2017 IMF Support Group Leaders Summit

From July 20th through the 23rd seventy support group leaders from nearly sixty support groups met at the Four Seasons Dallas at Las Colinas for the International Myeloma Foundation’s 18th annual Support Group Leaders Summit.  The stated goal of the meeting was to, “focus on IMF Support Group Leaders Roles and Responsibilities, Information Updates, Problem Solving, and Planning

Below are my notes from the event which cover a lot more ground than just the concerns of group leaders.
-Gerry Landy

IMF 2017 Support Group Leaders Summit Notes
IMF Goals are:
1.Education, 2. Research, 3. Advocacy, and 4. Support

Goals for this meeting:
1. Define roles & responsibilities of support group leaders
2. Provide information updates to leaders
3. Problem solving
4. Planning

Susie Novis:  President & Chief Executive Officer, IMF
• A quick history of the IMF
• Ten steps to better care https://www.myeloma.org/understanding/10-steps
• Website is accessed worldwide (125,000 visits from UK; 2,400 from Iran)
• Online ASH videos, roundups, and live streams.
• IMF Nurse Leadership Board helps standardize care and promote best practices at the patient level.
• Support groups are worldwide but by far the US is most active.
• Develop domestic criteria
• Advance MRD methods
• Identify smoldering MM guidelines
• International Myeloma Working Group (IMWG) live events streamed by over 53,000.
• IMF funding: $7,080,000 given since 1994
• Global Myeloma Action Network: a worldwide consortium of support groups – 40 Organizations in 37 countries on 5 continents

Brian Durie, MD, IMF Chairman of the Board
“Let us know what saying,your group members are saying, thinking and what they want to hear from us.”
Dr. Durie’s definition of “Cure” is,  “The same life expectancy as someone who never had Myeloma”.

Induction: treatments are changing faster than our approach to MM
Standards of Care:
• Now – Proteasome Inhibitor plus Dex
• Near Future – Revlimid, Proteasome Inhibitor plus Dex (outcomes over 6 years no longer unusual)
• Longer Term – Monoclonal agents, MCL-1, Vanetoclax, CAR-T cells – alone or in combination.

Ongoing Frontline Research
2 drug combos seem to work better than singles but 3 drug combos seem to offer even deeper and more durable responses.
• Kyprolis appears to be superior to Velcade in response and isn’t associated with similar neuropathy.
Monoclonal antibodies appear to work on high risk disease (at least in the short term.  Still too early to know long term response)
• BCMA-targeted CAR T-cell therapy is being tested for Myeloma.  this is the same type of therapy that just won FDA approval for B-cell lymphoma in children.
It is a very aggressive approach as it targets all B-cells, not just MM B-cells so side effects are to be expected.  Durie expects a MM version of BCMA-targeted CAR T-cell therapy within the next 2 years but only for subset of relapse / refractory patients as it is very stressful on the body and each treatment would cost $300K – $600K .

With a longer horizon we need to think of living longer and to expect multiple relapses.  Can we plan for our relapses? What is my next treatment?  What are my are my next two?  Three?  More?
Early Relapse Therapy
Revlimid Resistant Choices
• Daratumamib, Velcade, Dex
• Daratumamib, Pamalyst, Dex
• Kyprolis, Pamalyst, Dex
Velcade Resistant Choices
• Daratumamib, Revlimid, Dex
• Kyprolis, Pamalyst, Dex

• A recent study out of France showed similar survival rates for patients who had VRd plus Transplant with patients who had continuous VRd and no transplant.
• Most MM doctors still feel transplant can produce a solid deep remission that is a solid basis for further treatment.

We can’t yet use cytogenetics to suggest treatment except in some rare cases for patients with a few known mutations.  As genetics grow in importance we will move away from the FISH (fluorescence in situ hybridization) to more accurate and detailed test.

There was a question about going on maintenance less than 100 days after a transplant.  Dr. Durie sees this as a mistake as it takes time to determine the response to the transplant and the body needs time to recover from the transplant, particularly blood counts.

Black Swan & MRD  (Minimum Residual Disease)
Mounting evidence demonstrates that the depth of remission correlates with patient survival.
• New flow cytometric tests build upon existing methods.
• New test are able to show clonal plasma cells in the blood before they show up in bone biopsies.
IMF’s International Myeloma Working Group (IMWG) is working to achieve a globally recognized and accepted global standard for MRD testing.
• Over 50 researchers in 22 countries are taking part
• Reference labs are being established with Mayo hosting the first in the U.S.

ASCENT Trial (Aggressive Smoldering Cure Evaluating Novel Rx Transplant): High-risk smoldering myeloma patients receive intense therapy for two years. Goal is to see if it is safe to treat these patients and get them to a sustained MRD-negative status.  Lead investigator Dr. Shaji Kumar of the Mayo Clinic.

The StaMINA trial – 758 patients in 3 arms:
1. Transplant / Rev maintenance
2. Transplant / 4 cycles RVd / Rev maintenance
3. Tandem Transplant / Rev maintenance
Results show no difference in Progression Free Survival or Overall Survival between all 3 arms.

