Charlotte Community Workshop by International Myeloma Foundation

Community Workshop March 20, 2021

M-POWER CHARLOTTE: CHANGING THE COURSE OF MYELOMA

10AM ET

Welcome and Speaker Introductions Kelly Cox Senior Director, Regional Community Workshops

With Support From…

M-POWER CHARLOTTE COMMUNITY WORKSHOP Saturday March 20, 2021 ~ Agenda

Welcome & Speaker Introductions

M-Power Charlotte: Changing the Course of Myeloma

Kelly Cox & Dr. Joseph Mikhael, International Myeloma Foundation

Dr. Joseph Mikhael, International Myeloma Foundation

Race Matters in Myeloma Care & Survival

Can We Detect Myeloma Even Sooner?

Dr. Joseph Mikhael, International Myeloma Foundation

Myeloma for Patients Who Are Just Getting Started Dr. Joseph Mikhael, International Myeloma Foundation

When Myeloma Comes Back

Break 5 minutes

Dr. Manisha Bhutani, Levine Cancer Institute

Finding Your Voice and Talking with Your Team Tiffany Williams, Patient Advocate

Dr. Peter Voorhees, Levine Cancer Institute

How Your Healthcare Team Can Help You

How to Manage Myeloma Symptoms & Side Effects

Amy Pierre, Memorial Sloan Kettering Cancer Center

Audience Questions

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.

Race Matters in Myeloma Care & Survival Dr. Joseph Mikhael, IMF Chief Medical Officer Professor, Translational Genomics Research Institute (TGen) City of Hope Cancer Center

Race Matters in Myeloma Care and Survival

Important Facts about Myeloma and African Americans 1. Myeloma is the most common hematologic cancer in African Americans By 2034 it is estimated that African Americans will make up roughly 24% of the newly diagnosed MM population1

1. Rosenberg PS, Barker KA, Anderson WF, et al. Future distribution of multiple myeloma in the United States by sex, age, and race/ethnicity. Blood. 2015;125:410-412.

8 8

Important Facts about Myeloma and African Americans 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. 9 9

Important Facts about Myeloma and African Americans 3. African Americans are younger at diagnosis by about 5 years

10 10

Important Facts about Myeloma and African Americans 4. Survival improvements in myeloma have not been as pronounced in African Americans

11 11

Important Facts about Myeloma and 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

Ailawadhi et al. Racial disparities in treatment patterns and outcomes among patients with multiple myeloma: a SEER-Medicare analysis Blood Adv 2019; 3(20): 2986-94

12 12

Important Facts about Myeloma and 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):4358-4365

13 13

Important Facts about Myeloma and African Americans 7. African Americans are less likely to receive Stem Cell Transplants

14 14

Important Facts about Myeloma and African Americans 8. Although African Americans comprise 20% of all MM patients, they only represent 8% of patients on clinical trials

15 15

Important Facts about Myeloma and African Americans 9. There are biologic differences in African Americans with MM that may lead to lower risk disease

16 16

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

17 17

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 18 18

Myeloma For Patients Who Are Just Getting Started

Dr. Joseph Mikhael, IMF Chief Medical Officer 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

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

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.

Who’s at Risk for Multiple Myeloma About 1 in 132 people are diagnosed each year (MM is the second most common blood cancer diagnosed) Your risk of myeloma increases if you are: • Older than age 60 • African American (with a 2x greater risk than whites) • Closely related to someone with MM • A man (diagnosed more than women) • Very overweight or obese • Diagnosed with other plasma cell diseases, like MGUS (monoclonal gammopathy of undetermined significance).

Improving Survival in MM

*Year ranges represent the year of diagnosis. Note: By linking to the SSA Master Death File, survival was measured as time from diagnosis date to the date of death obtained from the SSA, time from diagnosis date to the date of inpatient death, or time from diagnosis date to September 30, 2015; Survival estimates were presented for multiple myeloma patients diagnosed and treated during 2006-2012 (n=9,521). Fonseca B et al. Leukemia 2017;31:1915-1921.

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

In 2020: 32,000 estimated new cases; 13,000 estimated deaths

Multiple Myeloma diagnosis can be challenging

Fatigue

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

Anemia

Multiple Myeloma Typically Preceded by Premalignant Conditions Premalignant

Condition

MGUS1-4

SMM1-5,8

(Monoclonal Gammopathy of Undetermined Significance)

(Smoldering Multiple Myeloma)

Active Multiple Myeloma6-8

<10%

10%-60%

>10%

None

Yes

~1% per year

~10% per year

Not Applicable

No; observation

Yes for high risk*; No for others

Yes

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.

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

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.

More About the Common “CRAB” Symptoms

Low Blood Counts • May lead to anemia and infection • Anemia is present in 60% at diagnosis

Weakness Fatigue Infection

Decreased Kidney Function • Occurs in over half of myeloma patients

Weakness

Bone Damage • Affects 85% of patients • Leads to fractures

Bone pain

Bone Turnover • Leads to high levels of calcium in blood (hypercalcemia)

Loss of Appetite & Weight loss

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

How to Choose a Treatment Plan Age

Lifestyle Goals of Therapy

Patient Preference

Myeloma Symptoms

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?

