Blog Posts

Our Approach To Myeloma Care Must Change! To Have Change, Something Must Change!

6/20/2018

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Einstein once said that insanity is doing the same thing over and over and expecting a different result. We patients frequently look at our symptoms of exhaustion, bone and joint pain, anemia, and kidney issues as part of the aging process, and often our General Practitioners look at us in a similar manner. In general this results in delayed diagnosis with late stage myeloma and end organ damage. In fact, depending on which study you read, only 6% to 23% of patients are found in stage one, while 73% to 94% are not found till they are either ISS(International Staging System) stage 2 or stage 3. This would make little difference if life expectancy were the same for all patients no matter what the stage, however there is a significant difference. An NCBI (National Center For Biotechnology Information) study reports the following life expectancy by ISS stage for myeloma.

So, if found in stage 1 you should live 5.2 years longer than if found in stage 3 or 240% longer. And if found in stage 1 instead of stage 2 you would live 2.4 more years or 165% longer. Let me assure you any clinical trial which could provide this result would be considered miraculous.

But given no change in what we do currently, the National Cancer Institute will continue to report 28% of myeloma patients will die within two years. This has remained the same for the last 6 years. In the development of the website www.myelomasurvival.com I received 2 year survival statistics from 6 exceptional myeloma treatment facilities. These facilities included Seattle Cancer Care, Cleveland Clinic, Medical College of Wisconsin, MSKCC, and The James at Ohio State. The average 2 year death rate for these six locations was a remarkable 4%, or 7 times lower than the NCI published rate for the entire US. Unfortunately as noted in my last blog post, 70 to 80 percent of myeloma patients are not being seen by a myeloma specialist. And the conundrum is that the current myeloma specialists are nearly fully booked and it would take years to get another 70 to 80% increase in myeloma specialists to handle the added work load.

So what is it then that needs to change? Dr. Irene Ghobrial of Dana Farber Cancer Institute said it best when she highlighted the following on a Cure Talk broadcast:

Her point was simple, straight forward, logical, and impossible to argue against. Multiple Myeloma is the only cancer where we wait for it to metastasize and show organ, bone damage, or anemia before we begin treatment.

She and many other specialists are coming to the conclusion that screening, early diagnosis, and early treatment is the future of myeloma treatment. There are a number of steps that must be taken to reach this goal. Those steps are as follows:

Step 1 - We need to prove early treatment will result in improved Overall Survival.

Step 2 - We need to determine which MGUS and smoldering patients will progress to active myeloma and are candidates for early treatment.

The first step has been proven with a number of trials in process and completed for high risk smoldering myeloma patients. The Spanish Group in Salamanca were the first to show the success of treating patients with Rd vs. the standard of care to watch and wait until the myeloma becomes active to treat. Dr. Maria -Victoria Mateos reported with a median follow-up of 75 months there was a 57% reduction in the risk of death for the early treatment with lenalidomide-dexamethasone vs not treatment arm. Dr. Mateos will be on Cure Talks in the near future to discuss her excellent work with smoldering myeloma patients. Since this initial study many more have followed two of which are considered CURE trials, the Spanish groups CESAR trial and US trial named ASCENT. Step one is well on its way!

The second step is being advanced by a number of organizations and myeloma centers of excellence. However the work of Dr. Ghorbial of Dana Farber has been one of the leaders in this effort. Their pCrowd program is designed to uncover the answers to Step 2. To view this program CLICK HERE.

To complete this post we must add a third step, and this just may be the most important step.

Step 3 - We MUST find them early to treat them early.

Because 73 to 94% of patients are not found until they have either stage 2 or 3 myeloma, there must be a way to find these patients before their disease has progressed to these later stages. The iStopMM program in Iceland to test every person over 40 years of age was a great first step. For Iceland this just might save many lives and years of life. A great next step is the StandUp2Cancer initiative headed by Dr. Ghobrial of Dana Farber and Dr. Ivan Borrello of John Hopkins. They will lead an outstanding team and test 50,000 people who are at higher risk of getting myeloma. The target population for the survey includes people with first-degree relatives who have had multiple myeloma, and African-Americans, since African-Americans are three times more likely than whites to develop the precursor conditions, and tend to develop them at an earlier age. You can read about this program if you CLICK HERE. Hopefully this early testing will one day include all people over 40 years of age.

I hope this gets to the point where all myeloma is found early and cured, but until then it just may be up to the patient to DEMAND a light chain and M Spike test if they have any of the the risk factors above or have any of the following symptoms: exhaustion, bone pain, anemia, kidney issue, confusion, and numbness are all symptoms of advancing myeloma. A more complete list of symptoms can be found if you CLICK HERE.

Good luck and may God Bless your Cancer Journey. For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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The Myeloma Conundrum! Myeloma Specialists Do Not Grow On Trees!

5/14/2018

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I think it is nearly universally accepted that you have a much better chance of a long life expectancy if you have a myeloma specialist or the input from one as part of your team. Time and time again the SEER data shows life expectancy of 4 to 6 years, while facilities like M.D. Anderson, Mayo Clinic, UAMS, The James, Mt. Sinai, Dana Farber, and many more expert facilities for myeloma state 9 to 12 year survival. The unfortunate fact is only 20 to 30% of patients are seen or treated by myeloma specialists. The remaining patients are treated in the local clinic by a Hematologist or Oncologist who may see one or two patients a year. In other words they are not getting the input required to ensure this longer 9 to 12 year life expectancy. So what is the conundrum? If everyone saw or obtained specialist input there is just not enough myeloma specialists to go around! I would say the existing specialist community is already overloaded with the current 20 to 30% they are now treating. How on earth can they take on 250 to 400% more work required of these additional patients? Unfortunately Myeloma Specialists do not grow on trees!

