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The IMF's Black Swan Research Initiative™ Opens a New Pathway to a Cure

| 22 Comments
DurieBlog_BSRI.jpg
EDIT 3/27/2013: Over the past few weeks I have received many comments my two most recent blogs. I apologize for not responding to your comments and questions. Please know that they are very important to me. I am travelling to the International Myeloma Workshop in Kyoto, Japan, and will respond on my return. In the meantime, if you have a medical question, please contact the IMF Hotline at 1-800-452-CURE (2873).

On Tuesday, March 12, we were excited to announce the launch of the IMF's BLACK SWAN RESEARCH INITIATIVE (BSRI) to develop the first definitive cure for myeloma. The BSRI now joins the groundbreaking and innovative myeloma research the IMF has actively supported for more than twenty years. 

Gratifyingly, the launch announcement is generating lots of enthusiasm ("Bring it on!" reads a post on our Facebook Page). It has also prompted questions from some patients who want to know how the BSRI will affect them depending on whether they are newly diagnosed or were diagnosed many years ago.

Let me explain by reviewing the key components of the Black Swan Research Initiative. 

A combination of new myeloma treatment options available now and the availability of ultra-sensitive means of measuring the disease has set the stage for this unique approach to research.

Within the new paradigm of the BSRI, the definitive key to the cure is something we call MRD-Zero. MRD stands for Minimal Residual Disease, and by measuring minimal residual disease we can determine how close a patient is to being cured of myeloma. With no detectable MRD, we are there. 

Sophisticated, ultra-sensitive testing tools that can measure MRD on cellular and molecular levels will allow researchers to study individual myeloma patients at all stages to determine which treatments given at which times yield the best results. The best results, of course, will be the eradication of all residual disease. 

Armed with that knowledge, acquired through clinical trials, we can begin to develop a cure for all myeloma patients. 

The BSRI announcement  focused on one avenue of curing myeloma for a subset of patients, but it is only the first step of many to come. Initial work began on the Black Swan Research Initiative in the summer of 2012, and while some early results are promising, a number of important ramifications will be revealed moving forward.  

The important point in our announcement this week was to set out the framework for the Black Swan Research Initiative's unique approach to a cure. Now that we have, we hope you are as excited as we are to see what materializes as we unlock the mysteries of myeloma. Our goal is to have testing in place and clinical trials ready to start by year's end.

Stay tuned.
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22 Comments

I was diagnosed in 1986 by an oncolgist and confired by Dr. Donna Weber at MD Anderson Cancer Center. I continued on oral chemo for about 12 years and still see Dr. Weber every six months and Dr.Checera with Ausin Cancer Institute every 6 months so I see a Doctor every 3 months. I have taken no Chemo for nearly 11 years.

I have no visual signs of Myeloma and would be relieved if I am cured. Thank you for your comments and I sincerely hope all Myeloma patients could look foreward to a cure.

Dick Dietz

Thank you. I am feeling unusually dense today and I need further clarification. As I understand it this initiative will use patients on existing treatment protocols and drugs available coupled with new more sensitive testing to define when a patient is "cured". This is confusing since it is further my understanding that since MM is actually many diseases that often mutate in a patient there has been no quantified cure achieved and in fact, patients invariably relapse. Is the imitative simply to measure residual disease?

I'm going on my 11th year since my ASCT and currently at early stage 1 myeloma. I'm not on any maintenance treatment right now, so how can this Black Swan help me. A possible cure excite me!

Roy

I was diagnosed with MM in 1998. I had an auto stem cell transplant atbStanford. Was in complete remission for 7 yesrs. When it showed I was out of remission I went on Revlimid and it was great for 5+ years.However thst streak ended this past year. I tried Velcade but it did not agree we me. I am now on Kyprolis and I have had 3 months of treatment. My Igg is still around 2400 but at leadtbit is not going up and reakly no side effects yet. The issue at hand however is that I had 2 compression fractures overvthe last 18 months. I actually had several v vertebroplasty proceedures on my L1 through L4. But I think we were too late. I am in real bad shape in refards to my spine. I cannot get around in excess of 15 minuetes unless I use a walker. The spine is really curved outward. I wish I could get back to being able to walk and run my life as before. I am confident that my MM will stay controlled plus we still have the new drug Pamolidomide. If the kyprolis does not prove to work well on me then I plan on going forwsrd on it. I feel strong that I will get great results from it since I did so well with Revlimid its' cousin drug. I have been real lucky over these last 15 years. I have been able to benefit from all of the new drugs. Now I really need advice on how to fix my spine. Everyone seems to shy away from any discussions on possible options.