Personalized Approach to Frontline Therapy Newly Diagnosed MM Newly Diagnosed MM and Risk Stratified and Risk Stratified

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

ASCT Eligible

ASCT Ineligible

ASCT Eligible

ASCT Ineligible

Treatment Algorithm in Frontline Newly Diagnosed MM

Not Transplant Candidate

Transplant Candidate VRd x 4 cycles

VRd x 8-12 cycles followed by Len

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

S0777 Trial: VRd vs Rd Eight 21-day Cycles of VRd

Randomization N = 525 Newly diagnosed MM

• •

Stratification: ISS (I, II, III) Intent to transplant @ progression (yes/no)

Bortezomib 1.3/mg2 IV Days 1, 4, 8, and 11 Lenalidomide 25 mg/day PO Days 1-14 Dexamethasone 20 mg/day PO Days 1, 2, 4, 5, 8, 9, 11, 12

Six 28-day Cycles of Rd Lenalidomide 25 mg/day PO Days 1-21 Dexamethasone 40 mg/day PO Days 1, 8, 15, 22

6 month of triplet followed by doublet Durie BGM, et al. ASH 2015

S0777 Trial: VRd vs Rd

41 months

OS 80% = 4 years Durie et al. Blood Cancer Journal (2020) 10:53 https://www.nature.com/articles/s41408-020-0311-8

55% = 7 years

MAIA Study Design • Phase 3 study of D-Rd vs Rd in transplant-ineligible NDMM (N = 737) D-Rd (n = 368) Key eligibility criteria: • Transplantineligible NDMM • ECOG 0-2 • Creatinine clearance ≥30 mL/min

1:1 Randomization

Primary endpoint: Daratumumab (16 mg/kg IV)a Cycles 1-2: QW Cycles 3-6: Q2W Cycles 7+: Q4W until PD R: 25 mg PO daily on Days 1-21 until PD d: 40 mgb PO or IV weekly until PD

Rd (n = 369) R: 25 mg PO daily on Days 1-21 until PD d: 40 mgb PO or IV weekly until PD

Stratification factors • ISS (I vs II vs III) • Region (NA vs other) • Age (<75 vs ≥75 years)

• PFS Key secondary endpointsc: • ≥CR rate • ≥VGPR rate • MRD-negative rate (NGS; 10–5) • ORR • OS • Safety

Cycle: 28 days aOn

days when daratumumab was administered, dexamethasone was administered to patients in the D-Rd arm and served as the treatment dose of steroid for that day, as well as the required pre-infusion medication. bFor patients older than 75 years of age or with BMI <18.5, dexamethasone was administered at a dose of 20 mg weekly. cEfficacy endpoints were sequentially tested in the order shown. ECOG, Eastern Cooperative Oncology Group; ISS, International Staging System; NA, North America; IV, intravenously; QW, once weekly; Q2W, every 2 weeks; Q4W, every 4 weeks; PD, progressive disease; PO, orally; CR, complete response; VGPR, very good partial response; MRD, minimal residual disease; NGS, next-generation sequencing; ORR, overall response rate; OS, overall survival; BMI, body mass index.

Efficacy: PFS Median follow-up: 28 months (range: 0.0-41.4)

% surviving without progression

100

30 moa

71% D-Rd Median: not reached

56%

Rd Median: 31.9 mo

HR, 0.56; 95% CI, 0.43-0.73; P <0.0001 0 0

No. at risk Rd D-Rd

149 203

94 146

50 86

18 35

3 11

2 1

0 0

Months 369 368

332 347

307 335

280 320

254 309

236 300

219 290

200 271

44% reduction in the risk of progression or death in patients receiving D-Rd CI, confidence interval. aKaplan-Meier estimate.

GRIFFIN: Randomized Phase • Phase 2 study of D-RVd vs RVd in transplant-eligible NDMM, 35 sites in US with enrollment from 12/2016 and 4/2018

Key eligibility criteria: • Transplanteligible NDMM • 18-70 years of age • ECOG PS score 0-2 • CrCl ≥30 ml/mina

1:1 Randomization

Induction: Cycles 1-4 D-RVd D: 16 mg/kg IV Days 1, 8, 15 R: 25 mg PO Days 1-14 V: 1.3 mg/m2 SC Days 1, 4, 8, 11 d: 20 mg PO Days 1, 2, 8, 9, 15, 16

RVd R: 25 mg PO Days 1-14 V: 1.3 mg/m2 SC Days 1, 4, 8, 11 d: 20 mg PO Days 1, 2 ,8, 9, 15, 16 21-day cycles

T R A N S P L A N T

Consolidation: Cycles 5-6c

Maintenance: Cycles 7-32d

D-RVd D: 16 mg/kg IV Day 1 R: 25 mg PO Days 1-14 V: 1.3 mg/m2 SC Days 1, 4, 8, 11 d: 20 mg PO Days 1, 2, 8, 9, 15, 16

D-R D: 16 mg/kg IV Day 1 Q4W or Q8We R: 10 mg PO Days 1-21 Cycles 7-9; 15 mg PO Days 1-21 Cycle 10+

RVd R: 25 mg PO Days 1-14 V: 1.3 mg/m2 SC Days 1, 4, 8, 11 d: 20 mg PO Days 1, 2, 8, 9, 15, 16

