Tag Archive for: Mayo Clinic

How is Treatment Fitness Determined in Multiple Myeloma?

How is Treatment Fitness Determined in Multiple Myeloma? from Patient Empowerment Network on Vimeo.

How is treatment suitability assessed in myeloma care? Dr. Sikander Ailawadhi, an expert from Mayo Clinic, elaborates on the factors taken into account when determining the appropriateness of treatment for myeloma patients.

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Transcript:

Lisa Hatfield:

Oh, great. Okay. Again, important to see a myeloma specialist to tease out all this information. Thank you. All right. This patient is asking, “I’m 81 and living with comorbidities. The myeloma was diagnosed after bone marrow test. How is treatment fitness determined?” And also a question about that is if you’re given an ECOG status of something you don’t like it, can that be improved after you’ve had treatment?

Dr. Sikander Ailawadhi:

Absolutely.

Lisa Hatfield:

Maybe be eligible for a trial or something.

Dr. Sikander Ailawadhi:

Correct. Correct. That is so important. When this patient mentioned that they’re 81-year-old and they’re living with comorbidities, I think, so when I’m talking to a patient who’s new to me, it’s very important for me to try to tease out what was their performance status or their fitness status prior to myeloma. Because my goal is to try to get them as close to that as possible.

Now if this patient is saying that they were already quite frail before the diagnosis of myeloma and myeloma is added to the frailty, then it becomes a little tricky because we’re starting in a difficult spot. We do determine fitness by asking questions, simple questions like, what can a patient do at baseline? Can they do grocery store or grocery shopping by themselves? Can they walk around the block? Do they get short of breath? Et cetera.

And frankly, there are 81-year-olds who are playing golf every day and are fitter than me. So I’m just saying that age by itself is not the criteria. And, Lisa, like you rightly mentioned, if there are fitness issues coming from the disease itself, then that’s the time that we actually have to work with the treatment, get the treatment started, and then assess the fitness a couple of months later, a couple of cycles later. Because the treatment may have worked and may have improved the fitness quite a bit.


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Navigating Myeloma CAR T-Cell Relapse: Patient Next Steps

Navigating Myeloma CAR T-Cell Relapse: Patient Next Steps from Patient Empowerment Network on Vimeo.

What are next steps for myeloma CAR T-cell patients who experience relapse? Expert Dr. Sikander Ailawadhi from Mayo Clinic explains options for relapsed myeloma patients and shares patient advice.

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Related Programs:

What Factors Shape Myeloma Treatment Options After Relapse?

Myeloma Treatment Timing: Prior Therapies and FDA Approval Rationale

How is Treatment Fitness Determined in Multiple Myeloma?


Transcript:

Lisa Hatfield:

Okay. So what would be the next steps, Dr. Ailawadhi, for a patient who’s had CAR T and reaches a relapse state or is relapsed?

Dr. Sikander Ailawadhi:

Yep. This is something, unfortunately is the truth of the matter in myeloma at least that we are, we don’t seek cures. We have had some long remissions. I have, for example, patients who are now reaching three, three-and-a-half years of remission on CAR T treatment who received it on clinical trials even before they got FDA-approved.

But, unfortunately, the disease does come back. So what happens is, we are seeing data that the novel, other novel immunotherapies like bispecific antibodies, even the ones who go after the same target as CAR T, BCMA targeting bispecifics, they do have some response rates, good response rates in post CAR T setting. So the bispecific antibodies by themselves may give us 60 to 65 percent response, but in the post CAR T setting, that response might go down to 40, 45 percent. So less responses, but still possible.

There are also bispecific antibodies. There is one available, which is not against BCMA, it is against GPRC5D. That’s a bispecific called talquetamab-tgvs (Talvey). So a novel target. There is…there are of course a lot of clinical trials. There are some clinical trials that are even looking at CAR T post-CAR T. So different kind of a CAR T. Those clinical trials are going out. So what I would suggest is that if your disease progresses after CAR T-cell treatment, you should very strongly consider getting to a specialist myeloma center and get an opinion like you mentioned, Lisa.

That is so important because the choice of treatment is extremely important at that time. And we are trying our best to sequence all the options we have, in a way, actually one of my patients mentioned, one of these days, ”Hey, does that mean that I’m basically buying time till something new and exciting comes along?” And I said, “In a way that is true. That we are trying to stretch all our treatments and get to the point that something new and promising just like CAR T comes, and hopefully we get longer benefits again.”

Lisa Hatfield:

So when you say there’s a possibility of CAR T and then a post-CAR T maybe a second CAR T. Would that be a different target then?

Dr. Sikander Ailawadhi:

So there could be a different target. I have, in fact, I saw a patient who had received one CAR T in a clinical trial and then they were subsequently able to receive a CAR T standard of care, which had been FDA-approved. So they used different CAR Ts, but one was in clinical trials and one was standard of care.


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Myeloma Treatment Timing: Prior Therapies and FDA Approval Rationale

Myeloma Treatment Timing: Prior Therapies and FDA Approval Rationale from Patient Empowerment Network on Vimeo.

What concerns do myeloma patients need to know about CAR T-cell therapy? Expert Dr. Sikander Ailawadhi from Mayo Clinic explains patient qualification for CAR T-cell therapy, including the number and type of prior therapies.

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How is Treatment Fitness Determined in Multiple Myeloma?


Transcript:

Lisa Hatfield:

So we have another patient asking, “Do myeloma patients require multiple prior therapies prior to being eligible for CAR T?” And what’s the rationale for not implementing CAR T immediately, which probably has to do with FDA approval based on clinical trials at this point?

Dr. Sikander Ailawadhi:

So any drug, let alone CAR T, any drug can only be given in the situation that it is approved by the FDA. So basically in accordance with that drug’s FDA approval label. Currently, CAR T-cell therapy is approved in the U.S. after at least four prior lines of therapy. And the patient must have had treatment with at least one proteasome inhibitor, for which we have three drugs, bortezomib (Velcade), ixazomib (Ninlaro), and carfilzomib. They must have been treated with at least one prior immunomodulatory drug; lenalidomide (Revlimid), thalidomide (Thalomid), pomalidomide.

And they must have been previously treated by at least one monoclonal antibody, daratumumab (Darzalex) or Isatuximab (Sarclisa). Once the patient has had all these criteria met, they’ve become a candidate for CAR T-cell therapy. Frankly, we cannot just use a drug anywhere because we cannot use a drug where it has not shown to be of benefit. And importantly, it has not shown to be of any risk. So CAR T-cell therapy in the first line setting is being studied in clinical trials, but is not FDA-approved. Currently approved only after four prior lines, but the FDA is reviewing data for both the CAR Ts to see if they may be available sooner. As of right now, that approval is still pending.

Lisa Hatfield:

Okay, thank you. We’re hopeful that that will happen soon.

Dr. Sikander Ailawadhi:

Hopeful.

Lisa Hatfield:

Yeah. So an interesting question from a patient, “Does CAR-T therapy actually change one’s DNA?”

Dr. Sikander Ailawadhi:

No. The CAR T therapy does not change one’s DNA. What happens is, there are T cells taken out of a patient. The DNA of those T cells is modified and then those T cells are given back to the patient. Those T cells do not go and integrate into your other healthy body cells or your stem cells, et cetera. Those T cells, it’s almost like giving a boost of immunity, which is targeted against your myeloma. So those T cells go in and they fill those myeloma cells.

Now we hope that those T cells perpetuate and teach or create some memory T cells and that immunity lasts a little bit longer. But all of that genetic modification stays within the T cells. It does not integrate anywhere else. Now, I know there was a previous question about T-cell lymphomas, that is related to this question in a way because the risk that is theoretical is, that that genetic modification in the T cells might make those T cells replicate uncontrollably leading to a T-cell cancer or T-cell lymphoma. But I’m saying that this is theoretical because while it is possible, it happens extremely rarely and even in the cases where the cancer happened, it has  been seen that the cancer may not come from that portion of the DNA that was…that’s where the modification was done. So, low risk.


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What Factors Shape Myeloma Treatment Options After Relapse?

What Factors Shape Myeloma Treatment Options After Relapse? from Patient Empowerment Network on Vimeo.

What myeloma treatment options are there for patients who relapse? Expert Dr. Sikander Ailawadhi from Mayo Clinic explains patient factors that must be considered in treatment options and how treatment options may be impacted.

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See More from START HERE Myeloma

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How is Treatment Fitness Determined in Multiple Myeloma?


Transcript:

Lisa Hatfield:

For those who relapse for the first time, what are the best treatment options?

Dr. Sikander Ailawadhi:

I think that’s a very important, and I can imagine a scary situation. So somebody who relapses in general, not just even the first time, the factors that are taken into account for deciding what treatment they should get, there are broadly three categories of factors. Patient factors deciding what’s the age, what’s the other comorbidities, are they diabetic, are they heart disease, kidney dysfunction, because those things go into the decision of what may or may not be given. So patient factors.

Also importantly, how close are you to your treatment center? Can you come in for infusional or injection drugs time? And again, can you prefer or do you prefer oral drugs only? Et cetera. Those things become important. Then that…so that’s patient factors and disease factors. How fast is the progression? Is it high-risk disease, standard risk disease? Is it biochemical progression like the previous person asked?

Or is it actually a clinical progression in which there’s kidney dysfunction or anemia or bone disease? Because the choices and the urgency of treatment may change. So patient factors, disease factors, and then drug factors are the third class or third category, which is what have you had before? How long have you been on it? Are you on maintenance or not? Is your disease considered refractory to a certain agent, meaning resistant to a certain agent?

Typically, if you were on a treatment and your disease is progressing, that same drug may not be used again. And there are some times that we will reuse a drug, but generally not. We can use the same class, but we may not typically use the same drug. So I think the choice of treatment depends on all of those factors put in. And then we come up with one or two or three regimens and we discuss them with patients. And, of course, being an academic, physician, I must say there is always, you must always seek out good clinical trials if they’re available to you. That is the way our field moves forward.


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What Are Guidelines for Rising Myeloma Marker Levels?

What Are Guidelines for Rising Myeloma Marker Levels? from Patient Empowerment Network on Vimeo.

What are multiple myeloma guidelines for marker levels? Expert Dr. Sikander Ailawadhi from Mayo Clinic discusses marker levels that are checked and levels that could be concerning for disease progression.

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Is There a Link Between CAR-T Therapy and T-Cell Malignancies?


Transcript:

Lisa Hatfield:

This patient is asking, “My M spike keeps rising in spite of chemo. What can I do?”

Dr. Sikander Ailawadhi:

Very important question, Lisa. Every patient must understand what their disease marker is. This patient is asking about the M spike, which is the monoclonal spike, whether it’s in the blood or in the urine. And if the M spike is continuing to increase and there is a significant increase, significant is defined by at least 25 percent from the nadir or from the bottom most point with the, at least an absolute increase of 0.5 gram per deciliter. So half a gram per deciliter. So we want a 25 percent increase, but we also want at least 0.5 gram per deciliter.

So if somebody had an M spike of one at their best point, then the increase to 1.5 is significant. If somebody had the M spike of 0.2, then it’s not the 25 percent increase, it’s the 0.5 that must happen. So they hit 0.7 and that’s a significant increase. So that’s how we think about M spike, 25 percent with an absolute of at least 0.5 gram per deciliter.

If that is indeed happening, this would be considered a biochemical progression. And at that point, it should be considered to switch around the treatment because we don’t want the disease to grow to the point that there are actually symptoms showing up or organ damage happening. We want to be able to capture the disease progression sooner and act upon it.

Lisa Hatfield:

Do you have any recommendations for people who, as we might have some patients watching this, who are light chain only? Any guidelines on if those numbers are rising?

Dr. Sikander Ailawadhi:

That’s an excellent question too. So if somebody has light chains as their marker, we are looking at an increase in the involved serum free light chain. So if somebody has kappa as their marker, the kappa is going up, or if they have lambda as the marker, the lambda is going up. Typically, if both of them go up, that is not disease progression. That could be coming from kidney dysfunction. Somebody is dehydrated and they get labs checked. Both kappa and lambda might be elevated. Again, a 25 percent increase in the absolute. But at the same time, we are also looking at at least 10 milligram per deciliter change. So if somebody had a light chain of two milligram per deciliter, if it goes to 12, that might be a significant change. But I can say that light chains are a little bit more volatile and they do get affected by our fluid status. So if I ever notice a patient with a light chain increase, I’m more likely to repeat the test very soon, maybe even at a couple of days, one week interval, just to make sure that there is a trend rather than just a fluctuating light chain.

Lisa Hatfield:

Okay. Thank you for that information.

Dr. Sikander Ailawadhi:

And I should maybe, very quickly add, we do not check light chains in the urine. Light chains should be checked in the blood. Urine light chains are very nonspecific, and there’s no need to test them.


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Is There a Link Between CAR-T Therapy and T-Cell Malignancies?

Is There a Link Between CAR-T Therapy and T-Cell Malignancies? from Patient Empowerment Network on Vimeo.

What should myeloma patients know about CAR T and T-cell malignancies? Expert Dr. Sikander Ailawadhi from Mayo Clinic discusses the benefits versus risks for myeloma patients who undergo CAR T-cell therapy.

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See More from START HERE Myeloma

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Navigating Priorities in the Expanding Myeloma Treatment Landscape

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What Are Guidelines for Rising Myeloma Marker Levels?


Transcript:

Lisa Hatfield:

There have been some discussions about post-CAR T, particularly with T-cell malignancies and monitoring for that. Can you just give a little description of that and any concerns that you have with that or any encouragement you have regarding that and whether that weighs into your treatment options that you give to patients when they are asking about CAR T therapy?

Dr. Sikander Ailawadhi:

Absolutely. Extremely important question, Lisa. This really had a lot of discussion going on. It’s been going on for the past few months now. Okay. So first let’s explain the landscape. The FDA reviewed CAR T-cell treatment because of the fact that there were about 19 T-cell malignancies noted in several thousand patients.