Developing 70 to 80 percent more myeloma specialists could take decades to achieve, and this is not the answer. However, if we can put expert information and guidance into the hands of the local hematologists, oncologists, and patients we may achieve much better outcomes for the myeloma patient community.

The first attempt at this was the effort of Mayo Clinic which developed the mSmart program. This program provided a template that doctors could follow to provide a care outline designed and developed by some of the very best minds in myeloma research and treatment. You can go to the mSmart program if you CLICK HERE. I get emails from people in India, Pakistan, Romania, Australia, and many other countries, and part of my advice is to have their oncologist follow the mSmart guidelines if possible. More recently Dr. Fonseca of Mayo, Phoenix and the Myeloma Crowd have put together what I would call the next step in the process to make expert advice individualized, and in a manner patients can use and understand. It was designed by myeloma experts, myeloma patients and is called The Myeloma Health Tree. There will be a roll-out through out the country, and an example of the June 6th Jacksonville, Florida workshop content is available if your CLICK HERE. A listing for national roll-out will be available at the www.myelomacrowd.org.

This will not only be used in the USA, but can be available and in use anywhere in the world. Not only that, but it may one day be considered a benchmark approach for use with many other complex, incurable or late stage cancers.

Good luck and may God Bless your Cancer Journey. For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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Myeloma 5 Year Survival Rate Remains Stagnant For The Second Year And Likely Not To Change In The Next Two Years.

4/21/2018

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At this time each year the National Cancer Institute(NCI) publishes survival data for many cancers and it was updated on 4/16/2018. Two years ago I wrote a blog post where I had thought survival would go from 5 years to 6 years. I was wrong, it remains at 5.5 years for the last two years. You can read this post if you CLICK HERE.

You can see the actual survival data for myeloma if you CLICK HERE. Based on this data, it looks as though life expectancy will not reach 6 years for another 2 years. Why? I had thought the improvements we had seen historically would continue at the same rate, however improvement has been stagnant. First the NCI data is always 2 years behind and as a result most of the recent new game changing drugs are not in the data (ie. Dara, Elo, and Ninlaro) because they were approved in 2015. The other less optimistic point is the two year survival rates have not changed in last 5 years, and the 3 year survival has not changed for 4 years. So what does this mean?

This means 20% of patients do not survive year one and 35% do not live past 3 years. So the good news is that if you make it to 3 years, each additional year death is less likely. High risk patients have had an average life expectancy of 2 years. But at 3 years this would only have an impact of approximately 11.25% or less than 1/3 of the total impact of 35% three year death rate of myeloma patients. Late diagnosis and other factors represent 1 in 5 patients or 20% die in the first 2 months based on the Myeloma UK data. A great You Tube video by Myeloma UK is below. The US rate must be a little bit lower because our one year rate is between 19 and 20%.

So we have not seen the result of the new drugs on overall survival, but unless we make inroads into finding myeloma early we will not be able to have any impact on those patients who do not make it past 2 months. Also we are hoping the newer therapies will help to improve the life expectancy of the high risk patients, but this is still to be determined. However, I am hopeful we will see advancements in our ability to find myeloma earlier in disease development. The IMF iStopMM program in Iceland is looking to test all of the population over 40 years old to find myeloma in the early stages of MGUS or smoldering myeloma. It has been shown patients live at least twice as long if they are found in stage 1 versus in the more advanced stage 3 diagnosis. In addition, Dr. Ghorbial of Dana Farber, and Dr. Maria-Victoria Mateos of Salamanca, Spain have shown treatment of patients before myeloma becomes symptomatic, but in the precursor state of high risk smoldering myeloma results in much longer life expectancy. The current standard of care is to watch and wait until the myeloma becomes active and symptomatic.

So the sky is the limit if we can just find myeloma in the precursor state, monitor it, and treat it early! That will be the key to extending life expectancy and potentially cure! In addition, finding an effective high risk myeloma therapy or cure is the ultimate end game.

Good luck and may God Bless your Cancer Journey. For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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The Best Of ASH (The American Society Of Hematology) By Some Of The Very Best Myeloma Specialists!

1/7/2018

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The American Society of Hematology meeting is the largest meeting of experts in the world for blood cancers. How any patient or patient advocate can sort through the mountain of data presented at these meetings is next to impossible? How do we uncover the “best of the best abstracts” on myeloma care and treatment? I asked some of the world’s best myeloma specialists what they considered to be their favorites from ASH 2017. I am so pleased to provide this summary of the “Best of the Best ASH 2017 Myeloma Abstracts” to the myeloma patient community. A few points of note are 1) BCMA is an excellent target for CAR T and monoclonal antibodies 2) Daratumumab has been tested in combination with many drugs and "Things always go better with DARA!" 3) Early treatment of myeloma improves Overall Survival. and 4) For Relapsed/Refractory Multiple Myeloma Patients new drugs are in the pipeline like Selinexor, Venetoclax, and Melflufen with much improved efficacy than existing drugs.

These doctors all have presented at ASH and all attended this year's meeting. I thank you for your long standing outreach to the myeloma patient community. We find that your efforts are extremely valuable to helping myeloma patients to become more knowledgeable and become our own best advocates. These outstanding doctors in alphabetical order:

C. Ola Landgren, MD - Memorial Sloan-Kettering Cancer Center, New York, NY
Gareth Morgan, M.D., Ph.D - University of Arkansas for Medical Sciences, Little    Rock, AR
Paul G Richardson, MD - Dana Farber Cancer Institute, Boston Mass.
Vincent Rajkumar, MD - Mayo Clinic, Rochester, MN
Saad Usmani, MD - Levine Cancer Institute, Charlotte, NC

Dr. Ola Landgren's Favorite Myeloma Abstracts

1. Abstract 435 - Minimal residual disease in multiple myeloma: Final analysis of the IFM 2009 trial.
This large randomized study for newly diagnosed multiple myeloma confirms that sequencing based MRD is more sensitive than flowcytometry (can rule out 1 tumor cell in 1 million cells versus 1 in 100,000), and that sequencing based MRD negativity has the same PFS independent of therapy (i.e. with versus without transplant). This study is clinically very important.
CLICK HERE for a Myeloma Crowd post on this abstract.

