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Holiday Blessings For Myeloma Patients? Now More Than Ever!

12/23/2015

In the twelve years between 2003 and 2011 we had 4 drugs approved for the treatment of multiple myeloma. This was 4% of the total of all oncology drugs approved during that period, and because myeloma is only 1% of all cancers you could think we were blessed to have drug approvals 4 times the number one might expect to be developed. I think this is testament to the coordinated and dedicated efforts of myeloma specialists and researchers, IMF, MMRF, drug companies and myeloma advocates. However, this year we have had 4 drugs approved in just one year and this is 21% of all oncology drugs approved this year to date. I say thank you for this outstanding effort and all who have contributed. A cancer which represents 1% of patients with 21% of drugs approved is MIRACULOUS. However, I have one HUGE caveat, which is myeloma specialists will be the only ones who will be able to provide patients the full potential of these new drugs. The importance of having a myeloma specialist on your team to provide treatment or a plan for your local hematologist/oncologist to administer has always been a must have for myeloma patients. Now, however this bounty of new drugs enhances this need, and can best be explained by use of an example.

I recently received an email from a patient who wrote the following,

Hi Gary

Was wondering if I can ask you a question regarding the survival stats you have on your site. Do you know if they reflect the usage of the "new" triplet combinations such as RVD? I was just reading this interview from a couple weeks ago at the ash conference: http://www.targetedonc.com/news/triplets-in-newly-diagnosed-multiple-myeloma-a-qa-with-s-vincent-rajkumar-md-?p=2

From this interview it sounds to me like the triplets are expected to increase survival even more? But I was under the impression that triplets such as RVD have been around for a while and thus were already accounted for in your survival stats.

Thanks for any info and Merry Christmas!!

This was a great question and he had me thinking, if RVD has been part of the mainstream treatment then why was the average life expectancy just 4 years on average and has not changed for the last 4 years. This did not make sense to me, and I did a little research and provided the following response.

You are right, RVd has been used for a long time as first line treatment for many patients, however it was not officially approved for first line use until Feb 2015. See the link: FDA Expands Indication for Revlimid (lenalidomide) in Combination with Dexamethasone to Include Patients Newly Diagnosed with Multiple Myeloma
And Velcade was approved for first line treatment in June of 2008 seen at the link: Velcade (bortezomib) is Approved for Initial Treatment of Patients with Multiple Myeloma

However Mayo offered me Rev as first line treatment in 2006, and UAMS treated me with Velcade in 2006 as well. Most myeloma specialists have been using it in clinical trials, off label, or through compassionate use years before official approval.
Local oncs many have followed labeling, so the answer to your question is yes and no. It was really blended, and it is also a large part of the reason myeloma specialists have reported average life expectancy 2 to 3 times the national average.

The addition of the 4 new drugs this year will just add to the need to have a myeloma specialist on your team. You do not need to go to a specialist all the time and the myeloma specialist can set a treatment plan in place to be followed and implemented by the local oncologist under the supervision of the myeloma specialist. And to follow up on this I will quote from a passage on my blog post on How To Beat the Average Myeloma Life Expectancy?

Multiple Myeloma is a rare blood cancer, so many hematologist/oncologists may not see one patient in a year. As a result not all oncologists or hematologists are the same. However, some are very skilled and experienced with Multiple Myeloma and have treated many myeloma patients. The data shows these myeloma specialists provide an average life expectancy of 10 years or more, while the average remains stagnant at 4 years. For a listing of these exceptional specialists CLICK HERE or for a more extensive list without survival history just CLICK HERE. And obviously, if your myeloma specialist has an average patient life expectancy of 10 years, their patients will beat the average by more than twice the average. This is what I did when I chose to get my SCT(stem cell transplants) at University of Arkansas for Medical Sciences, UAMS, which has a myeloma program called MIRT, Myeloma Institute of Research and Therapy.  At the time they had over 10,000 transplants under their belt, and as a result they were expert at the process, and knew what could go wrong and had a plan in place to get you through any potential complications.   I have found from my work on this site that centers like Mayo, Dr. Hari(Medical College of Wisconsin), UAMS, or Dr. Berenson's (IMBCR) have very different approaches to treatment, but because they are expert in what they do, they have similar results.   A brain surgeon is who you would choose over any other surgeon if you had a brain tumor, why would you not do the same for myeloma? Find out how to find a myeloma specialist by CLICKING HERE or CLICKING HERE .