Out of those 19 cases of T-cell malignancies, there was one case of multiple myeloma to the best of my knowledge. Now, risk of subsequent cancers is something, unfortunately, every cancer patient lives with, but in myeloma, we have known about that, especially from our historical knowledge of second malignancies with lenalidomide-based (Revlimid) maintenance therapy post-transplant. So subsequent malignancies have always been a risk.

There is some risk that is being talked about with CAR T, but frankly speaking, the way I look at it, the risk is significantly lesser than the potential benefit. Because remember when these CAR T therapies, the two agents got approved in myeloma, they were approved in a situation that there was no standard therapy. And we saw somewhere about 70, 75 percent response rate with one of them and about 98 percent response rate with the other one. So in a setting where there was nothing, you can see the degree of benefit. And the risk of second malignancies is relatively small. So we must discuss this.

A patient must be aware of it, but I think the benefit is way more than the risk. So we document, we discuss, we have specific documentation that we do and specific information that we share with patients, but I think still the benefit is significantly more than the risk.


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How Are Myeloma Survivorship and Treatment Planning Evolving?

How Are Myeloma Survivorship and Treatment Planning Evolving? from Patient Empowerment Network on Vimeo.

How have myeloma treatment planning and survivorship evolved? Expert Dr. Sikander Ailawadhi from Mayo Clinic discusses how patient outlooks have changed and the impact to patient treatment options and doctor-patient communication.

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See More from START HERE Myeloma

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Navigating Priorities in the Expanding Myeloma Treatment Landscape

Is There a Link Between CAR-T Therapy and T-Cell Malignancies?

What Are Guidelines for Rising Myeloma Marker Levels?

What Are Guidelines for Rising Myeloma Marker Levels?


Transcript:

Lisa Hatfield:

So how is myeloma survivorship evolving, and what’s different now than it was five or 10 years ago in terms of treatment planning?

Dr. Sikander Ailawadhi:

Yeah, I think it’s very important to keep that in mind. When I see a newly diagnosed patient, I’m not just telling them, “Hey, this is your induction therapy, and your transplant is the goal.’ We’re trying our best to decide that patient’s life journey with myeloma over the next 10, 15 and hopefully more years. So we’re trying to pick and choose the regimen that is most likely going to help the patient the most today and most likely will give a longer duration of the response.

So when you say survivorship, that also very importantly brings up the point that patients are living with myeloma longer. We have to manage their health overall. So looking for any side effects from treatment, managing them very well so the patient is able to stay on the treatment and maintain good quality of life.

There are actually, clinical trials looking at stopping treatment when there is a very deep, prolonged response. Again, going towards survivorship and giving the patient’s quality of life. There is looking for other cancers. In fact, I had a patient in the clinic and we were talking about just myeloma in general and I was telling them, “Okay, please remember you may not want to do a colonoscopy, but you already have one myeloma cancer diagnosis.

The risk of subsequent cancers is always there in any cancer patient.” So that was a male person. So I said, “Okay, please do not miss your colonoscopy. Please do not miss your prostate screening and whatever is age-appropriate must be done.” So managing everything because myeloma is not a sprint, it’s a marathon.

We want to make sure that we pace ourselves well so we manage all the symptoms, all the signs. Bone health becomes much, much more important because the same bone structure is now going to carry us longer and many more years. And as you rightly said, planning, which treatment comes first, which comes next, when does CAR T come? It’s not that everybody must get CAR T today. That’s not the answer. So what to use when becomes extremely more important.


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Navigating Priorities in the Expanding Myeloma Treatment Landscape

Navigating Priorities in the Expanding Myeloma Treatment Landscape from Patient Empowerment Network on Vimeo.

What should myeloma patients know about the latest treatments and monitoring? Expert Dr. Sikander Ailawadhi from Mayo Clinic shares updates about new research and treatments as well as new tools for monitoring myeloma progression and relapse.

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See More from START HERE Myeloma

Related Programs:

How Are Myeloma Survivorship and Treatment Planning Evolving?

Is There a Link Between CAR-T Therapy and T-Cell Malignancies?

What Are Guidelines for Rising Myeloma Marker Levels?

What Are Guidelines for Rising Myeloma Marker Levels?


Transcript:

Lisa Hatfield:

Dr. Ailawadhi, can you speak to the latest news and priorities in the rapidly expanding myeloma treatment landscape?

Dr. Sikander Ailawadhi:

I think, Lisa, that’s an excellent and important question. Because as you rightly mentioned, there is such a large amount of data that is coming through for myeloma all the time. I mean, it’s almost, we kind of talk about the fact that every time you turn your shoulder or look over your shoulder, there is a new drug approved. So I can imagine this can be very overwhelming. So what I’ll say is that in my opinion, there are some categories of new data that are pertinent and important for our patients.

The two or three out of them that come to my mind, one is what’s called CELMoDs, or there are a couple of agents there called iberdomide, mezigdomide. These are showing some interesting data. Important to keep in mind that they are somewhat related to the immunomodulatory drugs lenalidomide (Revlimid), pomalidomide (Pomalyst), but they’re showing benefit in patients who have had len and pom before and have progressed. So exciting stuff there.

We’re also seeing some interesting data about newer CAR Ts and bispecific antibodies. They are all coming up with some benefits in some cases. I think it’s important to keep in mind that the bispecifics are landing at the 60 to 70 percent response rate, and CAR Ts are typically landing at the 80 to 90 percent response rate, but there are more agents expected.

There are also some newer bispecifics in different classes, like one of them is called cevostamab, which is an FcRH5 inhibitor or targeting bispecific. So newer bispecific, not just more of the same category. And there has also been recent data about Bcl-2 inhibitors, which have been traditionally used for patients with translocation 11;14.

There have been some negative data, negative as in trials, which did not pan out with a drug called venetoclax (Venclexta), but there are two other drugs that had some recent data shown from different companies, which were exciting information. So in my mind, those are kind of the broad new drug categories. There is another, a couple of other quick things that I’ll mention.

One is we’re getting more and more information about real world experience with these new drugs. It’s good to see that CAR Ts are panning out very similar in the real world as they are in clinical trials. We’re also seeing that the side effect profile of a lot of these newer novel immunotherapy drugs is similar as seen in the clinical trials.

Racial ethnic disparities are something which are very close to my heart, and there is more and more information coming out in that. Unfortunately, highlighting the disparities more still rather than yet coming up with solutions. And I think the last thing that I feel which has been recent has been at the American Society of Hematology meeting in 2023, which was in December in San Diego. One of the myeloma studies actually became a plenary session presentation, which is a pretty big deal for any disease area. So one thing is that it gets highlighted. Secondly, it was a combination of a regimen called isatuximab-irfc (Sarclisa) with carfilzomib (Kyprolis), lenalidomide, and dexamethasone (Decadron) in newly diagnosed patients.

It’s a randomized trial, Phase III, which was presented. I think the important part is we saw unprecedented deep responses and patients in much, much higher numbers than before becoming MRD-negative. So very deep responses. So these are kind of some very broad, but lots of highlights that I talked about.

Lisa Hatfield:

So can you also talk about some of the newer tools for myeloma progression and relapse and what patients might want to know about that? And in particular, maybe talk a bit about MRD testing and the role of MRD testing for patients who relapse.

Dr. Sikander Ailawadhi:

Excellent question. Lisa, I think the first and foremost thing an important part for our patients to learn is what are their “tumor markers,” for the, or disease markers for myeloma. We can follow myeloma by either the M spike or monoclonal protein, by light chains, by monoclonal protein in the urine or blood. And it’s important to keep that in mind because every now and then we’ll see patients who say, Hey, my ratio changed. So I’m progressing. Well, that comes after the light chains change. So it’s important to understand the role of these things. So M spike in the urine, M spike in the serum and light chains. One of them is typically the marker for a patient.

Now the MRD status or minimal residual disease that is looking for one cell, one myeloma cell from amongst 100,000 cells in the bone marrow. So it is looking at a very deep level. The most important benefit of MRD testing right now is to understand that if a patient turns MRD negative, then they have a superior outcome. Their prognosis is better. Their progression free survival, or the time before their disease comes back is longer. 

But when a patient is MRD-negative and is being followed or maintenance or whatever, if the bone marrow turns MRD-positive, then that might be the sign that the disease might be coming back. Right now, we do not keep switching drugs to get to MRD-negative. That is not the goal of treatment. The way to think about it is we want to get to MRD-negative, but that means it’s incumbent upon us to try and pick a regimen that is more likely to get to MRD-negative. That’s the way to think about it.

Let’s pick a regimen more likely to get us into MRD-negative and hope that we get to MRD-negative. We see every now and then that the patients keep switching regimens just to get to MRD-negative. That’s not the way to go because you’re just using up options too quickly, too fast. A common question that patients ask is, well, does that mean I need to get annual bone marrow biopsies and MRD testing? Probably not.

That’s too much testing. So what I suggest is that once somebody has turned MRD-negative, it’s important to keep an eye on every single thing. Now, change in any of the routine labs, imaging, new symptoms, etcetera. That’s when we switch to the bone marrow again and see if the patient has turned MRD-positive. There are clinical trials going on right now which are stopping drugs based on repeat MRD negativity or starting drugs on MRD positivity. But those are clinical trial questions.

Lisa Hatfield:

So along those same lines, since you’re a Mayo physician, I’m curious about the mass spec testing. So if a patient say has been MRD-negative for some time, still wants to monitor at a deeper level, even though it’s not commercialized yet, do you see a role for mass spec testing on a regular basis in the future and being rolled out to community facilities also?

Dr. Sikander Ailawadhi:

Absolutely, Lisa. I did not specifically bring it up because mass spec is not, like you rightly said, is not yet commercially available. Now we’re doing mass spec quite frequently at Mayo Clinic. Basically mass spec is taking up a blood sample. Important to keep in mind, it’s not a bone marrow test, it’s a blood test, but it looks for those abnormal proteins based on the protein weight at a much, much lower level. Our SPEP or serum protein electrophoresis does not pick up very small quantities of the protein mass spec does. So in an essence, the mass spec, if somebody is negative on that, turning mass spec negative to mass spec positive may be an earlier sign of the disease coming back rather than the SPEP yet turning positive. But as you rightly said, it is not yet commercially available. I do see the benefit of it.

There is more and more data coming in favor of it, and there was data that was also at ASH. So I do see that in the future we’ll be able to most likely have it available more widely. At this point, it is just a blood test to attempt to check the disease level at a much deeper level and be able to notice if the disease is progressing sooner than our currently available tools.


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Myeloma Patient Expert Q&A: Dr. Sikander Ailawadhi

Myeloma Patient Expert Q&A: Dr. Sikander Ailawadhi from Patient Empowerment Network on Vimeo.

 In this START HERE myeloma program, Dr. Sikander Ailawadhi from Mayo Clinic spotlights priorities in the rapidly expanding myeloma treatment landscape. Watch as Dr. Ailawadhi addresses pressing questions submitted by patients and families, providing invaluable guidance and reassurance in navigating the complexities of myeloma care.

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What Treatments Are There for Myeloma Patients Who Relapse After CAR T


Transcript:

Lisa Hatifield:

Hello and welcome. My name is Lisa Hatfield, your host for this Patient Empowerment Network START HERE program, where we bridge the expert and patient voice to enable you and me to feel comfortable asking questions of our healthcare teams. The world is complicated, but understanding your multiple myeloma doesn’t have to be. The goal is to create actionable pathways for getting the most out of myeloma treatment and survivorship.

Joining me today is Dr. Ailawadhi, back by popular demand. Dr. Ailawadhi is a respected multiple myeloma expert from Mayo Clinic. Dr. Ailawadhi’s career focus includes the treatment of plasma cell disorders like myeloma and understanding the epidemiology and pathophysiology of this disorder. It’s always such a pleasure having you, Dr. Ailawadhi. I’m really excited you’re joining us again. So thank you for joining us.

Dr. Sikander Ailawadhi:

And thanks a lot for having me, Lisa. This is excellent. I look forward to this next iteration of the Patient Empowerment Network START HERE program.

Lisa Hatfield:

Thank you. So before we dive into today’s discussion, please take a moment to download the program resource guide using the QR code. This guide contains pertinent information to guide you both before and after the program. And this program will provide you with a comprehensive update on the latest myeloma news and its implications for you and your family. Following that, we’ll launch into some questions that we have received from you.

So let’s start here. Dr. Ailawadhi, at this juncture in myeloma history, we are witnessing unprecedented activity, a surge of new treatment options, and a wealth of insights. Today, we are privileged to have your expertise to help us decipher these developments and shed light on the advancements shaping the landscape of myeloma care. First, we’re going to get a high-level update from Dr. Ailawadhi on what the latest myeloma news means for you and your family. And then we’re going to talk about some questions that you’ve sent in. So let’s get started with the high-level update, Dr. Ailawadhi. Can you speak to the latest news and priorities in the rapidly expanding myeloma treatment landscape?

Dr. Sikander Ailawadhi:

Excellent. I think, Lisa, that’s an excellent and important question. Because as you rightly mentioned, there is such a large amount of data that is coming through for myeloma all the time. I mean, it’s almost, we kind of talk about the fact that every time you turn your shoulder or look over your shoulder, there is a new drug approved. So I can imagine this can be very overwhelming. So what I’ll say is that in my opinion, there are some categories of new data that are pertinent and important for our patients. 

The two or three out of them that come to my mind, one is what’s called CELMoDs, or there are a couple of agents there called iberdomide, mezigdomide. These are showing some interesting data. Important to keep in mind that they are somewhat related to the immunomodulatory drugs lenalidomide (Revlimid), pomalidomide (Pomalyst), but they’re showing benefit in patients who have had len and pom before and have progressed. So exciting stuff there.