2. Abstract 510 - Daratumumab monotherapy for patients with intermediate or high risk smoldering multiple myeloma: Centaurus, a randomized, open label multicenter phase 2 study.
An important randomized study showing that daratumumab is well tolerated in smoldering myeloma and it leads to significantly longer PFS. This study has already triggered a phase 3 trial of daratumumab in highrisk smoldering myeloma. Based on these preliminary results, I think the phase 3 will make daratumumab the first FDA approved drug for smoldering myeloma. Stay tuned!
CLICK HERE for a Myeloma Crowd post on this abstract.

3. Abstract 3133 - MRD Response-Driven Phase I/II Study for Newly Diagnosed Multiple Myeloma Patients Using Higher Doses of Twice-Weekly Carfilzomib (45 and 56 mg/m2) in Combination with Lenalidomide and Dexamethasone
This is an innovative study for newly diagnosed multiple myeloma patients that uses MRD status to determine the duration of combination therapy. Current treatment paradigm is to give every myeloma patient the same number of cycles. Here, patients who become MRD negative fast get fewer cycles, and patients who are slower to reach MRD negativity will receive more cycles.

4. Abstract 332 - Effect of autologous hematopoietic stem cell transplant on the development of second primary malignancies (SPMs) in multiple myeloma patients.
An increasingly important topic for myeloma drug development will be to consider longterm benefits and risks. As patients live longer and longer it will be very important to avoid unnecessary risks. This study evaluates longterm risks of transplant. With an increased range of treatment options and assays to determine MRD negativity this is very timely.

5. Abstract 741 - Deep and durable responses in patients with relapse/refractory myeloma treated with GSK2857916, an antibody drug conjugate against B-cell maturation antigen (BCMA): preliminary results from part 2 of study BMA117159
BCMA is an evolving target for the treatment of myeloma. Five ongoing CAR T cell trials target BCMA. Also, BCMA-targeted BiTE antibodies (CD3) are in development Here, a BCMA-targeted monoclonal antibody with a conjugated toxin shows 60% ORR in a monotherapy setting. This is very interesting and will be important to follow with regard to depth and duration of responses.
CLICK HERE for a Myeloma Crowd post on this abstract.

Dr. Garath Morgan's Favorite Myeloma Abstracts

1. Abstract 60 – Identification of Novel Oncogenes and Tumor Suppressor Genes in Newly Diagnosed Multiple Myeloma (Brian Walker)
This abstract is identifying the genes that drive the process of myeloma will play an important role in developing clinical approaches that treat specific pathways and biologically relevant pathways so as to develop both new treatments and new ways of evaluating those treatments.”
CLICK HERE for a Myeloma Crowd post on this abstract.

2. Abstract 265 - Crowdsourcing a High-Risk Classifier for Multiple Myeloma Patients (Andrew Dervan at Celgene)
Dr. Morgan states, “Crowdsourcing can lever an unknown quantity of highly relevant experience to address significant clinical questions. In this case high risk disease will benefit from investigators addressing whether it can be recognised when patients first present to the clinic.”
CLICK HERE for a Myeloma Crowd post on this abstract.

3) Abstract 396 - The Mutational Landscape of Relapse in High Risk Myeloma is Significantly Impacted by the Depth of Response but not Maintenance Lenalidomide (John Jones ICR UK)
This abstract shows evidence that lenalidomide maintenance does not affect the number of mutations or evolutionary pathways to relapse but the depth of response is a key determinant.

Dr. Paul G Richardson's Favorite Myeloma Abstracts

1) Abstract 740 – Durable Clinical Responses in Heavily Pretreated Patients with Relapsed/Refractory Multiple Myeloma: Updated Results from a Multicenter Study of bb2121 Anti-Bcma CAR T Cell Therapy
Dr. Richardson states, “This CAR T cell therapy shows remarkable results including an Overall Response Rate (ORR) of 94%. With a median follow-up of 40 weeks the rate of Complete Response (CR) is 54%, and high MRD(Minimal Residual Disease) negative rate, with generally manageable toxicity. Brilliant Results!”
CLICK HERE for a Myeloma Crowd post on this abstract.

2) Abstract 741 - Deep and durable responses in patients with relapse/refractory myeloma treated with GSK2857916, an antibody drug conjugate against B-cell maturation antigen (BCMA): preliminary results from part 2 of study BMA117159
This Phase II data is new and shows 60% response rate – a major new finding. This OSS is at levels never before recorded in the RRMM group. A response rate twice that of single agent Daratumumab.
CLICK HERE for a Myeloma Crowd post on this abstract.

3) Abstract 3135 – Selinexor in Combination with Weekly Low Dose Bortezomib and Dexamethasone (SVd) Induces a High Response Rate with Durable Responses in Patients with Refractory Multiple Myeloma (MM)
Dr. Richardson states, In Relapsed Refractory Multiple Myeloma – Selinexor in combination with Bortezomib and Dexamethasone (SVT) has better tolerability and impressive activity in heavily pretreated relapsed refractory multiple myeloma patients.”
CLICK HERE for a Myeloma Crowd post on this abstract.

4) Abstract LBA-4 - Phase 3 Randomized Study of Daratumumab Plus Bortezomib, Melphalan, and Prednisone (D-VMP) Versus Bortezomib, Melphalan, and Prednisone (VMP) in Newly Diagnosed Multiple Myeloma (NDMM) Patients (Pts) Ineligible for Transplant (ALCYONE)
This trial shows striking benefit to adding DARA to a standard combo – recognizing that VMP is not usually given in the USA but is a very important platform outside of the USA in non- transplant eligible MM patients.

