Welcome and Introduction
Robin Tuohy Vice President, Patient Support
24 Year Myeloma Care Partner
Robin Tuohy Vice President, Patient Support
24 Year Myeloma Care Partner
August 16-17, 2024
THANK YOU TO OUR SPONSORS!
More than 1 year since diagnosis
Stem cell transplant recipient
Less than 1 year diagnosed
7:00 – 8:00 AM Registration & Breakfast
8:00 – 8:10 AM Welcome & Announcements
Yelak Biru, CEO and 28-year Myeloma Patient
Robin Tuohy, VP, Support Groups
8:10 – 8:30 AM Patient, President & CEO
Address
Yelak Biru, 28-year Myeloma Patient
8:30 – 9:15 AM Keynote Lecture: What is the
Future of Myeloma? w/ Q&A
Rafael Fonseca, MD, Mayo Clinic – Phoenix, AZ
9:15 – 9:30 AM BREAK
9:30 – 10:30 AM Breakout Session #1: Treatment Approaches in Myeloma
30-minute lecture w/20-minute facilitated discussion
• Breakout A: Newly Diagnosed: An Approach to Frontline Therapy
Sagar Lonial, MD, FACP, Winship Cancer Institute of Emory University Club Room
• Breakout B: An Approach to Relapsed Myeloma
Angela Dispenzieri, MD, Mayo Clinic – Rochester, MN
Main Ballroom CD
10:30 – 10:40 AM RETURN TO MAIN SESSION
After Break, return to designated Break-Out Room
10:40 – 11:00 AM Partnering with the IMF
Sylvia Dsouza – Vice President, Development
11:00 – 11:40 AM Seasons of Multiple Myeloma
Tiffany Richards, MS, ANP, AOCNP, MD, Anderson
11:40 AM – 12:00 PM Health Disparities in Myeloma,
Joseph Mikhael, MD, MEd, FRCPC, FACP
12:00 – 1:00 PM LUNCH
Reminder: After Lunch, return to designated Break-Out Room
1:00 – 1:40 PM Breakout Session #2:
Patients and Care Partners
Breakout A: Patients Only – Lessons Learned
Yelak Biru, 28-year Myeloma Patient &
Michael Tuohy, Patient Advocate & 24-year Myeloma Patient
Todd Kennedy, Patient Advocate & 7-year Myeloma Patient
Main Ballroom CD
Breakout B: Care Partners Only
Robin Tuohy, VP Patient Support & 24 Year Care Partner
Teresa Miceli, RN, BSN, OCN –Mayo Clinic-Rochester, SG Leader
Diane Kennedy, Care Partner
Hiro Room
1:40 – 1:45 PM RETURN TO GENERAL SESSION 1:45 – 2:15 PM Wild Card Topic: Diet and Myeloma Urvi Shah, MD, Memorial Sloan Kettering Cancer Center
2:15 – 2:55 PM Ask – the – Experts with Guest Faculty
2:55 – 3:00 PM Closing Remarks & Program Evaluation
Please be sure to complete your program evaluation today.
Questions 1 – 5 can be completed before the program begins.
Questions 7 & 8 can be answered after each presentation.
If you are attending Friday program only, we ask that you turn the survey in at the end of the day.
If you are coming back for the Saturday sessions, please hold onto your survey, bring it back tomorrow and turn it in at the end of the program.
We greatly appreciate your time and feedback!
Yelak Biru President and CEO
Biru President and CEO
28 Years Myeloma Patient International Myeloma Foundation
Los Angeles, CA
The IMF is dedicated to improving the quality of life of myeloma patients while working toward prevention and a cure.
In 1995 Yelak was Diagnosed with Multiple Myeloma
Diagnosed with myeloma at age 25 in 1995
Given 2-3 years to live
Told I will be dead before the age of 30
28 Years ago!
January 29, 2021
MRI reveals cancerous lesions of unknown origin in spine
Unclear if I have 3 months, 1 year, 5 years
Body, mind and soul in turmoil!
January 29, 2021
MRI reveals cancerous lesions of unknown origin in spine
Unclear if I have 3 months, 1 year, 5 years
Body, mind and soul in turmoil!
She had many question!
• This can't be happening to me.
• What will the future hold? How will this progress?
• Will treatment be painful? Will I be able to handle the side effects?
• How long do I have? What will my final days be like?
• Even after treatment, the fear of the cancer coming back can be very real.
• No one understands what I'm going through."
• What is myeloma? What stage is it?
• What are my treatment options?
• What are the side effects of treatment? Would it be painful?
• What is my prognosis?
• Can myeloma be cured?
• Will I be able to work and live a normal life?
• How will this affect my family?
• Are there clinical trials I can participate in?
• What resources are available to help me cope with this disease?
• What kind of doctor should I see?
• What tests do I need to have done?
• How will I pay for treatment?
• What kind of support groups are available?
• How do I talk to my family and friends about my diagnosis?
A powerful purpose drives us:
Myeloma can be a relentless opponent!
To empower patients with myeloma and their loved ones.
To fight alongside you every step of the way.
A world where every myeloma patient can live life to the fullest, unburdened by the disease.
Improving the quality of life of myeloma patients while working toward prevention and a cure!
Examine the why of all our actions to ensure they are purpose-driven, meaningful, and effective.
Address unmet patient needs by expanding our reach to diverse & underserved populations in everything we do.
Innovate Every Step of The Way
Provide those who need it most with what they need the most, throughout their myeloma journeys.
IMWG – International Myeloma Working Group
320 KOLs from 41 countries with 62 published guidelines
IMWG Guidelines & Research | Global Researcher Pipeline | Global Clinical Trials | BSRI – from MRD to CURE
Bone Disease & Imaging Guideline
• Bone Diseases Treatment Recommendation
• Vertebroplasty and Kyphoplasty Guidelines
• Pet/CT | MRI | WBLDCT
• MRD Definition
• Tissue Bank MRD (A BSRI Project)
An IMWG Project
• Flow Cytometry | MASSSPEC | LIQUID BIOPSY 10-8 Sensitivity
• MRD Surrogate End Point to OS and Clinical Trials i2 Team
• Immunotherapy Database
Other
• Plasma Cell Leukemia
• Infection Management
1. ENSURE ACCESS TO CARE
INSURANC E REFORM: DRUG ACCESS
INSURANC E REFORM:
2. ELIMINATE FINANCIAL BARRIERS
3. SECURE RESEARCH FUNDING Step Therapy Protocols Safe Step Act
H.R. 2630 / S. 652
DRUG ACCESS PBM Reform PBM Reform Act
H.R. 5378 / S. 1339
INSURANC E REFORM: COINSURANCE
Annual Appropriations
MEDICARE REFORM: PHYSICIAN ACCESS
Tele-Health/Medicine
Telehealth Modern. Act
H.R. 7623 / S. 2016
INSURANC E REFORM: COPAYS Copay Accumulators HELP Copays Act
MEDICARE REFORM: ANNUAL COST LIMITS
H.R. 830 / S. 1375 Oral Parity Cancer Drug Parity Act H.R. 6301 / S. 2039
FEDERAL FUNDING
ANNUAL APPROPS
NIH: National Cancer Institute, National Institute on Minority Health, ARPA-H
CDC: Comprehensive Cancer Control Initiative
DoD: Congressionally Directed Medical Research Program (CDMRP) for Myeloma.
Inflation Reduction Act implementation Cap & Smoothing (MPPP), Drug Pricing
CLINICAL TRIAL DIVERSITY
Focus on underserved, POC, rural settings and socioeconomically disadvantaged groups
The IMF has made incredible strides in empowering patients. Imagine a newly diagnosed patient, overwhelmed and scared.
• Clear, concise information and Education
• Support groups
• We advocate on your behalf.
• We do and conduct research. These are vital steps, but…
The answer is a resounding Yes, but we need to do
• We envision a future where patients can thrive, not just survive.
• Myeloma shouldn't dictate your quality of life.
• You shouldn't have to choose between effective treatment and debilitating side effects.