R R: 10 mg PO Days 1-21 Cycles 7-9; 15 mg PO Days 1-21 Cycle 10+

21-day cycles

28-day cycles

Endpoints & statistical assumptions Primary endpoint: sCR rate (by end of consolidation); 1-sided alpha of 0.1 80% power to detect 15% improvement (50% vs 35%), N = 200

Secondary endpoints: rates of MRD negativity (NGS 10–5), CR, ORR, ≥VGPR

Stem cell mobilization with G-CSF ± plerixaforb D-RVd, daratumumab plus lenalidomide/bortezomib/dexamethasone; RVd, lenalidomide/bortezomib/dexamethasone; NDMM, newly diagnosed multiple myeloma; US, United States; ECOG PS, Eastern Cooperative Oncology Group performance status; CrCl, creatinine clearance; IV, intravenously; PO, orally; SC, subcutaneously; G-CSF, granulocyte colony-stimulating factor; D-R, daratumumab-lenalidomide; Q4W, every 4 weeks; Q8W, every 8 weeks; NGS, next-generation sequencing; ORR, overall response rate; VGPR, very good partial response. aLenalidomide dose adjustments were made for patients with CrCl ≤50 mL/min. bCyclophosphamide-based mobilization was permitted if unsuccessful. cConsolidation was initiated 60-100 days post transplant. dPatients who complete maintenance cycles 7-32 may continue single-agent lenalidomide thereafter. eProtocol Amendment 2 allowed for the option to dose daratumumab Q4W, based on pharmacokinetic results from study SMM2001 (NCT02316106).

Winship Cancer Institute | Emory University

GRIFFIN: Randomized Phase • Phase 2 study of D-RVd versus RVd in transplant-eligible NDMM, 35 sites in the United States with enrollment between December 2016 and April 2018 Induction: Cycles 1-4

• Transplanteligible NDMM • 18-70 years of age • ECOG PS score 0-2 • CrCl ≥30 mL/mina

D-RVd

1:1 randomization

Key eligibility criteria:

D: 16 mg/kg IV Days 1, 8, 15 R: 25 mg PO Days 1-14 V: 1.3 mg/m2 SC Days 1, 4, 8, 11 d: 20 mg PO Days 1, 2, 8, 9, 15, 16

RVd R: 25 mg PO Days 1-14 V: 1.3 mg/m2 SC Days 1, 4, 8, 11 d: 20 mg PO Days 1, 2, 8, 9, 15, 16 21-day cycles

T R A N S P L A N T

Consolidation: Cycles 5-6c

Maintenance: Cycles 7-32d D-R

D-RVd

D: 16 mg/kg IV Day 1 Q4W or Q8We R: 10 mg PO Days 1-21 Cycles 7-9; 15 mg PO Days 1-21 Cycles 10+

D: 16 mg/kg IV Day 1 R: 25 mg PO Days 1-14 V: 1.3 mg/m2 SC Days 1, 4, 8, 11 d: 20 mg PO Days 1, 2, 8, 9, 15, 16

RVd

R: 25 mg PO Days 1-14 V: 1.3 mg/m2 SC Days 1, 4, 8, 11 d: 20 mg PO Days 1, 2, 8, 9, 15, 16

R: 10 mg PO Days 1-21 Cycles 7-9; 15 mg PO Days 1-21 Cycles 10+

21-day cycles

28-day cycles

Endpoints and statistical assumptions Primary endpoint: sCR rate (by end of consolidation); 1-sided alpha of 0.1 80% power to detect 15% improvement (50% vs 35%), N = 200

Secondary endpoints: Rates of MRD negativity (NGS 10–5), ORR, ≥VGPR, CR

Stem cell mobilization with G-CSF ± plerixaforb

ECOG PS, Eastern Cooperative Oncology Group performance status; CrCl, creatinine clearance; IV, intravenous; PO, oral; G-CSF, granulocyte colony-stimulating factor; Q4W, every 4 weeks; Q8W, every 8 weeks; NGS, next-generation sequencing; ORR, overall response rate; VGPR, very good partial response; CR, complete response. aLenalidomide dose adjustments were made for patients with CrCl ≤50 mL/min. bCyclophosphamide-based mobilization was permitted if unsuccessful. cConsolidation was initiated 60 to 100 days post transplant. dPatients who complete maintenance cycles 7 to 32 may continue single-agent lenalidomide thereafter. eProtocol Amendment 2 allowed for the option to dose daratumumab Q4W, based on pharmacokinetic results from study SMM2001 (NCT02316106).

Responses Deepened over Timea sCR, P = 0.0253b ≥CR, P = 0.0014b 100 90

Patients, %

12.1 7.1

≥CR: 19.2%

21.2

≥CR: 27.3%

6.1

7.2 6.2

≥CR: 51.5%

42.4

70 52.5

63.6

39.4

18.2

20 26.3 10

2.0

0 End of induction

12.1 End of ASCT

32.0

≥CR: 42.3%

10.3

8.1

1.0

End of consolidation

D-RVd

3.0

1.0

12-months-ofmaintenance cutoff

≥CR: 60.8%

13.4

30.9 35.1

18.6 25.8

18.6

13.4

14.1

1.0

47.4

46.4

sCR CR VGPR PR SD/PD/NE

59.6

≥CR: 19.6%

43.3

≥CR: 81.8%

9.1

14.4 5.2

60 50

≥CR: 13.4%

8.2

7.2

End of induction

End of ASCT

End of consolidation

12-months-ofmaintenance cutoff

RVd

• Results for end of induction, ASCT, and consolidation are based on a median follow up of 13.5 months at the primary analysis • Median follow up at 12-months-of-maintenance therapy cutoff was 27.4 months

Response rates and depths were greater for D-RVd at all time points PR, partial response. SD/PD/NE, stable disease/progressive disease/not evaluable. aData are shown for the response-evaluable population. bP values (2-sided) were calculated using the Cochran–Mantel–Haenszel chi-square test.

