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
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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
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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.
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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%
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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;
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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.
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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.
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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
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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)
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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?
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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
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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
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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)
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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…
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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
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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?
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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
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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 ++++++++
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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
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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
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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
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• 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
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Winship Cancer Institute | Emory University
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Winship Cancer Institute | Emory University
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• 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
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Winship Cancer Institute | Emory University
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• 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
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Winship Cancer Institute | Emory University
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• 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
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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
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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
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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.
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Mechanism of action of PIs
Winship Cancer Institute | Emory University
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Mechanism of action of daratumumab
Winship Cancer Institute | Emory University
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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
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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
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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
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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
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Questions anooka@emory.edu @AjayNookaMD
Winship Cancer Institute | Emory University
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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
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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
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M-Power Website
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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
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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
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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.
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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.
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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
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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
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