• C U R E
1. Initiate and run a concierge service for myeloma patients (and community oncologists)
1. Reduce Time to Hope
2. Personalized and customized warm blanket
3. Lifelong partnership
2. Meaningfully collect the patient's voice to generate Real-World Evidence and inform research, policy, and care.
1. IMF has unprecedented access to the patient and patient voice. We aim to reach 90% of the patients in 90 days, including ways to reach patients at scale at diagnosis.
2. Collect the patient's voice meaningfully to generate Real World Evidence and inform research and policy.
3. The question is the answer
1. What are the unmet research needs we can ask and accelerate through
2. Large-scale funding of the top 1-3 research questions
3. Formation of a US Myeloma Clinical Trial Network
First time ever non-founder President and CEO
New set of Board of Directors Collaborative research through the Scientific Advisory Board
Live with, not for myeloma!
For Myeloma Patients
Avoiding to Die
There is no finish line. No bell to ring Living with myeloma!
While avoiding dying, don’t forget to live!
Rafael Fonseca, MD
Mayo Clinic – Phoenix, AZ
Rafael Fonseca, M.D. Chief Innovation Officer
Phoenix, Arizona
Rochester, Minnesota
Jacksonville, Florida
• Consulting: AbbVie, Adaptive, Amgen, Apple, BMS/Celgene, GSK, Janssen, Karyopharm, Pfizer, RA Capital, Regeneron, Sanofi.
• Scientific Advisory Board: Caris Life Sciences
• Board of Directors: Antengene
• Patent for FISH in MM - ~$2000/year
• Believe in stem cell transplant
Response-adapted treatment strategy
Newly diagnosed MM, transplant eligible
Age > 18, no upper age limit
ECOG PS 0 – 2
MRD-directed treatment cessation
x 4 cycles
MRD assessment (primary endpoint) DKRd
D: 16 mg/kg QW in C1, 2; Q2W in C3-6; d1 in C7+
K: (20) 56 mg/m2 d1, 8, 15
R: 25 mg d1 – 21
d: 40 mg weekly
x 4 cycles
x 4 cycles
Patients with two consecutive MRDnegative assessments entered treatment-free MRD surveillance
(< 10-
MRD-SURE: Treatment-free observation and MRD surveillance 2nd
(< 10-
monoclonal protein
Kappa and lambda from IgG
Kappa and lambda from IgA
Kappa and lambda from IgM
Kappa from IgG, IgA & IgM
Lambda from IgG, IgA & IgM
• Patient worried about response
• clonoSEQ 17 cells/M
• PET negative
• sFLC normal
• M spike 0.5?
• MALDI M spike 0.062
Key eligibility criteria
• Transplanteligible NDMM
• Age 18-70 years
• ECOG PS ≤2 1 : 1 r a
Consolidatio
Induction
V: 1.3 mg/m2 SC
Days 1, 4, 8, 11
R: 25 mg PO Days 1-21
d: 40 mg PO/IV Days 1-4, 9-12
DARA: 1,800 mg SCb QW Cycles 1-2 Q2W Cycles 3-4
VRd administered as in the VRd group
4 cycles of 28 days
Primary endpoint: PFSc
V: 1.3 mg/m2 SC Days 1, 4, 8, 11
R: 25 mg PO Days 1-21 d: 40 mg PO/IV Days 1-4, 9-12 D-VRd
DARA: 1,800 mg SCb Q2W
VRd administered as in the VRd group
R: 10 mg PO Days 1-28 until PD
DARA: 1,800 mg SCb Q4W
R: 10 mg PO Days 1-28
Discontinue DARA therapy only D-R
e Continue D-R until PD
28-day cycles 2 cycles of 28 days
Key secondary endpoints: Overall CR rate,c overall MRD-negativity rate,d OS
Discontinue DARA therapy only after 24 months of D-R maintenance for patients with CR and 12 months of sustained MRD negativity
Restart DARA therapy upon confirmed loss of CR without PD or recurrence of MRD
• 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
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
Primary endpoint:
• PFS Key secondary endpointsc:
• ≥CR rate
• ≥VGPR rate
• MRD-negative rate (NGS; 10–5)
• ORR
• OS • Safety
HR, 0.53; 95% CI, 0.43-0.66; P <0.0001
• Conservative 27.2% attrition Rd in 1L, DARA in 2L VRd in 1L, DARA in 2L D-Rd in 1L, POM/CAR in 2L
Data set includes both non-randomized Part 1 patients and randomized Part 3 patients. No statistical comparisons were performed. Dd, daratumumab and dexamethasone; DVd, bortezomib, daratumumab, and dexamethasone; PFS; progression-free survival; Ven, Venetoclax.
Long-Term Survival After Elranatamab Monotherapy in Patients With Relapsed or Refractory Multiple Myeloma: MagnetisMM-3
Reminder: After Break, return to designated Break-Out Room
Breakout Session #1: Treatment Approaches in Myeloma
30-minute lecture w/20-minute facilitated discussion
Breakout A: Newly Diagnosed: An Approach to Frontline Therapy
Sagar Lonial, MD, FACP, Winship Cancer Institute of Emory University Club Room
Breakout B: An Approach to Relapsed Myeloma
Angela Dispenzieri, MD, Mayo Clinic – Rochester, MN
Main Ballroom
Angela Dispenzieri, MD,
Mayo Clinic – Rochester, MN
Angela Dispenzieri, M.D.
The Serene M. and Frances C. Durling Professor of Medicine and of Laboratory Medicine
August 16, 2024
Companies Role
Janssen Advisory board and independent review committee
HaemaLogiX Advisory board
Alynlam, Pfizer, Takeda, BMS, AbbVie Research dollars
The presentation includes off-label information on treatment regimens
1. Background
2. Let’s talk immunotherapy
3. Back to general principles
4. mSMART recommendations
1. Therapies change over time—clinical trials make this possible
2. Outcomes (e.g. survival) changes over time, as new therapies emerge
3. If one therapy did not work well, it doesn’t mean another won’t
4. Terms like “overall survival” and “progression free survival” typically refer to statistical probabilities for GROUPS of people and do not seal the fate of an INDIVIDUAL
5. At a given point in time, there may not be a known “right answer;” hence many opinions. Again, think clinical trials
10/9/200711/2020072/4/20083/10/20086/3/20087/9/20088/12/200811/6/20082/19/2008
Modified from: Shah A, Mailankody S. BMJ 2020; 370
Examples:
1. Daratumumab (Darzalex) — recognizes CD38
2. Isatuximab (Sarclisa) — recognizes CD38
3. Elotuzumab (Empliciti) — recognizes SLAMF7
Naked monoclonal antibody
Cancer cell
Progression free Survival Overall Survival
Hungria V. NEJM; 391(5): 393-407.
Progression free Survival
Dimopoulos MA. NEJM 2024; 391(5): 408-421.
Overall Survival
Bispecific MM target Brand name
Teclistamab BCMA Tecvayli
Talquetamab GPRC5D Talvey
Elranatamab BCMA Elrexfio
Cevostamab FcRH5
Livoseltamab BCMA
T-cell
Plasma cell aka myeloma cell
Bispecific antibody
Fc domain
• Cytokine release
• T cell activation
• Perforin/Granzymes
• Overall response rate ~ 60% with most of the responses being VGPR or better
• If patients respond, duration of response is about 18 months
• Less CRS and neurologic toxicity than CAR-T
• Serious infection in about 1/3 of patients, but improved with IVIG
• Handy because right out of the box; approved for after 4 lines of therapy
• Cumbersome because weekly (though this is starting to improve to every other week and even every 4 weeks) 1
• Note: Talquetamab can be given either weekly or every other week, has lower infection rate, overall response rate of about 70%, but issues with skin, nails and taste
• Major questions
• Induction, consolidation, maintenance?
• Sequence relative to similar target but different modality or relative to different target but same modality (another TCE)?
• In combination with other agents?