We’re also seeing some interesting data about newer CAR Ts and bispecific antibodies. They are all coming up with some benefits in some cases. I think it’s important to keep in mind that the bispecifics are landing at the 60 to 70 percent response rate, and CAR Ts are typically landing at the 80 to 90 percent response rate, but there are more agents expected.

There are also some newer bispecifics in different classes, like one of them is called cevostamab, which is an FcRH5 inhibitor or targeting bispecific. So newer bispecific, not just more of the same category. And there has also been recent data about Bcl-2 inhibitors, which have been traditionally used for patients with translocation 11;14.

There have been some negative data, negative as in trials, which did not pan out with a drug called venetoclax (Venclexta), but there are two other drugs that had some recent data shown from different companies, which were exciting information. So in my mind, those are kind of the broad new drug categories. There is another, a couple of other quick things that I’ll mention.

One is we’re getting more and more information about real world experience with these new drugs. It’s good to see that CAR Ts are panning out very similar in the real world as they are in clinical trials. We’re also seeing that the side effect profile of a lot of these newer novel immunotherapy drugs is similar as seen in the clinical trials.

Racial ethnic disparities are something which are very close to my heart, and there is more and more information coming out in that. Unfortunately, highlighting the disparities more still rather than yet coming up with solutions. And I think the last thing that I feel which has been recent has been at the American Society of Hematology meeting in 2023, which was in December in San Diego.

One of the myeloma studies actually became a plenary session presentation, which is a pretty big deal for any disease area. So one thing is that it gets highlighted. Secondly, it was a combination of a regimen called isatuximab-irfc (Sarclisa) with carfilzomib (Kyprolis), lenalidomide, and dexamethasone (Decadron) in newly diagnosed patients.

It’s a randomized trial, Phase III, which was presented. I think the important part is we saw unprecedented deep responses and patients in much, much higher numbers than before becoming MRD-negative. So very deep responses. So these are kind of some very broad, but lots of highlights that I talked about.

Lisa Hatfield:  

All right. Thank you. So can you also talk about some of the newer tools for myeloma progression and relapse and what patients might want to know about that? And in particular, maybe talk a bit about MRD testing and the role of MRD testing for patients who relapse.

Dr. Sikander Ailawadhi:

Excellent question. Lisa, I think the first and foremost thing an important part for our patients to learn is what are their “tumor markers,” for the, or disease markers for myeloma. We can follow myeloma by either the M spike or monoclonal protein, by light chains, by monoclonal protein in the urine or blood. And it’s important to keep that in mind because every now and then we’ll see patients who say, Hey, my ratio changed. So I’m progressing. Well, that comes after the light chains change. So it’s important to understand the role of these things.

So M spike in the urine, M spike in the serum and light chains. One of them is typically the marker for a patient. Now the MRD status or minimal residual disease that is looking for one cell, one myeloma cell from amongst 100,000 cells in the bone marrow. So it is looking at a very deep level. The most important benefit of MRD testing right now is to understand that if a patient turns MRD negative, then they have a superior outcome. Their prognosis is better. Their progression free survival, or the time before their disease comes back is longer. 

But when a patient is MRD-negative and is being followed or maintenance or whatever, if the bone marrow turns MRD-positive, then that might be the sign that the disease might be coming back. Right now, we do not keep switching drugs to get to MRD-negative. That is not the goal of treatment. The way to think about it is we want to get to MRD-negative, but that means it’s incumbent upon us to try and pick a regimen that is more likely to get to MRD-negative. That’s the way to think about it.

Let’s pick a regimen more likely to get us into MRD-negative and hope that we get to MRD-negative. We see every now and then that the patients keep switching regimens just to get to MRD-negative. That’s not the way to go because you’re just using up options too quickly, too fast. A common question that patients ask is, well, does that mean I need to get annual bone marrow biopsies and MRD testing? Probably not.

That’s too much testing. So what I suggest is that once somebody has turned MRD-negative, it’s important to keep an eye on every single thing. Now, change in any of the routine labs, imaging, new symptoms, etcetera. That’s when we switch to the bone marrow again and see if the patient has turned MRD-positive. There are clinical trials going on right now which are stopping drugs based on repeat MRD negativity or starting drugs on MRD positivity. But those are clinical trial questions.

Lisa Hatfield:

Okay. Thank you for that. So along those same lines, since you’re a Mayo physician, I’m curious about the mass spec testing. So if a patient say has been MRD-negative for some time, still wants to monitor at a deeper level, even though it’s not commercialized yet, do you see a role for mass spec testing on a regular basis in the future and being rolled out to community facilities also?

Dr. Sikander Ailawadhi:

Absolutely, Lisa. I did not specifically bring it up because mass spec is not, like you rightly said, is not yet commercially available. Now we’re doing mass spec quite frequently at Mayo Clinic. Basically mass spec is taking up a blood sample. Important to keep in mind, it’s not a bone marrow test, it’s a blood test, but it looks for those abnormal proteins based on the protein weight at a much, much lower level. Our SPEP or serum protein electrophoresis does not pick up very small quantities of the protein mass spec does. So in an essence, the mass spec, if somebody is negative on that, turning mass spec negative to mass spec positive may be an earlier sign of the disease coming back rather than the SPEP yet turning positive. But as you rightly said, it is not yet commercially available. I do see the benefit of it.

There is more and more data coming in favor of it, and there was data that was also at ASH. So I do see that in the future we’ll be able to most likely have it available more widely. At this point, it is just a blood test to attempt to check the disease level at a much deeper level and be able to notice if the disease is progressing sooner than our currently available tools.

Lisa Hatfield:

Great. Thank you. And as a patient, I like to have one more data point that they can get from my blood, not from my bone marrow to assess the disease. So thank you for explaining that. Regarding survivorship, patients are living longer with myeloma in general because of the novel therapies that have come out in the past few years. So how is myeloma survivorship evolving, and what’s different now than it was five or 10 years ago in terms of treatment planning?

Dr. Sikander Ailawadhi:

Yeah, I think it’s very important to keep that in mind. When I see a newly diagnosed patient, I’m not just telling them, “Hey, this is your induction therapy, and your transplant is the goal.’ We’re trying our best to decide that patient’s life journey with myeloma over the next 10, 15 and hopefully more years. So we’re trying to pick and choose the regimen that is most likely going to help the patient the most today and most likely will give a longer duration of the response. So when you say survivorship, that also very importantly brings up the point that patients are living with myeloma longer. We have to manage their health overall. So looking for any side effects from treatment, managing them very well so the patient is able to stay on the treatment and maintain good quality of life.

There are actually, are clinical trials looking at stopping treatment when there is a very deep, prolonged response. Again, going towards survivorship and giving the patient’s quality of life. There is looking for other cancers. In fact, I had a patient in the clinic and we were talking about just myeloma in general and I was telling them, “Okay, please remember you may not want to do a colonoscopy, but you already have one myeloma cancer diagnosis. The risk of subsequent cancers is always there in any cancer patient.” So that was a male person. So I said, “Okay, please do not miss your colonoscopy. Please do not miss your prostate screening and whatever is age-appropriate must be done.” So managing everything because myeloma is not a sprint, it’s a marathon.

We want to make sure that we pace ourselves well so we manage all the symptoms, all the signs. Bone health becomes much, much more important because the same bone structure is now going to carry us longer and many more years. And as you rightly said, planning, which treatment comes first, which comes next, when does CAR T come? It’s not that everybody must get CAR T today. That’s not the answer. So what to use when becomes extremely more important.

Lisa Hatfield:

Thank you for that. And thank you, Dr. Ailawadhi, for that important reminder. All of you watching, get your regular screenings, like he said, prostate cancer, mammograms, colonoscopies, get it done. So thank you for that.

One of the things that comes up with that regular, not regular screening, but monitoring after certain therapies for future malignancies, there’s been some discussions about post-CAR T, particularly with T-cell malignancies and monitoring for that. Can you just give a little description of that and any concerns that you have with that or any encouragement you have regarding that and whether that weighs into your treatment options that you give to patients when they are asking about CAR T therapy?

Dr. Sikander Ailawadhi:

Absolutely. Extremely important question, Lisa. This really had a lot of discussion going on. It’s been going on for the past few months now. Okay. So first let’s explain the landscape. The FDA reviewed CAR T-cell treatment because of the fact that there were about 19 T-cell malignancies noted in several thousand patients.

Out of those 19 cases of T-cell malignancies, there was one case of multiple myeloma to the best of my knowledge. Now, risk of subsequent cancers is something, unfortunately, every cancer patient lives with, but in myeloma, we have known about that, especially from our historical knowledge of second malignancies with lenalidomide-based maintenance therapy post-transplant. So subsequent malignancies have always been a risk. There is some risk that is being talked about with CAR T, but frankly speaking, the way I look at it, the risk is significantly lesser than the potential benefit.

Because remember when these CAR T therapies, the two agents got approved in myeloma, they were approved in a situation that there was no standard therapy. And we saw somewhere about 70, 75 percent response rate with one of them and about 98 percent response rate with the other one. So in a setting where there was nothing, you can see the degree of benefit. And the risk of second malignancies is relatively small. So we must discuss this.

A patient must be aware of it, but I think the benefit is way more than the risk. So we document, we discuss, we have specific documentation that we do and specific information that we share with patients, but I think still the benefit is significantly more than the risk.

Lisa Hatfield:

Great. Thank you so much for explaining that. And for any of you out there watching this, Dr. Ailawadhi is a myeloma specialist, and I highly encourage anybody who is looking at CAR T therapy or even for a first consult for myeloma, seek out even one consult from a myeloma specialist. It is so important in trying to understand these therapies and any fears you may have regarding those therapies and the risks of that. So really appreciate that, Dr. Ailawadhi. Thank you. So I think it’s time now to start answering questions from patients that we received from all of you in the audience.

Please remember, this is not a substitute for medical care. Always consult with your medical team. And we are going to jump right in, Dr. Ailawadhi. We have a lot of questions from patients here and I’ll just start with the first one. This patient is asking, my M spike keeps rising in spite of chemo. What can I do?

Dr. Sikander Ailawadhi:

Very important question, Lisa. Every patient must understand what their disease marker is. This patient is asking about the M spike, which is the monoclonal spike, whether it’s in the blood or in the urine. And if the M spike is continuing to increase and there is a significant increase, significant is defined by at least 25 percent from the nadir or from the bottom most point with the, at least a absolute increase of 0.5 gram per deciliter. So half a gram per deciliter. So we want a 25 percent increase, but we also want at least 0.5 gram per deciliter.

So if somebody had an M spike of one at their best point, then the increase to 1.5 is significant. If somebody had the M spike of 0.2, then it’s not the 25 percent increase, it’s the 0.5 that must happen. So they hit 0.7 and that’s a significant increase. So that’s how we think about M spike, 25 percent with an absolute of at least 0.5 gram per deciliter.

If that is indeed happening, this would be considered a biochemical progression. And at that point, it should be considered to switch around the treatment because we don’t want the disease to grow to the point that there are actually symptoms showing up or organ damage happening. We want to be able to capture the disease progression sooner and act upon it.

Lisa Hatfield:

Great, thank you. Do you have any recommendations for people who, as we might have some patients watching this, who are light chain only? Any guidelines on if those numbers are rising?

Dr. Sikander Ailawadhi:

That’s an excellent question too. So if somebody has light chains as their marker, we are looking at an increase in the involved serum free light chain. So if somebody has kappa as their marker, the kappa is going up, or if they have lambda as the marker, the lambda is going up. Typically, if both of them go up, that is not disease progression. That could be coming from kidney dysfunction. Somebody is dehydrated and they get labs checked. Both kappa and lambda might be elevated. Again, a 25 percent increase in the absolute. But at the same time, we are also looking at at least 10 milligram per deciliter change.

So if somebody had a light chain of two milligram per deciliter, if it goes to 12, that might be a significant change. But I can say that light chains are a little bit more volatile and they do get affected by our fluid status. So if I ever notice a patient with a light chain increase, I’m more likely to repeat the test very soon, maybe even at a couple of days, one week interval, just to make sure that there is a trend rather than just a fluctuating light chain.

Lisa Hatfield:

Okay. Thank you for that information.

Dr. Sikander Ailawadhi:

And I should maybe, very quickly add, we do not check light chains in the urine. Light chains should be checked in the blood. Urine light chains are very nonspecific and there’s no need to test them.

Lisa Hatfield:

Okay. That’s helpful also. So patients don’t have to walk around with their big orange jugs full of fluids. So thank you. All right. This might be a complicated question to answer. But in general terms, for those who relapse for the first time, what are the best treatment options?

Dr. Sikander Ailawadhi:

I think that’s a very important, and I can imagine a scary situation. So somebody who relapses in general, not just even the first time, the factors that are taken into account for deciding what treatment they should get, there are broadly three categories of factors. Patient factors deciding what’s the age, what’s the other comorbidities, are they diabetic, are they heart disease, kidney dysfunction, because those things go into the decision of what may or may not be given. So patient factors.

Also importantly, how close are you to your treatment center? Can you come in for infusion or injection drugs time? And again, can you prefer or do you prefer oral drugs only? Et cetera. Those things become important. Then that…so that’s patient factors and disease factors. How fast is the progression? Is it high-risk disease, standard risk disease? Is it biochemical progression like the previous person asked?

Or is it actually a clinical progression in which there’s kidney dysfunction or anemia or bone disease? Because the choices and the urgency of treatment may change. So patient factors, disease factors, and then drug factors are the third class or third category, which is what have you had before? How long have you been on it? Are you on maintenance or not? Is your disease considered refractory to a certain agent, meaning resistant to a certain agent? Typically, if you were on a treatment and your disease is progressing, that same drug may not be used again.

And there are some times that we will reuse a drug, but generally not. We can use the same class, but we may not typically use the same drug. So I think the choice of treatment depends on all of those factors put in. And then we come up with one or two or three regimens and we discuss them with patients. And, of course, being an academic, physician, I must say there is always, you must always seek out good clinical trials if they’re available to you. That is the way our field moves forward.