MASTER: Phase 2 Study of Dara-KRd in TEMM

MRD assessment by NGS

Consolidation

Dara-KRd x 4

2nd MRD (-) (<10-5)

MRD

Dara-KRd x 4

AHCT

Consolidation

MRD

Induction

Lenalidomide Maintenance

2nd MRD (-) (<10-5)

Treatment-free observation and MRD surveillance*

Dara-Based Quads: Depth of Response N

Post-Induction

Post-ASCT

Post-Consolidation

sCR

≥VGPR

sCR

≥VGPR

sCR

≥VGPR

MRD-

VTd

542

6.5%

56.1%

9.4%

67.4%

20.3%

78.0%

43%

D-VTd

542

7.4%

64.9%

13.4%

76.7%

28.9%

83.4%

62%

RVd

103

7.2%

56.7%

14.4%

66.0%

32.0%

72.9%

20.4%

D-RVd

104

12.1%

71.7%

21.2%

86.9%

42.4%

90.9%

51.0%

D-KRd

39%

91%

81%

100%

95%

100%

82%

Costa L, et al. ASH 2019. Moreau, P et al. Lancet 2019;394:29-38.

Voorhees P, et al. ASH 2019.

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

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 ++++++++

THANK YOU!

Joseph Mikhael, MD, MEd, FRCPC 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

When Myeloma Comes Back Dr. Peter Voorhees Levine Cancer Institute / Atrium Health

When Myeloma Comes Back Peter Voorhees, M.D. Professor of Medicine Member, Plasma Cell Disorders Division

LEVINE CANCER INSTITUTE

Outline:

-What is relapse? -Available treatment for relapse -Choosing therapy -Novel treatments -Conclusions

Doc, Am I in Remission?

National Cancer Institute Dictionary of Cancer Terms: •Progressive Disease: Cancer that is growing, spreading, or getting worse. •Relapse: The return of a disease or the signs and symptoms of a disease after a period of improvement. Disease progression / progressive disease, disease coming out of remission, and relapse interchangeably. In all cases, it means that the myeloma cells are growing and dividing, and the burden of disease is therefore increasing.

https://www.cancer.gov/publications/dictionaries/cancer-terms/

Identifying Relapse • Blood and urine studies • Myeloma cells produce a unique antibody that can be identified on blood and urine tests. This myeloma antibody may consist of: • An M spike, consisting of a heavy chain protein and light chain protein component • The heavy chain is either IgG, IgA or IgM, (in rare cases IgD or IgE) • The light chain component is a kappa or lambda light chain • A free light chain antibody that is not attached to a heavy chain • Both an M spike and a free light chain antibody • The M spike is measured directly with the SPEP test • Free kappa and lambda light chains are measured with the serum free light chain test and 24-hour urine testing (the UPEP)

Intact antibodies

Light chains

Plasma cell Adapted from Serum Free Light Chain Analysis. 4th Edition. AR Bradwell.

Identifying Relapse

• Blood and urine studies • Regular SPEP and serum free light chain testing • Serum free light chain can replace 24-hour urine testing in many cases

• Free light chain escape • When myeloma cells stop making the heavy chain and just make the light chain part of the antibody • e.g. IgA kappa myeloma changes into free kappa light chain myeloma • Picked up by serum free light chain testing.

• Non-secretory and oligo-secretory myeloma. • The myeloma cells lose the ability to make any antibody or make minimal antibody • Not measurable by SPEP and serum free light chains • More frequent imaging and bone marrow biopsies required to track the myeloma

Identifying Relapse

• Imaging • Bone Imaging • Skeletal survey • Low dose CT • Whole body MRI • CT, MRI, whole body PET-CT • Monitoring for disease outside of the bones (extra-medullary multiple myeloma) • PET-CT, CT, MRI • Clinical symptoms • New, progressive bone pain • Worsening fatigue

Kinds of Relapse

• Biochemical Relapse • The myeloma biomarkers are rising but no clinical signs or symptoms of disease • There is more freedom of treatment choice in this scenario. • No change in therapy, adjust current therapy or change therapy • Factors influencing choice: pace of progression, characteristics of the disease at original diagnosis • Clinical Relapse • The disease has come back, and the patient has signs / symptoms of advancing disease • Worsening anemia or kidney function, new bone pain, increasing calcium level • Patients with clinical relapse need to start / change therapy immediately

Does Myeloma Always Relapse? • 344 pts undergoing ASCT between 1989 and 1998 • Median follow-up 12.5 years

• Landmark analysis demonstrates an absolute plateau in the PFS curve after 11 years (median follow-up for 11-year landmark 5 years) Joaquin Martinez-Lopez et al. Blood 2011;118:529-534

When to Expect Relapse: Upfront Transplant Setting 1000 consecutive myeloma patients treated with Revlimid/Velcade/Dexamethasone Induction Therapy Transplant  Risk-adapted maintenance