Remove blood from patient to get T cells
T cell
Benefits
• High response rates (~ 75% of patients)
• No maintenance
• No steroids
• Effective even in heavily pretreated or previously refractory patients
Antigens
CAR T cells bind to cancer cells and kill them
CAR T cell
Make CAR T cells in the lab
Insert gene for CAR
Chimeric antigen receptor (CAR)
Grow millions of CAR T cells
Lymphodepleting chemotherapy
• Cytokine release syndrome (CRS)
• Fevers, chills
• Low blood pressure
• Low oxygen levels
• Multi-system organ damage
• Neurotoxicity
• Delirium
• Loss of ability to speak
• Inability to write
• Decreased alertness (obtundation)
• seizures
• Prolonged cytopenias
May occur within minutes or hours but generally appears within days or weeks Coincides with maximal T-cell expansion May need hospital/ICU care
Real world experience (Sidana ASH 2023)
• Neurologic toxicity 27%
• Prolonged neutropenia 13%
• Prolonged thrombocytopenia 25%
• Secondary primary malignancies 4.5%
Rodriguez-Otero
Neurologic toxicities in 24% (69/285)
• ICANS 13%
• Peripheral neuropathy 7%
• Cranial nerve palsy in 7%
Secondary primary malignancies
• Parkinsonism 3%
• Immune mediated 1%
• Major questions
• Induction, consolidation, maintenance?
• Sequence relative to similar target but different modality or relative to different target but same modality (another TCE)?
• In combination with other agents, i.e use maintenance after?
• Waiting on faster production, better products, products from stored cells, new targets
•
Data
so
far suggest that CAR-T likely better to do first, but data
aggregating
4 LOT and triple refractory
Richardson Blood 2014; 123:1826-32
Siegel Blood 2012; 120:2817-25
Lonial Lancet 2016; 387:1551-60
Rasche EHA 2024, P915
Van de Donk ASCO 2023; abs 8011
Lesohkin Nat Med 2023; 29:2259-67
Munshi NEJM 2021; 384:705-16
Munshi EHA 2023; S202
Huang ASCO 2024; 7511
The good news...
The bad news.. ..there are many treatment options ..there are many treatment options
Keats Blood 2012:120:1067-76
Tolerability? Sequencing? Duration? Dosing?
1 + 1 > 3 !
Not Refractory to Lenalidomide* Refractory to Lenalidomide*#
Not refractory to Anti-CD38 monoclonal antibody
Refractory to or relapse while on Anti-CD38 monoclonal antibody
Not refractory to Anti-CD38 monoclonal antibody
Refractory to or relapse while on Anti-CD38 monoclonal antibody
PI plus Rd PI plus Cd or PI plus Pd
Anti-38 moAB plus PI-dex or Anti-38 moAB plus Pd
*Consider salvage ASCT in patients eligible for ASCT who have not had transplant before # CART may be an option for triple class refractory patients at first relapse or early relapse after quadruplet induction and ASCT
PI, proteasome inhibitor; Preferred PI is bortezomib or carfilzomib moAB, monoclonal antibody: daratumumab or isatuximab
Not Plasma Cell Leukemia (PCL) or Similar extramedullary disease (EMD)
Triple Class Refractory, Type 1*
Refractory to:
• Bortezomib
• Lenalidomide
• Anti-CD38 moAB
Off-Study Treatment Options
Triple Class Refractory, Type 2*
Refractory to:
• Bortezomib and Carfilzomib
• Lenalidomide
• Anti-CD38 moAB
Triple Class Refractory, Type 3*
Refractory to:
• Bortezomib & Carfilzomib
• Lenalidomide & Pomalidomide
• Anti-CD38 moAB
Venetoclax -based therapy if t(11;14)
Venetoclax-based therapy if t(11;14)
CART
Bispecific Antibody
Venetoclax-based therapy if t(11;14)
# Listed regimens are not in the order of preference
*Auto transplant is an option, if transplant candidate and feasible; **If known to be refractory to Daratumumab as single agent, use elotuzumab instead
Refractory to IMIDs (Lenalidomide and Pomalidomide), PIs
Bortezomib and Carfilzomib), Alkylators, CD38, and BCMA
Options
• Talquetamab
• Another anti-BCMA treatment approach
• Other non-BCMA immunotherapy (eg., cevostamab on clinical trial)
• Selinexor-based regimen
• VDT-PACE
• Alkylator or Bendamustine-based regimens
*CVAD or similar regimen can be used in place of VDT-PACE in older patients or patients with poor functional status
VDT-PACE or similar to debulk x 1-2 cycles;*
Then: Auto transplant if transplant candidate, or anti-BCMA approach, or Venetoclax-based therapy for t(11;14)
*CVAD or similar regimen can be used in place of VDT-PACE in older patients or patients with poor functional status
https://www.dreamstime.com/stock-photos-golden-path-bright-future-eps-image5580023
Sagar Lonial, MD Professor and Chair
Department of Hematology and Medical Oncology
Anne
and Bernard Gray Professor in Cancer Chief Medical Officer, Winship Cancer Institute
Emory University School of Medicine
– In 2022, 34,470 new cases will be diagnosed (19,100 in men and 15,370 in women) and 12,640 deaths are expected to occur (7090 in men and 5550 in women)[a]
– In 2019, there were an estimated 159,787 people living with myeloma in the United States[b] (5-year survival rate 57.9%, median age at diagnosis: 69 years and median age of death is 75 years[b])
– Prognosis has significantly improved, with median survival estimated at 12 years[c,d]
– Disease is sensitive to treatment, but curable only in a small subset
•a. American Cancer Society. Accessed August 19, 2022. www.cancer.org/research/cancer-facts-statistics/all-cancer-factsfigures/cancer-facts-figures-2022.html;
b. SEER 12. Accessed August 19, 2022. https://seer.cancer.gov/statfacts/html/mulmy.html; c. Parikh R, et
al. J Clin Oncol. 2022;40(16_suppl):8061; d. Joseph NS, et al. J Clin Oncol. 2020;38:1928-1937.
•Diagnosis
•Risk
•MRD
•Treatment
CRAB:
-hyperCalcemia
-Renal failure
-Anemia
-Bone lytic lesions
Biomarker based diagnosis:
-BMBx with >60% BM PCs
- WB MRI with > 1 lesion
-Involved/uninvolved SFLC ratio > 100*
High Risk Features in NDMM Include:
•R-ISS III
•Extramedullary disease
•Circulating plasma cells
•Cytogenetic abnormalities
– Del(1p32)
– t(4;14)
– t(14;16)
– t(14;20)
– Del(17p)
– Monosomy 17
– TP53 mutation
– 1q21 gain/amplification
– MYC translocation
•High risk gene expression profile
•High risk
– Deletion 17p >20% and/or p53 mutation
– Deletion 1p and +1q (1 extra copy of 1q not high risk alone)
– High risk 14q32 trans and (+1q or deletion 1p)
•Standard risk
– Hyperdiploidy
– t(11;14)
Criteria for HRMM
Del(17p)a and/or TP53 mutationb
One of these translocations—t(4;14) or t(14;16) or t(14;20)—co-occurring with +1q and/or del(1p32)
Monoallelic del(1p32) along with +1q, or biallelic del(1p32)
High β2M (>5.5 mg/dL) with normal creatinine (<1.2 mg/dL)
aCCF ≥20%, by analyses conducted on CD138-positive/purified cells.
bAssessed using an NGS-based method. +1q, gain (3 copies) or amplification (≥4 copies) of the long arm of chromosome 1; CCF, cancer clonal fraction; HRMM, high-risk multiple myeloma; NGS, nextgeneration sequencing.
Manuscript under review
Challenges
(b) Minimal Residual Disease
(a) Malignant Transformatio n Monthsyears
Yearsdecades
(c) Multi-therapy Resistance (Relapsed/Refractory) T u m o r b u r d e n ( Ms p i k e )
(d) Every patient is an individual
(a) Prevention/Early Tx
Interventions (b) MRD guided Tx
(e) Personalized Medicine
1. Prevent and/or reverse myeloma-induced end organ damage.
2. Reduce disease burden.
3. Management of symptoms/sequelae of MM and/or therapy.
4. Maximize long term control of disease e.g. maximize progression free survival as a surrogate for overall survival.
Strive for improved long- term control of disease for our patients and their families.
et al Blood Adv 2020
a. Parikh R, et al. J Clin Oncol. 2022;40(16_suppl):8061; b. Joseph NS, et al. J Clin Oncol. 2020;38:1928-1937.
Subgroup analysis
Non-frail patients had longer PFS than frail patients
The PFS benefit of the addition of Dara was maintained across frailty subgroups
. Facon T et al. Leukemia
Depth response matter (MRD-ve)
1- Achieving a deeper response (MRD-ve status) greatly benefited NDMM t-ineligible patients.