Lisa Hatfield:

Yes, thank you for that information. So we have another patient asking, “Do myeloma patients require multiple prior therapies prior to being eligible for CAR T?” And what’s the rationale for not implementing CAR T immediately, which probably has to do with FDA approval based on clinical trials at this point?

Dr. Sikander Ailawadhi:

Absolutely. You’re absolutely right, Lisa. So any drug, let alone CAR T, any drug can only be given in the situation that it is approved by the FDA. So basically in accordance with that drug’s FDA approval label. Currently, CAR T-cell therapy is approved in the U.S. after at least four prior lines of therapy. And the patient must have had treatment with at least one proteasome inhibitor,  for which we have three drugs, bortezomib (Velcade), ixazomib (Ninlaro), and carfilzomib. They must have been treated with at least one prior immunomodulatory drug; lenalidomide, thalidomide (Thalomid), pomalidomide. And they must have been previously treated by at least one monoclonal antibody, daratumumab (Darzalex) or Isatuximab (Sarclisa).

Once the patient has had all these criteria met, they’ve become a candidate for CAR T-cell therapy. Frankly, we cannot just use a drug anywhere because we cannot use a drug where it has not shown to be of benefit. And importantly, it has not shown to be of any risk. So CAR T-cell therapy in the first line setting is being studied in clinical trials, but is not FDA-approved. Currently approved only after four prior lines, but the FDA is reviewing data for both the CAR T’s to see if they may be available sooner. As of right now, that approval is still pending.

Lisa Hatfield:

Okay, thank you. We’re hopeful that that will happen soon.

Dr. Sikander Ailawadhi:

Hopeful.

Lisa Hatfield:

Yeah. So interesting question from a patient, “Does CAR-T therapy actually change one’s DNA?”

Dr. Sikander Ailawadhi:

No. The CAR T therapy does not change one’s DNA. What happens is, there are T cells taken out of a patient. The DNA of those T cells is modified and then those T cells are given back to the patient. Those T cells do not go and integrate into your other healthy body cells or your stem cells, et cetera. Those T cells, it’s almost like giving a boost of immunity, which is targeted against your myeloma. So those T cells go in and they fill those myeloma cells. Now we hope that those T cells perpetuate and teach or create some memory T cells and that immunity lasts a little bit longer. But all of that genetic modification stays within the T cells. It does not integrate anywhere else.

Now, I know there was a previous question about T-cell lymphomas, that is related to this question in a way because the risk that is theoretical is, that that genetic modification in the T cells might make those T cells replicate uncontrollably leading to a T-cell cancer or T-cell lymphoma. But I’m saying that this is theoretical because while it is possible, it happens extremely rarely and even in the cases where the cancer happened, it has been seen that the cancer may not come from that portion of the DNA that was…that’s where the modification was done. So, low risk.

Lisa Hatfield:

Okay. Thank you very much for that.

Lisa Hatfield:

Okay. So what would be the next steps, Dr. Ailawadhi for a patient who’s had CAR T and reaches a relapse state or is relapsed?

Dr. Sikander Ailawadhi:

Yep. This is something, unfortunately is the truth of the matter in myeloma at least that we are, we don’t seek cures. We have had some long remissions. I have, for example, patients who are now reaching three, three-and-a-half years of remission on CAR T treatment who received it on clinical trials even before they got FDA-approved.

But, unfortunately, the disease does come back. So what happens is, we are seeing data that the novel, other novel immunotherapies like bispecific antibodies, even the ones who go after the same target as CAR T, BCMA targeting bispecifics, they do have some response rates, good response rates in post CAR T setting. So the bispecific antibodies by themselves may give us 60 to 65 percent response, but in the post CAR T setting, that response might go down to 40, 45 percent. So less responses, but still possible.

There are also bispecific antibody. There is one available, which is not against BCMA, it is against GPRC5D. That’s a bispecific called talquetamab-tgvs (Talvey). So a novel target. There is…there are of course a lot of clinical trials. There are some clinical trials that are even looking at CAR T post-CAR T. So different kind of a CAR T. Those clinical trials are going out. So what I would suggest is that if your disease progresses after CAR T-cell treatment, you should very strongly consider getting to a specialist myeloma center and get an opinion like you mentioned, Lisa.

That is so important because the choice of treatment is extremely important at that time. And we are trying our best to sequence all the options we have, in a way, actually one of my patients mentioned, one of these days, Hey, does that mean that I’m basically buying time till something new and exciting comes along? And I said in a way that is true. That we are trying to stretch all our treatments and get to the point that something new and promising just like CAR T comes, and hopefully we get longer benefits again.

Lisa Hatfield:

Thank you for that. So when you say there’s a possibility of CAR T and then a post-CAR T maybe a second CAR T. Would that be a different target then?

Dr. Sikander Ailawadhi:

So there could be a different target. I have, in fact, just yesterday I saw a patient who had received one CAR T in a clinical trial and then they were subsequently able to receive a CAR T standard of care, which had been FDA approved. So they used different CAR Ts, but one was in clinical trials and one was standard of care.

Lisa Hatfield:

Oh, great. Okay. Again, important to see a myeloma specialist to tease out all this information. Thank you. All right. This patient is asking, “I’m 81 and living with comorbidities. The myeloma was diagnosed after bone marrow test. How is treatment fitness determined?” And also a question about that is if you’re given an ECOG status of something you don’t like it, can that be improved after you’ve had treatment?

Dr. Sikander Ailawadhi:

Absolutely.

Lisa Hatfield:

Maybe be eligible for a trial or something.

Dr. Sikander Ailawadhi:

Correct. Correct. That is so important. When this patient mentioned that they’re 81-year-old and they’re living with comorbidities, I think, so when I’m talking to a patient who’s new to me, it’s very important for me to try to tease out what was their performance status or their fitness status prior to myeloma. Because my goal is to try to get them as close to that as possible. Now if this patient is saying that they were already quite frail before the diagnosis of myeloma and myeloma is added to the frailty, then it becomes a little tricky because we’re starting in a difficult spot. We do determine fitness by asking questions, simple questions like, what can a patient do at baseline? Can they do grocery store or grocery shopping by themselves? Can they walk around the block? Do they get short of breath? Et cetera.

And frankly, there are 81-year-olds who are playing golf every day and are fitter than me. So I’m just saying that age by itself is not the criteria. And, Lisa, like you rightly mentioned, if there are fitness issues coming from the disease itself, then that’s the time that we actually have to work with the treatment, get the treatment started, and then assess the fitness a couple of months later, a couple of cycles later. Because the treatment may have worked and may have improved the fitness quite a bit.

Lisa Hatfield:

Great thank you for that. So this person is asking, their husband is starting maintenance therapy, so I am assuming they just finished induction therapy, having leg pains mostly at night. Could this be a form of peripheral neuropathy or is maybe from bisphosphonates or from any of the medications that maybe were used during induction?

Dr. Sikander Ailawadhi:

So, excellent question. So, this is almost going back to that survivorship question that we discussed earlier, that it’s so important to manage the side effects and maintain quality of life. So, a lot of patients with myeloma will say that I have cramping or symptoms or some pins and needles at night more so. Part of it is because body’s at rest, relaxed, things, symptoms become more focused. Yes, it could be peripheral neuropathy, but at the same time certain drugs caused muscle cramping or what’s called myalgias, sometimes maintenance therapies can cause that.

It’s important for somebody to be able to determine is it coming from muscles or nerves? Is it coming because some electrolytes are abnormal. Like one of the common things is low magnesium or low potassium can cause neuropathy, for example, or cramping. I’ve had patients who will get some over-the-counter lotions or some forms et cetera, which are infused with some electrolytes and say that they feel some benefit. So topical things are good. So I think it’s important to figure out is it muscle or nerve and is it coming from drugs or disease? And that’s where your physician can help tease it out.

Lisa Hatfield:

Okay, thank you. So we have a patient who is talking about her genetic abnormalities, but has been through both auto and allo stem cell transplant in the last two years and has relapsed. And is asking, “Can CAR T-cell therapy help me?” And would she even be eligible for CAR T therapy given the allotransplant?

Dr. Sikander Ailawadhi:

That’s an important question. So first of all, sorry to hear that, that your disease is behaving that aggressively, that you’ve had both the transplants in the past two years and still having issues. So yes, CAR T can still be used after an allotransplant. There are some criteria. You should not be on any graft versus host suppressive medications, and you should not have any active graft versus host disease going on. So depending on those, yes patients can get CAR T post. And, in fact, I’ve had a couple of patients who’ve had CAR T after allotransplant.

Lisa Hatfield:

Great, thank you. I’m sure that’ll give this patient some hope. Are there any studies showing that treatment can be tapered? Tapered to by daily, once 90 percent reduction in myeloma has occurred with various therapies. So in general, you may know what medication this patient’s talking about, but is that possible to do that, to taper therapy?

Dr. Sikander Ailawadhi:

So, absolutely, first of all, in myeloma care, Lisa, you had mentioned initially that as somebody went to maintenance, they have had induction. So there are these terms used for categories of treatment, induction, consolidation, maintenance. But if the disease gets controlled adequately at a certain time point, the treatment can be modified to a maintenance. It depends on the regimen.

Some regimens, for example, we are able to get rid of the steroids after a certain time and then in certain regimens the drugs can be reduced in dose or frequency, et cetera. All of the drugs we use have maintenance regimens and maintenance doses. But I should put a word of caution there. I see very frequently that the moment the labs improve, this quote unquote “maintenance” is brought in.

That’s not the right way to do things. The right way is to go back to the clinical trial based on which this regimen was started. And according to that clinical trial, after however many cycles of treatment the maintenance was supposed to happen, it should happen. So if I’ll very quickly say if somebody stays, starts on a regimen and within four months their M spike comes down, and now it has plateaued. Because our drugs are so good that they work that fast. And somebody says, “Okay, four months of that is enough, let’s save it for the future. Let’s go to maintenance.” I would say, “Absolutely not.”

In fact, there is data suggested from a couple of regimens that if significant modifications were made prior to one year of the regimen, then the outcomes were inferior. And I’m not going in specific regimens and I’m not saying that that is applicable to everything, but what I’m saying is, yes, maintenance and tapering is possible. In fact, there are clinical trials looking at even stopping medication. But when and how that change is to be made is very very important. It’s critical. If your physician is not comfortable about that time point, reach out to a myeloma specialist. They should be able to guide when and how to reduce or taper or put on maintenance.

Lisa Hatfield:

Thank you. And that’s very important what you said about induction therapy. Go back to the clinical trial and look and see what the clinical trial said as far as how long that treatment should last because it is exciting as a patient when you start seeing those numbers dropping exponentially. They’re just plummeting, and you want to go off it, you don’t feel great. It’s hard to stay on a therapy for 6 to 12 months that you don’t really enjoy and nobody really does. So that’s important. And then maybe talk about maintenance therapy later. It would be nice to have limited duration maintenance, sometime in the future for induction therapy. Stick with what the clinical trial says. So, okay, this patient is asking another really important question, “I have myeloma and now my daughter does as well. She’s 37, is multiple myeloma hereditary?”

Dr. Sikander Ailawadhi:

I’m sorry to hear about this situation and I’m so sorry that your daughter who’s 37 got diagnosed. There is a small, very small number of very young patients and I’m saying using this term very young, which is just a generic thing that I’ve said because myeloma median age of diagnosis 68. I saw a patient who was diagnosed at 33 and they’re 40 now and they’ve already gone through every single thing that they can think of. And we were talking about clinical trials. So, typically myeloma is not hereditary. It is not something that is passed along through the generations. But what I would say is that there is, if this sort of a situation is happening that you have myeloma and now your daughter has it at a young age, it is important for you to consider getting genetic counseling.

So a genetic counsel for them to be able to look deeper into it. There is not a very standard specific test, so for me to say, Hey, you go and get this genetic test done and that’ll find out this mutation, whatever. But it’s important to get, go through some genetic counseling for them to be able to look a little bit deeper, some next-generation sequencing, what is called germline testing or somatic testing. They should be able to compare both the parent and the daughter’s disease as well as what’s called germline, which is their native DNA, which they were born with, to see if there is anything that jumps out of that. But that would be important to go through at a larger cancer center or if that service is available through your local physician also. That would be great.

Lisa Hatfield:

Great, thank you. Well, I think that’s it for our questions. That’s all that we have time for. But Dr. Ailawadhi, thank you so much for once again, being part of our Patient Empowerment Network START HERE Program. Because it really is these kinds of conversations that help patients, me included, feel more empowered to take questions back to our providers and our healthcare team. So thank you so much for joining us and thank you out there to everybody who’s watching this program, we appreciate you and we appreciate your time and expertise.

Dr. Sikander Ailawadhi:

Thanks and I look forward to the next time.

Lisa Hatfield:

Thank you. I’m Lisa Hatfield. Thank you for joining this Patient Empowerment Network Program and we look forward to seeing you again soon.


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Dr. Vinicius Ernani: Why Is It Important for You to Empower Patients?

Dr. Vinicius Ernani: Why Is It Important for You to Empower Patients? from Patient Empowerment Network on Vimeo.

Why is it vital for small cell lung cancer patients  to be empowered by cancer experts? Expert Dr. Vinicius Ernani from the Mayo Clinic discusses the power of giving patients hope and the importance of clinical trials.

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Transcript:

Dr. Vinicius Ernani:

So I think it’s always important to give the patient hope. It doesn’t matter how aggressive the disease is. I think the patients, they need to have hope to go home and continue moving with their lives. So again, small cell, it’s an aggressive disease, yes, but it responds very well to treatment. And now, we know that immunotherapy is there, it improves survival. We know that about 10 percent, 12 percent of the…50 percent of the patients are alive at one year after they start treatment. If you look at two years, there’s about 20 percent of the patients are alive. And if we look at five years, there’s about 10 percent of the patients that are alive with small cell. So we are seeing some progress with immunotherapy.