* Word of the day: Pentarefractory – The state of having failed 5 major drugs.  (I didn’t say it was a good word.)

Beth Faiman
Beth spoke about health, wellness, and nutrition.  Most of what she discussed was covered by our recent meetings on diet & nutrition (TwinCities 7/8/2017, Stillwater 4/12/2017)
Other things Beth noted:
The importance of uninterrupted nighttime sleep.
You must be your best advocate: If you think you need a test, ask for it… but… if finances are a problem, ask your doctor if you really need every test they order.
Revlimid can cause inflammation of the bowel which causes diarrhea.

Yelak Biru IMF Patient Advocate
IMF Global Myeloma Action Network (GMAN)
GMAN is a group of myeloma patient organizations around the world whose aim is to support myeloma patients’ needs.
Improve the life of MM patients around the world through:
• Standardizing care
• Providing  people in poor, war or environmentally ravaged, or underdeveloped counties access to MM therapies and treatments.
Achieve the above by:
• Helping to expand patient-centric organizations worldwide.
• Increase worldwide MM awareness.
• Improve access to treatments world wide.
• Build new member groups and strengthen existing member groups that need help.  (Mentoring)
• Susie Novis Durie Grant goes to projects in areas of the world that don’t yet meet basic MM needs.
• March 30, International Myeloma Action Day.
Surprising fact: Allogenic transplants are still popular in Eastern Europe.

Robin Levy, IMF Senior Director of Public Policy and Advocacy &  Kelley Jones, Advocacy Associate
Advocacy: Definition – “public support for or recommendation of a particular cause or policy”.
The Three  “A’s”  of Advocacy
• Awareness – Your own, friends, family, colleagues, & legislators
• Advancement – By getting involved, you can help advance a movement or  effect policy change
• Action – Make contacts, write letters, call or visit your elected officials,  and support an organization

You may “hate” politics, but you can’t ignore  the consequences of politics.  Make sure your voice is heard.
What can you do?
• Change a Law
• Pass a Law
• Impact Regulations
• Raise Awareness of and Issue
• Give People a Voice

Oral Parity, though not Federal law yet, has been passed in 43 states and DC.  However, the IMF can’t monitor implementation without the help of the people in those states.

IMF National Priorities
• Health Care Reform
• Cancer Drug Coverage Parity
• Medicare Part D Doughnut Hole Closure
• Medicare Specialty Tiers
• Appropriations
◦ National Institutes of Health Funding
◦ National Cancer Institute Funding
◦ Department of Defense (Congressionally Directed Medical  Research Programs)

Breakout Groups
Attendees were divided into 4 breakout groups: New Support Groups, Existing Support Groups (Mature), Caregivers, and Technology.  The problems and solutions which were discussed cut across all groups.

The New Groups (dubbed “Recruitment & Retention” ) suggested that, since all clinics use EMR – electronic medical records, see if you can get your brochure added to their patient discharge orders for those diagnosed with MM.
Give your cards and brochures to your group members so they can hand them out and bring them to their providers.

The Existing Group (self named “Bones”) focused on creating a strong but flexible meeting structure.
• Does your agenda meet your group’s needs?
• Do your speakers address what members request?
• How do we communicate to our members
• Pre-meeting

• Create an ongoing editable resource for caregivers
• Contribute stories (written & video) to share
• Create a Wiki
• Do the caregivers in your group have a support system
• Both caregivers and patients can use mental check-up sessions (breakouts)

• Use Google Docs to share information
• Email – Many groups like their IMF accounts.

Other Leader Ideas, Recommendations, and Observations
Irving, TX: A member interviews a newcomer before the meeting then presents them to the group.  Name tags have stars for patients and hearts for caregivers along with a number indicating years since diagnosis.
Columbus OH: When possible meet a new member before the meeting for coffee to discuss them and the group.
Robin Tuohy, IMF Senior Director of Support Groups : Save deaths for the near end followed by a positive wrap up.
Palm Coast FL: Ask newbies to guess who in your group is a patient and who is a caregiver.  It gives hope.
Atlanta GA: Only a 90-minute meeting.  Greet one another, silent prayer, speakers are 15-30 minutes.  All members are expected to set up the room and help out.  Use the IMF Support Group Toolkit’s Signup Sheet and Patient Info Sheet
NE Tennessee:  New this year we are doing a member survey (online & written) asking what programs members would like to see. (Meeting structure, outreach, tech, grieving, clinical/medical)
Philadelphia PA & Dallas TX: Mix of meetings with individual outreach
The Villages, FL: Call people who have missed meetings to see if they’re okay.
Columbus, OH: Review your literature.  Is it up to date?  Do you know what you have and what it says?
All – How can (should) we share the responsibility of running the group and meetings with members?
Grand Rapids, MI:  Perhaps the key is a specific ask for a specific task.
Memphis, TN: Most people are coming to find help, not lead.
Pasadena, CA:  Find a balance of support vs education.  Keep things interesting and people will want to take part.