2- Inclusion of Dara increases number of MRD –ve individuals (106 (28.8%) vs 34 (9.2%))
DRd overcomes risk of frailty
3- DRd significantly extended PFS In all fitness groups
4- Triplet (DRd) is the standard of care in t-ineligible NDMM
Model for elimination of the malignant clone
D e p t h
Probably different drugs
To address resistant clones
• Myeloma induction has evolved to a 4 drug regimen fot fit patients
• Transplant continues to play an important role for suitable candidates and improves duration of first remission substantially
• MRD is prognostic, predictive remains unknown
• New definitions of high risk coming soon from the IMS
• Novel consolidations including CART or TCE will hopefully begin to open to the door to limited duration therapy
Jonathan Kaufman
Ajay Nooka
Craig Hofmeister
Madhav Dhodapkar
L.T. Heffner
Vikas Gupta
Nisha Joseph
Leon Bernal
Charise Gleason
Danielle Roberts
Donald Harvey
Amelia Langston
Y. Gu
S-Y Sun
Jing Chen
Mala Shanmugan
Larry Boise
Bryan Burton
Sam Gagnon
Sylvia Dsouza
Vice President, Development
Sylvia Dsouza, Vice President, Development
Vice President of Development for the IMF
Securing philanthropic support and resources for the IMF through diverse mechanisms
Oversee a team of passionate and determined fundraising professionals who are committed to advancing the mission of the IMF
Have the incredible honor of working with dedicated volunteers from the US and across the globe.
• Make a philanthropic gift to support research, education, advocacy or patient support programs.
• Organize or participate in fundraising events such as walks, runs, golf tournaments, community block parties, or galas.
• Create a fundraising campaign online to raise awareness and funds.
• Join your local support group/become a Support Group Leader
• Join our grassroots patient Advocacy program
• Volunteer your time at local races organized by the IMF to engage the community
• Engage on social media to connect with others affected by myeloma and spread awareness and empower patients with knowledge and resources.
Intellectual capacity
• Offer your expertise as a speaker or panelist at events.
• Be a beta tester for various new tools and products and provide reviews and feedback
• Peer-to-Peer Fundraisers are created from YOUR ideas. Starting a Fundraiser is easy and fun. They also make a world of difference in the myeloma community.
• Engage your family, friends, co-workers, your network who honor your journey with myeloma and want to support you. Let them show you that you are not alone.
• Help us cultivate the future by joining the International Myeloma Foundation's Hope Society.
• Monthly and annual gifts support IMF core programs, including educational events, publications, the toll-free InfoLine, and more.
• Start with a monthly contribution and when ready turn it into a yearly commitment. You will be a part of likeminded individuals united in the quest to find a cure for myeloma and a better quaity of life for all myeloma patients.
• Gifts can be designated toward a specific program, project or initiative .
• Is there something specific that resonates deeply with you and you want to see change happening?
• Gifts can also be unrestricted, expendable and/or an endowment
P2P
• Laughs 4 Life -- 8 years, $483,850!
• Miracles for Myeloma -- 12 years, $804,422!
• Iceland Cycling Expedition-- Inaugural Event and opportunity to be a part of a group of patients, doctors, nurses to train together, bike across Iceland and raise money to support iStopMM cure trials.
• Hole In One – Inaugural golf tournament that has raised almost $40k in three months.
• Join our flagship monthly and annual giving program, the HOPE Society.
• Get invited to Regional Salon Dinners in your area with IMF leadership and KOLs.
• Receive exclusive updates on research and trials fresh off the press.
• Play a pivotal role in supporting our four pillars.
• Support long-term initiatives that make a lasting difference.
The Black Swan Research Initiative was funded by a Board member/donor who was a visionary and saw the need for the IMF to launch this initiative
The IMF's Black Swan Research Initiative serves as a conductor of sorts to this orchestra of collaborating experts in the field of myeloma.
The BSRI sponsors more than 50 projects around the world aimed at curing multiple myeloma. Among them:
SPAIN: The CESAR trial uses the combination of Kyprolis, Revlimid, and dexamethasone plus autologous stem-cell transplant to treat high-risk smoldering multiple myeloma. It applies precise minimal residual disease (MRD) testing using next-generation flow cytometry (NGF) and Blood testing for routine monitoring
USA: The ASCENT trial tests early intervention in high-risk smoldering multiple myeloma.
ICELAND: Launched in 2016, the iStopMM project identifies and treats multiple myeloma at the earliest signs of disease.
GERMANY: Studies are exploring long-term survival and hereditary risk factors in multiple myeloma.
AUSTRALIA: Identifying mechanisms of the progression of multiple myeloma and testing DNA mutations in the blood.
SINGAPORE: Hub for the clinical trials network in Asia led for the IMF’s Asian Myeloma Network (AMN) program by Prof Wee Joo Chng. A collaboration of eight countries (or regions), the AMN is unique in providing access to novel agents in a clinical trial setting throughout Asia. In addition, research projects appropriate for the region are conducted in an effort to improve outcomes and achieve a cure.
• Join the Brian D. Novis Legacy Society and make a planned gift!
• Gain immediate tax benefits
• Potentially increase your income during your lifetime.
• Continue to fund our core programs and four pillars.
• Make a bequest (a gift from your estate)
• Include a provision in your will or living trust.
• Designated us as a beneficiary of a life insurance policy, or retirement plan (IRA, 401(k), or 403(b).
• Leave us in your will is one of the most profound ways to support the people and causes important to you.
• Your organization can contribute a corporate gift or foundation grant
• Provide seed funding that is necessary to accelerate the path to a cure.
>210,000 raised toward goal of $250,000!
• Each year, patients and care partners gather to share their stories, experiences, and knowledge. It is through the tireless dedication of our support group leaders that we’ve been able to extend our reach and foster connected communities across the world.
"The Support Group Leaders Summit has empowered me to network with leaders nationwide, learn from their experiences, and appreciate the dedication of the International Myeloma Foundation (IMF) to patients, caregivers, and families affected by myeloma."
We welcome you to continue to learn more about our programs, projects, and initiatives at the IMF and find alignment with your own myeloma journey as well as ways to deepen and strengthen your engagement with us. Reach out to the IMF Development Team to start a conversation on how you can make a difference in the lives of the people impacted by myeloma.
Sylvia Dsouza Vice President, Development sdsouza@myeloma.org (310) 947.4126
Kate Fitzpatrick Assistant Director, Monthly and Annual Giving kfitzpatrick@myeloma.org (818) 487-7455 x 303
Kimberly Francis Assistant Director, Peer-to-Peer Fundraising kfitzpatrick@myeloma.org (818) 487-7455 x304
Matthew Broughton Assistant Director, Operations mbroughton@myeloma.org (818) 487-7455 x299
Tiffany Richards, MS, ANP, AOCNP, FRCPC, FACP, MD
Myeloma Treatment Common Combinations
Velcade® (bortezomib)
DVRd, VRd, Vd
Lenalidomide DVRd, VRd, Rd
Kyprolis® (carfilzomib) KRd, Kd, DKd, Isa-Kd
Pomalyst® (pomalidomide) Pd, DPd, EPd, PCd, Isa-Pd
Darzalex® (daratumumab) DVRd, DRd, DVd, DPd, DVMP, DKd
Ninlaro®(ixazomib) IRd
Empliciti® (elotuzumab) ERd, EPd
Xpovio® (Selinexor) XVd, XPd, XKd
Sarclisa® (Isatuximab) Isa-Kd, Isa-Pd
Blenrep® (Belantamab mafodotin) Bela-d
Abecma® (Idecabtagene Vicleucel) --
Carvykti™ (ciltacabtagene autoleucel) --
Elrexfio™ (elranatamab) --
Tecvayli® (teclistamab)
Talvey™ (talquetamab)
Venclexta® (venetoclax) Vd + ven
New agents or regimens in clinical trials are possible options
ASCT = autologous stem cell transplant; Bela = belantamab; C = cyclophosphamide; D = daratumumab; d = dexamethasone; E = elotuzumab; Isa = isatuximab; I = ixazomib; K = carfilzomib; M = melphalan; P = pomalidomide; R = lenalidomide; V = bortezomib; ven = venetoclax.