And again, I encourage, this is a disease that responds very quickly. It’s going to make you feel better very soon. I think that any patient with extensive stage small cell lung cancer deserves to be treated. And again, there’s more clinical trials coming with the immunotherapy, with the antibody drug conjugates. So hopefully, we’re going to continue to move the needle in small cell lung cancer.

Small Cell Lung Cancer Clinical Trials and DeLLphi Study Update

Small Cell Lung Cancer Clinical Trials and DeLLphi Study Update from Patient Empowerment Network on Vimeo.

What value might small cell lung cancer (SCLC) clinical trial participation and the DeLLphi study offer patients? Expert Dr. Vinicius Ernani from the Mayo Clinic explains the significance of clinical trial participation and what is being studied in the DeLLphi trial for SCLC care.

[ACT]IVATION TIP

“…always ask your team about clinical trials. And again, I recommend patients, if it’s a reasonable clinical trial, I will always recommend my patients to be enrolled in it.”

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Advice for Small Cell Lung Cancer Patients Considering Clinical Trials 


Transcript:

Lisa Hatfield:

Dr. Ernani, can you speak to the importance of expression of DLL3, what it is and what it means for small cell lung cancer research, and why is clinical trial participation so important in small cell lung cancer? And what advice do you have for patients who are considering a clinical trial?

Dr. Vinicius Ernani:

Yeah, so DLL3 is a protein expressed on the cancer cell of the majority of those patients with small cell lung cancer. And that’s where, exactly where tarlatamab, which is, it’s the BiTE, the T-cell engager that I mentioned before, that’s one of the targets. So the tarlatamab, it binds to the DLL3 on the surface of the cancer cell, and also bind to the CD3 at the T cell, right?

So that activation, the tarlatamab does that bridge and that activation enhances or activates the T cells to go there and fight the cancer. What we’ve seen in DeLLphi study with the tarlatamab is that the responses are irrespective of the DLL3 expression. But that being said, again, is the target of tarlatamab. And so it, again, it binds to the DLL3 the cancer cell, and it binds to the CD3 on the T cell.

And that activation enhances the T cell to fight against the cancer. Why is clinical trial participation so important in small cell? Well, I think I encourage all my patients to participate in clinical trials because some of the treatments that you can only get in clinical trials today, they might become the standard of care tomorrow.

Let’s say patients on immunotherapy five years ago, there are still some patients that are on trial, they’re still getting immunotherapy. And now, basically every disease you can treat the patients with immunotherapy. So you never know. The trial that you are enrolled in today might be the new standard of care tomorrow, and you might be having this chance to get it very early in the course of your disease.

So my activation tip for this question is, always ask your team about clinical trials. And again, I recommend patients, if it’s a reasonable clinical trial, I will always recommend my patients to be enrolled in it.


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Understanding Small Cell Lung Cancer Research News and Future Treatments

Understanding Small Cell Lung Cancer Research News and Future Treatments from Patient Empowerment Network on Vimeo.

What do small cell lung cancer (SCLC) treatment and the future of treatment look like? Expert Dr. Vinicius Ernani from the Mayo Clinic discusses SCLC treatment progress and small cell lung cancer clinical trials including the DeLLphi trial.

[ACT]IVATION TIP

I think stay tuned. This tarlatamab might become, down the road, a new standard of care for our patients.”

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Woman doctor speaking with woman patient.

Advice for Small Cell Lung Cancer Patients Considering Clinical Trials 


Transcript:

Lisa Hatfield:

And, Dr. Ernani, can you please explain research advancements in immuno-oncology and what this means for extensive-stage small cell lung cancer patients? And how do you envision the treatment landscape evolving over the next five to 10 years? 

Dr. Vinicius Ernani:

Yes. So over the last 30 years, we’ve had multiple Phase II, Phase III trials and, unfortunately, we were not able to move the needle in small cell lung cancer. However, over the last few years with the advancement of immunotherapy and incorporating immunotherapy to the standard carboplatin (Paraplatin) and etoposide (Toposar), we were able to finally make some progress in small cell lung cancer.

So now we know that the standard of care is to give chemotherapy plus immunotherapy, and we have at least three to four randomized Phase III trials showing the benefit of adding immunotherapy to chemotherapy. And I think this is a very exciting time for small cell. We are seeing at least over the last couple of meetings, over the last year, I’ve been seeing at least two promising drugs.

 One is tarlatamab that was the Phase II studies called the DeLLphi trial, was recently presented at ESMO. And there’s also an antibody drug conjugate that has also been very promising in small cell. So we’ll see how these studies are going to play out, especially the antibody drug conjugate, that’s still a Phase I study. So it’s a little bit early, but encouraging response rates. And the tarlatamab, which is a BiTE, and what I mean by BiTE, is a bi T-cell specific engager. I think it’s probably going to be soon approved by the FDA, and I think it’s going to change the standard of care in small cell again.

 Lisa Hatfield:

Dr. Ernani, with regard to the DeLLphi trial, can you explain who that is for and more specifically maybe what the hope is for patients and their families?

Dr. Vinicius Ernani:

Yeah. So the DeLLphi trial was a Phase II study. So usually we have three types of study, right? First, we have the Phase I study. Phase I studies are usually looking at how safe is a drug, but we are not looking too much of how active the drug is. We’re just making sure that the drug is safe to give to the patients. A Phase II study is a little bit bigger than a Phase I, and we are looking still at safety, if the treatment is safe, but we are trying to look a little bit more careful and how active this drug is.

In Phase III, those are usually big studies that randomizes 200, 300, 400 patients to the standard of care compared to the new drug. And that’s usually where we get the FDA approvals. So the DeLLphi-301 trial was a Phase II study that enrolled patients with heavily pretreated small cell lung cancer, extensive stage small cell lung cancer, to receive tarlatamab.

 And they had two doses. It was 10 milligrams and 100 milligrams. And it seems that the 10 milligram cohort, that actually the responses were even better than the 100 milligrams. So we saw the presentation at ESMO, it was actually published in one of the most respected…probably the most respected journal of medicine, the New England Journal of Medicine, and there was a response rate of 40 percent. So if we could give tarlatamab for patients that fail at least two lines of treatment, the chances of them responding to tarlatamab is about 40 percent.

And more importantly, I think that the duration of response was greater than six months. So what I mean by that, more than 50 percent of the patients that received this drug, they controlled the cancer for at least six months. So I think that’s a very positive about this drug.

Lisa Hatfield:

Great, thank you. And then one follow-up question I have about that. So if a patient were to come to you or go to their local oncologist and say, I’m really interested, I heard about this DeLLphi trial or any clinical trial, what is the advice you would give to that patient on how to access that clinical trial?

Dr. Vinicius Ernani:

Well, unfortunately, we don’t have at our institution, what I usually help my patients,  I go to clinicaltrials.gov and I type their cancer, and I go over with them on where the trials are open, and we try to find a facility or a cancer center that is close to where they live. So that’s what I usually do when I’m trying to find a clinical trial that I don’t have available in my site.

My activation tip for this question is, again, I think stay tuned. This tarlatamab might become, down the road, a new standard of care for our patients.


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Starting Time-Sensitive Small Cell Lung Cancer Treatment

Starting Time-Sensitive Small Cell Lung Cancer Treatment from Patient Empowerment Network on Vimeo.

Some small cell lung cancer (SCLC) treatment calls for time-sensitive treatment. Expert Dr. Vinicius Ernani from the Mayo Clinic shares how he works with patients who will most likely have optimal results with prompt treatment and advice for patients considering rapid treatment.

[ACT]IVATION TIP

“…at least give the treatment a try. I think that you’re going to be positively surprised that you’re going to feel better within a few weeks.”

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Transcript:

Lisa Hatfield:

Dr. Ernani, for some small cell lung cancer patients, understanding treatment options is crucial and sometimes requires swift decisions. How do you work with your patients and families to make treatment decisions that might have to be made rather rapidly? 

Dr. Vinicius Ernani:

Well, small cell, as we know, it’s an aggressive type of cancer, it divides very quickly. And because of that the patients usually, they tend to be symptomatic, so they have a lot of symptoms at the time that we see them. And if this disease, if we left untreated and the patient has extensive stage, so the disease has spread, the prognosis can be poor.

That being said, because small cell divides very quickly, chemotherapy combined with immunotherapy can help these patients fairly quickly. We can see patients in a matter of two to three weeks, they report that their shortness of breath is much better, they’re feeling better, they’re more energetic, they can do more things at home.

So we can see a rapid positive response to treatment very quickly. So when I explain this to my patients, most of the patients, they have no hesitation to say, yeah, I want to proceed with chemotherapy. And I tell them chemotherapy will help you feel better and also help you survive longer. And we are very fortunate that sometimes the patients are able to live years, they’re able to meet some live, let’s say, like a wedding of a grandkid or important events in their life. So I always recommend them to at least give it a shot.

My activation tip for this question is at least give the treatment a try. I think that you’re going to be positively surprised that you’re going to feel better within a few weeks.


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MPN Specialized Care and Technology: The Ongoing Role of Telemedicine

MPN Specialized Care and Technology: The Ongoing Role of Telemedicine from Patient Empowerment Network on Vimeo.

Why should MPN patients keep telemedicine in their toolbox post-COVID? How can patients and caregivers feel more confident in voicing concerns and communicating with their healthcare teams regarding telemedicine options? In this unique program, Drs. Jeanne Palmer and S. Joseph Sirintrapun discuss the impact of telemedicine on MPN care and technological tools accelerating the fight against cancer.

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Transcript:

Lisa Hatfield: 

Hello and welcome to this Patient Empowerment Network program. I’m your host, Lisa Hatfield. And in this unique program, we are going to explore cancer care and technology, specifically the importance of specialized care in myeloproliferative neoplasms and the ongoing role of telemedicine. And just to abbreviate myeloproliferative neoplasms going forward, I think we’ll just use the acronym MPNs, it’s a little bit easier to say. So today, I’m joined by two incredible experts. Dr. Jeanne Palmer is a respected hematologist oncologist, treating MPNs at Mayo Clinic. Dr. Palmer’s a Program Director for the Blood and Marrow Transplant Program. And, Dr. Palmer, it’s really a pleasure to connect with you today. Thanks for being here.

Dr. Palmer: 

Thank you for having me. I always enjoy coming to these presentations and being able to share some knowledge.

Lisa Hatfield:

Awesome, great. Well, thank you. We also have joining us, Dr. Joseph Sirintrapun, a noted clinical informatics expert from Memorial Sloan Kettering Cancer Center. And for some of our audience members, this term informatics may be unfamiliar or new to you. So briefly, informatics integrates the worlds of medicine and technology, and, Dr. Sirintrapun, it’s really nice to connect with you also. This is something that I’ve been wanting to learn more about anyway, the merging of medicine and technology. So it’ll be great to talk with you today. Thank you.

Dr. Sirintrapun:

Well, thank you for having me, I appreciate it.

Lisa Hatfield:

Thank you. We’re going to have a real-time look at telemedicine. I like to start with the current landscape and the ever-changing yet ongoing role of telemedicine. So starting with, Dr. Palmer, how does telemedicine work, and how does an MPN patient ask for or access telemedicine? How do you do that at your center?

Dr. Palmer:

So telemedicine has been a real…one of the blessings that’s come out of this whole COVID pandemic because it put fast-forward on the development of it and certainly has opened a lot of doors. I think one of the beneficial things of telemedicine is in a disease like MPNs, these are very rare diseases, and there are not a lot of specialists in the country. So depending on where you live, there may or may not be somebody who specializes in this disease focus. So by having telemedicine, you can have access to a provider who has a higher level of specialty in that specific disease. I think this is really important for any rare disease, just because of the difficulty in finding specialists. Many of them are in urban areas. And so if you live in a rural area or somewhere outside of that specific zone, it can be very difficult to come and see a specialist. Additionally, it can be very costly.

If you look at the cost of the airfare and the lodging and everything else, I think of people coming to Scottsdale can pay an enormous amount of money just to come for two nights and to be able to see me. So the fact that we can do this via telemedicine, they can get the information, receive the education about the disease and help for maybe their local provider and managing it can make a huge difference in the quality of care.

Lisa Hatfield:

Great. Well, thank you. So from a practical perspective and if you have a newly diagnosed MPN patient and they wanted to get specialized care or talk to an expert, would they just call…would they just look up online and find a phone number and try to call your clinic? Or how would they get access maybe as an expert opinion from you, via telemedicine?

Dr. Palmer:

So as of right now, the best way to access it is if you go on to the Mayo Clinic website, there’s actually a referral phone number where people can self-refer for a consultation. Now, the changing part of this, the changing part of this landscape is that right now we’re still in the public health emergency. So a lot of the barriers between seeing patients in different states based on…because I have a license in Arizona, I don’t have a license in another state. That’s going to become a bit more challenging because of the fact that if the physician…like, for example, myself, if there’s a patient who wants an opinion who lives in Nebraska, I don’t have a Nebraska license. So therefore it would be a lot more challenging, because I can’t actually do an initial consultation via telemedicine once the public health emergency ends.

I think this is a really important thing that needs to be worked on, probably on more of a legislative level of trying to change some of the rules and laws associated with this. And something that I know there’s a number of people working on, but as of right now, and I think…I don’t remember when the public health emergency will be ending, but during the public health emergency, it’s just been a matter of just calling in like you’d normally try to get a consult. However, that will change and hopefully, as more awareness of telemedicine and some of its benefits are really understood that some of these laws can change and some of these processes can change so that they can allow people to get access to care they otherwise wouldn’t be able to receive.

Lisa Hatfield:

Yes, I appreciate that, and I will be a fierce advocate out there trying to have those telemedicine benefits continue, because I do come from a more rural state, so I appreciate those.

Dr. Sirintrapun:

Can I jump in?

Lisa Hatfield:

Yes, please do. Yeah.

