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Myeloma Patient Expert Q&A: Start Here

Myeloma Patient Expert Q&A: Start Here from Patient Empowerment Network on Vimeo.

In this myeloma patient expert Q&A, Mayo Clinic expert Dr. Sikander Ailawadhi provides highlights around the myeloma novel alphabet soup and actionable steps on how patients and care partners can start the treatment conversation.

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Transcript:

Lisa Hatfield:

Hello and welcome, my name is Lisa Hatfield, your host for this Patient Empowerment Network program. In this important dialogue, we bridge the expert and patient voice to enable you and me as a myeloma patient to feel comfortable asking questions of our healthcare teams with more precision, more precision, the world is complicated, but understanding your disease doesn’t have to be. The goal is to create actual pathways for getting the most out of multiple myeloma treatment and survivorship. Joining me today is Dr. Sikander Ailawadhi, a respected multiple myeloma expert from Mayo Clinic. Thank you so much for joining us today, Dr. Ailawadhi, we really appreciate your time.

Dr. Sikander Ailawadhi:

Thanks a lot, Lisa, for having me, and I look forward to this program.

Lisa Hatfield:

Okay, so before we get started, please remember to download the program resource guide via the QR code, and we are going to jump right into a discussion about some of the novel therapies that there is much buzz about right now, and it’s kind of an alphabet soup these novel therapies. I actually was trying to digest all of this information and divide it into the general categories. And correct me if I’m wrong, but we have monoclonal antibodies, we have bispecific antibodies like the CAR-T therapies, and they target different things. We have BCMA, we have GPRC5D, FcRH5, we have things called antibody drug conjugates and cell mods.

So, Dr. Ailawadhi, if you can just give us kind of a broad overview of these therapies and how they may be used to harness our immune system, and how they come into play when you’re treating your patients, how and when they come into play when treating your patients.

Dr. Sikander Ailawadhi: 

Surely, so I think thanks a lot for bringing up that discussion, this is extremely important, and I think it’s most important because if a myeloma patient goes online and wants to search for information or research, these things start coming up this term start coming up. So it’s extremely important for a knowledgeable and empowered patient to learn about these, understand them, so that they are able to digest that information.

And I should mention that a lot of what we’ll talk about about these particular treatments may not be applicable to newly diagnosed patients or a recently diagnosed patient, but this is important enough and exciting enough that I would want every single patient to pick up this information. Learn it hopefully, and maybe park it for now somewhere, so that hopefully down the road it becomes important and handy. So you asked about monoclonals, bispecific, CAR-Ts, cell mols, etcetera. Let’s take a step back, let’s think about these as strategies to target myeloma.

Myeloma treatment is going through a change where immunotherapy and harnessing the body’s own immune system is becoming extremely important, and when we do that, the immunotherapy is typically very targeted, so what these drugs these agents, these terms, this alphabet soup is doing is it is targeting specific markers on the myeloma cell on the plasma cell.

For example, one of the markers is CD38. There is a monoclonal antibody. There are actually two monoclonal antibodies. Daratumumab (Darzalex), rituximab (Rituxan) that are FDA-approved, but there are other ways of targeting CD38, for example, CD38 targeting CAR-T cells, CD38 targeting antibody drug conjugates, etcetera. So CD38 is one important part. A very, very, very important thing in the past one year or a year-and-a-half has been what’s called B-C-M-A, B cell maturation antigen. BCMA is another target on plasma cells. Very effective, very specific.

So there are many, many drugs that are available and becoming available to target BCMA. Right now, there are three drugs that are FDA-approved that can target BCMA. Two of them are CAR-T cells, a particular way of going after BCMA in which the body’s own T cells are collected. These are not stem cells, these are T cells, T lymphocytes, these T cells are collected, they are actually genetically modified to go and fight against the BCMA, and then those modified T cells are multiplied in the lab and given to the person as a drug, they go and seek the plasma cells because of BCMA kill them harnessing the body’s immune system.

So there are two CAR-T cells against BCMA, one called ide-cel (Abecma) and one called cilta-cel (Avekti). There has recently been available a bispecific antibody against BCMA, we call it bispecific because it connects to BCMA from one end and from a second it connects to the body’s T cells again, bring the T cells close to the plasma cells to kill them. Then bispecific antibodies called teclistamab (Tecvayli). And until recently there was another drug available against BCMA which was what’s called an antibody drug conjugate. This drug is called belantamab (Blenrep) for the timing, belantamab has been removed or withdrawn from the market in the US, but there are ongoing clinical trials and down the road, it may come back again.