Measuring Treatment Response
Determining Transplant Eligibility
Insurance Authorization Collecting Stem Cells
High Dose Chemotherapy
Stem Cell Infusion
Supportive Care Engraftment
Duration: Approximately 2 weeks
Location: Transplant Center
Duration: Approximately 3-4 weeks
Location: Transplant Center
P H A S E 1 P H A S E 2 P H A S E 3
POSTTRANSPLANT
Restrengthening
Appetite recovery “Day 100” assessment
Begin maintenance therapy
Duration: Approximately 10-12 weeks
Location: HOME
Ask for a referral to CAR Tcell center as soon as it is possible as next treatment option (ie, before relapse)
Manufacturing takes ≈ 4 to 6 weeks
Bridging therapy may be needed
T-Cell Collection
No driving for 8 weeks
“One & Done” with continued monitoring
• Away from home
• Often some hospital stay
• Care Partner needed
• Side effect management
• CRS, ICANS
• Low blood counts
• Fatigue and fever
• Some patients need ongoing transfusion support
• Different bispecific antibodies have differences in efficacy, side effects
– Available after 4 prior lines of therapy (or clinical trial)
– About 7 in 10 patients respond
– Off-the-shelf treatment; no waiting for engineering cells
– CRS and neurotoxicity
– Risk of infection
• BCMA target: greater potential for infection
– Tecvayli® (teclistamab)
– Elrexfio™ (elranatamab)
• GPRC5D target: potential for skin and nail side effects, GI issues of taste change, anorexia and weight loss
– Talvey™ (talquetamab)
CAR = chimeric antigen receptor; CRS = cytokine release syndrome. Oluwole OO, Davila ML. J Leukoc Biol. 2016;100:1265-1272. June CH, et al. Science. 2018;359:1361-1365. Brudno JN, Kochenderfer JN. Blood. 2016;127(26):3321-3330. Brudno JN, Kochenderfer JN. Blood Rev. 2019:34:45-55. Shimabukuro-Vornhagen, et al. J Immunother Cancer. 2018;6:56. Lee DW, et al. Biol Blood Marrow Transplant. 2019;25:625-638.
Your team may be able to help, but only if they know how you feel.
Unmanaged Myeloma can cause:
• Calcium elevation
• Renal dysfunction
• Low blood counts
• Infection Risk
• Blood clots
• Bone pain
• Neuropathy
• Fatigue
cause:
• GI symptoms
• Renal dysfunction
• Low blood counts
• Infection Risk
• Blood clots
• Neuropathy
• Fatigue
Tip: Keep a Symptom Diary and bring it to appointments
Tip: proactively discuss common side effects and what to do if they occur
Steroids enhance the effectiveness of other myeloma therapies
Your provider may adjust your dose. Do not stop or alter your dose of steroids without discussing it with your provider
• Irritability, mood swings, depression
• Consistent schedule (AM vs. PM)
• Take with food
• Stomach discomfort: Over-the-counter or prescription medications
• Medications to prevent shingles, thrush, or other infections
• Difficulty sleeping (insomnia), fatigue
• Blurred vision, cataracts
• Flushing/sweating
• Increased risk of infections, heart disease
• Muscle weakness, cramping
• Increased blood pressure, water retention
• Stomach bloating, hiccups, heartburn, ulcers, or gas
• Weight gain, hair thinning/loss, skin rashes
• Increased blood sugar levels, diabetes
[P]reventing infections is paramount.
Infection remains the leading cause of death in patients with multiple myeloma. Several factors account for this infection risk, including the overall state of immunosuppression from multiple myeloma, treatment, age, and comorbidities (e.g., renal failure and frailty).
IMWG Consensus guidelines and recommendations for infection prevention in multiple myeloma; Lancet Haematol.2022;9(2):143–161.
Good personal hygiene (skin, oral)
Environmental control (avoid crowds and sick people; use a high-quality mask when close contact is unavoidable)
Report fever of more than 100.4°F, shaking chills even without fever, dizziness, shortness of breath, low blood pressure to HCP as directed.
As recommended by your healthcare team:
Immunizations:
Flu, COVID, RSV & and pneumococcal vaccinations; avoid live vaccines
Preventative and/or supportive medications (next slide)
Type of Infection Risk
Viral: Herpes Simplex (HSV/VZV); CMV
Bacterial: blood, pneumonia, and urinary tract infection
PJP (P. jirovecii pneumonia)
Fungal infections
COVID-19 and Influenza
IgG < 400 mg/dL (general infection risk)
ANC < 1000 cells/μL (general infection risk)
Medication Recommendation(s) for Healthcare Team Consideration
Acyclovir prophylaxis
Consider prophylaxis with levofloxacin
Consider prophylaxis with trimethoprim-sulfamethoxazole
Consider prophylaxis with fluconazole
Antiviral therapy if exposed or positive for covid per institution recommendations
IVIg recommended
Consider GCSF 2 or 3 times/wk (or as frequently as needed) to maintain ANC > 1000 cells/μL and maintain treatment dose intensity
Some people receiving BCMA-targeting therapies have experienced infections that are less common like CMV, PJP and fungal infections
Dry Mouth
OTC dry mouth rinse, gel, spray are recommended. Advise patients to avoid hot beverages. Initiate antifungal therapy for oral thrush
Dexamethasone oral solutions “swish and spit” have been tried but with no proven benefit yet. Sour citrus or candies before meals are also recommended. Taste Changes
Dietary modifications with small bites, eating upright, and sips with food can help manage symptoms.
Some medications lead to weight gain, others to weight loss.
Dry mouth leads to taste changes which can lead to anorexia. Meet
Diarrhea may be caused by medications and supplements
• Laxatives, antacids with magnesium
• Antibiotics, antidepressants, other (check with provider, pharmacist)
• Supplements: milk thistle, aloe, cayenne, saw palmetto, ginseng
Avoid caffeinated, carbonated, or heavily sugared beverages
Take anti-diarrheal medication if recommended and no cause related to infection
Constipation may be caused by medications and supplements
• Opioid pain relievers, antidepressants, heart or blood pressure medications (check with provider, pharmacist)
• 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®
Discuss GI issues with healthcare providers to identify causes and make adjustments to medications and supplements
Possible side effect to some treatments and supportive care medications
Skin Rash:
• Prevent dry skin; apply lotion
• Report changes to your care team
• Medication interruption or alternative, as needed
• Steroids:
– Topical for grades 1-2,
– Systemic and topical for Grade 3
• Antihistamines, as needed
• Keep your nails short and clean. Watch for “catching and tearing”
• Apply a heavy moisturizer like Vaseline or salve. Wear cotton hand coverings to bed
• A nail hardener may help with thinning
• Tell the team if you have signs of a fungal infection, like thickened or discolored nails
Sources of pain include bone disease, neuropathy and medical procedures
• Management
– Prevent pain when possible
• Bone strengtheners to decrease fracture risk
• Antiviral to prevent shingles
• Sedation before procedures
– Interventions depend on source of pain
• May include medications, activity, surgical intervention, radiation therapy, etc
• Complementary therapies (Mind-body, medication, yoga, supplements, acupuncture, etc)
• Scrambler therapy for neuropathy
Tell your healthcare provider about any new bone or chronic pain that is not adequately controlled
Peripheral neuropathy happens when there is damage to nerves in the extremities (hands, feet, limbs). Damage can be the result of myeloma, treatment or unrelated conditions (i.e. diabetes).
Symptoms:
• Numbness
• Tingling
• Prickling sensations
• Sensitivity to touch
• Burning and/or cold sensation
• Muscle weakness
Prevention / management:
• Bortezomib once-weekly and/or subcutaneous administration
• Massage area with cocoa butter regularly
• Neuroprotective Supplements:
– B-complex vitamins (B1, B6, B12)
– Green tea
• Safe environment: rugs, furnishings, shoes
If neuropathy worsens, your provider may:
• Adjust your treatment plan
• Prescribe oral or topical pain medication
• Suggest physical therapy
Report symptoms of peripheral neuropathy early to your healthcare provider; nerve damage from neuropathy can be permanent if unaddressed
• Risk Factors
– Active multiple myeloma (light chains, high calcium)
– Other medical issues (ex: Diabetes, dehydration, infection)
– Medications (MM treatment, antibiotics, contrast dye)
– Poor Nutrition
• Prevention
– Stay hydrated – drink water
– Avoid certain medications when possible (eg, NSAIDs), dose adjust as needed
• Treatment
– Treatment for myeloma
– Hydration
– Dialysis
Many myeloma patients will experience kidney issues at some point; protecting your kidney function early and over time is important
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.