Dr. Sirintrapun:

To help answer some of the points that Jeanne had brought up. The American Telemedicine Association works very hard in terms of looking at the same problem about the state laws, being able to be licensed and have ways to overcome state barriers, and then another one about the public health emergency…and it is true, I’ve been hearing that it’s going to end some time in a couple of months, so that’s one thing to keep in mind as well, and they’re going to have to look in terms of what to do afterwards. Because there’s a lot of things that patients enjoy, providers enjoy that they’ll have to continue that technically go away, but we don’t necessarily want to see that go and so these are the things that we’ll have to keep in mind moving forward after the public health emergency ends.

Lisa Hatfield:

I appreciate that, and I think you’re right, and I think that telemedicine has had… It can have a detrimental impact on outcomes for patients too, and to remove that would be devastating for some patients like myself. All right, so Dr. Palmer, the COVID pandemic has resulted in significant changes to many aspects of daily living for all of us, but for patients like myself who are living with cancer, there are different realities that we have to deal with, so can you give a brief overview of the impact that COVID-19 has had on MPNs.

Dr. Palmer:

So I think the impact of COVID-19, I think we just spoke about some of the favorable things that telemedicine became a real reality, some of the detrimental things, enrolling in clinical trials has been very, very difficult because of the fact that, number one, the public health emergency, some patients weren’t able to travel. And then number two is, I think there has been sort of an exodus of people working in healthcare, I think healthcare has become extremely stressful because of all the pressures associated with the COVID pandemic. So having the appropriate staffing for clinical trials has been difficult, but one of the things that I think is coming out of this that I think will be really positive is there are a number of studies that are being looked at now that are actually creating ability to have some of the visits done by a telemedicine. So taking what’s not as critical to be seen in-person, and what labs we don’t need to necessarily get that need to go to a central processing area, but there are actually ways that we are working with home health care companies with different labs to be able to provide some of this ability to do telemedicine, especially on the clinical trials where there’s monthly visits.

I have had patients travel from multiple different areas of the country to be on clinical trials. I’m usually more in the Southwest or at least the West Coast, but I think that with some of these changes, it’s going to be a lot more of a reality for it. So I think some of the pressures of the COVID pandemic will…again, there will be sort of a silver lining of it, and that we may have this ability to do that, because even if I looked at…you look at the pre-COVID clinical trials, if there was a trial that needed monthly visits, which a great number of them do. I would say the majority of my studies that I have for patients with MPNs require monthly visits, at least the first six months. Being able to have that extended out is hugely important and will allow access for it, so if we can have a virtual visit, even every other visit, that can make a big difference in somebody’s ability to access new treatments.

Lisa Hatfield:

All right. Well, thank you again, the push for continued telemedicine benefits would be great. So another question for Dr. Palmer, is technology playing a role in accelerating progress in MPN care, not just the technology of telemedicine, but other technologies? And what role does technology play in symptom management and in clinical trials? You mentioned that you can maybe do telemedicine every other month, but what other roles does technology play?

Dr. Palmer:

So that’s a great question. I actually have been fortunate enough to work with an informaticist who will be joining our faculty this summer, and what we are trying to do is be able to utilize our electronic medical record and some of the forms and texts that you can use within it to be able to capture data and be able to understand it. From the standpoint of even my day-to-day practice, one of the things that’s very important in myeloproliferative diseases is capturing the symptoms score. And this is a way of measuring some of the symptoms that can be very bothersome and troublesome to patients with myeloproliferative diseases and has been validated and utilized throughout multiple studies and multiple settings. So I’m actually in the process of getting that built into our EMR here, so that before patients even come and see me, they can fill out that form of questions. And I think that the sky is the limit. There’s so many patient-reported outcomes and so many things that are going to be important to capture as we move forward. And a lot of times you can ask somebody, “How do you feel?” And they say, “Oh, I feel great.”

Because what else are they supposed to say? Social norm is to say everything’s fine, and then you start to ask them specific things like, “Are you having itching? Are you having fatigue?” And all of a sudden it comes out that they’re really not feeling that well. So this will be really important, and if you can have people do that beforehand, and I think that we can gain a lot of information that can really help utilize the small amount of time we have to focus it on the areas that need to be focused upon.

Lisa Hatfield:

That’s great to hear. Yeah.

Dr. Palmer:

Yeah, the other thing that I didn’t mention is that I think being able to do research. It will be very helpful if we can capture all the data about patients in a way that can be outsourced to a database and then analyzed versus having to hire people to extract information directly from the chart, which is a very laborious process and often not very accurate. So that’s one of the things that we’re working on here is to say,” How do I not only create this template for capturing information from the patient, but how do I make my clinical notes into something that can be harnessed for a database that can then be queried for different questions to try to understand the disease better?”

Lisa Hatfield:

Well, and that is a great segue into what we’re going to talk about with Dr. Sirintrapun. So, Dr. Sirintrapun, as far as informatics goes, can you give us the lay person or a patient-friendly version of what informatics is and what it means for cancer care?

Dr. Sirintrapun:

I really appreciate Dr. Palmer giving the segue for the informatic system. So this is…let me start with maybe when I explain to colleagues and other people about what informatics is. When you think of informatics, you think of three pillars, and we always..I almost have it down like a parrot. So it’s people, processes, and technology. And people always think it’s the technology, but it’s also people and processes, and that’s always been…whenever you see informatics, that’s the three pillars, but I wanted to add one more that Dr. Palmer also mentioned is data and information. You incorporate all those, so imagine all the four pillars coming together to enable the practice of medicine care and at a very high level, what I like to think of informatics is, it’s the science of bridging the gap, decreasing the chasm between the right caregiver to the patient who needs it. Because there are chasms everywhere, in terms of logistics, space, physicality, you have to travel five states to get help with a rare tumor.

Those are chasms there. And I see informatics as bringing all those different pillars together. How do we do it so that the chasm is decreased? Or if it’s not a chasm, decreasing the friction, decreasing the burden between making these things work, making things more efficient. So I think I was hearing a little bit earlier about how can we automate things? As Dr. Palmer mentioned before, data, data abstraction data, being able to pull data from these gigantic enormous resources, it’s tough. And it’s not like we can hire the entire high school student population on their summer internship to go and read through these notes. And there’s not enough money, there’s not enough knowledge. And we need to find different ways that we can use automation, AI, or other things like that to do it.

And this is where informatics kind of delves in. How do we apply all these different things so that people can use it, because you never can forget about people. It works in the processes that take place and it’s the right technology. Because sometimes technology, it’s a great technology, but it’s not ready for certain things. I see a lot of technology kind of ahead of its time. It’s basically a tool in search of a problem and people try to stick it somewhere where it doesn’t fit. So it’s a lot of that. And as you can tell, I’m pretty excited about it because that in a nutshell gives you a feel of what informatics is all about, so.

Lisa Hatfield:

Great. Well, thank you for that. So pre-pandemic…we were talking a bit with Dr. Palmer about telemedicine. Pre-pandemic, you and your colleagues explore the role of telemedicine in cancer care. Can you give a brief overview from your perspective, how telemedicine has evolved and continues to evolve and how you think it might evolve going forward? I guess that’s what evolve means, but. [laughter]

Dr. Sirintrapun:

Yeah, I think I like pulling out these old sayings and I think Winston Churchill was credited with it even though I don’t think he said it, but never let a good crisis go to waste. You probably heard that during COVID, and COVID really blew open the door for telemedicine. I think because we just had to, there was no choice behind that. And thankfully, people…organizations, people recognized it. And I remember in March, March 2020, the public health emergency was declared and a lot of different things that were barriers and a lot of them were regulatory. They were opened up so that it can enable reimbursements, all these different things that factor in. And being able to leverage the technologies, because keep in mind with providers, I knew providers that didn’t know how to use Zoom and other technologies. And because of COVID, they were forced and they found out, “Hey, it’s not that bad.” But if I were to do that before the pandemic, they’d be like, “Well, why should I? We’ll just show up in this conference room. We’ll just be there at six o’clock in the morning.”

So it opens people’s minds. And I think that really helped. I don’t think that Genie’s going back into the bottle, not at least completely. I think we’re going to figure different ways to leverage those technologies moving forward. So in terms of telemedicine moving forward, some of the things I’d like to see and hence I think this is maybe one of the reasons why I’m here, is like how do we enable clinical trials to embrace the telemedicine model? Because clinical trials till now historically has been kind of a physical model. You have to go to some ivory tower, some centralized place and that really limits down, the patients can do it. There’s access problems. Even if you had the richest study in the world, you had to fly people from all over the world. You can imagine that just drains the budget. There are just all these different things there. And when you think of the way clinical trials are conducted, it didn’t really take into account telemedicine visits.

At my institution Memorial Sloan Kettering, we developed an entire ecosystem of telemedicine tools to actually try to encompass the patient experience as close as we could. Because the experience, it can never be completely duplicated, but you can do certain things definitely through telemedicine. We tried to do our best to do it so it’s easier for patients, the nurse coordinators as well as the providers to use that. And clinical trials, they’re moving towards it. They’re acknowledging the issue and they’re rethinking the ways to do it. How can we enable it so that we can decrease the chasm between the patient and being able to enroll in a clinical trial? So in a nutshell, that’s the way things are going. We’re not there yet, but we’re definitely thinking about it. It’s definitely a discussion. I think the future will see a much more clinically- and a telemedicine-enabled clinical trial framework.

Lisa Hatfield:

That’s great to hear. For patients, I think that’s really, really encouraging to hear that we’re utilizing that technology. So in addition to the telemedicine technology, there are other types of technology that are influencing cancer care. Can you speak to some of those technologies? I know I’ve always been really interested in the CRISPR technology, which I don’t hear about as much anymore. Artificial intelligence, my oldest daughter is graduating from college this year. That’s what she’s studying. So can you touch on some of those technologies and how those are continuing to evolve also?

Dr. Sirintrapun:

Oh yeah, there’s a lot. So maybe as a disclaimer also, in addition to being an informaticist, I’m a pathologist. So it’s a great honor to speak in front of patients, because many patients may not necessarily know whenever you get a diagnosis, there’s a pathologist who made the diagnosis on a glass slide through a lab test. So that’s my path as a pathologist. So a lot of my technology mindset is in terms of diagnostic. So how do you make the diagnosis better? And you mentioned about…well, I mean, we’ll start with CRISPR. CRISPR is not necessarily in the diagnostic front, but it’s a very exciting thing, especially for those tumors that have genetics. One of the simple genetics. You misplace one gene here, and all of a sudden it just alters the way one protein goes, and it leads to a disease, a cancer. And if you’re able to surgically or genetically microsurgery, you can imagine the implications and the transformation for that.

We’re already looking at it with hereditary diseases like Huntington’s and some of the different blood disorders out there, which have like single genes or maybe a couple that you can just sort of pick out there. It’s still early. And that’s maybe the reason why you haven’t heard the technologies there that can do it. But how to deliver it, how to do the microsurgery. You can have the scalpel, but somebody has to hold the scalpel and how to do that in terms of what type of nanotechnology is out there, all these different things. But CRISPR is very exciting. I do expect over the next, definitely in the next couple of decades, you’ll see something, some brilliant application coming out of that.

Now you mentioned AI, that’s definitely down my wheelhouse because I implement a lot of…I see a lot of AI, and I try to figure out different ways to implement the AI into healthcare. Because there’s tons of AI out there, but the idea is to basically use the right AI at the right time with the right person using it and for the right problem. And there’s a lot of rights in there, and it sounds simple. But you have to keep in mind that in the AI world, we sort of separate AI into like general AI and narrow AI. General AI is kind of the, is what some people term the singularity. Like it knows everything. It can read your mind. You can switch the setting of whatever it is. It can write poetry in one setting, play the piano in another. There really is no such thing.

So if you hear ChatGPT, if you ask it to play the piano, it’s not quite applied for that. It’s really for language. And I try to illustrate that point because that…all these AI currently that’s out there is still in a narrow AI. It doesn’t do what a person does. As people, we can switch. We can task switch. We may not beat the robot, but we can certainly task, if the setting changes, we can adjust. And that’s the power with our intelligence. We’re generalized. While most AI is narrow, but very good. They can be…obviously, when IBM Watson beat everybody at Jeopardy, and now you hear ChatGPT beat people in passing the boards. So a lot of med students are going, oh my gosh. Keep in mind that it’s narrow. I mean, this is what the robot is really good at. They’re very good at facts. They’re good at other things. And you can use that. You can, but they’re not going to be able to task switch.

And they’re not going to be able to know when they need to deploy the right situation. Remember, they’re narrow. So they’re not going to know when you change a situation. It’s not going to know when to switch. That’s the job of a physician, maybe the patient. And it’s my job as kind of the engineer or an informaticist to figure out when those come in. When should it trigger at the right time? When to make sure that people don’t misuse it at the wrong time and deploy the right problem to the right AI. And so, for instance, as a pathologist, one of the big hottest things that we have right now is prostate biopsy. I deal with male cancer. So I deal a lot with prostate. But the AI is pretty good at actually even, I would argue, probably getting better at catching cancer in a small prostate biopsy than humans are. There are small things that maybe, for whatever reason, human factors being tired, the AI can actually catch it quicker.

It might overflag. It might catch things that are not necessarily cancer. But it will catch it. It will catch it. And it can be very helpful. Because you can imagine as humans tire, they can use that to screen. It may not be perfect at diagnosing, but it can screen. And at least it won’t miss anything. And then the human, the pathologist who comes in, can go and say, I can confirm that that’s cancer or not. So you save a lot of mental power, mental energy in terms of things. And this is an application of AI helping providers, and I can see in the future even patients sort of answer questions that would have been very laborious, tedious. This goes back to the automation theme that we had earlier. How do we make things easier? How do we decrease the friction? I sort of illustrated a case where they had friction points and tiredness and things like that. And so these are things that are on the horizon.