Pharma Presentations
Celgene: Chad Saward, Director of Advocacy
“Celgene is focusing on unmet needs”:
• Striving for a cure while aiming for long term disease suppression.
• Growth done organically and through strategic acquisition
• Celgene invest 39.9% into R&D
• Celgene uses a distributed research model with 32 partners and 50 drugs in the pipeline (I’m not sure how much of that is for MM – GL)
Recent & ongoing studies
• Rev for those not transplanting
• Rev approved for maintenance in post transplant
• Rev, Dex, and Daratumumab
Post transplant maintenance increases survival by 25% (7+ years)
RVd becoming a standard upfront setting.
bb2121 Celgene parnership with Bluebird Bio for a Multicenter Study of bb2121 Anti-BCMA CAR-T cell therapy in relapsed/refractory multiple myeloma.   Mayo is one of the sites (Link to Mayo bb2121 trial page).  Though still new and a small 15 patient study, results are promising with 100% response and 25% reaching MRD.  Cytokine release syndrome is associate with CAR-T therapy so caution must be taken (Cytokine-release syndrome: overview and nursing implications.)

NOTE: You can do REMS monthly survey online rather than doing it on the phone (Online REMS Portal)

Takeda Chris Danes, Medical Science Liaison
Takeda doing extensive studies on Ninlaro (Ixazomib), oral Velcade research alone, with dex, and with other agents.
Tourmaline study has over 2500 participants in 6 arms (MM1 through MM6)
• TOURMALINE-MM1, (Phase 3) investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in relapsed and/or refractory multiple myeloma.  Ongoing but results indicate that the trio extends PFS by 6-months.
• TOURMALINE-MM2, (Phase 3) investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma
• TOURMALINE-MM3, (Phase 3) investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma following induction therapy and autologous stem cell transplant (ASCT)
• TOURMALINE-MM4, (Phase 3) investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma who have not undergone ASCT; this study is currently enrolling
• TOURMALINE-AL1, investigating ixazomib plus dexamethasone vs. physician choice of selected regimens in patients with relapsed or refractory AL amyloidosis; this study is currently enrolling
• TOURMALINE-MM5, (Phase 3) investigating ixazomib plus dexamethasone vs. pomalidomide plus dexamethasone in patients with relapsed and/or refractory multiple myeloma who have become resistant to lenalidomide
• TOURMALINE-MM6, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in patients with multiple myeloma transitioning from a bortezomib-based triplet induction regimen
• In addition to the TOURMALINE program, ixazomib is being evaluated in multiple therapeutic combinations for various patient populations in investigator initiated studies globally.

There are also 24 ongoing “Investigator initiated” studies at independent institutions.

Takeda is currently enrolling patients in its INSIGHT-MM study, the largest pharmaceutical company-sponsored study of its kind in multiple myeloma; 5,000 relapsed/refractory patients, 150 study sites, 15 countries.  Over an extended period of time volunteers will be self reporting how they use Ninlaro and their results.

Bristol-Myers Squibb: Ima Garcia,  Immuno-Oncology Clinical Liaison/Hematology
Elotuzumab (brand name Empliciti) is a humanized monoclonal antibody used in combination for relapsed multiple myeloma.
Studies being done comparing Elo / Pam /Dex -v- Pam / Dex

Opdivo (brand name Nivolumab) is an immune checkpoint inhibitor that binds and blocks the activation of PD-1 in T-cells, enhancing their ability to recognize and attack tumor cells. Currently Phase 1b and Phase 2 trials of Opdivo and Duratumab
Darzalex (daratumumab) in multiple myeloma patients and in several solid tumors.

Ipilimumab (brand name Yervoy) a monoclonal antibody that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.  Ported over from metastatic melanoma treatment.  Studies being done on:
• Nivolumab / Daratumumab
• Nivolumab / Ipilimumab
• Nivolumab / Daratumumab / Pam / Dex
Nivolumab is approved for people with Hodgkins who have failed their initial treatment.
Janssen Biotech: Kim Burney (inVentiv Health for Janssen)
Darzalex (daratumumab) is the first monoclonal antibody approved for treating multiple myeloma.  It’s a human anti-CD38 monoclonal antibody.  It can act on CD38 directly or stimulate the immune system to kill the cancer cell.

Darzalex has been approved as a single agent for those who have failed 2 prior therapies
FDA has approved Darzalex (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for those who have failed one prior therapy
Darzalex may interfere with certain tests that are done by blood banks (such as antibody screening) for patients who need a blood transfusion.

Darzalex has had good results with people who have failed 3 prior lines of therapy including IMIDs (Thal, Rev & Pam) and proteasome inhibitors (Valcade & Kyprolis) – 29% response.  It took 1 to 5.6 months for a response.
It could re-initiate shingles so an anti viral should be given.


This entry was posted in Advocacy, International Myeloma Foundation, Myeloma and tagged , , , , , , , , , . Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )


Connecting to %s