Now, antibody drug conjugate is another way of targeting something in which there is a seeker for the BCMA in this case, and it has a payload of some kind of a toxin, so that when the drug connects to the plasma cell through the BCMA in this case, that toxin is released, it can kill the cell, so either we harness the body’s immune cells, the T cells by CAR-T or bispecific, or we kill the cell by releasing a toxic payload from a drug, antibody drug conjugate, these are all different methods of targeting the myeloma cell.

So I talked to you about monoclonal bispecific CAR-T and ADC as different strategies, CD38 and BCMA, some of these strategies are available, but there are other targets which are very exciting and new drugs are being developed against them, two of the very interesting targets there one is called GPRC5D, and the other is FcRH5. 

These GPR5CD or FcRH5 are two different targets on myeloma cells. No drugs are currently FDA-approved, but they are being developed very rapidly, and we have a couple of extremely promising agents which will be coming down the pipe. And you also mentioned something called cell mods. Cell mods are some newer drugs in the family of what’s called IMiDs or immunomodulators, in which our patients may be aware of thalidomide (Thalomid), lenalidomide (Revlimid), and pomalidomide (Pomalyst). The cell mods are kind of the same family, and there are a couple of them that are also being developed.

So why is this important for everybody, whether they are newly diagnosed or relapsed or long-term survivor with myeloma, because this tells you that not only are we getting newer drugs in the same classes, we are also getting brand new classes of drugs, and you can imagine that means that those brand new strategies are ways to target the plasma cell, we know cancer cells are smart and they develop invasive mechanisms to become resistant to drugs, but every time something gets resistant if we have a brand new mechanism to go against the disease, but that’s exciting because that’s why we are seeing deeper responses, even in very heavily pre-treated patients, because we are using newer specific, relatively safe, convenient strategies to going after the plasma cell.

I know that was a lot of information, but I hope this helps our listeners learn a little bit about what you rightly said is an alphabet soup, but I would like us to think about it as an exciting time for being a myeloma doctor, and certainly a very hopeful situation for all our patients.

Lisa Hatfield:

Thank you so much for that great description. And one question comes to mind that I have heard from other myeloma patients, and you mentioned that we are seeing deep responses, or they’re seeing deep responses in clinical trials for some of these in refractory relapse patients.

Do you think that bringing these…do you think it’s possible to bring some of these therapies to the forefront of myeloma care, maybe an induction therapy or after first relapse, and if so, do you think that that could lead to even deeper responses in those patients because their immune system isn’t quite so tired and potentially cure?

Dr. Sikander Ailawadhi:

Again, Lisa, that is such an important and such a spot-on question that you’ve asked because absolutely, you can imagine, if we are thinking of harnessing the body’s immune system, the T cells, but we’re talking about patients who have had five, six, seven, then, prior lines of therapy. But that immune system is also a little exhausted, a little tired, but if you were to use the immune system of a newly diagnosed patient, patient who’s not been created that much…well, those T cells are going to be way more robust. Whether we use a CAR-T kind of strategy where we remove the T cells, train them and put them back, or we use a bispecific kind of strategy where we put in a drug that pulls the T cells closer to the myeloma cells and kills them using these smart thoughtful strategies which are not just dumb drugs that go in and kill everything, these are smart targeted drugs, using them early on in the treatment paradigm will certainly be more beneficial. In fact, there is some data showing up where some of these strategies like CAR-T cell are being used sooner in the treatment paradigm.

But again, as drug development goes, We first want to make sure it is safe, it is effective, and typically the starting point is patients who have exhausted other options, but very soon we will be seeing all of these strategies, and in fact, some of these strategies combined with each other coming in, early lines of therapy and hopefully providing excellent, deep responses, and you mentioned that term that has been very invasive for us cure, I don’t know if we are…

So we are not there yet. I don’t know how long it’ll take us to get there, but there is certainly much more hope today for getting to that cure than it was before.