And I think we’ll learn a lot in the next decade or so. You’ll see a lot pop up. You’ll probably see some mistakes too, people overusing it or being in the wrong situation. But that’s the way medicine works. Medicine works through some trial and error. You make your best guess. You have experts. But in the end, there’s a lot of unforeseen things. But you learn a lot along the way. And you learn when to use it. And eventually, you reach this equally important point where everything works very well. It’s part of the workflow. It’s just part of…you just expect it. It’s just when you go to care, you just expect that there is a human overseeing some AI that’s making sure that you’ve got the right diagnosis that nothing’s left out, nothing’s omitted, and you can trust it. That’s kind of the place you eventually end up being.

Lisa Hatfield:

Well, and you hit right on something that I think a lot of people worry about is how can we trust AI and all of the ethics surrounding that? Can we really trust AI? As a patient, I’m fascinated by that. And I know that the Cancer Moonshot Program has directed some funds to AI and cancer research. I look forward to the day when there’s a bridging of that gap between research and then clinical practice with humans involved in a lot of the decision-making along the way also. I’m not sure that we can ever move away from that. But that was a great overview of technology. I hope it continues to evolve. I hope what I’ve seen, what you talked about, you work more in solid tumors. I have a hematologic cancer myself. But I do see that there is some AI being used in earlier screening and also in the identifying of different genetic mutations within those cancers. So I look forward to that continuing to evolve.

Dr. Sirintrapun:

That reminds me, too, and I left that part out. Some of these technologies…I’m sorry I left that out, but genomics has become a big thing over the last decade because of the Cancer Genome Atlas and other things that actually allowed us to map the genome. But along that front, we have technologies that can monitor progression. So we can at the cellular level. If you’re actually circulating cell-free DNA as a technology that’s out there. Where if you can implement it correctly, you can actually follow the patients just through blood without anything invasive. And it’s much better than any imaging study out there. So there are technologies that are evolving on this. And because of all the progress we’ve made over the last 10 years, you can see that being incorporated in a clinical trial where you can monitor patients much better. You can intervene faster and more effectively and all those other things like that. And thanks for reminding me about that. I forgot to mention cell-free DNA is another one that I’m very excited about, still early.

Lisa Hatfield:

Yeah. Well, thanks for that information. Dr. Palmer, do you have anything to add to this informatics description or discussion?

Dr. Palmer:

Well, I think there’s a couple of things about the technology component of it. I know it was several years back, CRISPR, when it first came about. It’s a brilliant technology. Everyone got very excited. Okay, if you look at a lot of the myeloproliferative neoplasms, there are three driver mutations that are really felt to contribute strongly to the development and the ongoing nature of the disease. Everyone said, “Oh, I can go in and if you take out that gene and replace it with the new one, I can fix it.” I think that where the role of CRISPR right now is, is it’s doing amazing things to help us understand the biology of the disease.

I think in terms of treating a lot of the malignancies, they’re so genetically complex that even though we say, okay, well, you have, for example, a JAK2-positive essential thrombocythemia, which is JAK2 is one of the driver mutations and essential thrombocythemia is too many platelets. Unfortunately, I probably can’t go in there and get all the JAK2 mutations in the blood system to replace them. Now, where it is making huge strides is in things like sickle cell disease and thalassemia, where there is one gene that is the problem. And even if you only replace it in 50 percent of the cells, you can really drastically change somebody’s life. So I think that it is used in certain situations and is absolutely astounding and amazing. I think its utility and completely eradicating cancer is going to be something that is going to take a long time to come about. But I do acknowledge that it’s making enormous strides in understanding how everything can work, because you can quickly remove something, replace it with something else, and really understand what the function of that mutation or that gene happens to be. In terms of the artificial intelligence, I’m looking forward to seeing how it can be used.

I think it’s right. You try to find, how can I come up with the right answer? And once you think, “Oh, this should be easy, I should be able to look at somebody’s blood counts over the course of a year and be able to predict something.” But to actually be able to do that, I think, is going to take a lot more thought. So it is something that I’m hopeful that we can all start to utilize more. I think the last thing is, is some of these really fancy ways of detecting minute amounts of diseases. I think circulating DNA, which I frankly don’t know a lot about, because I don’t treat a lot of solid tumors. But also, when I look at just bone marrow disorders, like acute leukemias, we often look for something called minimal residual disease, which is this below the microscopic level. You’re looking at like one cell out of 0.001 percent of the cells.

And honestly, we don’t really know how to deal with that. And I think sometimes it ends up providing more anxiety, because you have otherwise a disease that you would say, under all historical purposes, you’re in remission, this is great. And then you have this little amount of disease. And sometimes it’s good, because it can help us determine the next steps of therapy in a more effective way. But sometimes it just creates stress, and we don’t truly know the actual meaning of it.

Lisa Hatfield:

That’s a really great point, the minimal residual disease, is we’re testing such a deep level of sensitivity. Do I want to know that much, because would it be treated anyway? Will it make a difference? Or will I be overtreating a cancer with the chemotherapy agents or agents that are more toxic? That’s a great point you bring up.

Dr. Palmer:

Yeah.

Lisa Hatfield:

So, yeah.

Dr. Palmer:

It’s a very difficult one. As we get more and more of these tests, we’re finding more stuff that we don’t really know what to do with.

Lisa Hatfield:

Yeah. So and I just want to take a step back really quick. So we were talking about the CRISPR technology. And, Dr. Sirintrapun, if you can just clarify for me, for any patients watching this, so CRISPR is the technology that is used, or the methods used to edit genes. Is that correct? It’s not an actual therapy a person can receive. But it’s the technology that’s used to edit genes.

Dr. Sirintrapun:

Yeah, it’s just the technique.

Lisa Hatfield:

Okay.

Dr. Sirintrapun:

But it’s not…but yeah, therapy is a bigger…you can imagine therapy being a big umbrella. And then the technique would be there. So it’s more…

Lisa Hatfield:

Okay. Just wanted to clarify that for people watching this, since we’re talking about that CRISPR. So and Dr. Palmer had touched a little bit on the personalized medicine for MPNs, looking at specific mutations like the JAK2 mutation, MPL mutation. Dr. Palmer, can you share some examples of how telemedicine is influencing personalized medicine in MPN care?

Dr. Palmer:

So I think one of the key…so when we look at treating different myeloproliferative neoplasms, you have to take what’s your goal of therapy. So for the ones like essential thrombocythemia, where you have too many platelets, or polycythemia vera, where there’s too many red cells. A lot of times what you’re doing there is you’re just saying, well, how can I predict whether you’re going to have a blood clot or something? Because people can live, these can be fairly chronic diseases that with appropriate therapy, people can live a long time.

So a lot of that’s risk mitigation. Where I think a lot of the personalized aspect of it is coming in is probably in myelofibrosis, which is a disease where I view it as too much inflammation, scar tissue develops in the bone marrow, people could get a large spleen, high white blood cell count. A number of different manifestations. And in that, we’re learning more and more that in addition to the three driver mutations, the JAK2, the MPL, and the calreticulin, there’s probably a whole other group of mutations that can really be used to help us predict and try to take a look into the future to help guide them. And what is the timing for transplant? Should we be more aggressive as we’re getting more and more agents being evaluated and hopefully approved in the treatment of myeloproliferative diseases? Who are the people who should utilize these agents?

Because again, you don’t want to overtreat. And so I think that being able to hone in on these different mutations to be able to help us predict what we think will happen and maybe different treatment options that we would have, that’s going to be important. Now, one of the things that’s really exciting is that some of these companies that actually do this deep sequence, like looking at multiple, multiple genes, actually have mechanisms by which they will send somebody to a person’s house and then draw the blood and take it over and run it. And so I’ve actually had that done before, where somebody I saw via telemedicine, and we really wanted to get that information so I could appropriately advise on what I anticipated was going to happen in the course of the disease.

And we were able to actually get that information through using home care, saying, I want this order to be done. The home care people went out, drew the blood, sent it to where it needed to go in the right format, and I was able to get that information. So I think that telemedicine allows them access to people who understand how to interpret that information. But I think we have to give a lot of props to a lot of these companies that are really getting innovative in how they’re capturing the data, saying, “No, you know what? You don’t need to have this done in Scottsdale, Arizona or Phoenix, Arizona. You can have this done in your own home and wherever your home happens to be.”

So I think that that type of thing is really changing some of how we can utilize that data that’s very personalized, but be able to use it in a telemedicine format where we don’t need people to physically come here to get their blood taken. Now, I do want to add the caveat. There are a number of different institutions that have enormous amounts of lab work that’s looking at things above and beyond the approved tests that have been validated and everything. And that would be a lot harder to get. There still are ways of doing that, but I think that we have to acknowledge that there is something that we do lose by doing that. Although I can get a lot of information, be able to provide a lot of input to a patient. It still doesn’t address the fact that by physically being there, sometimes you can get samples that you can biobank, and you can send to somebody’s lab. And then these are the people who are discovering the new things that really that’s how we learned what we know so far. Is because somebody went and looked at these genes and more and more and more of this is going on. So I want to temper this with saying not everything can be done by a telemedicine.

That we have to be thoughtful about our approaches and really utilize combining in-person visits along with telemedicine to really do care. And to give an example, what I do for patients is if I follow them by a telemedicine only, I won’t actually be a prescribing doctor. I won’t be a primary provider. I have to at least see them once a year if I’m going to give medicines or do things like that. So I think that there’s a hybrid model that’s going to be really important to do as well for patients who are able to do that.

Lisa Hatfield:

Thanks for that.

Dr. Palmer:

If that makes…yeah.

Lisa Hatfield:

It does make sense. And I just had a quick question too. So if I’m coming in or I’m going to see my…I’m a newly diagnosed MPN patient going into my local oncologist. I’m watching this webinar and I hear, “Oh, if somebody came to my home. I could maybe do telemedicine, or I can have somebody come to my home and take my blood and look at these genetic mutations. My local oncologist doesn’t know exactly how to go about doing that.” Would that be the point where they might try to contact a specialist or go through the consult center through Mayo Clinic or somewhere to say, “Oh, I need a specialist to help me access this type of testing?”

Dr. Palmer:

So I have to be very honest. I just learned about this type of testing in the last year or so. And so it’s something that I’ve started to be able to utilize. With myeloproliferative diseases, I think, and very honestly, and there’s a number of us specialists around the country, I think everyone seeing one at least once in terms of just saying, “Hey, what’s our plan of care going to be?” Are we looking at all the angles of it is a really important thing to do. And I think there’s a number of excellent physicians out there in different parts of the country that some of whom are using telemedicine, some I’m not sure that they are. But I think that getting that specialized opinion is extremely important. I think then in terms of managing care, there’s multiple… Give me a second, I’m sorry. There’s multiple ways that can be configured that will help take care of the patient depending on their individual needs and their ability to travel and everything.

Lisa Hatfield:

Okay. That’s really helpful. Just as someone who has an excellent local oncologist but we don’t do some of the tests here. So that’s why I see a specialist. And they send me actually a kit, a lab kit to have something sent back to Mayo Clinic. And I love that. It makes it so nice to know where I’m at with my disease. 

Okay. So, Dr. Sirintrapun, the importance of connecting to specialized care when living with a rare cancer is so paramount. But with anything comes risk and rewards. What are the risks and rewards of telemedicine and maybe even some of the limitations? You both touched on that a little bit. But if you can talk about that a little bit, that would be great.

Dr. Sirintrapun:

Yeah, I’m so glad that Dr. Palmer actually illustrated to everybody, including myself, kind of how the processes work and if you had a trial, particularly with monitoring, and getting the right tests. So being a pathologist, that’s the other hat, I look at glass slides, but I also handle a lot of tests in particular, is looking at them. And in Memorial we do those complex humongous genome panels, it’s actually become much more commonplace to have 500 genes. And as Dr. Palmer had alluded to, sometimes you don’t know out of the 500, which are really meaningful, which are not. But out of that, you do know with some of them. I see it like the initial diagnosis, at least with technology, like the complex testing being done, still centered. It’s hard to outsource that to locally.

But in terms of convenience, I can see a future where a lot of these tests can be done more closer to the patient, where they’re simpler, there’s more automation. Somebody who might be a lab tech or nurse practitioner might, the instrument might be simple enough to press a button, and you’ll get your results. And that’ll be just the right amount of genomes to monitor. Now going back to rare diseases and such, it depends on the rare disease. Because rare diseases have been kind of the classic paradigm for a clinical trial where you have to go to a centralized center because a lot of times the way rare diseases work is that they’re, at least in pathology, there centrally to an expert. Because there’s only one person that’s ever looked at it in the entire world and nobody else really knows. And you end up sending it to that guru.

And so the problem with that is that somebody has to know from the outside, “Hey, I think it’s this, I should send it to that person.” So you have, you already have friction and a gap right there. And you have the logistics of it just, okay, once it’s there and you get the diagnosis, what happens next? Can the patient who might be living from wherever be able to go and get enrolled in that trial? So you have all these different barriers that I alluded to before. So the advantage of the telemedicine is that you basically might have diminished the gap. You can bring that expert in terms of consultation to the patient who lives very far away. Now, going back to all the logistics about monitoring, if you had the right lab tests, and this is where the FDA comes in, and we don’t have time to go into the way lab tests are developed, but if the lab test is simple enough, you can do the monitoring more closer to the patient.

And in that way the clinical trial is much more enabling. They don’t have to fly somewhere, you have to go some…it all depends on how they can actually get the test to the right quality level and closer to the patient so that you can have the monitoring as more frequently, and you don’t have the cost of actually having to ship either the patient or the sample elsewhere. So things that are changing, I’m hoping, because the technology’s there, and it takes architects of clinical trials to rethink that. What’s the right technology now that we can apply it locally, so that we don’t have to do all this back and forth. And so that’s the type of thing. So going with the record, there’s lots of opportunity. I think the cautionary part would be is that tech, if you’re going to deploy something, let’s say near the patient, we call it point of care in lab testing, point of care, right?