Myeloma specialists have access to drugs that other oncologists do not. Because they are the thought leaders, they are involved in clinical trials, and can obtain some drugs through other programs that lesser known oncologists do not have access to. Worse yet, oncologists who are not myeloma specialists may not even know that some of these drugs even exist. For example, some of the well connected specialists have access to unapproved drugs through special programs. Or some specialists can use drugs that are only approved for relapse or secondary therapy options (Krypolis and Pomalyst, Elotuzumab, and Daratumumab), and obtain approval to use them for newly diagnosed patients. They also have access to the best clinical trials like KRD for first line therapy which provides a response in nearly100 percent of patients. When you run out of options with the currently approved drugs, they can provide access to those that have done great in clinical trial, but are not currently available to the general public. Because you need a significant infrastructure to conduct clinical trials at your facility and they cost the facility $15,000 per patient, few local oncologists have access to clinical trials.  Sometimes it is who you know!

Merry Christmas, Happy Hanukkah, Happy Holidays, Happy New Year, Good luck and God Bless your Myeloma Journey/ editor@myelomasurvival.com

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

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What Did ASH 2015 Mean For The Myeloma Patient? HOPE!

12/11/2015

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There was so much great news that came out of ASH 2015, and the volume of technical information was more than enough to get your head to spin and to let yourself get overwhelmed with the complexity and detail. It continues to support my belief that myeloma specialists are very knowledgeable about this disease and keep up with the most recent flood of new promising research, and they are the only ones truly able to adequately treat or provide a treatment plan for myeloma patients. Now that I have had time to digest the mountain of information, and I can actually break ASH 2015 into just one word for the myeloma patient community and the word is HOPE. My takeaways from the meeting include.

- Great new drugs have been approved for Relapsed and Refractory myeloma patients. Daratumumab, Elotuzumab, and Ninlaro all could be game changers, and will work best in combination with existing novel agents.

- Immunotherapy has taken center stage at ASH in general and for myeloma in specific. Great work is underway with the use of CAR T cells, MIL,s. and the use of dendritic cells to develop a vaccine. Initial results have shown some patients with 90+ percent plasma cells in the marrow going all the way to 0. Cure potential? Maybe!.

- The existing treatments have become seasoned and now show improved progression free survival and overall survival. RVd (Revlimid, Velcade,dex) has been proven to be more effective than Rd. Mayo Clinic has modified their excellent mSmart treatment recommendations to substitute RVd for Rd and CyBorD for standard and intermediate risk patients. The use of Kyprolis and Pomalyst are being used in combination with just about everything in clinical trials and will one day be part of approved initial therapy for newly diagnosed patients. KRd, with and without transplant, has shown some great results.

- There has been a consolidation of the treatment continuum. Most now agree to a regimen for newly diagnosed transplant eligible myeloma patients of induction, transplant(one or two), consolidation, and maintenance(finite or continuous).

- High Risk disease has been identified as an unmet need in the specialist community with many new treatments developed which now negate some negative prognostic indicators, and more are in the clinical trial pipeline. Daratumumab and Elotuzumab in various combinations have shown efficacy for some high risk features.

- Minimal Residual Disease testing has become a required test to help to follow disease progression. New Next Generation Sequencing has made testing for residual disease far more sensitive. It appears to be the next leap forward in testing.

- Gene Expression Profiling is the key to future advances in patient specific treatments. This provides a baseline to guide treatment discussions in the future. You will never have an accurate baseline without this profiling.

- Drug companies have begun to partner with patient advocates to help improve awareness in the general population and in the General Practitioner community. Takeda supported the MCRI high risk cure initiative, and Sanofi supported the Mambo for Myeloma awareness and funding initiative. I hope this becomes part of all drug company patient advocacy programs. This is a big step in changing the image of the drug companies from Big Bad Pharma to a real Myeloma Partnership. Misdiagnosis and delayed diagnosis is one of the biggest unmet needs and this might be a life saving cooperative effort to change this.