This sounds like an exciting initiative. I know that my doctor at the NIH, Ola Landgren, is a part of Black Swan. He is definitely someone you want on your team and an amazingly caring physician. I am currently in his CRD trial on maintenance and doing well. Godspeed to you!

Terry

In October 2004, I was diagnosed with MM plus Amyloidosis and I was given three chemo treatments of VAD. In December, 2004, I was in remission. I later found out that they had given me 12 to 18 months to live. Because of my age and a heart condition, I was not given a bone marrow stem cell treatment. Four years later, in 2008, my oncologist told me that I was cured. It has now been over 8 years since my diagnosis and all my numbers are low but stable and I have had no medication or treatment for MM during the last 4 years. I see my oncologist once every 6 months and the report is always favorable.

There must be more of us survivors of MM out there and I admit that we may be the rare odd case, but I never hear anything about those who are cured. I would like to share this good news with them - or to anyone else who is interested.

As noted in the comments tabled above, I may now start to hear about and correspond with other MM survivors. Why don't we start a MM Cured Survivor's Support Group.

I lead a normal life, walk over 2 miles a day, mow the lawn, shovel snow, trim the hedge, travel where I want to go and feel 20 years old every time I drive my antique 1958 Triumph TR3A sports car which I bought brand new at the age of 20.

Don Elliott, age 75, Montreal Canada

Hi Don, that is great news and provides hope for all of us. You indicated that you still have low levels but are stable. Has your MM reverted to an MGUS-like state? I have heard of this happening in other patients.

Terry - I'm no expert on such details but I enclose the following:-

Rajkumar SV et al have reported "Serum free light chain ratio is an independent risk factor for progression in monoclonal gammopathy of undetermined significance (MGUS) Blood."

2005;106:812�817 Abstract/FREE Full Text � the American Society of Hematology

Here are my numbers for the past six years which indicate that the MM is not on its way back.
I keep a positive attitude, don't think about it at all and I have eliminated the word "relapse" from my vocabulary.

Kappa/Lambda
Light Chain
Ratio
Normal Range =
0.35 - 1.65

2007 July 23 1.19
2008 Aug 8 1.67
July 28 1.19
2009 Jan 9 1.44
July 10 1.42
2010 May 26 1.32
Oct 12 1.46
2011 May 17 1.12
Sept 8 1.69
2012 Jan 24 1.50
July 4 1.26
2013 Jan 3 1.42

I was diagnosed with Multiple Myeloma, type lambda, Stage III-b, with 90% marrow plasma cells in March of 1993. I have just observed the twentieth anniversary of my diagnosis, and, since a clinical trial in "Intensification of Stem Cell Transplantation" in November of 1996, I have been monitored every three months for years, and recently decided to monitor every six months. My monitoring tests show no detectible disease.

I am a resident of Canada, and, in keeping with my determination to advance research (as evidenced by my enrollment in the clinical trial), offer to play any part in the development of myeloma research. Will there be opportunities to participate in Canada?

Nice article, it's good to see that MM is getting such a dedicated high focus. I had an ASCT in December of 2010 at Hackensack University Hospital in NJ. I have been sCR since March of 2011. The gnawing question for folks like me is: "when am I going to relapse." Perhaps very sensitive testing would help to answer that question. Where is the testing being done? Is it part of a clinical trial or available to all patients?

I was very excited to hear about this initiative. As a younger patient that was blessed to have an unrelated donor and a skilled allo Doctor, I feel younger patients are already being cured when they do allos in first complete response. It will be a great day when the older patients also have an opportunity to be cured as well. The new tests will hopefully be more sensitive than the currently available molecular testing. We know that allo patients that achieve a sustained molecular response have a low chance of relapse, but I would have kept on treating if I thought I could get it to zero! Thanks again for starting this initiative.

I�m wondering about the structure/definition of future trials wrt Maintenance when incorporating MRD testing. Would maintenance even be permitted? Maybe MRD test before and after maintenance if there�s a fixed length maintenance schedule? Or would one continue maintenance until MRD Zero? Lots of thoughts. Anyway, exciting to look at potential cure via MRD test rather than dependant solely on future drug development.

Dear Dr. Durie,

We live in Norway, and my husband (53) has just this week had an autologous stem cell transplant. We are of course hoping for a complete response, and the BSRI makes me optimistic. It seems to me that compared to US doctors, the doctors here are less forthcoming when it comes to providing information and discussing details of results with patients. I am hoping to ensure a good and open dialogue with the hospital on how the testing of the response is carried out and on identification of MRD. We have two young children and I need to know that all that can be done is in fact done. I would therefore be most thankful if you could let me know if there are any Norwegian experts involved in BSRI? I am also keen to learn more about what we should do/say in the weeks and months ahead to ensure that the necessary tests and actions are taken.