The median time to myeloma coming back was 5 years and 5 months Joseph NS, et al. J Clin Oncol 2020;38:1928-37

When to Expect Relapse: Non-Transplant Setting

48-month PFS 48-Month PFS

Alive and Without % of Patients % surviving without progression Progression

100

60%

D-Rd: NR

38%

Rd: 34.4 months 20

HR, 0.54; 95% CI, 0.43-0.67; P <0.0001 0 0

15 18 21

24 27

30 33 36

42 45

51 54

57 60 63

Months No. at risk Rd

369

333

307

280

255

237

220

205

196

179

172

155

145

132

114

D-Rd

368

347

335

320

309

300

290

276

266

256

246

237

232

221

201

153

111

Kumar S, et al. ASH 2020

• MAIA: A phase III study comparing revlimid and dexamethasone to darzalex, revlimid and dexamethasone in newly diagnosed myeloma patients not undergoing transplant • 60% of patients receiving the 3drug combination remain alive and free of their myeloma coming back 4 years from diagnosis

The Natural History of Relapsed Multiple Myeloma Mayo Clinic experience from 1/01/1985 – 12/31/1998

With each relapse, the duration of response diminishes Kumar S, et al. Mayo Clin Proc 2004;79:867-74

The Modern Natural History of Relapsed Multiple Myeloma

Median PFS, months

1st Line (IFM 2009: ASCT Arm)

2nd line (Dara-Rd) POLLUX

3rd Line (Dara-Kd) CANDOR

4th Line (Elo-Pd) ELOQUENT-3

44.5

28.6

10.3

Take home message: Put your best foot forward • Optimize the duration of remission early in the course of the disease • The longer the remission, the more treatments available to you at next relapse

Attal, M, et al. NEJM 2017;376:1311-20. Dimopoulos, MA, et al. NEJM 2016;375:1319-31. Dimopoulos, MA, et al. ASH 2020.

Dimopoulos. N Engl J Med. 2018;379:1811. Bahlis, N, et al. ASH 2018.

Drug Classes Available for Relapsed Multiple Myeloma • IMiDs • Lenalidomide • Pomalidomide • Proteasome inhibitors • Bortezomib • Carfilzomib • Ixazomib • BCMA-Targeted Therapy • Belantamab mafodotin • Exportin-1 inhibitors • Selinexor

• Alkylating Agents • Cyclophosphamide • Melphalan • Bendamustine • Melphalan Flufenamide (Melflufen) • Histone deacetylase inhibitors • Panobinostat • Monoclonal antibodies • Elotuzumab • Daratumumab • Isatuximab • Steroids • Dexamethasone • Prednisone

45 regimens in the NCCN guidelines for relapsed myeloma: 9 preferred, 19 other recommended, 17 useful in certain circumstances NCCN Guidelines, Version 5.2021, accessed March 2021.

PABST: The Blue Ribbon Approach to Therapy Decisions for Previously Treated Multiple Myeloma •Past medical history • What co-morbidities will impact tolerability of therapy?

•Adverse events • What toxicities were experienced with prior therapy?

•Biochemical vs clinical relapse/progression •Standard vs high-risk disease biology •Treatment history • Is the disease resistant to specific drug classes? • Carfilzomib refractory = bortezomib and ixazomib refractory • Pomalidomide refractory = lenalidomide refractory

Trojan Horse Approaches to Myeloma Treatment: Melphalan Flufenamide and Belantamab Mafodotin Belantamab Mafodotin Antibody

Cytotoxic drug payload

Binding to cell surface antigen Lysosomal degradation

Linker Endocytosis of ADC-antigen complex

Lipophilic structure diffuses readily across cell membrane

Cytotoxic payload Peptide carrier

Melphalan Flufenamide

Aminopeptidases are expressed in several cancers, including multiple myeloma

Release of active cytotoxic payload (tubulin inhibitor)

Cytotoxic payload causes microtubule disruption leading to cell death

Aminopeptidase cleavage Hydrophilic cytotoxic Cleavage drives releases hydrophilic payload entrapped within concentration gradient, cytotoxic payload cell increasing diffusion into cell

Alkylator payload enters nucleus, causing DNA breakage and inhibition of synthesis, leading to cell death

Melphalan Flufenamide and Belantamab Mafodotin

Belantamab Mafodotin (DREAMM-2)

Melphalan Flufenamide + Dex (HORIZON)

31%

29%

sCR

VGPR

11%

13%

18%

16%

CBR

36%

45%

Median DoR, mos (95% CIs)

11.0 (4.2 – NR)

5.5 (3.9-7.6)

Median PFS, mos (95% CIs)

2.8 (1.6 – 3.6)

4.2 (3.4-4.9)

Median OS, mos (95% CIs)

13.7 (9.9 – NR)

11.6 (9.3-15.4)

Overall Response Rate

Lonial, S et al. Lancet Oncol 2020;21:207-21 Richardson, P et al. J Clin Oncol 2021;39:757-67