B, et al. CJON. 2011;15suppl:66-76. Miceli TS, et al. CJON. 2011;15(4)suppl:9-23.
Faiman B, et al. CJON. 2017;21(5)suppl:19-36.
Fatigue is the most reported symptom. Sources include anemia, pain, reduced activity, insomnia, treatment toxicity, bone marrow suppression 98.8%
Often, people do not share these symptoms with their providers. Talk to your provider about symptoms that are not well controlled or if you have thoughts of self-harm.
>35% of patients
of patients
If you want to go fast, go alone, if you want to go far, go together
• Care partners may help with medical appointments, managing medication, daily living, physical assistance, emotional support, myeloma knowledge, healthy lifestyle, patient advocacy, financial decisions
• Care partners can be a spouse, close relative, a network of people (family, friends, neighbors, church members, etc)
African Proverb
• Caring for the Care Partner
– Recognize that caregiving is difficult/stressful
– Encourage care partners to maintain their health, interests, and friendships
– The IMF has information and resources to help care partners
• Multiple studies demonstrate that strong social ties are associated with
– Increased longevity including people with cancer
– Improved adherence to medical treatment leading to improved health outcomes
– Lower risk of cardiovascular diseases
– Increased sense of purpose & life satisfaction
– Improved mood and happiness
– Reduced stress and anxiety
– Enhanced resilience
Martino J, et al. Am J of Lifestyle Med. 2015;11(6):466-475. Yang YC, et al. Proc Natl Acad Sci U S A. 2016;113(3):578583.
Pinquart M and Duberstein PR. Crit Rev Oncol Hematol. 2010; 75(2):122–137.
• Strategies for enhancing social connection
– Deepen existing relationships with family, friends, and loved ones
– Build new relationships by participating in a support group, joining clubs or organizations, or volunteering
Tip: Start with small steps outside your comfort zone. Call a loved one you haven’t spoken to in a while. Invite a person you’d like to know better for lunch, coffee, or a walk.
Hetherington C. Healthnews.
https://healthnews.com/longevity/healthspan/social-connection-andlongevity/#:~:text=Research%20consistently%20demonstrates %20that%20people,of%20fulfillment%20in%20your%20life. Accessed Feb 1 2024.
Have a Primary Care Provider & Have Recommended Health Screenings
• Blood pressure
• Cholesterol
• Cardiovascular disease
• Diabetes
• Colonoscopy
• Women specific: mammography, pap smear
• Men specific: prostate
• Vision
• Hearing
• Dermatologic evaluation
• Dental checkups & cleaning
Develop & maintain healthy behaviors
• Good nutrition
• Regular activity
• Quit tobacco use
• Sufficient Sleep (next slide)
An ounce of prevention is worth a pound of cure. Benjamin Franklin
Faiman B, et al. CJON. 2017;21(5)suppl:19-36. Dimopoulous M, et al. Leukemia. 2009;23(9):1545-56. Brigle K, et al. CJON. 2017;21(5)suppl:60-76. Faiman B, et al. CJON. 2017;21(5)suppl:19-36. Faiman B, et al. CJON. 2011;15suppl:66-76. Miceli TS, et al. CJON. 2011;15(4)suppl:9-23.
• Adequate rest and sleep are essential to a healthful lifestyle
• Shortened and disturbed sleep cause
– Increased heart-related death
– Increased anxiety
– Weakened immune system
– Worsened pain
– Increased falls and personal injury
• Things that can interfere with sleep
– Medications: steroids, stimulants, herbal supplements
– Psychologic: fear, anxiety, stress
– Physiologic: sleep apnea, heart issues, pain
• Sleep hygiene is necessary for quality nighttime sleep and daytime alertness
– Engage in exercise but not too near bedtime
– Increase daytime natural light exposure
– Avoid daytime napping
– Establish a bedtime routine - warm bath, cup of warm milk or tea
• Associate your bed ONLY with sleep
– Avoid before bedtime:
• Caffeine, nicotine, alcohol and sugar
• Large meals and especially spicy, greasy foods • Computer screen time
Sleep
Joseph Mikhael MD, MEd, FRCPC
Chief Medical Officer, International Myeloma Foundation, Professor, Translational Genomics Research Institute,
City of Hope Cancer Center
Joseph Mikhael MD, MEd, FRCPC
Chief Medical Officer, International Myeloma Foundation
Professor, Translational Genomics Research Institute, City of Hope Cancer Center
•Health disparities are preventable differences in the burden of disease, injury, violence, or opportunities to achieve optimal health that are experienced by socially disadvantaged populations
- Centers for Disease Control (CDC)
•Health equity generally refers to individuals achieving their highest level of health through the elimination of disparities in health and health care
1. Systemic racism
2. The Healthcare system
3. Social Determinants of Health
4. Biology of the disease and concomitant comorbidities
5. Delayed Diagnosis
6. Access to Care – Triplets, Transplants, Trials and Car T
7. Lack of diversity, cultural sensitivity and optimal communication in healthcare professionals
The core vision of this initiative is to improve the short- and long-term outcomes for African American patients with myeloma.
We want to empower patients and communities to change the course of myeloma…
Enhance access to optimal care by educating myeloma providers about the disparity and how to reduce it
Engage the community to increase awareness and provide support
Shorten the time to diagnosis by educating primary care providers to recognize the disease and order the right tests
April 1, 2023
50+ attended
81% African American
• 100% rated v good or excellent
• 100% learned something new!
June 17, 2023
50+ attended 68% African American
September 24, 2023
35+ attended
41% African American
75+ attended
61% African American
• 80% at the Grace Baptist Church learned of the Workshop through their congregation
• 63% at the Riverside Church location learned of the Workshop from IMF
• 96% of attendees rated the program as excellent
• 92% of the attendees reported learning something new
• 100% plan to share something they learned
• 76% had not previously attended an IMF program
Our goal is to reduce DELAYS in diagnosis among African Americans by educating the primary care community with a focus on:
• Recognizing the signs and symptoms of myeloma
• Discriminating myeloma from other diagnoses such as diabetes
• Capturing an accurate diagnosis through proper use of testing
• Providing referral guidelines for Hematology and Oncology
• Grand Rounds
• Postcards mailed to 6,000+ PCPs in target cities
• Free PCP CME course “Don’t Miss Myeloma”
• Cobb Institute talk
Talk at NMA Annual Meeting Articles and pending publications
8,000
Jane Cooke Wright Symposium on Health
Disparities
• Hosted by Dr. Edith Mitchell
• Keynote speaker - Dr. Monica Bertagnolli, the director of the National Cancer Institute (NCI)
• Dr. Mikhael spoke about health disparities in myeloma
Poster Walk
Student research was presented to Yelak Biru, Dr. Mikhael, Dr. Mitchell, Dr. Morgan (CEO of the Cobb Institute) and Dr. Bertagnolli.
Over 400,000 visits to M-Power site!
M-Power Website:
•Web Stats: Over 40k Page views across main, city sites & myeloma.org
•Google PPC targeted web traffic
Email Stats:
•Total Sent: 18 emails
•Total Audience: 38k*
•Open Rate Avg: 31%*
*Note: We have continued to refine lists, contributing to a more engaged audience as evidenced in the Open Rates (The industry standard high-mark is 21%).