Thank you for you hard work. It means the world to me and so many people.

Best wishes from Grethe

I am like Jack in that I do not fully understand the types of patients who will be tested and the types of tests. I heard Dr. Drurie say that only those who have had a SCT after receiving one or more chemo regimens will be tested initially. How would you determine which treatment actually created the MRD condition? I would think that using someone who had received only one treatment protocol and achieved CR for a period of two years or more (such as my wife has) might yield better insight into the efficacy of each treatment. I fully support BSRI and hope that it will bring about a cure sooner than later.

Any cure would be a blessing. I am 71 and have been diagnosed for two years. Had Velcade for a year and now on Revlimid plus dexa and cyclophosphamide. Treatment is not fun. Blood scores are returning to 'under control range', but side effects are awful. Hemoglobin went down to 72 last week, and have now had first blood products transfusion. Effects do not last long. So yes, a cure please, please please because MM has horrible lifestyle effects for some of us.

with the absence of a bone marrow biopsy, can myeloma be diagnosed with a positive presence of protein in the urine and antibody testing in the blood.

I'll be 55 in April 2013. I was diagnosed with MM in November of 2003. From 2006 to 2010 I was in what they call remission after going thru several treatments. I did do an Autologous Cell Transplant in 2005. It was a single because my body wouldn't give up enough cells for a double. I was taking Morphine Sulphate for my bone pain, still am, during this time. No other drugs.
After my numbers reached critical stage again I went on low dose Velcade and Dexamethasone. I was then bumped up to high dose. My body wouldn't tolerate the Velcade and because of that ended up in the hospital. Later while in the hospital I was diagnosed with 2 forms of the most deadly type of staph infections. I was in the hospital for a couple weeks.
I am currently on Revlimid and Dexamethasone. I started this treatment in late August of 2012.
It seems to be helping some.

How soon do they think that this new treatment will be available? Will it be realized in time for it to help someone like me?

Dear Dr. Durie,

The news regarding the BSRI is thrilling. Just to read the word "cure" in the same sentence with myeloma gives me hope. However, my spouse is a high risk myeloma patient (65 yrs) who still has a few treatment options available, but not nearly enough, as you are well aware.
He had one auto-stem cell transplant in 2010, which gave him about one year of partial remission with maintenance therapy.

When possible after your return from Kyoto, with new good news we hope, could you comment on how the BSRI might have an impact for patients with high risk disease?

With gratitude, an anxious spouse.

Hello Dr. Durie,

In the quote below from the IMF web page could you please elaborate (quantify) what you consider to be "long-term complete remissions"?

"Through medical innovation we can already achieve long-term complete remissions in 15 to 20 percent of myeloma patients." -- IMF

Again, from the quote below on the IMF web page could you please elaborate on how the best treatments are/will be identified at the best time to achieve the best objective?

"Now, by identifying the best treatments at the best time to achieve the best objective, we�re ready to bridge the gap from long-term remission to cure." --IMF

Thank you!

Hi dr Durie,

I was diagnosed In 2005 and had my second auto tplant 2 yrs ago August. Currently in CR with 5 mg Revlimid maintenance regime. Would BSRI be something I would be eligible for?

Thank you

Hi dr Durie,

How does someone apply for BSRI evaluation?

Thank you,

Jon p

Dr. Durie - We met at a conference here in Montreal about 2005. I was "in remission" at that time after 3 monthly treatments of VAD and then I continued on one capsule of Thalidomide per day for about 4 years as maintenance.

I am quoting from your text above, "Within the new paradigm of the BSRI, the definitive key to the cure is something we call MRD-Zero. MRD stands for Minimal Residual Disease, and by measuring minimal residual disease we can determine how close a patient is to being cured of myeloma. With no detectable MRD, we are there."

I have taken no medication or treatment for the Multiple Myeloma or the Amyloidosis for last 5 years.

Would you agree the I have "Minimal Residual Disease" - i.e. No detectable MRD ?

Would you agree with me that - for my case - "we are there" ? I.e. - I am cured ?

I have led a full and normal life for the past 5 years and all my numbers are stable. My effort level is just as it was before 2004 when I was diagnosed with MM.

Would this mean that I qualify for BSRI evaluation ? I would love to help in any way I can. Please let me know.

Don Elliott, age 75, Montreal Canada

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