What is high-risk smoldering myeloma? Criteria, risks, and ongoing research

This week's "Ask Dr. Durie" comes from  a patient who is very interested in high-risk smoldering multiple myeloma,  and specifically about how secure is the doctor when they say that a patient has  high-risk smoldering multiple myeloma? And this is important because these  days there are a number of protocols to recommend treatment options for patients  with high-risk smoldering multiple myeloma. And one needs to be secure that there is a need  for this kind of therapy. And so, high-risk smolder

ing is a situation where there  is evidence of some aspects of myeloma, but no CRAB criteria, no indications of  activity destroying bones, causing anemia or the like. The criteria that we use to  say that someone has high-risk smoldering are indicators that would suggest that  myeloma will emerge within 12-to-18 months. The criteria that we currently use are the  20/2/20 criteria. The two is the level of the "m" component, the myeloma protein  in the blood. The 20 is the percentage of plasma ce

lls in the bone marrow, and  the other 20 is the free light ratio. The abnormal over the normal. And using these  indicators, patients with these numbers or higher fall into the category of being likely to  develop active myeloma within 12-to-18 months. And this is the kind of patients where  discussions are frequently held to see whether early active treatment could be  helpful in achieving a really excellent result, even in an effort to try to cure such a patient.  Questions have been raised a

s to whether or not this 20/2/20 system is reliable enough. And  there are other systems that doctors can use. And so, I think it is a very reasonable  question for this patient. What I can tell you is that using the to 20/2/20  system, having a risk score of at least 12 is really quite secure. Such patients,  70-to-80% of these patients will in fact develop active myeloma within a year.  And so, patients in this group can be quite secure that the risk is indeed true  and important in terms of d

ecision making. For other categories, there is a need to  try to improve to be a little bit more secure beyond the 50/50 risk level. And so, the  IMWG members and the subcommittee are actively looking at new methods. One of the methods is  to follow patients for six months to one year to be sure that perhaps there is evidence  of early progression. And another new idea, which I think will turn out to  be perhaps the most important, is to see if there are myeloma cells in the blood  and how many

myeloma cells there are in the blood. We have indications from studies by several  experts now which indicate that if there are myeloma cells in the blood, this does reliably  indicate a trend towards active myeloma. And so, these kinds of testing are now being  evaluated and will likely be implemented soon. And so, the BOTTOM LINE for this patient today  is that this is a very important question. We are looking at the reliability of the 20/2/20  system, which is reliable, particularly for the h

igher risk groups such as 12 risk score or  better. But we are looking for improvements. And if there is any doubt for sure there should be  a decision to watch and wait and make sure what is the status of the patient. The main thing is  to be sure that no CRAB criteria are emerging. We do not want patients to evolve such  that they might develop bone lesions or kidney problems or some other indications of  active myeloma. So it is a fine line and we will be very keen to see our new studies  and

to see if we can do as good a job as possible to accurately predict patients who  do indeed have high-risk smoldering myeloma.