Lisa Hatfield:

Thank you, and I think as a myeloma patient and on behalf of other myeloma patients, hearing about all of this research and how our immune system is being used to help us, does give all of us hope to keep continuing, and then you want a moving forward. And I think that was probably a good time to step into some questions here that we’ve received from other patients who have written in prior to this program. I will start with those, but I do want to take a step back, first of all, we’re going to kind of talk about a newly diagnosed patient and all of your explanation of all of these different therapies, these are things that typically are talked about later in therapy as of right now.

It also reminds me to tell everybody that there is great importance in seeking out the expertise of a myeloma specialist, I think everybody heard what Dr. Ailawadhi had to say about these therapies, really, even if it’s just when you’re newly diagnosed, going for a consult once and then maybe upon relapse going again, if you don’t live near it, a specialist, seeking out the expertise of a specialist is really critical.

I think I’ve had to do that and I’m so thankful I’ve been able to…we do have resources that we can guide you forward at Patient Empowerment Network, but I think it’s really critical to seek out that expertise of a myeloma specialist. So now we’re going to jump into our questions. So, thank you again, Dr. Ailawadhi.

So we have a patient asking for newly diagnosed patients, say a patient comes into you, maybe they were sent by their community oncologist or a family practitioner, something…I have myeloma, doesn’t know anything about it. Have even heard of it before. How do you start that conversation? How did you explain myeloma and the treatment and very importantly to the patient, how do you explain the prognosis when you know it’s not curable yet?

Dr. Sikander Ailawadhi:

An extremely important question. And I agree that we should be starting at the beginning, so I think I had the privilege of working at an institution where we tend to spend a lot of face time with the patient, so typically in the outpatient, I have at least about an hour of time blocked is how we’re set up.

So at that visit, first of all, I’m hoping that a patient comes in with a caregiver, but if they don’t have a caregiver with them, I start off by asking them, Is there someone they would like us to call during the visit? Because it is always better to have a caregiver or an extra set of ears listening in, and once that has started, then I typically will explain to them literally from what is a plasma cell, what is the role of a normal plasma cell, because that tells us the type of proteins plasma cells produce.

And that leads us to how a plasma cell can become cancerous and lead to multiple myeloma, what are the signs and symptoms of multiple myeloma? What are the markers, these protein markers that come in the blood and are picked up as markers of disease for patients, because again, patients need to know what they’re looking for in the labs that are drawn, so very frequently.

We talked about the role of a bone marrow biopsy, a lot of times it has been done, sometimes it has to be done after that visit, we talk about the genetic mutations in plasma cells that can be seen because that is what helps determine the risk category of standard risk or high risk.

I do offer to patients about discussing the prognosis, again, it’s a good time where we know that the average survival of patients is close to about 8 to 10 years when they look at a general national data, U.S. data, but all the large centers, all of us who focus on myeloma, we have several patients who are living quite a bit in excess of 10 years, so more hopeful time, but it is important to put that prognosis in perspective with high risk or standard risk disease that can be determined based on mutation testing from the plasma cells from the bone marrow, something called the FISH test, part of it is to explain to the patient the prognosis, but other reason is also because sometimes that can determine the type of treatment, and this also importantly tells the patients about their disease much better, so they can be more educated, they can interact with other patients, they can ask the right kind of questions, and they can understand their disease process and follow-up better.

Now, after we have discussed all of this, we start talking about treatment, I can tell you when I talk to a newly diagnosed patient, I will tell them that in my way of thinking their treatment initially is broadly divided into three different discussions during three different visits. The initial visit is talking about any symptom or sign from the myeloma, increased calcium, kidney dysfunction and tumors, how are we going to tackle that? So we will come up with the right “induction regimen.”

I really don’t think one-size-fits-all, so based on the patient’s age, comorbidities, other diagnosis or the treatment drugs, family support system, financial situation, there are so many factors that go into it. We come up with an induction regimen, I’ll tell them that the second component is about controlling all the symptoms and manifestations of the disease, whether that means radiation therapy, bone-strengthening agents, multivitamins, minerals, whatever we need to do as supplements, then we’ll talk about…starting that treatment. What does it involve? Side effects, we will set that path, you will notice I have not even talked about transplant, and I’ll tell the patients that only thing I mentioned to patients in that first planning, visitors and down the road, we will be talking about transplant…

Today is not the time, because, in my experience at the moment, we start talking about bone matter, transplant, stem cell transplant everything goes out the window. That’s what patients think about…and I don’t want them to do that. The second part of my discussion comes around a month or so into the treatment, because by then we want to start seeing some responses, some symptoms turning around, but that month two to three is very importantly the time to rebuild things.