M-Minute Promotion
Stats:
•Total Sent: 19 emails
•Total Audience: 323k
•Open Rate Avg: 38.91%
M-Power Related Video
Stats:
Engage
• 2024 Juneteenth Workshop, NYC
• M-Power Richmond – Oct 10, 2024
• Expand online and social media strategy
• Primary care program in Charlotte
• Lab based education
• Electronic Medical Record Initiative
Enhance
• Clinical Trial Mentor (CTM) as part of the Diversity in Clinical Trials initiative
• Nurse equity decision tool
•Health disparities are sadly prevalent across all diseases, but particularly in multiple myeloma
•There are MANY other types of inequity in myeloma, including geography, age, gender, orientation…
•Being aware of these disparities is critical to overcoming them
•The IMF’s M-Power is designed to reduce the inequity with specific emphasis on
• ENGAGING the community to raise awareness of MM
• EDUCATING primary care provides to shorten the time to diagnosis
• ENHANCING the care of patients through increased access delivered in a culturally sensitive manner...
Be more conscious of the topics of health equity
Evaluate the opportunities in your experience to reduce disparities Support the M-Power movement!
THANK YOU TO OUR SPONSORS!
12:00 – 1:00 PM LUNCH
Reminder: After Lunch, return to designated Break-Out Room
1:00 – 1:40 PM Breakout Session #2:
Patients and Care Partners
Breakout A: Patients Only – Lessons Learned
Yelak Biru, 28-year Myeloma Patient &
Michael Tuohy, Patient Advocate & 24-year Myeloma Patient
Todd Kennedy, Patient Advocate & Myeloma Patient
Main Ballroom
Breakout B: Care Partners Only
Robin Tuohy, VP Patient Support & Care Partner
Teresa Miceli, RN, BSN, OCN –Mayo Clinic-Rochester, SG Leader
Diane Kennedy, Care Partner
Hiro Room
1:40 – 1:45 PM RETURN TO GENERAL SESSION 1:45 – 2:15 PM Wild Card Topic: Diet and Myeloma
Urvi Shah, MD, Memorial Sloan Kettering Cancer Center 2:15 – 2:55 PM Ask – the – Experts with Guest Faculty
2:55 – 3:00 PM Closing Remarks & Program Evaluation
Reminder: After Lunch, return to designated
Break-Out Room
Breakout A: Patients Only – Lessons Learned
Yelak Biru, 28-year Myeloma Patient &
Michael Tuohy, Patient Advocate & 24-year Myeloma Patient
Todd Kennedy, Patient Advocate & Myeloma Patient
Main Ballroom
Breakout B: Care Partners Only
Robin Tuohy, VP Patient Support & Care Partner
Teresa Miceli, RN, BSN, OCN –Mayo Clinic-Rochester, SG Leader
Diane Kennedy, Care Partner
Hiro Room
Yelak Biru 28-year Myeloma Patient
Michael Tuohy Patient Advocate 24-year Myeloma Patient
Todd Kennedy Patient Advocate Myeloma Patient
Urvi Shah, MD
Memorial Sloan Kettering Cancer Center
Urvi A. Shah, MD
Assistant Attending, Myeloma Service
@UrviShahMD
August 17, 2024
• Disease Stage – Newly diagnosed, on maintenance, relapsed
• Patient Choice – Receptive to hearing about this and empowered by it or overwhelmed and would not help
• Medical issues related to the cancer – Do they have significant weight loss from their cancer and side effects to treatment like nausea and diarrhea that they aren’t tolerating most foods.
• Medical issues related to metabolic health – Obesity, diabetes, cardiovascular disease, high cholesterol
• Gradual versus drastic changes to habits
Research program to study nutrition, microbiome and metabolism in cancer.
USDA recommended daily intakes
• Fruit (1.5-2 cup-eq)
• Vegetable (2-3 cup-eq)
• Fiber (25-35g)
• Ideal Healthy Eating Index score 100
% Americans meeting recommended daily intakes
• Fruit: 12%
• Vegetable: 10%
• Fiber: <5%
• USDA Guidelines: <20%
• Average American diet scores 59 out of 100 on the Healthy Eating Index (which measures adherence to the Dietary Guidelines).
Past Medical History
Coronary Artery Disease
Atrial fibrillation
Neuropathy
Hypertension
Hyperlipidemia
Stroke with weakness in wheelchair
Deep vein thrombosis
Sleep apnea
Morbid Obesity
Major depressive disorder
Frequent hospital admissions
Cognitive decline/dementia
Degenerative joint disease
Cellulitis
Abdominal hernia
• Kidney stone
• Hyperthyroidism
• Multifocal pneumonia
• Type 2 DM
• Congestive heart failure
• Preglaucoma
• left lower lymphedema from CABG.
Past Surgical History
• Right knee repair
• Right knee joint replacement surgery Umbilical hernia repair
• Tonsillectomy x 2
• Cardioversions x 10
• Multiple cardiac ablation.
• Coronary Artery Bypass Graft
Therefore, not a candidate
EPIC Oxford + Oxford
Vegetarian Cohort
61,647 people UK
Vegans had 19% less cancer than meat eaters
Adventist Health Study-2
69,120 people USA Key et al. Am J Clin Nutr 2014; Tantamango-Bartley et al CEBP 2013; Kane-Diallo IJC 2018
Vegans had 16% less cancer than non vegetarians
NutriNet-Sante
Cohort
42,544 people
France
Higher plant-based dietary score had 15% less cancer than lower score.
EPIC Oxford + Oxford Vegetarian Cohort
61,647 people; 65 MM
Key, Am J Clin Nutr 2014
NIH AARP study
392,589 participants; 1,366 MM
Vegans/vegetarians had lower risk of MM than meat eaters
RR 0.23
95% CI: 0.09, 0.59; p=0.01
Nurses’ Health and Health Professionals Follow-up Study 116,983 participants; 478 MM
Lee et al. JNCI Can Spectr 2019
Higher empirical dietary inflammatory pattern associated with increased risk of MM in men
HR (per 1 SD increase): 1.16;
95% CI: 1.02, 1.32
Higher healthy plant-based diet index associated with reduced risk of MM
HR (Q4 vs Q1): 0.83;
95% CI: 0.71, 0.96, p=0.005
NHANES study 373 MGUS; 1406 controls
https://www.aicr.org/cancer-prevention/food-facts/
Human = 30 trillion
Bacteria = 38 trillion
• Gut microbiome alpha diversity: Diversity of bacterial species within the gut microbiome of the same individual
Given early detection, as hematologists and oncologists, we have an
Monoclonal Gammopathy Smoldering MM Multiple Myeloma
Immune Function
Genomic Alterations
Modifiable Factors
Nutrition/Dietary Patterns, Obesity, Diabetes Mellitus, Microbiome
Physical Activity, Sleep, Stress
Smoking, Alcohol, Drugs, Medications
Overweight
7878 US veterans diagnosed with MGUS between 1999-2009
Obese
Normal weight
594 MGUS in Olmsted County, Minnesota, between 1995-2003
P = 0.002
Hazard Ratio (HR) for developing myeloma (multivariable analysis)
Normal weight = HR 1 (reference)
Overweight = HR 1.55 (p= 0.003)
Obese = HR 1.98 (p= <0.001)
HR for developing myeloma (multivariable analysis) BMI <25 = HR 1 (reference)
≥25 = HR 1.92 (p= 0.09)
MGUS/SMM
Body Mass Index ≥25
N=20 NCT04920084
PI: Urvi Shah, MD
et al. ASH 2023; IMS 2023; manuscript under review.
• Patients were eating to satiety with no calorie restriction.
• Focus on unprocessed high fiber plant foods.
Shah UA et al ASH 2023; IMS 2023; manuscript under review.
A significant improvement in quality of life
Global health status (p=0.03)
Shortness of breath (p=0.001) • Fatigue (p=0.06)
During the dietary intervention, did you notice changes in any of the following?
15 responses received
• All patients reported the intervention to be easy to follow (15 very/somewhat easy, 0 somewhat/very difficult)
• 4 patients reported they were able to stop medications, saving an average of $62.50 per month (range $20-100)
“I was able to attain a healthy weight and have maintained the weight since starting the meals. I feel good, have energy and no bloating.”
Fecal Microbiome Diversity Reduced Fasting Insulin
Shah UA et al ASH 2023; IMS 2023; manuscript under review.
71-yo M (Mayo Int Risk IgGκ/IgGλ MGUS)
61-yo F (IMWG Int Risk IgGκ SMM)
Shah UA et al ASH 2023; IMS 2023; manuscript under review in Cell.