These are my top line reads of what the game changing developments were at ASH 2015. If you want to drill down into the detail you can search by the keyword Multiple Myeloma and read all of the abstracts from the conference.if you CLICK HERE. There are nearly 300 myeloma abstracts. So we have some outstanding news out of ASH, but where do we go from here?

- The new monoclonal antibodies (DARA and ELO) drugs have been approved for Relapsed and Refractory patients, and will be mixed and matched with all of the currently approved drugs in the newly diagnosed and relapsed and refractory population.

- Ninlaro as an oral treatment will eliminate the myeloma patient's weekly or biweekly infusions when taking IV or subQ injections of a protesaome inhibitor. Insurance companies should love this because it will eliminate the $1500 to $3000 infusion cost. The cost to Medicare patients will be an issue because the law prevents drug companies from providing copay assistance to the elderly. They do allow it for younger working patients with commercial insurance. I hope our government is ignorant of this unmet need and not uncaring of the needs of elderly cancer patients.

- Investment in Immunotherapy is a challenge. Most funding for new drugs come from the drug companies, and they have not as yet jumped on this bandwagon. Celgene is the first to do so, and now we have such great initial data I think the wagon will be full in no time. Those that do not get with this program will be at a competitive disadvantage..

- Myeloma Specialists know about these new drugs, the importance of MRD testing, and the need for Gene Expression Profiling, but how do we get the local oncologist up to speed on the breakneck progress being made in myeloma treatment? And 1 in 5 myeloma patients continue to die from misdiagnosis and delayed diagnosis. This is an unmet need and I am hopeful the new drug company patient partnership may have an impact.

- Progress in High Risk disease will ultimately be the key to a cure in all myeloma. Myeloma Specialists recognize this and a new focus is being made in high risk disease. A specialist and patient advocate initiative called the MCRI (Myeloma Crowd Research Initiative) is another part of this new focus.

Good luck and God Bless your Myeloma Journey/ editor@myelomasurvival.com

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

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Front and Center at ASH 2015 – The Immunotherapy Revolution in Multiple Myeloma

12/10/2015

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As the name implies, there seems to be great excitement and hope in using the patients’ own immune system to fight and ultimately cure myeloma. For the most part, chemotherapy has been the primary weapon in the myeloma specialists’ treatment toolbox and immunotherapy was considered “Not Ready For Prime Time”. I attended an ASH symposium where Dr. Jatin Shah from MD Anderson Cancer Center was the program chair, with presentations from Dr. Sundar Jagannath of Mount Sinai, and David Avigan of Harvard Medical School.

As a preamble, I have to let you know this topic is very complex, and in the beginning they asked a number of questions used to see how much the audience knew about the biology of immunotherapy. The answers were multiple choice and from the results it looked like we might have gotten more consensus if we used darts at 100 yards. After the meeting, the same questions were asked and the results did not change that much. The audience was made up of doctors, researchers, knowledgeable patients, and health care professionals. So I will try to do my best to give you a top line overview of the meeting, but skip the technical information.

Dr. Shah provided a preface and outline of the program. He stated there have been many areas of new understanding in the myeloma specialist community. Triplet combos are much better than doublets, early transplant is better than delaying transplant till relapse, and maintenance is preferred to no maintenance. However there are still challenges: High-risk myeloma, relapsed and refractory myeloma, and we are not curing a significant number of patients.

He stated some of the treatment goals should be to manage the clonal evolution, focus on high risk disease, and target the immune system.

Dr. Jagannath first pointed out that myeloma presents at diagnosis with many clones. When you go through treatment all but the drug resistant clones remain. As a result, more resistant clones are developed. In myeloma cells CS1 (also known as SLAM-F7) is expressed on 95% or myeloma cells and in NK cells but not in other cells, in the body. This makes it a good target for any immunotherapy.

Elotuzumab uses this as a target and has recently been approved. It does not work well as a single agent but does work in a synergistic way with Revlimid. Elotuzumab, Revlimid, and Decadron had a 32 month progression free survival in a pretreated patient populations. Elotuzumab may negate some of the high risk cytogenetics. Elotuzumab, Revlimid and dex vs. Revlimid and dex alone have a very similar toxicity profile, so the addition of Elotulzumab does not add to toxicity which is usually not the case with other drugs.

