May 20, 2021

This week, the IMF is pleased to announce the publication of the first results of the iStopMM screening study, the largest country-wide study of its kind ever conducted. The accrual of over 80,000 participants, as described in Blood Cancer Journal, is an amazing achievement. We congratulate the lead principal investigator Dr. Sigurdur Kristinsson and his team in Iceland!

There is now a dedicated screening clinic in Iceland that coordinates the initial testing and follow-up of all participants. The key goal of the study is to assess the pros and cons of this type of early screening. 

The value of early screening

The potential benefits of early screening are well established in multiple myeloma. Starting treatment early, at an earlier stage of disease, leads to improved outcomes in terms of both length of remission and ultimate overall survival. Within the IMF Black Swan Research Initiative there is also the option to offer the Cure Trial approach in which decisive treatment can provide not just deep response, but longer remissions and the potential for cure in some patients. 

What are potential drawbacks of early screening?

The iStopMM project is specifically structured to capture any potential risks or downsides to screening. It asks questions such as:

• Is there a negative psychological impact of becoming aware of an early abnormality in the blood when it requires monitoring but not immediate treatment? With careful testing, the initial findings of the study are very encouraging. Participants are not only very pleased to contribute to ongoing learning of this disease, but do not develop increased anxiety or negative effects. Regular monitoring out to five years and beyond will assess the longer-term impacts. But, so far so good. 
• What about the cost of early screening? This is a common concern. Fortunately, the costs of screening testing are very low (versus general medical testing costs) and this is not a major concern. Initial costs are balanced against much higher costs of interventions needed if patients later develop the complications of full-blown myeloma. 
• What about false positive results, such as those results that give misleading information? Screening in the study includes very sensitive testing for myeloma-type proteins in the blood, a method called “mass spectrometry.” The amazing commitment of the U.K.-based laboratory Binding Site to undertake this specialized assessment spectrometry testing for such a huge number of individuals is an enormous feat and greatly appreciated by all involved. This testing is already revealing information about the very earliest stages of disease development. At this earliest point, some tiny protein changes may even disappear over time, whereas others persist and progress. Clearly, there is much to be learned about the development of disease at this stage. 

Undoubtedly, these groundbreaking observations will lead to re-classification and reassessment of management guidelines. What do we tell the participant or patient?  What monitoring is to be recommended? These are good questions that must be approached with input from both the patient and scientific communities. 

The value of specialized testing

The iStopMM project has the capacity for very rich, specialized testing to be used in a correlated fashion. A major advantage of being in Iceland is the genetic testing conducted by deCODE genetics for the whole Icelandic population. This means that those individuals within the study who develop MGUS, smoldering myeloma or active myeloma can be compared at the genetic level with the over-300,000 individuals in the rest of the Icelandic population who do not develop any blood changes. 

An additional part of the project is a comprehensive biobanking (tissue banking) effort, which will enable many new and innovative research studies.  

Study participants are followed (anonymously) using an electronic medical record system that permits medical health issues to be tracked and correlated with outcomes. The detailed background information will allow the iStopMM team to better categorize the different participant subgroups and subtypes. 

Bottom Line Value

Over time, the iStopMM project will lead to many new observations which, in turn, will shed light on the optimal interventions to achieve both prevention and a cure. These are the fundamental goals for all of us in the myeloma community. It is truly wonderful to see this project moving so strongly forward! 

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