Combination Therapy in Myeloma: More may be Better

Belantamab Mafodotin + Pomalyst and Dex

Melphalan Flufenamide and Dex + Darzalex

88.0%

73%

sCR + CR

14.7%

VGPR

52.9%

30%

20.6%

36%

Overall Response Rate

Trudel, S et al. ASH 2020 Ocio, E et al. ASH 2020

Precision Medicine in Myeloma: Venetoclax in t(11;14)+ Disease

Venetoclax Monotherapy

Venetoclax-DaratumumabDex t(11;14)+

Study Phase

Sample Size

Median Prior Lines of Therapy

2.5

ORR

t(11;14)+

t(11;14)-

40%

14%

25%

VGPR

13%

70.8%

13%

Median DOR, mos

9.7

18-mo: 94.1%

Median TTP, mos

6.6

1.9

18-mo: 94.1%

Kumar, S et al. Blood 2017;130:2401-2409 Kaufman J et al. ASH 2020

96%

CAR T Cell Therapy in Myeloma

Maus MV et al. Clin Cancer Res 2016;22:1875

Ide-Cel: The KarMMa-2 Trial

Ide-Cel

Belantamab

73%

31%

sCR + CR

33%

VGPR

20%

11%

21%

13%

10.7

11.0

ORR

Median DoR, mos

Munshi N et al. N Engl J Med 2021;384:705-16

Conclusions •Treatment of relapsed multiple myeloma is complicated •Many regimens, many factors to weigh in narrowing choices •Think about having a myeloma specialist involved in your care

•Survival for patients with relapsed multiple myeloma continues to improve •Many new options available with novel mechanisms of action

•Immunotherapy options on the horizon promise to improve survival even more •CAR T cell therapy, bispecific antibodies

•These improved outcomes could not be possible without the brave and altruistic involvement of patients in myeloma research

How to Manage Myeloma Symptoms & Side Effects Amy E. Pierre, RN, MSN, ANP-BC Memorial Sloan Kettering Cancer Center, Flatiron Health & IMF Nurse Leadership Board

Myeloma and Treatments Both Contribute to How You Feel

Myeloma cells in excess can cause symptoms

Treatments for myeloma kill myeloma cells but can cause symptoms

• Calcium elevation

• Fatigue

• Myelosuppression

• Renal dysfunction

• Infection

• Peripheral neuropathy

• Anemia

• Other symptoms

• Diarrhea

• Bone pain

• Fatigue

• Deep vein thrombosis • Infection (eg, shingles) • Other symptoms

How You Feel 73

Steroid Side Effects and Management Steroid Side Effects • Irritability,

mood swings, depression • Difficulty sleeping

(insomnia), fatigue • Increased risk of

infections, heart disease • Muscle weakness, cramping

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

hiccups, heartburn, ulcers, or gas

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

• Weight gain, hair

thinning/loss, skin rashes • Increase in blood

sugar levels, diabetes

Steroids help kill myeloma cells. Do not stop or adjust steroid doses without discussing it with your health care provider.

• Increase in blood pressure,

water retention 74 King T, Faiman B. CJON. 2017; 21(5)suppl:240-249. Faiman B, et al. CJON. 2008;12(3)suppl:53-63.

Fatigue, Depression, and Anxiety • All can affect quality of life and relationships • Sources include anemia, pain, reduced activity, insomnia, treatment toxicity, bone marrow suppression

Management

• Exercise (walking, yoga, etc) • Proper rest • Support (social network, support group, professional counseling, etc) • Prayer, meditation, spiritual support • Mindfulness-based stress reduction

• • • • •

Medications Massage, aroma therapy Supplements: ginseng Transfusion, if indicated Effective management of other symptoms

At least 70% of patients experience fatigue, but only 20% tell their provider. Let your provider know about symptoms that are not well controlled or thoughts of self harm. 75

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)

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!

• New research: for patients receiving active myeloma therapy, levofloxacin 500 mg once daily for 12 weeks reduced infection (fevers, death) (ASH 2017 #903) 76 76 Brigle K, et al. CJON. 2017; 21(5)suppl:60-76.

Deep Vein Thrombosis (DVT ) and Pulmonary Embolism (PE) • Risk Factors

• Provider Management

• Personal or family history • Lifestyle (obesity, smoking, inactivity) • Medical (medications, surgery

• Symptoms • Swelling, tightness, ache/pain, change in color or temperature • Chest or shoulder pain • Shortness of breath, difficult/labored breathing • Anxiety • Rapid heart rate

• Adjusting medications and schedules (weekly steroids, types of chemo) • Prescribing blood-thinning medications according to assessed risk (aspirin, warfarin, heparin or Direct Oral Anticoagulant[DOAC]) • Anti-embolism stockings (elastic stockings)

• Self Management • Lifestyle changes (stop smoking, weight mgmt) • Activity; Moving frequently when sitting long periods; Travel precautions

Report DVT and PE symptoms immediately! These are considered a medical emergency & require immediate care. 77 Noonan K, et al. CJON. 2017;21(5)suppl:37-46. Rome S, et al. CJON. 2008;12(3)suppl:21-8.

GI Symptoms Diarrhea and Constipation: Prevention & Management • Diarrhea may be caused by – Laxatives, antacids with magnesium – Antibiotics, antidepressants, others – Milk thistle, aloe, cayenne, saw palmetto, ginseng – Sugar substitutes in sugar free gum

• Increase fluid intake – Avoid caffeinated, carbonated, or heavily sugared beverages

• Take anti-diarrheal medication – Imodium®, Lomotil®, or Colestid if recommended – Fiber binding agents – Metamucil®, Citrucel®, Benefiber® – Welchol® if recommended

• 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®

• Increase fluid intake – to work with fiber, also good for kidneys

Discuss GI issues with health care providers to identify causes of and make adjustments to medications and supplements. 78 78 Smith LC, et al. CJON.2008;12(3)suppl:37-52. Faiman B. CJON. 2016;20(4):E100-E105.