5) Abstract 3150 - First Report on Overall Survival (OS) and Improved Progression Free Survival (PFS) in a Completed Phase 2a Study of Melflufen in Advanced Relapsed Refractory Multiple Myeloma (RRMM)
In RRMM patients, the combination of Melflufen/dex has shown remarkable ORR of 40% in RRMM patietns as well as PFS and OS in two large phase 2 studies shown after novel therapies have failed. Melflufen may stop multiple myeloma growth by binding to and damaging the DNA in cancer cells. Once inside the cell, it is converted to melphalan, a drug already used to treat multiple myeloma.

Dr. Vincent Rajkumar's Favorite Myeloma Abstracts

1) Abstract 903 - Tackling Early Morbidity and Mortality in Myeloma (TEAMM): Assessing the Benefit of Antibiotic Prophylaxis and Its Effect on Healthcare Associated Infections in 977 Patients
Dr. Rajkumar states, "Here's why this abstract is important: Early deaths now with effective therapy for MM are mainly due to infections. #1 Drayson et al show that prophylactic levofloxacin can save lives."
CLICK HERE for a Myeloma Crowd post on this abstract.

2) Abstract 510 - Daratumumab Monotherapy for Patients with Intermediate or High-Risk Smoldering Multiple Myeloma (SMM): Centaurus, a Randomized, Open-Label, Multicenter Phase 2 Study
Dr. Craig Hofmeister et al Daratumumab phase 2 trial provides critical data for upcoming Dara Phase III trials in SMM. Early available data is encouraging.
CLICK HERE for a Myeloma Crowd post on this abstract.

3) Abstract 402 - Curative Strategy for High-Risk Smoldering Myeloma (GEM-CESAR): Carfilzomib, Lenalidomide and Dexamethasone (KRd) As Induction Followed By HDT-ASCT, Consolidation with Krd and Maintenance with Rd
Dr. Mateos Cesar trial tests the hypothesis that myeloma can be cured if treated early with the most effective drugs. Along with upcoming ASCENT trial in USA, it’s part of a long term plan of strategic phase 2 trials to determine curability of myeloma. The intent is not to change practice.

4) Abstract LBA-4 - Phase 3 Randomized Study of Daratumumab Plus Bortezomib, Melphalan, and Prednisone (D-VMP) Versus Bortezomib, Melphalan, and Prednisone (VMP) in Newly Diagnosed Multiple Myeloma (NDMM) Patients (Pts) Ineligible for Transplant (ALCYONE)
Dr. Rajkumar states, "Dr. Mateos et al gives first Phase III data of Dara in frontline setting. Wish there was a 3rd arm without Dara maintenance. Still important data and will sync with many other monoclonal antibody frontline RCTs."

5) Abstract 741 - Deep and Durable Responses in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (MM) Treated with Monotherapy GSK2857916, an Antibody Drug Conjugate Against B-Cell Maturation Antigen (BCMA): Preliminary results from Part 2 of Study BMA117159
Dr. Rajkumar states, "This Phase II data is new and shows 60% response rate - a major new finding. Trudel Anti BCMA is exciting. Single agent activity in RRMM."
CLICK HERE for a Myeloma Crowd post on this abstract.

Dr. Saad Usmani's Favorite Myeloma Abstracts

1) Abstract 3110 - Daratumumab (DARA) in Combination with Carfilzomib, Lenalidomide, and Dexamethasone (KRd) in Patients with Newly Diagnosed Multiple Myeloma (MMY1001): Updated Results from an Open-Label, Phase 1b Study
Dr. Usmani states “I have chosen this abstract because of the favorable safety data, the primary end-point of this small phase I, as it sets up the stage for larger Phase II/III trial designs to build on the Kyprolix/Revlimid/dex experience generated by Drs. Landgren and Jakubowiak. This study lines up well with other presentations that have combined Dara with front line regimens (such as Dara-VMP, Mateos et al; Dara-RVd, Voorhees PV et al). We still have to wait for more data before preferentially assigning one regimen over the other based on disease biology/risk at diagnosis.”
CLICK HERE for a Myeloma Crowd post on this abstract.

2) Abstract 1879 - Interim Safety Analysis of a Phase 2 Randomized Study of Daratumumab (Dara), Lenalidomide (R), Bortezomib (V), and Dexamethasone (d; Dara‐Rvd) Vs. Rvd in Patients with Newly Diagnosed Multiple Myeloma Eligible for High‐Dose Therapy and Autologous Stem Cell Transplantation.
Dr. Usmani states “I have chosen this abstract because it is clinically very relevant to the current standard of care practice in the US, also asks the question whether or not we can put more patients in MRD negativity by introducing Dara in to the standard of care schema.”
CLICK HERE for a Myeloma Crowd post on this abstract.

3) Abstract LBA-4 - Phase 3 Randomized Study of Daratumumab Plus Bortezomib, Melphalan, and Prednisone (D-VMP) Versus Bortezomib, Melphalan, and Prednisone (VMP) in Newly Diagnosed Multiple Myeloma (NDMM) Patients (Pts) Ineligible for Transplant (ALCYONE)
This trial shows striking benefit to adding DARA to a standard combo – recognizing that VMP is not usually given in the USA but is a very important platform outside of the USA in non- transplant eligible MM patients.

The future for myeloma patients looks bright based on all these outstanding abstracts highlighted by these remarkable myeloma specialists. Good luck and may God Bless your cancer journey.   For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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LLS Co Pay Program For Myeloma Reopens, BUT, And It Is a BIG BUTT!

