educate primary care providers • Host fundraiser • Host awareness drives • Pass out information during family gatherings


Your 5- Points: Oncologist & Primary Care Physician o

All trains run through the hub - Marta’s Five Points Station

o

Yo u r p r i m a r y c a r e p r o v i d e r a n d o n c o l o g y t e a m (including Palliative/ Supportive Care) is your Five Points Station

o

Yo u n e e d a t r u s t e d r e l a t i o n s h i p w i t h y o u r primary care doctor (PCP) and your supportive care team

o

Every action should be an outcome of an appointment with your Five Points Station


Navigating a Disability Diagnosis

An ounce of prevention is worth a pound of cure Treatment •

Continuity of Care – a connected medical care team • lack of continuity leads to wasted time & money, delayed diagnosis & treatment, & communication issues.

Disability: REMEMBER you have to the right to appeal and/or file a complaint if you are denied


Navigating Financials Healthcare is expensive BUT there are many programs available for all socioeconomic groups “If you’re saving, you're succeeding.” ~Steve Burkholder

Speak with a Nurse Navigator, Social Worker, or Financial Navigator at your institution Governmental agencies / Non-profit programs

800-452 CURE (2873) InfoLine

Myeloma.org


Navigating Recovery HEAD IN THE RIGHT DIRECTION Medical Records

- You always have medical data on hand via patient portals for new appointments

Make the most of Telehealth & Technology & Patient Portals

“It doesn’t matter how many resources you have. If you don’t know how to use them, it will never be enough.” ~ Unknown

Myeloma.org


Navigating Survivorship - GET BACK ON TRACK & HELP SOMEONE ELSE TO DO THE SAME •

Acknowledge the emotional and mental impact of a cancer diagnosis

Survivorship requires honesty, awareness, & support Wellness / Cancer Wellness Programs Your brain needs healing •

- Barack Obama

CRT, Cognitive Rehab Therapy

You need support • • • •

“…Asking for help isn't a sign of weakness, it's a sign of strength. It shows you have the courage to admit when you don't know something, and to learn something new.”

Family Friends Counselor / therapist Chaplain

Myeloma.org


You Can Navigate the Multiple Myeloma Transit System

The Information Booth find people to advise you on your journey: support groups, navigators, friends, family, and of course your healthcare team

MARTA Law Enforcement you and your advocates are the officers; become familiar with policies, procedures, and your rights

Focus on healing

YOU WILL LEARN AS YOU GO


You Can Navigate the Multiple Myeloma Transit System Somehow God Knew Somehow God knew way before you were born, All that you’d need to brave every storm. He gave you the graces and the intellect, too, for all of the things you were meant to do. ~Unknown



Webinar Q&A

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.

The host may also answer your question live. You may see a notification in the Q&A window if the host plans to do this.

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


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!


Workshop Video Replay & Slides

As a follow up to today's workshop, we will have the speaker slides and a video replay available. They will be provided to you shortly after the workshop concludes.


Turn static files into dynamic content formats.

Create a flipbook
Issuu converts static files into: digital portfolios, online yearbooks, online catalogs, digital photo albums and more. Sign up and create your flipbook.