The iStopMM Trial & Importance of Early Screening

2019-08-05 13:00:00
Tags: multiple myeloma,specialty pharmacy



Peter Salgo, MD: And then there’s this 1 study out there. I’m just going to read the official title: “Iceland screens treats or prevents multiple myeloma.” What a coincidence that this spells “Stop MM.” What is this study, and how does this impact everything we’ve been discussing?

Noa Biran, MD: So the country of Iceland has agreed to screen every single person over the age of 50, I believe, for multiple myeloma to see if we can catch it, because almost all patients with myeloma had a preceding MGUS, which is a kind of an indolent quiet myeloma, or a smoldering myeloma.

Peter Salgo, MD: OK, you’re going to have to tell me what MGUS stands for.

Noa Biran, MD: MGUS is monoclonal gammopathy of undetermined significance, which is the myeloma protein in your blood, but it doesn’t do any damage to the body. These people almost never progress to multiple myeloma; they just have a quiet, smoldering state. So Iceland is going to screen every single patient in the country of a certain age to see if they have the protein, to see if they are going to be able to treat myeloma earlier. So what do you think this is going to do? Patients who now are going to have an incidental finding of a monoclonal protein, who may or may not have multiple myeloma, will need to be evaluated, and some will eventually go on to treatment. So you’re going to have a much larger percentage of patients on therapy. At the end of the day, it’s not going to cure their disease, and you’re just extending the time that they are on therapy.

Peter Salgo, MD: You know, why does this remind me of PSA [prostate-specific antigen] testing for prostate cancer? Everybody gets tested, lots more men get therapy who may never have needed it.

Noa Biran, MD: Right.

Cheryl Allen, BPharm, MBA: Well, I look at this a little bit more optimistically.

Peter Salgo, MD: Good. Convince me.

Cheryl Allen, BPharm, MBA: Yeah. I think the key there is early screening. One of the problems that we have today is many of our patients are asymptomatic, and once we finally discover that a patient does have multiple myeloma, they have bone disease, and there are all sorts of other quality-of-life issues that we have to deal with, in addition to the multiple myeloma. So I think the goal of the Black Swan Research Initiative, in collaboration with the study in Iceland, is to screen early. And this is an opt-in screening for Icelanders. And I think it’s age 40, because we said before age 50 it’s about 1% of the population. So the screening begins earlier, and then the patients are segmented into, I think, 3 different arms of the trial for observation.

But you know, if we think about MGUS or even asymptomatic, those patients, you’re right, they are asymptomatic for a period of time. And then there’s a trigger, and then they flip over to become symptomatic. Right? So then we treat them. But what is that trigger? Is it an environmental figure? You know? What causes it.

Peter Salgo, MD: Or maybe there’s no trigger at all. They just do it.

Cheryl Allen, BPharm, MBA: Maybe, maybe, who knows? But I think that the overall goal from the International Myeloma Foundation with Black Swan is to say, “We get patients way over here. Is there anything that we can do to look at patients earlier on to help possibly put these patients into remission earlier?”

Peter Salgo, MD: You like this, actually? I’m getting the feeling.

Cheryl Allen, BPharm, MBA: Or even understand why they work.

Noa Biran, MD: So I think there’s a big distinction between smoldering myeloma and symptomatic multiple myeloma. Multiple myeloma is the only cancer that requires an end-organ symptom for which to start therapy. For breast cancer, you don’t need a symptom. You have a lump in your breast, and you get chemotherapy; that’s the end of it. For multiple myeloma you need CRAB criteria: high-calcium, renal, anemia, or boney lesions. It’s almost like watching your patient for the high-risk smoldering myeloma, so there are patients who you know are going to need therapy because they have such a high burden of disease, but you can’t justify treating them because they don’t meet the criteria.

It’s like watching somebody run toward a cliff, and you want to stop them because you know they’re going to fall. And that led to the development of SLiM CRAB criteria, which is basically identifying a subset of high-risk smoldering patients who are almost certainly going to progress. Even for those patients, when the SLiM CRAB criteria came out, which was 2½ years ago, we were already following patients for 5, 6, 7 years who met that SLiM CRAB criteria but never progressed. So what is it about patients who never progress? And distinguishing them from patients who do progress, what is that triggering event?

Cheryl Allen, BPharm, MBA: Is it genetic?

Noa Biran, MD: That’s what this study is going to identify. And the idea is that it’s the immune system.

Peter Salgo, MD: I’ll tell you what this tells me. I’m glad you’re doing this. This is way too complicated for me. I’ll do more surgical-related problems and leave this tough stuff to you guys. In the few moments we’ve got left to us, what I’d like to do is get some final thoughts from each of you. And why don’t we with you, Cheryl Allen?

Cheryl Allen, BPharm, MBA: Well, thank you so much. Thank you both for a great conversation. When we start thinking about our patients with multiple myeloma, it’s a tough disease state for the patient and for the caregiver. And then added on top of that is the therapy that has to be most times infused. So it’s a very complicated issue for our patients to deal with. I think working together in a continuum care helping one another to understand, from a physician, over into the pharmacy, and then back to the patient-supportive caregiver is our best way to help these patients. Because again, we generally get our patients where their disease has progressed. They do live years or decades, but we have a quality-of-life issue, so we have to continually check in with the patient.

Peter Salgo, MD: OK. Dr. Biran, the last word is yours.

Noa Biran, MD: Thank you. I enjoyed this conversation, and I think the fact that we’re sitting here and talking is a testament to the progress that we’ve made for patients with this disease. And in a way, we are lucky to have these problems, because there are so many treatment options, and it’s just amazing when a patient progresses, and they say, “Well, what else do you have for me?” “Well, I have a list of 5 options. There are a lot of treatments, and I’m confident that we’re going to work together as we did before to make this work.”

Peter Salgo, MD: You know, when I hear you 2 talk, I’m impressed at the brilliance of you both. And something you said just now has real resonance. We wouldn’t have been having this conversation 20 years ago, 25 years ago.

Noa Biran, MD: That’s right.

Peter Salgo, MD: We didn’t have the options, patients weren’t living this long, and treatments didn’t cost this much. The fact that this is a problem is great. I’ll take this problem. We’ll fix it, probably. At least we hope we will.

Noa Biran, MD: We will.

Peter Salgo, MD: And if we have people such as the 2 of you who are working in good faith, that’s my most optimistic comment. It’s just great. Thank you both for being here.
I want to thank you, our viewers, on behalf of our panel and me, for joining us. We hope you found these Practice Pearls® to be useful and informative. I’m Dr. Pet