11/17/2017

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Note: Sadly the day this was published I received the following update from Dana Holmes. "Gary! The fund is already fully subscribed! I posted an update earlier today...it took less than 24 hour...sigh...they hope to get additional funding, but there is no way to project when."

First the good news, the LLS CoPay program has reopened. Dana Holmes has posted on her Smoldering Myeloma site the following:

A lot of people have worked to make this happen. Dana Holmes, IMF, LLS, MMRF, Myeloma Crowd, Doctors, Patient Advocates, Patients, our pharmaceutical partners. Thank You to ALL, ours lives depend on it!

There are limited funds, and all those who have been previously approved must sign up again. Your prior myeloma approvals are no longer in force, and you must call to reapply for the program. This time it has changed in a few important ways. The first of which is if you apply and are approved the money will be guaranteed for one year from approval. Also to keep your approval active you must enter expenses at least once every 3 months. Funds are limited, so to obtain funding it is first come first served. The copay amount has been reduced from $10,000 to a maximum of $7500. Once the funds are allocated no more applications will be accepted until new funds become available. You can learn more about the program if you CLICK HERE.

So where is the BIG BUTT? As mentioned before all people except seniors have or can buy private insurance and the federal government can not mandate a no copay policy. Drug companies can provide copay assistance DIRECTLY to the 85% of Americans that fall into this category. However for the 15% of the population who are seniors, drug companies are forbidden by law from providing direct copay assistance. To me this sounds like an issue of Federally mandated AGE DISCRIMINATION. And sadly this is a crisis for seniors, but for African American Seniors with myeloma it is 2.5 times the crisis. African Americans are 2.5 times more likely to get myeloma than the general population. As stated previously, the Federal Government made this provision to promote the use of generics for Medicare patients, but did not exclude single source or patented drugs from this program. For more information on this Medicare Faux Pas or BLUNDER CLICK HERE.

So the lack of copay assistance for Medicare patients is a key part of the BIG BUTT. If drug companies could not pay the copays directly, then maybe they can give third parties like LLS, PAN, etc, money, and these non drug company third parties could then provide the copay to Medicare patients and thus solve the Federal COPAY BLUNDER!   This was great for the medicare patients who could now afford their life saving drugs. Myeloma patients could have copays of $10000 to $30000 per year or more than their Social Security Checks. The equation is NO COPAY = NO DRUGS = SENIOR GENOCIDE!

As one fine Mayo Doctor once said, this makes sense to the drug companies because they can spend $10000 to $20000 in co-pays and sell their drugs for $120,000 to $300,000. Who wouldn't spend $10 to make $120. Something obviously has gone very wrong because the 3rd party Well went dry for myeloma in March for PAN and in September for LLS. It did not however go dry for lymphoma and leukemia. So why myeloma? Some reasons could include the myeloma drug companies are having trouble with basic math, the lymphoma and leukemia guys are much better at math than the myeloma drug companies, there is another agenda in play???(The Conspiracy Theory), or drug companies just did not have a system in place to know how much funding was going out vs. what was coming in. Seems like the most basic of math problems.   Why it takes over 6 months to correct is unconscionable and beyond comprehension!

So for all of us with myeloma, we hope they solve the last BIG BUTT, and that is to make sure the well is NEVER AGAIN EMPTY, or allow drug companies to provide copay assistance for single source and patented drugs. If we interrupt our treatment we are far more likely to die, and 30% of us already die in the first year.

Good luck and may God Bless your cancer journey.   For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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Dr. Carl June, The Father Of CAR T Immunotherapy! A New Last Chance For Cancer Patients? By Shweta Mishra

11/14/2017

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CAR-T cell therapy (chimeric antigen receptor T-cell therapy) has been in news since the time it got FDA approval in August 2017. In what is #newincancer and the first treatment based on gene transfer approved by the FDA, this immunotherapy treatment works by extracting a patient’s T cells, re-engineering it with some surface proteins, and then injecting the redesigned T-cells back into the body to allow them to proliferate, hunt and kill cancer cells. For now, this therapy, named Kymriah by Novartis, is approved to treat children and young adults up to age 25 with a recurrent form of the the blood cancer called acute lymphoblastic leukemia (ALL).
Dr. Carl H. June, MD, of the University of Pennsylvania, who is one of the pioneers of CAR-T cell therapy, will share all about his CAR T-Cell Journey and the Cancer Treatment Revolution with CureTalks on November 15, 2017, 1 PM EST.

Dr. June, who is a Richard W. Vague Professor in Immunotherapy, Perelman School of Medicine at the University of Pennsylvania, first wowed the science community in 2011 with promising results from a small study of three advanced chronic lymphocytic leukemia patients that was published in The New England Journal of Medicine and Science Translational Medicine. The findings, which detailed how Dr. June’s personalised immune cell therapy wiped out all signs of leukemia in two of three patients, showed the first successful gene transfer therapy to create T cells aimed at battling cancerous tumors. In addition, these findings helped put a spotlight on the big role that small human trials can play in early-stage drug research.
Dr. June was motivated to do cancer research after his wife passed away in 2001, due to ovarian cancer.

After graduating from the US Naval Academy in 1975, and serving as a naval officer before graduating from Baylor College of Medicine in 1979, Dr. June studied immunology and malaria with Dr. Paul-Henri Lambert at the World Health Organization in Switzerland. As a postdoc fellow he worked in transplantation biology with Dr. E. Donnell Thomas and Dr. John Hansen at the Fred Hutchinson Cancer Center in Seattle from 1983 to 1986, after which he joined Uniformed Services University as a professor of medicine and cell and molecular biology. He is currently a tenured professor at the University of Pennsylvania since 1999.
Dr. June, was awarded the 2017 David A. Karnofsky Memorial Award at ASCO 2017 in June, an honor bestowed for his pioneering work on CAR-T cell therapy. His Peers and Mentors say that “Carl is unique in many aspects”. Along with having won numerous awards, being a brilliant researcher, and an ultra-marathoner, he is “such a wonderful and humble person.”