Daratumumab targets CD38 which is expressed on most myeloma cells, however it is also expressed on some CD4, CD8, and NK cells. Daratumumab has many different mechanisms of action, and as a single agent had a response rate of 36%. In addition, there were low grade 3 and 4 side effects, which is quite good. It worked across all types of myeloma including those that were refractory to 4 lines of treatment. All however was not a bed of roses, in that the duration of the infusion can take up to 8 hours, and there is an infusion reaction in 43% of the patients during the first infusion. The second infusion takes on average 4 hours and follow-on infusion time is drastically reduced to around around an hour or less. CD38 is expressed on red blood cells and as a result patient may require a blood bank infusion. In addition, the Daratumumab interferes with blood typing so patients need to know their blood type before they receive a Daratumumab infusion.

How might these drugs be used? They both are for relapsed and refractory myeloma and we were told, “Think E before D.” Elotuzumab has been approved for use with at least one prior therapy while Daratumumab has been approved only after 3 lines of treatment. Future trials will be forthcoming as a first line treatment.

Dr. Avigan discussed a new immunotherapy approach which combined marrow cells with dendritic cells and these were used to vaccinate heavily pretreated patients. The approach showed good results and were combined with Revlimid, which helps to expand T cells. This trial has treatment arms either with and without Revlimid maintenance and a multi-center clinical trial is planned.

At the conference, check point inhibitors were also discussed, which help the immune system hit the gas or the brakes to kill disease or not. Some of these checkpoint inhibitors (PD1 and PDL-1) are now being investigated as ways to take the brakes off the immune system so it can do it’s myeloma-killing job.

This is Gary Petersen editor@myelomasurvival.com and member of the MCRI Myeloma Crowd Research Initiative reporting to you from Orlando at ASH 2015. For more information about multiple myeloma CLICK HERE.

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Multiple Myeloma - ASH 2015 Part 1

12/6/2015

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ASH 2015 – The Global Advances in Myeloma: Providing the Best Options for Treatment in 2015

I attended a symposium chaired by Dr. Brian Durie which centered on providing information on the best options for therapy in 2015. However, it was focused on debates around several questions. The panel was superior, with members being some of the very best myeloma specialists in the world. There was Dr. Jesus San-Miguel from Spain, Phillppe Moreau from France, Shaji Kumar from the United States, Antonio Palumbo from Italy, and Bruno Paiva from Spain. Dr. Durie started the forum by remarking what a wonderful preamble we had going into ASH with the approval of three new myeloma drugs in the last month. Two immunotherapy drugs of Daratumumab, Elotuzumab, and Ixazomid an oral protesone inhibitor.

The questions were as follow:

Will New Diagnostic Criteria and Early Treatment of MM Improve Survival or Result in a More Aggressive Disease at Relapse?

Dr. San-Miguel made the case for early treatment referencing a recently published high risk smoldering clinical trial which companied Rd vs watchful waiting which showed better PFS (progression free survival), and OS (overall survival). Dr. San-Miguel was also excited about a new clinical trial, KRd, transplant, and maintenance for high risk smoldering disease. Dr. Phillip Moreau was more cautious and believed we can not have a treatment based on one trial. Because 30% of high risk patients will not progress to active myeloma in two years so we might be over-treated these patients. To this layman, I think Dr. San-Miguel has got it pegged.

Should Risk-Adapted Therapy Be Used for Patients with Newly Diagnosed MM?

On this question Dr. Shaji Kumar took the pro side of the debate and mentioned the mSmart program. I noticed the mSmart program was recently updated and now recommends VRd for standard risk patients from the previous Rd regimen. Dr. Palumbo took the more aggressive approach and thought the best treatment should be used with all patients. Me being a Total Therapy patient which is a very aggressive approach and younger at diagnosis has a tendency to want to swing for the fences, but I do understand infirm and frail patients may go for less intense therapy.

Should Minimal Residual Disease Be Used to Guide Treatment?

Dr. Bruno Paiva believes MRD or Minimum Residual Disease is not ready for prime time. He believes NGS or Next Generation Sequencing will be a better more accurate testing method.. Dr. Antonio Palumbo believes even with NGS there will still be some myeloma left so continued maintenance is required. He noted 45% of patients who are MRD negative are not PET/CT negative or they have active lesions in their bone marrow. I remember once Dr. Barlogie had mentioned he noted this as well and believed a better measure of disease control would be the combination of MRD negative and PET/CT negative. On this one it looks like the jury is still out.