Understanding Changes to Kidney/ Renal Function Risk Factors

Prevention

• Active multiple myeloma (light chains, high calcium) • Other medical issues (ex: Diabetes, dehydration, infection) • Medications (MM treatment, antibiotics, contrast dye)

• Drink, Drink, Drink • Avoid certain medications, when possible

Treatment • Treatment for myeloma • Hydration • Dialysis

Many myeloma patients will experience kidney function problems at some point; it is important to protect your kidney function early and over time. 79

Myeloma Cells Can Cause Damage To Bones Approximately 85% of myeloma patients develop bone disease • Protecting bone health – Nutrition – Weight-bearing activity – Medications • Vitamin D • Calcium (if approved by doctor) • Bone strengthening agents: Zometa® zoledronic acid, Aredia (pamidronate), or Xgeva® denousamab)

• Report new pain to your health care provider

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

Most myeloma patients will experience bone involvement at some point; it is important to protect your bone health

Figure 1. Bones at Highest Risk of Being Affected by Multiple Myeloma

80 80 Faiman B, et al. CJON. 2017;21(5)suppl:19-36. Miceli TS, et al. CJON. 2011;15(4)suppl:9-23. Dimopoulous M, et al. Leukemia. 2009;23(9):1545-56.

Peripheral Neuropathy (PN) Management • Peripheral neuropathy: damage to nerves in extremities (hands, feet, or limbs) – – – – – –

Numbness Tingling Prickling sensations Sensitivity to touch Muscle weakness Burning pain or cold sensation

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

Faiman B, et al. CJON. 2017;21(5)suppl:19-36. Tariman, et al. CJON.2008;12(3)suppl:29-36.

• 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 PN worsens, your HCP may: – Change your treatment – Prescribe oral or topical pain medication – Suggest physical therapy

IMF has many free resources to help you

http://m-powercharlotte.myeloma.org

http://myeloma.org

IMF TV

IMF InfoLine: 1-800-452-CURE | 9am to 4pm PST 82

Panel Discussion

Community Questions and Answers Audience Questions

Type and submit your questions here. Click the Q&A icon circled below if you have minimized the Ask Question window.

5 minute break

M-POWER CHARLOTTE: CHANGING THE COURSE OF MYELOMA

M-Power Charlotte: Changing the Course of Myeloma

Dr. Joseph Mikhael, IMF Chief Medical Officer Professor, Translational Genomics Research Institute (TGen) City of Hope Cancer Center

IMF PATIENT EMPOWERMEN T MISSION

Advancing early and equitable access to myeloma information, screening and treatment in vulnerable communities worldwide 86

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

AWARNESS

EDUCATION 88

The IMF African American Initiative The core vision of the IMF African American Initiative is to improve the short and long-term outcomes of African American patients through engagement of the community, education of health care providers, and support of patients The overall objective of the IMF African American initiative is to improve outcomes in African American patient care by: • • •

actively engaging the African American community in a better understanding of myeloma educating the primary health care community regarding early and accurate diagnosis of myeloma supporting the Hematology Oncology community in their care of African American patients with myeloma 89

M-POWER CHARLOTTE INITIATIVE OBJECTIVES

Why Charlotte: Charlotte is an ideal location: • 35% of the population is African American • A world class myeloma center: Levine Cancer Institute • An integrated primary care network • Southern United States are particularly underrepresented in cancer research

NY PA IL

OH VA

GOAL: Charlotte will provide a template where aspects of the initiative can be reproduced in other cities nationwide

GA TX FL

10 states have 62% of AA MM national cases

M-Power Charlotte Website: mpowercharlotte.myeloma.org

Toolkit

M-Power Website

Please reach out to us! Website myeloma.org IMF InfoLine 800 452 CURE (2873) Website mpowercharlotte.myeloma.org Website atriumhealth.org Phone 800 821 1535 96

Can We Detect Myeloma Even Sooner? Dr. Manisha Bhutani Levine Cancer Institute / Atrium Health

Can we Detect Myeloma Even Sooner ? Manisha Bhutani, MD Associate Professor Department of Hematologic Malignancy and Blood Disorders

LEVINE CANCER INSTITUTE 3/20/2021

What is MGUS?