RSVP to listen to Dr. Carl June live on November 15, 2017 at 1 PM EST on CureTalks to learn all about this #newincancer breakthrough treatment.

Shweta Mirshra is an author/blogger/content creator/editor, and Internet radio talk show host @curetalks #Digitalmarketing #mhealth @trialx @appinformatics #fertility #ivf #conception

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The Myeloma Cancer Community In Crisis! By Patient Advocate Cynthia Chmielewski

11/3/2017

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Recently, I received an urgent text message from one of my dear friends. “Did you hear LLS (the Leukemia and Lymphoma Society’s) Co-Pay Assistance Program is closed to multiple myeloma due to the demand? Is this true? Have you heard? I count on the LLS.” At that point I hadn’t heard anything about the fund being closed. I figured there would be some warning if this was true so I didn’t give it a second thought. I suggested she call the LLS if she was concerned. She was afraid to do this, because she feared she would hear news that she didn’t want to face. By the next day, the Internet was buzzing with this unexpected news.

It was true The Leukemia & Lymphoma Society (LLS) abruptly closed the Myeloma Co-Pay Assistance Program. The Myeloma Co-Pay Assistance Program offered financial help toward blood cancer treatment-related co-payments, private health insurance premiums and Medicare Part B, Medicare Plan D, Medicare Supplementary Health Insurance, Medicare Advantage premium, Medicaid Spend-down or co-pay obligations. This program was a godsend to many in the myeloma community. Myeloma treatment is expensive. Funding for the LLS Co-Pay Assistance Program is based on disease type. The Myeloma Fund of the Co-Pay Assistance Program awarded eligible myeloma patients up to $10,000.00 a year to help cover their treatment costs. Without this assistance many patients are unable to afford their insurance premiums or prescription and treatment co-pays. The LLS said, “… this unfortunate occurrence led to inconvenience to many of the patients we strive to serve.” The closing of this fund is more than an “inconvenience”; it is devastation to many.
What happened? It was a perfect storm. Earlier this year, two other co-pay assistance programs closed their myeloma funds. With the closure of these funds, the LLS received an influx of new applications from myeloma patients. The LLS accepted all eligible patients into their program. The LLS Myeloma Co-Pay Assistance Program was never closed to new applicants. Applicants received acceptance letters up until the day it closed.
The LLS Myeloma Co-pay Assistance Program started 8 years ago, and it is closely monitored by the Office of the Inspector General, which is part of the Department of Health and Human Services. At the time of the Myeloma Co-Pay Assistance Program’s formation, the LLS made the decision that this fund should be a pooled fund. The LLS believed that they would be able to serve more patients in this manner. In a pooled fund, the monies from the pharmaceutical companies supporting the myeloma co-pay assistance fund were put into one general myeloma account instead of individual patient accounts. When a myeloma patient requested a reimbursement, the money was taken from the general myeloma account fund. This method of disbursement of funds worked for 8 years.
Over the last decade, myeloma treatment has evolved. Treatment is more expensive than ever before. Eight years ago, monoclonal antibodies for myeloma didn’t exist and doublets (two-drug combination therapies) were more commonly prescribed than triplets (three-drug combination therapies). Eight years ago, patients weren’t living as long as they are today. Eight years ago, maintenance therapy was in its infancy. Patients weren’t treated with expensive oral therapies until progression. They stopped treatment once a maximum response was reached. Eight years ago, insurance premiums were less. Eight years ago, many patients didn’t use their entire award.
Recently, the LLS Myeloma Co-Pay Assistance Program depleted all its funds. The LLS was counting on additional funding from pharmaceutical companies to come in. As of now, it hasn’t arrived. Since funding was pooled that meant that not only was the fund closed to new applicants, but patients that were already awarded grants no longer had funding. This came as a shock to the myeloma community depending on these monies. They were in disbelief. Many had questions that were unanswered in the initial letters that they received informing them they no longer had funding available for them. The LLS published a Statement on Closure of the Myeloma Fund last week that answered many of these questions. Some questions still remain unanswered.
Patients quickly scrambled to apply for funding through other foundations, but within days those funds were closed to new applicants. Many patients have nowhere to turn. They cannot afford their prescription and insurance co-pays. They are worried and stressed. (We all know that stress is not a good thing for a cancer patient). They need to make tough decisions—do I pay for my treatment, or do I pay my mortgage? Patients with private insurance may be able to request assistance for prescription co-pays (not insurance co-pays) from the maker of their treatment. Patients on Medicare cannot get direct assistance from the pharmaceutical companies. Where should they turn to? Patients have shared their hopelessness in many of the online patient communities.
The myeloma community is in a crisis. A call to ACTION is needed. It’s not time to point fingers. It is time to work together. ALL stakeholders must come to the SAME table and brainstorm possible solutions. This needs to be done NOW! It can NOT wait. Pharmaceutical companies, advocacy foundations, research foundations, patients, caregivers, insurance companies, pharmacies, pharmacy benefit managers, medical professionals and government regulatory agencies need to work together. The system is broken. It needs to be fixed. Patients need access to treatment. What good are the latest and greatest treatments if patients cannot afford to take them?
Who’s in? My hand is raised. Is yours?
What can you do? Educate yourself, but more importantly make you voice heard. Write to your legislators about the current lack of co-pay assistance funding for the myeloma community voicing your concern that this is just the tip of the iceberg. Support legislation that will help reduce the cost of care and increase access to treatment. Contact pharmaceutical companies voicing your concern that you may be unable to afford your treatment. Share your stories with anyone who will listen. Stories are very powerful. Use social media to educate your communities. Join coalitions of like-minded advocates. Take ACTION! Together we can make a difference. There is power in numbers.