Does the patient need to go to physical therapy, pain control? Supportive or palliative care services? Lipoblasty or tuboplasty to strengthen their spine. I mentioned physical therapy, I’ll say it again, because I really think that’s very, very, very important for controlling the pain and supporting the movement and quality of life, managing any side effects, making sure that the dose is correct, do we need to tweak the doses, etcetera. And at that visit is tell them that, “Okay, very soon we will be talking about…we’ll be going into the details of a transplant, we will be passing along more information to you. But at your next visit, which would be probably at that two- to three-month mark, two- to three-cycle mark,” is when I will really sit and talk to them about our transplant…

So for me, the main transplant discussion comes at that cycle to recycle the two to three, two to three cycles have already gone and patients feeling better, they are much more receptive for the next phase of treatment, which is when we talk about transplant, that’s how I do it, typically. And then we’ll explain a lot about what this transplant need…what does it involve? Caregiver needs a supportive care, vital organ testing, bone marrow biopsy, response depth, MRD, all of that.

So for me, this is kind of the journey that a patient, newly diagnosed patient goes through for the first few months, then their transplant, then their maintenance and hopefully good long disease control state.

Lisa Hatfield:

Great, how often do you expect a patient will have to have appointments during that…talk about the induction phase, the first month to three months, how often do you think they will have appointments, whether it’s for treatment or to come see you? What should they expect that way?

Dr. Sikander Ailawadhi:

Sure, so the regimens that we typically use in myeloma, some of them, the drugs are given twice a week, a majority of the way we give the drugs, it’s once a week, so one to two times a week would be visits, we do the labs for the first month, we will do sometimes every week, but by the time the patient has gone to the second or third cycle, once every two to four weeks, labs are reasonable because by then things have stabilized, but the treatment still would, I think the once or twice every week depending upon the regimen that they have, we don’t typically see the patient for a clinic appointment every time, but a lot of centers do, so every time the patient comes, as I said, one to two times a week, typically that translates to about four visits in every three to four weeks they coming on the cycle, some regimens are three weeks regimens, some regiments are four week regimens, etcetera.

So patients come, I can say that the first one to two months are most intensive for follow-up for labs, we wanna make sure everything’s been fine, been start reading the treatment, they are not having side effects it and etcetera, and then things can be spaced out a little bit for the next couple of months before we go into the transplant thing, if the patient is going for transplant.

Lisa Hatfield:

Okay, well, great. Thanks for that information. It helps patients plan a little bit better to their life around myeloma and myeloma treatment, so we have a pretty specific question here about amyloidosis, so how often does amyloidosis occur in myeloma patients, and does it change the treatment if they do have amyloidosis?

Dr. Sikander Ailawadhi:

Excellent question again. So I would like to clarify that amyloid is a specific kind of different kind of abnormal protein that can be produced by plasma cells. All of us have these proteins that are…these proteins that are developed as very…or produced in the body is very small molecules and then they fold upon themselves to make different building blocks for the body. If that folding process is misfolded or abnormal, these amyloid fibers can develop and they can deposit anywhere in the body, and whatever the deposit they cause their symptoms. Now, amyloid can be present in two different ways, either melodies, the primary problem and is being produced by the plasma cells, or sometimes patients who have multiple myeloma and are on treatment for multiple myeloma can either start developing some amyloid protein or…or they can have amyloid deposited in certain organ, Heart, kidneys, like the gut, etcetera, the occurrence of amyloid in a myeloma patient, it’s not a common phenomenon, I would say anywhere in 10 to 15 percent of cases that we know of, maybe this present, others that we don’t pick, but once even we find out that amyloid is present in a case of multiple myeloma.

If, for example, amyloid is present in the heart, if we are using any drugs that may have some heart-related side effects, we may need to adjust doses, if amyloid is present in the kidneys, if you’re using some drugs that have kidney-related implications, we may need to adjust the dose, etcetera, broadly, the treatment stays the same, but there is a higher risk to kidneys, higher risk to heart, etcetera in amyloid patients or patients who develop amyloid, so we have to take that into account, sometimes choice of treatment changes, sometimes dose of treatment changes sometimes impact on certain organs change broadly. For a myeloma patient who develops amyloid, the treatment can stay very similar to what would have happened even if amyloid was not present, except some small tweaks.