Blue: Pre-Intervention
Red: Post-Intervention
“It looked pretty dark back in 2010. Thanks to this trial, I’m into the light.”
https://www.mskcc.org/msk-news/summer-2023/food-as-medicine-why-one-doctor-thinks-diet-cou ld-help-control (with patient permission)
Median time to progression
High fiber: 30w Ctrl: 12w
Eligibility
• Smoldering Myeloma
• Live in the United States
Can sign up through HealthTree Foundation website
Q: Impact of dietary vs supplementary vs placebo interventions on microbiome diversity in MGUS and SMM patients
MGUS/SMM N=150 NCT05640843 Currently enrolling at MSK in NYC
Participant needs 6 visits to MSK spread over 12 months once enrolled.
PI: Urvi Shah, MD
Synergy with
- Checkpoint inhibitors
- Bispecific antibodies
- CAR T cells
- Monoclonal antibodies
- Vaccines
- Immunomodulatory drugs
- Chemotherapies
Fewer comorbidities means fewer side effects and ability to give full dose treatment.
Drug?
Additive or synergistic activity of diet with standard of care?
Diet + Drug?
Improved
• MRD Negativity?
• PFS?
• OS?
• Quality of Life?
In combination with maintenance therapy or as single agent
Decreasing the likelihood of a relapse once in remission.
Reduce the risk of other medical problems and cancers.
Negativity
Clinical trial at MSK
MM on Lenalidomide
Maintenance therapy
Lenalidomide 10 mg 21/28 days for 5 years
Producers
Enrolling at MSK (NYC) - NCT04497961
Primary Endpoint: Quality of Life
Carbohydrates – ↑ whole, unrefined
• ↑Whole grains (>3 servings/day)
• ↓Processed/refined carbohydrates/foods
• ↓↓Sugary foods/drinks
Fiber (↑ >30 grams/day)
• ↑ Fruits/Vegetables (>5-6 servings/day)
• ↑Diversity of plant foods (>30 types/week)
Protein - Plant >> Animal sources
• ↑Beans/Tofu/Tempeh
• ↓Red/processed meats
Fermented Foods: ↑ ↑
Fats – ↑ Unsaturated fats
• ↑Nuts/Seeds, fish, olive oil, avocados
• ↓Fried foods
• ↓Dairy/Cheese
• Regular omega 3 fatty acids
• Vitamin D (>30 ng/mL)
• Calorie counting/restriction are difficult to sustain long term
• Meal planning and preparation in advance
• Regular mealtimes not waiting until one is starving
• Ensure adequate hydration
• Learning to read ingredient lists and nutrition labels
• Gradual changes are more sustainable
• Making healthy swaps
• Make it a lifestyle and not a diet
• Frozen fruits/vegetable bags are healthy
• Doesn’t have to be raw salads. Cooked foods healthy too
Eating healthy doesn’t have to be boring! It just needs some planning.
It doesn’t have to be salads and raw vegetables and fruits alone.
Zero animal products.
Ethical and environmental reasons.
No meat, fish, eggs, dairy.
Doesn’t have to be healthy but can be very healthy.
Some animal products.
Ethical or religious reasons.
No meat or fish. Eggs and dairy allowed.
Doesn’t have to be healthy but can be very healthy.
Minimal animal products.
Health reasons.
Focus on whole foods & mainly plants, avoids processed foods.
Healthy.
Whole Food Plant-based Vegan
Whole Food Plant-based Vegetarian
Whole Food Plant-based Pescatarian
Whole Food Plant-based Mediterranean
Whole Food Plant-based Paleo
Whole Food Plant-based Low Carb
Whole Food Plant-based Keto
What does
cancer have in common with climbing a mountain?
Both are putting our bodies through hard challenges
We want to be our fittest as we face them!
WoMMen trekking 30 miles in Peru Aussangate region upto
17,000 feet or 5,200 meters
• 1 cup beans (plant protein) daily
• 2 cups fruit daily
• 3 serving fermented food daily
• 4 cups vegetables daily
• 1/3 cup nuts/seeds daily
• <6 teaspoons added sugars
• <2,300 mg salt
• >30 plant foods/week
• 1.5 cups whole grains daily
• >75% of your plate will be plant-based foods
Dietary Intervention
• Newly diagnosed myeloma • Myeloma on maintenance therapy • Myeloma on various immunotherapies
• Similar trials in other cancers
Funding needed to do such studies
incorporating lifestyle changes • Better Nutrition • Improved Fitness
To reduce comorbidities and improve quality of life.
MSK Myeloma/BMT Faculty
Alexander Lesokhin, MD
Marcel van den Brink, MD, PhD
Saad Z Usmani, MD
Sergio Giralt, MD
Jonathan Peled, MD, PhD
Sham Mailankody, MD
Neha Korde, MD
Hani Hassoun, MD
Malin Hultcrantz, MD, PhD
Carlyn Tan, MD
Gunjan Shah, MD
David Chung, MD
Oscar Lahoud, MD
Heather Landau, MD
Michael Scordo, MD
Kylee McLachlan, MD, PhD
Biostatistician
Andriy Derkach, PhD
Teng Fei, PhD
Research Dietitian
Francesca Castro, RD
Research RN
Jenna Blaslov, RN
Research Associate
Jeannen Santos
Research Manager
Laura Guttentag
Fellows/Residents/Post docs
Richa Parekh, MD
Janine Joseph, MS (Moysich lab)
Juan Jose Garces, PhD
Ross Firestone, MD
Laura Cogrossi, PhD (Bellone lab) Collaborators
Matteo Bellone, MD (Italy)
Neil Iyengar, MD (MSK)
Ola Landgren, MD, PhD (UofMiami)
Anita D’Souza, MD (U of Wisconsin)
Jun Mao, MD (MSK)
Kinga Hosszu, PhD (SKI)
Justin Cross, PhD (SKI)
Michael Pollak, MD (McGill U)
Susan Chimonas, PhD (MSK)
Jens Hillengass, MD (Roswell Park)
Samir Parekh, MD (Mount Sinai)
Emily Gallagher, MD (Mount Sinai)
Catherine Marinac, PhD (DFCI)
Susan Dewolf, MD (MSK)
Francesco Maura, MD (UofMiami)
Patients with plasma cell disorders
Recommended daily intake = 30 grams
(Males = 38 grams; Females = 25 grams)
Breakfast 1 egg = 0g 3 strips bacon = 0g 1 slice wheat bread = 1g 1 cup cooked oatmeal = 4g 1 tbsp peanut butter = 1g
Lunch Small chicken breast = 0g
1 bag frozen broccoli = 12g
1 bag frozen broccoli = 12g
1 cup lentils = 16g
1 cup brown rice = 4g Dinner
1 serving = 0g 1 cup white rice = 1g 1 baked potato = 3g 1 cup black beans = 15g 1 medium ear corn = 2g 1 avocado = 9g
Snack 1 cup yogurt = 0g 1 slice cheese = 0g 1/4 cup almonds = 5g 1 banana = 3g
Recommended daily intake = 0.8-1.2 g/kg
60 kg person = 48-72 grams
Breakfast 1 egg = 6g
3 strips bacon = 12g
1 slice wheat bread = 3g
1 cup cooked oatmeal = 6g
1 tbsp peanut butter = 4g
Lunch
Small chicken breast = 23g
1 bag frozen broccoli = 7g
1 bag frozen broccoli = 7g
1 cup lentils = 18g
1 cup brown rice = 4g
Dinner
Beef 1 serving = 34g
1 cup white rice = 4g
1 baked potato = 4g
Snack 1 cup yogurt = 9g
1 slice cheese = 4g
1 cup black beans = 15g
1 corn on the cob = 5g
1 avocado = 3g
1/4 cup almonds = 8g 1 banana = 1.5g
Led by Dr. Joseph Mikhael
Rafael Fonseca, MD
Sagar Lonial, MD, FACP
Angela Dispenzieri, MD
Tiffany Richards, MS, APN, AOCNP, MD
Urvi Shah, MD
Robert Vescio, MD
Thank you for joining us today! Please take a moment to complete your program evaluation form. Our team members will collect these from you on your way out.
We greatly appreciate your time and feedback!
THANK YOU TO OUR SPONSORS!