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June 2013 Archives : Myeloma Voices

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As it approached 11 p.m. on our first night in Stockholm, the IMF team started to experience the lighter side of Stockholm: it was not yet dark! There was a rose-colored glow in the clouds to the west as midsummer's day was approaching in a few days.  June 20th was the summer solstice this year, when in the north, there is no night, and Stockholm has only three or four hours of darkness.

Our bodies, coping with jetlag, had mixed reactions to sunrise at 3:30 a.m. Even with blacked-out rooms, it was difficult as multiple meetings with 7 or 8 a.m deadlines unfolded.  But the energy and excitement of the meetings were infectious.  The opportunity to discuss freely the myeloma "hot topics" during the IMWG Summit was greatly appreciated by all.  

The Kyle Lifetime Achievement Award presentation to Prof Gosta Gahrton in the Hall of Mirrors on Tuesday evening, June 11, was elegant and rewarding, especially since almost all the past award recipients were in attendance, reinforcing the significance of the event. (See separate story.)

The 2013 International Myeloma Working Group reports session on Wednesday morning was widely attended by the myeloma researchers who had gathered at the Stockholm Summit from more 29 different countries.  Short- and longer-term plans for myeloma guideline development and research initiatives were presented. Collegial arrangements to address new questions and projects were put in place. There was a definite sense of accomplishment. 

A result of the IMWG's guideline development process is the recent updated recommendations for the treatment of bone disease in multiple myeloma patients.  Also on the horizon is an IMWG report on "New Drugs and Novel Mechanisms of Action in MM" just being submitted for publication.

Immediately following was the debate!  It was a compact session involving myself as moderator plus Drs. Antonio Palumbo, Ola Landgren, and Joe Mikhael.  This webcast, third in the IMWG Conference Series "Making Sense of Treatment," dealt with everything from frontline treatment options to maintenance, second primary malignancies to everyone's perspective of new ideas for the future. As the interactive discussions drew to a close, a seminal question emerged: "If we were going to identify myeloma patients for potential therapy before "CRAB" (clinical) features emerge: what category will this "pre-CRAB" group become?"  The answer from Joe Mikhael of "LOBSTER" brought waves of laughter from the panel and audience and was a fitting place to close as Joe pondered the details of this potential acronym!

As day became night, and night rapidly became day again, the IMF team moved forward to the final event during our week in Stockholm: the International Journalists' Workshop.  This evening event was held at the spectacular Fotografiska, the Swedish Museum of Photography, an old customs house located by the water, restored at great expense by the city of Stockholm.  Reporters from 11 countries as well as patient representatives from 13 countries (from the IMF's Global Patient Summit, which preceded the event) were part of the audience in a room whose walls were illuminated color photographs of Stockholm: "surround pictures" rather than surround sound!  

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The panel for the evening was Susie Novis, Aldo del Col (Myeloma Canada), myself, Dr. Paul Richardson (DFCI), and Dr. Xavier Leleu (Lille, France).  The theme for the evening was "the impact of innovation."  I started by illustrating the impact of penicillin in the area of infectious diseases.  From that, I summarized the doubling of myeloma survival (average now more than seven years) with the advent of novel therapies: thalidomide, Velcade, Revlimid, plus the more recent additions.  

Dr. Leleu summarized the amazingly positive results with the new IMiD pomalidomide (Pomalyst), which led to FDA approval early in 2013 and should lead to European (EMEA) approval later this fall.  Dr. Richardson focused upon results with the proteasome inhibitors (Velcade and carfilzomib [Kyrpolis]), emphasizing the very encouraging results with Kyprolis, which led to the FDA approval for that agent.  He also reviewed the range of new agents moving forward in drug development, especially Elotuzumab, HDAC inhibitors, and anti-CD38 inhibitor compounds- recently granted special accelerated or "breakthrough" review status by the FDA.

In closing, I presented an overview of the IMF's Black Swan Research Initiative (BSRI).  This extremely exciting new research has led to much discussion.  The details have been summarized in a recent "OncLive" interview.

And so, exhausted, our packed Stockholm schedule came to a close.  Scanning the evening sky, we watched as the sun wended its way to a late evening sunset and very shortly, an early sunrise and our departure.

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At the 4th Annual International Myeloma Working Group Summit, which just wrapped up in Stockholm, important questions were again considered by over 70 IMWG myeloma researchers from 29 different countries. With a format structured to facilitate and encourage open discussion, the "hot topic" was clearly the diagnosis and management of high-risk smoldering or early active myeloma. 

In anticipation of the upcoming publication of the results of the University of Salamanca's  "High-Risk Smoldering Myeloma" trial, Dr. Maria-Victoria Mateos presented the results of the randomized trial showing survival benefit for high-risk smoldering myeloma patients receiving Lenalidomide-Dexamethasone therapy versus patients without therapy.

A concern voiced by many, including Maria-Victoria, is that although there is a survival advantage that is positive and encouraging this does not mean that this is a recommended approach. Quite the contrary, in fact! The focus of discussion was on how to identify patients who can be classified as having "early active myeloma," and select therapy appropriate for typical "symptomatic," so-called "CRAB positive" myeloma.  This would mean that lower-level smoldering patients would not be treated.

So two questions emerged: 1) How to define what is now being called "CRAB negative" myeloma--to be renamed henceforth as early active myeloma? and 2) Is normal myeloma therapy to be recommended for this new "CRAB negative" subgroup? This is when the discussion format--both in the open sessions and work groups--proved effective in soliciting the maximum input from the myeloma experts gathered at the IMWG Summit. Fortunately, there have been pertinent studies and publications to guide the way, especially from the Mayo Clinic and the University of Salamanca teams, as well as corroboration by teams from the U.S, NCI and the University of Athens.

A high risk of early active myeloma is, for example, linked to:

  • >60% plasma cells in the bone marrow, which carries a >90% risk of progression in 1 to 2 years
  • serum Freelite > 100 mg/dL FLC and FLC ratio > 100 (>80% chance of progression in 2 years)

There was also much discussion about whether additional criteria are necessary to accurately define early active myeloma. 

These are a couple of examples:

  • a PET/CT which shows active disease with evidence of bone destruction on CT (even if x-rays are negative) 
  • and/or  > a single focal "lesion" (or abnormality) on MRI imaging, this later being much less certain as a criterion.  
It was agreed that it is a priority to consider all these and additional parameters carefully as a basis to clearly define "early active myeloma" as soon as possible, using widely available testing procedures. There was also consensus among IMWG members that this subgroup is one of those most amenable to curative approaches to therapy, linking in directly with the IMF's Black Swan Research Initiative. 

Many more issues were raised and discussed. These will be the focus of future blog posts to give a full flavor of the diverse and important outcomes from this year's IMWG Summit. 

One simple and clear outcome is that everyone is already anticipating the IMWG Breakfast Meeting at the American Society of Hematology (ASH) annual meeting in New Orleans in December and ready to book their flights to Milan, Italy as soon as possible for the 2014 IMWG Summit!