• MGUS is a precursor state to multiple myeloma • Median age at diagnosis is 70 years

• It occurs in 3% of people older than 50, affecting 9% those over age 80 • Detecting at the stage of MGUS allows the earliest diagnosis of multiple myeloma

MGUS: Monoclonal Gammopathy of Undetermined Significance SMM: Smoldering Multiple Myeloma MM: Multiple Myeloma PCL: Plasma Cell Leukemia

MGUS always comes before Multiple Myeloma

MGUS was detected in all cases from their samples collected and stored prior to multiple myeloma diagnosis

Landgren et al. Blood 2009;113(22):5412-7

What causes MGUS? Factors that increase the risk of developing MGUS include: •

African American or black race

•

Male gender

•

Older Age

•

Family history of MGUS and/ or multiple myeloma

•

Immunosuppression

•

Exposure to certain environmental hazards and radiation

The exact cause of MGUS is largely unknown

From MGUS to Multiple Myeloma

First step to diagnosis

Free light chain assay (FLC)

Often these tests are ordered for investigation of other conditions

Mass Spectrometry, a more sensitive test! • Mass spec can detect M-protein in blood below the level of detection by conventional methods so diagnosis can be made earlier • Mass spec measures the molecular mass of M protein (heavy and/ or light chain), which is unique to each patient • Not every lab can perform this test but in coming years we will see this becoming a standard test

Subtypes of MGUS 1)

Non-IgM MGUS 

Accounts for 85% of cases



commonly IgG or IgA



rarely IgD or IgE



It may progress to MM or solitary plasmacytoma or AL amyloidosis

IgM MGUS 

Lymphoplasmacytic features)



It may progress to Waldenstrom Macroglobulinemia, NHL or AL amyloidosis or very rarely to MM

Light-chain MGUS 

It may progress to free light chain MM

Rate of progression: MGUS to MM 20-year progression rate

Number of risk factors

Risk Factors 1

21%

37%

58%

On average ~1% per year

Rajkumar SV et al. Br J Haematol. 2004;127(3):308-310

•

M- protein ≥1.5g/dL

•

Non-IgG MGUS

•

FLC ratio <0.26 or >1.65

Are we underexploring the significance of MGUS?

How is MGUS treated? • Persons diagnosed with MGUS do not need treatment unless they choose to take part in a clinical trial • No evidence (yet) that early treatment will improve outcomes • Standard of care remains periodic follow up and monitoring. Follow up is beneficial to avoid morbidity and death • For monoclonal gammopathy of clinical significance, if there are problematic symptoms, a shared decision can be made with your physician to treat the condition

Impact of prior diagnosis of MGUS OS from diagnosis of MM

Studies have suggested better outcomes in patients with myeloma previously under follow-up for MGUS compared with those without a previous diagnosis

2.8 yr

2.1 yr

Swedish Cancer Registry - between 1976 and 2005

Sigurdardottir E, et al. JAMA Oncol. 2015;1:168–74

MGUS in African Americans

• 2-3 times higher rates than Caucasians in the US • Occurs at a young age • Have features associated with a higher risk of progression to full-blown MM

There is an existing gap in our understanding of risk factors and biologic characteristics that lead to increased risk of MGUS in African Americans Landgren O et al. Blood Cancer J 2017;7:e618

What is Screening?

The goals are early detection, lifestyle changes, surveillance, risk reduction, and early treatment

Does MGUS meet the criteria for screening? Is there a recognized need ? Is there a simple screening test? Do we have an intervention? Do we have a highrisk population? Do we have infrastructure to support the screening program?

CHAAMP (Charlotte African American MGUS Project)

Finding Your Voice and Talking with Your Team Tiffany H. Williams, DNP, APRN, CPNP-PC IMF Support Group Leader & Patient with Myeloma

Finding Your Voice Confidence, Freedom, Courage

Challenges to Finding and Using Your Voice

The Care Team

Subspecialists

Primary Care Provider (PCP)

General Hem/Onc

You and Your Caregiver(s)

Family/Support Network

Allied Health Staff

Myeloma Specialist

What is a Myeloma Specialist?

The Importance of Having a Myeloma Specialist

Being an Empowered Patient

Communicating Effectively with Your Care Team

It’s not about finding your voice; it’s about giving yourself permission to use your voice. Kris Carr

How Your Healthcare Team Can Help You Amy E. Pierre, RN, MSN, ANP-BC Memorial Sloan Kettering Cancer Center, Flatiron Health & IMF Nurse Leadership Board

Communicate Your Needs to Your Healthcare Team Have these conversations again…

• 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

Take Time to Consider Your Preferences Before an Appointment Yes or No? It is important for me to understand my treatment plan I prefer the most aggressive approach to treat my cancer I prefer to receive treatment in an outpatient setting I prefer to take medications at home I prefer to take the least possible amount of pills to control my cancer

Tool available at m-powercharlotte.myeloma.org/

Take Time to Consider Your Preferences Before an Appointment Yes or No? I am willing to endure as many side effects as necessary to control my cancer Quality of life is more important to me than quantity of life Clinical trial participation is of interest to me My out-of-pocket cost of treatment is important to me I prefer to continue an active lifestyle during my cancer treatment

I worry about how my treatment will affect my future treatment options

Tool available at m-powercharlotte.myeloma.org/

Ask Important Questions of Your Healthcare Team

What Can I Expect Now?

What treatments have I been on before my current treatment?

What is the goal of my current treatment? How will I know if treatment is working? How might my labs and tests change with a new treatment? What are the major side effects of the chosen treatment(s)? How to I know if urgent medical care is needed?

Ask Important Questions of Your Healthcare Team

What Can I Expect In the Future? What are my future treatment options if my current treatment does not work? In what order would you suggest subsequent treatments? How might a certain treatment affect subsequent treatments? Are there treatments I’ve had that I could consider again? Are there clinical trials to consider when treatment no longer works? How do side effects differ between treatment options?

Panel Discussion

Community Questions and Answers Audience Questions

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Audience Questions

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