Cynthia Chmielewski
@MyelomaTeacherPatient Advocate, Patient Engagement

Andrew Schorr of Patient Power published this post first and has written an editorial on the undermining of financial access to medical care. To see this editorial, click here.

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They Know Not What They Do! Is This Cancer Patients 9/11?

10/24/2017

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The system is broken, and another example of this is in the fact that not only the PAN co pay program is out of funds (early 2017)for myeloma, but the LLS has been out of co pay funds since the middle of September. I hear the desperation on the patient blogs and I am just sickened. Patient advocate Michelle Ferguson-Cohen wrote the following: "patients are diagnosed younger, living longer, often disabled, making less, we have no social safety net and prices are rising higher and higher. co-pay assistance funds are drying up and we can't count on them coming back and even the foundations focused on myeloma research do not have patient support as part of their mission. We have mortgaged our children's futures, bankrupted our families, applied for every grant, and scrambled to jump on every clinical trial. It's time to find a solution that works for patients."

Patients say they cannot get their life saving drugs because they have no way of paying the co pays, and this is mostly the seniors on medicare who are living on a very limited income, where the co pay for Revlamid, Pomalyst, or Ninlaro could be 25 to 50% of their annual income. Many younger patients with insurance can receive co pay help directly from the drug companies, however drug companies are forbidden from providing this to any government run program. This also disproportionately impacts the poor and disabled(many myeloma patients are disabled). So to provide the aid to Medicare and Medicaid patients, drug companies would provide money to a 3rd party like PAN or LLS,and they would offer co pay assistance to those patients.

But now this system no longer works because the 3rd party funding has been dried up, PAN in the 1st quarter of 2017 and LLS in September. This however is not just a Myeloma Issue but for any chronic disease of the aged which has a high copay. For more information on how the process works you can view my first report if you CLICK HERE!   What does this mean to any cancer patient? It means they may have to stop treatment, which could be a death sentence or at least reduce their life expectancy.   Most new cancer drugs have patent protection, and cost over $100,000 a year, and there is no generic substitute. So why on earth would the government mandate no co pay assistance for the very patients that need it most?

The government argument is outlined in a recent Medicare study:

EXECUTIVE SUMMARY: MANUFACTURER SAFEGUARDS MAY NOT PREVENT COPAYMENT COUPON USE FOR PART D DRUGS OEI-05-12-00540

WHY WE DID THIS STUDY

Pharmaceutical manufacturers offer copayment coupons to reduce or eliminate the cost of patients’ out-of-pocket copayments for specific brand-name drugs. The anti-kickback statute prohibits the knowing and willful offer or payment of remuneration to a person to induce the purchase of any item or service for which payment may be made by a Federal health care program. Manufacturers may be liable under the anti-kickback statute if they offer coupons to induce the purchase of drugs paid for by Federal health care programs, including Medicare Part D. The anti-kickback statute applies to all Federal health care programs, but this study focused on Part D. The use of coupons by Medicare beneficiaries could impose significant costs on the Part D program because many coupons encourage beneficiaries to choose more expensive brand-name drugs over less expensive alternative drugs. In two surveys by outside groups, approximately 6 percent to 7 percent of seniors surveyed reported using coupons to purchase prescription drugs.

Sounds like a good plan to get patients to use generic drugs over those that are branded but off patent. Why should a person want Lipitor when simvastatin is just fine, or Zoloft when sertraline is a satisfactory alternative. BUT when a drug is under patent protection, is very expensive, and there is no generic alternative, this logic is just not at all applicable.   The state of California understands this and has passed a state law which applies to non federal insurers(not Medicare), to require the use of generics over branded drugs if generic are available. To view the LA Times article CLICK HERE. Medicare co pay laws need to exclude those drugs which are on patent, or have no generic equivalent. Drug companies should be allowed to provide copay programs for these life saving drugs. This would allow the government to obtain the saving from generics but not limit the available drugs to Medicare cancer patients.

This negligent behavior by the Social Security program can result in wrongful death of those patients on Medicare who can not continue treatment. If a hospital withheld treatment they would be sued, and the government can be sued, but a person would have to show negligence and send the Social Security inspector general, Gale S Stone, a standard form 95, and then a wrongful death suit can be filed. You can learn more about the process if you CLICK HERE.

The existing Jerry-rigged cancer safety net is now broken, and will result in patients dying too soon caused by the inability to afford life saving treatments. Effectively this is government forced hospice care, as withholding life extending care can be a part of the hospice process.

Good luck and may God Bless your cancer journey.   For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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To Transplant Or Not To Transplant? That Should No Longer Be A Question, But Stem Cell Transplant Is The Most Underused Myeloma Treatment In the USA!

9/25/2017

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Dr. Rafael Fonseca Mayo Clinic

To find out more about stem cell transplants, Dr. Rafael Fonseca of Mayo Clinic was the featured speaker on Cure Talks, October 4th. You can listen to the rebroadcast of this exceptional program if you CLICK HERE.

The IMF (International Myeloma Foundation) has just published the 2017 report from the Summit of The International Myeloma Working Group. This group of 100 of the best myeloma specialists in the world provided a summary of their collective position on many topics including Stem Cell Transplant(SCT). They published the following:

Role of transplant in myeloma
"Dr. Gordon Cook (University of Leeds, UK) accompanied by panelists Drs. Morie Gertz (Mayo Clinic, Rochester, MN), Pieter Sonneveld (University of Utrecht, the Netherlands), and Sergio Giralt (Memorial Sloan-Kettering, New York), stated his fervent hope that this would be the last time the role of transplant in myeloma would need to be validated with further large clinical trials or discussed at the IMWG meeting. Data from the three large transplant trials – IFM 2009, CTN0702, and EMN02/HO95 – overwhelmingly demonstrate the benefit of upfront transplant for almost all sub-groups of patients. All concurred that autologous stem cell transplant remains an important treatment and that not enough US patients are opting for it. A remaining issue in the US is the need to make it possible for patients to store stem cells for later use."