Right, right near the patient. You have to make sure that lab test is quality, it’s actually good enough, like it met all the standards, and then you can trust the results. That’s the trick. And that’s where the cautionary part comes in. Are these things really good enough that anybody with a little experience can use it and that people can interpret the result and you can trust the result. That all these things are in place. I’m giving you the ins and outs with the way, when you want to deploy something, these are the different things you have to consider. But there’s a lot of potential as I mentioned.

Lisa Hatfield:

Sure. Great. Dr. Palmer, do you have anything that you want to share or add to that? Risks, rewards, limitations for MPN patients about telemedicine?

Dr. Palmer:

So, I think that brought up a really good point. So when we look at these tests that you can order, I think there’s a lot of companies that do very reputable tests that are even sometimes utilized by some centers. And so at the first diagnosis, I think there’s the piece that what is going to help clinically based on the knowledge that we know, and that is some of these tests that actually can, are very good quality have somebody to be deployed, draw the blood, send it to wherever and do the test. Sometimes it’s good to be at the center itself where there are actually labs and that increases the learning. I think that the architecture of the clinical trial which was a great way to put it, is going to be really important, because if I take a complete blood count, honestly, I mean, anyone can do a complete blood count and I can get the information that I really need to get out of it.

If we look at drug levels, that’s a far different animal is to make sure that these drug levels get drawn in the right way at the right time, sent to the right place. That can be a real challenge. So there are going to be different aspects of the clinical trial that can and cannot be done virtually and through outside resources. So I think that, that it’s certainly not all created equal. So there’s no way I can do the entirety of a clinical trial without physically having a patient at the center. However, on the other side of that coin, I think there’s probably a number of things, especially with like really routine visits where we’re not getting drug levels, we’re just checking a CBC, or a complete blood count or chemistries or something in the blood, that that can probably be done almost anywhere.

So it’s just going to take an extra layer of thought. I think that a lot of times you use what you know, so you say, “Well, this is how this clinical trial was run, and they have to come in, and they have to get an exam, and they have to get a CBC and they have to get everything else.” I think that there are going to be ways that we can alter that to really think what are the meaningful things we need? Like we don’t use every single solitary time point, “What are the safety measures we need to make sure we capture?” So it is going to require sort of a lot of thoughtful processing to figure out how to do that. The other thing to be cautious about is if you have the interpretation of the test.

So let’s say I send out a lab to one of the companies that does really extensive panels of genes, and then it goes back to their primary provider. They might look at that and go, “Well, geez, I don’t know what any of this actually means.” I mean, frankly, out of those 400 genes, there’s a number of them that I don’t even know how to interpret. I say, “Well, this is interesting, but these are the ones that I know are really critically important and can impact your, what I anticipate is going to happen to you. But some of these we don’t know yet.” I mean, I think that’s what we’re learning about. So doing these tests, sometimes getting these big panels can be confusing and frankly scary if you don’t have somebody there who is able to say, “Yes, these are the important ones. These are probably not that important. So it’s interesting that you have them, but we don’t need to worry about them right now.”

And so that’s really key ’cause otherwise you start to go to Dr. Google and, which is not anybody’s friend, and get yourself really terrified. So I think that that ability to put things into perspective is also, and have the ability to incorporate it into the education given and the treatment plan is really critical. So again, a hybrid model is really necessary for a lot of these to work well. And how that hybrid model works is going to be dependent on the disease type, the clinical trial in that situation. But I think that there are ways to do it, and I personally in my own practice have created a set of rules that I’m like, “Okay, well, for this and this and this and for this you have to do that and I need to do this.” So I have certain things set up to make sure that I feel like I am providing safe-care, but also being able to provide it virtually.

Lisa Hatfield:

Great. That’s great information too. And I am guilty of using Dr. Google probably more often than talking to my doctor. So most of your patients probably are, and they just won’t admit it. So I’ll admit it for all of us. [chuckle] Yes, thanks for explaining that. So I think we’re going to talk just a little bit, we’re going to move on to talking about best practices for MPN patients and families using telemedicine. Dr. Palmer, we’ll just start with you and then talk to Dr. Sirintrapun about that. But what are the best practices for MPN patients utilizing telemedicine? And what are some of the newer technologies that we’ve even talked about today that are being explored that you’re most excited about?

Dr. Palmer:

Well, again, I think it’s hard to say the right way to use telemedicine. I think that, as much as automation and trying to come up with processes that are very standard is important, I think it is still a learning process. How long is it safe to do telemedicine? How many, if I’m the only provider seeing this person and there’s not somebody physically looking at them, am I doing a disadvantage? So like, what’s the safety realm in that? I mean, that is something that I know comes up, and it comes up with a lot of physicians, like, “Well, I have to examine the patient, I have to eyeball the patient.” So trying to figure out that balance of making sure you’re providing good quality and safe care, but that you’re also allowing for people to have access to things they otherwise wouldn’t have access to.

And some of that is a matter of having good collaborations with providers in different places and the willingness of the local providers to work with one of us. And some of that’s just kind of saying, “Well, I’m going to try this.” And then after a while if you say, “Hey, this isn’t working well,” then you switch it. But I think a lot of this is something that you can’t prescribe. It is something that needs to be the level of comfort for the provider, the level of comfort for the local provider and the patient. And it’s not going to be the same for any two patients. There certainly is going to be some variability. I’m very excited about the ongoing telemedicine and our ability to utilize it. I’m really hoping that even after the public health emergency, some of the barriers to being able to provide telemedicine outside of your own state will not be a problem. And I think each institution’s handling it a little bit differently.

So that’s something I’m excited for, and there’s probably going to be a lot more that I can’t even begin to think about that’s going to come up in terms of ways that people can, like there’s handheld imaging machines and stuff like that. Is there going to be a way that we can actually have patients apply it? So, for example, I like to feel spleens in patients who have myeloproliferative diseases, because they’re often enlarged. Is there going to be a way that there’s some type of equipment or some type of material that can do a spleen exam without me actually having to physically see the patient and lay hands on them? This is something that I probably, people are thinking about who are a lot smarter than me. And I’m looking forward to something like that being developed. But that’s what I’m hopeful is that we get to the point where I can feel like I’m providing really top quality care to people who could be anywhere in the United States or even honestly the world.

Lisa Hatfield:

Yeah. That’s fascinating. And from the patient perspective, again, it gives me a lot of hope to think that there might be a way to complement the care that we’re receiving locally through telemedicine. So, Dr. Sirintrapun, we’re always looking for hope, we cancer patients. So what are some of the novel technologies and therapies that you’re most excited about?

Dr. Sirintrapun:

Oh, my gosh. Let me just say that it’s great to be excited and I spend a lot of…what keeps me going is just being excited about things. But it’s also important not to be reckless. And I think for a lot of people that are in this technology thing, you see the balance between, well, you don’t even necessarily see the balance. They’re more excited, and then you overstep. And so that’s really the guiding principle, excited but not too reckless to take things with caution to study, learn from things. And I really appreciate Dr. Palmer sharing that, because she brought up a lot of different points. Like as you move forward, you have to consider X, Y, Z, I think a lot of the audiences heard that. That said, I’m excited about a lot and getting a little wonky with the technical things.

I’m excited about the mobile technologies, I don’t exactly know this is going to be somebody else more creative than myself about how do we incorporate that? These different biosensors, if heart rate’s important and that’s a side effect of a drug, how do you incorporate that into the healthcare information system? I’m going to put a little knock on the healthcare information systems or a little less technologically advanced is then what you see with the iWatch. I would argue that the stuff with iPhones is much more advanced to the dismay of many patients…maybe surprise of many patients. [laughter] We deal with some old technologies in healthcare. And so how do we incorporate these new technologies into this old ecosystem? But that said, there’s a lot of potential wearables, biosensors testing that could be close to point of care on the connectivity aspect with the 5G and stuff.

I don’t fully know all the 5G aspects, but think of the prior Gs that were there that allowed for GPS and all these different things that were not possible when you had 1G. Now we have 5G. Who knows what you could do. You can actually apply AI in real time before you would take 10 minutes to process it. Now it’s just happening somewhere at a cloud close by, and it’s happening very quickly. You can imagine all that. So things like robotic surgeries can happen. Processing of immense data can happen very quickly. You can get your information without waiting a day or two weeks. So those things are very disruptive, and I’m excited about that. I’m hoping that the players that are out there also keep the cautionary aspect that as you move forward, don’t jump too soon.

Try to learn things. Do not overpromise. Because it’s a thing for patients as well. I mean, many physicians don’t necessarily know they’re not, when you see something, they’re enamored by it. But the questions you should ask, “Is it ready? Has it been through the paces yet? Can I trust it enough?” And that’s the part that…and I try to maintain it, and I hope as people go and innovate that they don’t overpromise on things. Think the Theranos aspect, we could do all this X, Y, Z. That’s one lesson and there’s going to be more. Trust me, that’s not the end of it. Because as I mentioned, people tend to get excited, but it’s also very important to be cautious and not reckless. And I think that’s the lesson I would convey to anybody excited about this.

But there is a lot excitement, there’s a lot of potential people who think very smartly about it can think of all the different cautionaries of how to implement it because it’s all about the implementation. How do you make sure it’s ready, and you can implement it correctly so that the people that are using it and people that have to interpret it and the people that it’s going to impact it all matches? It actually really is appropriate for that time that, that’s beyond just the technical. That’s why I said I…hen I said informatics, it’s people processes. It’s not just the technology I wanted to focus on it, it’s the entire picture of things. And so that’s it. That’s kind of the way I sort of see us moving forward. 

Lisa Hatfield:

We’re moving forward. We are progressing, but we have to take caution in how we implement. So yeah, that makes a lot of sense. Thank you for that. So I have a lot more questions, but it’s time for us to wrap up and you spend a lot of time with me as a patient helping me and hopefully with other patients watching this. It’s really refreshing to hear about advances in technology that can potentially extend my life and the lives of other patients living with life-threatening conditions. We appreciate all the new tools, we appreciate all the information being put together, and utilized to help cancer patients everywhere. And thank you so much. I don’t have an MPN like I mentioned before. I have multiple myeloma, and I have been dealing with that for four years.

I’m looking forward to a technology someday where I don’t have to have bone marrow biopsies to determine how much cancer I have in my bone marrow. But that might be a pipe dream. I don’t know. [laughter] So anyway, thank you so much for spending time with us, Dr. Palmer and Dr. Sirintrapun. We really appreciate the time and as a patient myself, I’m always grateful when you come on these programs. I watch webinars all the time to get more information, so I can better advocate for myself or for my friends who have cancer. So thank you so much for your time and for your expertise. Really appreciate it.

And just a reminder to anyone watching this program to always consult with your own medical team about what is right for you and about your own healthcare. Thank you again, Dr. Palmer and Dr. Sirintrapun. Hopefully, we’ll see you again on a future webinar. Thank you.

What Are the Beginning Stages of Multiple Myeloma (MM)?

What Are the Beginning Stages of Multiple Myeloma (MM)? from Patient Empowerment Network on Vimeo.

What happens in early stages of multiple myeloma? Watch as early multiple myeloma is explained as expert Dr. Rafael Fonseca details what occurs in the body, and patient Lisa Hatfield shares the symptoms that she experienced early in her myeloma journey.

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Related Resources:

What is Multiple Myeloma (MM)

What is Multiple Myeloma (MM)?

Where Should I START Following My Myeloma Diagnosis

What is Smoldering Myeloma

Transcript:

Dr. Rafael Fonseca:

These cells live predominantly inside the bones in the space we call the bone marrow. They can do a number of things that actually lead to the symptoms and to the clinical presentation. As they grow in the bone marrow, they take some of that real estate. A person may experience fatigue and that is because they have anemia. The myeloma cells are also very characteristic because they can erode into the structure of bones, so destruction of bone is another feature that we see in patients with myeloma. That can be either seen on X-rays or sometimes people will present with symptoms related to bone pain or discomfort with movement or weight bearing. Those are signs that we look for.

Lisa Hatfield:

For me, early on with myeloma, I really had none of the classic symptoms. All  of my blood work was coming back normal. I would see my regular primary care physician every two years. My lab work was coming back normal. Nothing really stood out. I wasn’t anemic. My kidney function was okay. What did stand out over the course of two years was I was experiencing progressively worsening pain in my hip. It felt like kind of a pinched kink pain in my hip to the point where it progressed to the point where I could barely walk was when I finally talked to my primary care doctor. And requested very strongly to have a scan done, and that’s when I was diagnosed with myeloma.

So the primary reason I went in was for the pain to begin with, and my doctor did look at the pain. He tried to assess it several times over the course of two years. But it wasn’t until I had the MRI that showed a large plasmacytoma on my spine when I realized that something was wrong. A couple other signs that I did have looking back now that I complained about to my doctor and I thought were rather curious, I shrunk a little bit. I shrunk in height. My daughters were laughing, and they’re like “Mom, we’re just growing.” But I did shrink in height by about 2-1/2 inches from the compression fractures in my spine and the plasmacytoma that had eaten away at my spine. And then another thing that a lot of people don’t talk about is sometimes people will have foamy urine. We don’t like to talk about body functions.

But it’s important to know that if you experience that, there are proteins that they can find that  are called Bence Jones proteins that are a sign of multiple myeloma. So if you notice anything unique like that – foamy urine, extreme fatigue, anemia in your blood tests,  it’s definitely worth asking your doctor about. And also relentless, persistent pain in your hips, in your back, in your ribs, any of those areas, it’s worth talking to your doctor about just to assess those thoroughly to make sure there’s not something more significant going on.

If myeloma  goes undiagnosed and untreated, the cancer cells can make a patient experience:

  • Lowered immune function due to white cells being crowded out, resulting in frequent infections
  • High levels of protein in the urine and  blood, which may cause kidney damage
  • Build-up of cancer cells in the bones, which can cause bone weakening, bone pain, and bone fractures