Emerging Systemic Therapies: Best in Patients With Newly Diagnosed MM or Those With Relapsed Disease?

This debate was not that clear to me. Dr. Shaji Kumar made the point that it depended on the circumstances, and Dr. Moreau believed they should never be used until they have been proven effective in a phase 3 trial.

I was wondering if some of the views were taken just for the argument sake, however I was still surprised at how well prepared and convincing each debater was. Also surprising was how much progress we have make in the last few years in the consolidations of the treatment continuum, yet there is still such diverse views.

Good luck and God Bless your Myeloma Journey/ editor@myelomasurvival.com

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

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Funding For Research and Awareness Is Critical To Improved Myeloma Survival, And You Can Help At No Cost To You. Just #IMambo4Myeloma

12/1/2015

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Cancer in general is so grossly underfunded, and myeloma gets just 10% of the funding per life lost as compared to melanoma. Melanoma is the cancer often confused with myeloma.. One in 5 myeloma patients die within the first two months of diagnosis because of delayed diagnosis, due in large part by a lack of awareness by the public and the general practitioners and local oncologists. So the two most important unmet needs, in my mind, are funding for research and awareness of the general public, the general practitioners, and oncologists who are not myeloma specialists.

Recently, I have seen a shift in the specialist community to finding myeloma early and treating it before it causes organ damage, and drug companies partnering with the patient community to help fund research and increase awareness thru social media. It appears Big Bad Pharma is not so bad after all. Historically they have supported local IMF groups and some web sites, but this is the first time they have come out of the shadows to try to make an awareness DIFFERENCE . The first such effort was the MCRI, Myeloma Crowd Research Initiative where Takeda contributed $5 for every tweet to the tune of $50000 for research. But maybe a more important factor is that they helped to get the word out on social media, therefore possibly helping awareness to go above the dismal current 3%. Everyone has heard of lymphoma and leukemia, but few people ever hear about myeloma until they are diagnosed.

A new initiative funded by Sanofi will contribute $5 for each tweet which includes the hash tag #IMambo4Myeloma. So far $30,000 has been collected. If you go to twitter and search #IMambo4Myeloma you will find hundreds of posts which you can retweet and make hundreds and thousands for cancer research at no cost to you. Please participate, it might just save lives, maybe yours. Dana Holmes was the key to setting up this program with ASH and Sanofi, and has provided the following update on the program.

Dana Holmes "A shout out to the members of our group who continue to actively participate in the ‪#‎IMambo4Myeloma‬ awareness and $$ for the American Society of Hematologists...THANK YOU for stepping up...this alternative to fundraising for research/educational $$ from a major pharmaceutical company (SanofiUS) to help the myeloma community continues to be one of the easiest fundraisers to actively engage in..the myeloma researchers need funding to conduct their research, and it is getting more difficult for them to access funds...this may not amount to much in the big scheme, but it certainly adds to the pot ...It is easier to raise $1,000 from tweeting or sharing posts than it is to sometimes rally your personal network of family and friends to donate to a particular cause...it can at least augment your personal efforts to raise $$ for a particular organization or the overall good for the myeloma patient community, which we are all unwilling members of.

Many of you created a Twitter account or reactivated your account just to join in.

Again, thank YOU for stepping up. Because of YOUR continued efforts, we have already raised $31,000...and we still have 10 more days to do some additional good and just as important, to raise AWARENESS !!"

Dana has been tireless in getting the participation of her smoldering support group, and I am hoping this post will help to improve participation even more among the myeloma patient community.

Good luck and God Bless your Myeloma Journey/ editor@myelomasurvival.com

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

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Holiday Blessings For Myeloma Patients? Now More Than Ever!

What Did ASH 2015 Mean For The Myeloma Patient? HOPE!

Front and Center at ASH 2015 – The Immunotherapy Revolution in Multiple Myeloma

Multiple Myeloma - ASH 2015 Part 1

Funding For Research and Awareness Is Critical To Improved Myeloma Survival, And You Can Help At No Cost To You. Just #IMambo4Myeloma

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