Another report by Dr. Parameswaran Hari and Dr.Luciana Costa titled "Autologous Transplantation for Myeloma: Don’t Change the Winning Team", provides the following rational for the continured use of SCT. They conclude with the following comments:

Premature to Abandon Upfront AHCT
"As discussed in The ASCO Post on May 10, 2017, a recent updated analysis of the two major upfront AHCT followed by lenalidomide maintenance studies (CALGB 100104 and IFM 2005-02) has shown an unprecedented median overall survival of 111 and 106 months, respectively. This 10-year overall survival of almost 50%." You can read the entire publication if you CLICK HERE.

You can compare this performance to the current average myeloma life expectancy reported by the National Cancer Institute of just 5 years or just half of that reported for the Stem Cell Transplant and lenalidomide maintenance group. In addition, Dr. Hari is also Scientific Director of the plasma cell disorders and lymphoma working committees of the Center for International Blood and Marrow Transplant Research (CIBMTR), and states, "For the US the rate of transplant is very low. The overall use of transplant for “eligible patients” is about 30% meaning 70% never even get referred. As you know transplant and maintenance results in 50% survival at the 9-10 year mark and this is just so sad." In the EU, Dr. Laurent Garderet who is in charge of myeloma for The European Society for Blood and Marrow Transplantation (EBMT) database stated, "I can confirm that in Europe we tend to transplant all myeloma patients under the age of 65-70 upfront and lenalidomide maintenance post auto has just recently been approved." So Europe recommends transplant for 100% of transplant eligible patients vs. the USA which recommends transplant for just 30% of transplant eligible patients.

If 50% of the 30,000 myeloma patients diagnosed each year in the USA are transplant eligible then 70% of those 15,000 patients or 10,500 myeloma patients could have been provided the current standard of care and were not given that opportunity. Dr. Landgren of Memorial Sloan Kettering is a believer that one day (with longer followup on current trials and more trials) we may be able to use MRD testing as the end point for treatment, however a stem cell transplant may just be part of the treatment regimen needed to get the patient to a MRD negative, lesion free state.

So why is there such a low SCT referral rate when the evidence is overwhelming? SCT is the standard of care for fit patients and provides the best PFS(progression free survival) and OS(overall survival). Is it misinformation, fear, a doctors lack of myeloma experience, transplant hospitals not available locally, unfounded concern of high death rates from transplant, unproven belief new drugs eliminate the need for transplant. A few times I have head from patients that they fear getting leukemia from SCT, I found no evidence to support this misconception. The 10 year rate of a secondary leukemia is less than 1%, whereas there is a 20% chance of dying from myeloma in the first year! Please listen to the October 4th Cure Panel with Dr. Fonseca to get the straight scope from a world class myeloma specialist. You can also view a YouTube video Dr. Fonseca made for his patients if you CLICK HERE.

Good luck and God Bless your Myeloma Journey/ [email protected] For more information on multiple myeloma CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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Dr. Ola Landgren Of Memorial Sloan Kettering Discusses MRD Testing As An End Point For Treatment And Research

8/26/2017

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Dr. Ola Landgren of Memorial Sloan Kettering Cancer Center in New York was the myeloma expert guest on Cure Talks 8/31/17 program. CLICK HERE to listen to this Cure Talk, and his answers to questions provided by the Cure Panel and listeners.

MRD testing just may be one of the most important initiatives in the area of treatment and research for myeloma, and Dr. Landgren has been at the very forefront of its development. Can MRD be used as a new endpoint for treatment??

One thing that has hindered progress in myeloma treatment is the lack of a test for myeloma which had the potential to be used as an indicator of disease cure. We had M spike tests, light chain tests, and bone marrow tests, all of which we came to understand were not sensitive enough to ensure the myeloma was truly gone. Other diseases like leukemia had MRD(minimum residual disease) tests, which were sensitive enough to be used as a confirmation that your disease had been eliminated if you were MRD negative. The treatment had been successful in eliminating the leukemia and there was a high probability if it stayed that way for 5 years, you were in fact cured. No such test has been developed for myeloma, and being incurable treatments were thought in most cases to allow an undetected residual cancer to remain in your bones and bone marrow. We were never told we were in remission which would lead to cure, we were told we had a CR(complete response) and later with improved testing a sCR(scringent complete response). However, the many new drugs and drug combinations have improved the depth of response to treatments and a more sensitive test was now felt to be of far more valure. In Europe, they had been working on tests which would have much greater accuracy, with the hope of duplicating the success MRD testing had achieved with leukemia.

Both the MMRF and IMF have been working with the worlds myeloma specialists community to develop a test which will be able to perform to levels sensitive to find 1 in 1 million plasma cells in the detection of myeloma cells in the bone marrow. It is felt if we can do this and absent of bone lesions, where myeloma can hide outside the marrow, this may just be the measure we have been looking to achieve.

Dr. Ola Landgren providing us with his knowledge and incites into myeloma testing and MRD test development, differences in MRD accuracy, types of MRD tests, as well as the limitations of testing of the bone marrow and its heterogeneity. Please do listen to his entire broadcast because MRD will become a key part of the new future of myeloma treatment and cure.

Good luck and God Bless your Myeloma Journey/ [email protected]

For more information on multiple myeloma CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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To Transplant Or Not To Transplant? That Should No Longer Be A Question, But Stem Cell Transplant Is The Most Underused Myeloma Treatment In the USA!

Dr. Ola Landgren Of Memorial Sloan Kettering Discusses MRD Testing As An End Point For Treatment And Research

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