Lisa Hatfield:

All right, thank you. Another question from a patient since my diagnosis and bone marrow transplant, my teeth have been deteriorating, is there a connection between dental health and myeloma?

Dr. Sikander Ailawadhi:

Very important question because although this is not a very common finding, it is something that really affects quality of life, so myeloma itself does not always or frequently cause teeth problems or dentition problems, which you can imagine teeth are bones. Myeloma affects bones, Myeloma affects calcium deposition in bone so teeth can get damaged in two or three different ways in myeloma patients, first, if myeloma involves the job or you can imagine that the teeth in that particular area could become loose or they could become a little off because the structure is getting affected.

Sometimes if my novels present on the job, for example, and radiation is given, but that bone becomes weaker, so teeth can become weaker, another way myeloma and dental health can be connected is because we use certain bone-strengthening agents for myeloma. These drugs are called either bisphosphonates, for example, or zoledronic acid (Zometa) or pamidronate acid (Aredia), patients may know as Zometa or Aredia, or there’s a second category called RANK ligand inhibitors, one of the drugs there is denosumab or Xgeva, these are all drugs that are given for bone-strengthening for myeloma. Patients are recommended to take calcium and vitamin D, but a rare but definitive side effect that is known to happen or can happen with these drugs is what’s called osteonecrosis of the jaw, where basically the jaw bone is becoming necrosed or less viable.

And you can imagine if the jaw is less viable, the teeth that go into the jaw in that spot, they’ll become loose and hurt, painful…it’s not a good condition to have it very…it affects quality of life significantly. So while it is rare, this osteonecrosis of the jaw can occur maybe less than 10 percent of the cases, but it is a significant morbidity-causing issue.

What I recommend to patients is that one, if that is happening, first of all, we’re not…we typically don’t continue that drug that is causing it, like a bisphosphonate or RANK ligand inhibitor. Secondly, the patient needs to see a good oral maxillofacial surgeon or a good dentist, preferably someone who has knowledge and experience in handling osteonecrosis of the jaw. So different ways in which myeloma treatment can affect the jaw, there is not a direct correlation, but in about 10 to 15 percent of cases, there may be jaw or teeth-related implications in myeloma patients either from the disease or its treatment like radiation or bone-strengthening drugs.

Lisa Hatfield:

Okay, thank you, and that’s a great segue into the next question we have from a patient, so if a patient cannot take bisphosphates doesn’t explain the reason why, are there other bone-building therapies that are recommended to protect them?

Dr. Sikander Ailawadhi:

Sure, so I would say that while we talk about these drugs like bisphosphonates, RANK ligand inhibitors, there are some other drugs that can be used to strengthen the bones, because you can imagine these bone-strengthening agents are used in a lot of different cancer, breast cancer, prostate cancer, etcetera.

So this family of drugs can be used, there are some that are used less frequently, but can be used instead of bisphosphonates and denosumab, but I would bring the patients back to even more basic stuff, calcium, vitamin D, exercise, bone-strengthening exercise. These are the first steps. Then come the other bone-modifying drugs, so even if a patient has been told that they cannot get any of those drugs because of the side effects, they could certainly say calcium vitamin D after discussing with their doctors, and they can regularly do some bone-strengthening building exercises sometimes it’s as simple as swimming, as simple as spinning, but those are like on the stationary bike, but those are extremely important activities to help build bone mass.

Lisa Hatfield:

All right, thank you. Have you ever had a patient that has reached complete response that you said, Well, maybe you don’t need to continue on bisphosphonates, that ever an option for patients to not continue after a certain period of time?

Dr. Sikander Ailawadhi:

Again, excellent question. And, in fact, historically, all the bisphosphonate-related clinical trials had up to a two-year follow-up, so a lot of times we used to say, “Well, at two years we need to stop them because there’s no safety data beyond that.” But more recently, there are studies that have shown that even every three months of bisphosphonates is as good as every month. So if somebody has active bone-affecting myeloma, then their treatment can be given every month or every three months.

But if a person has gone into remission, and remember, the myeloma was the inciting event that was causing the bone loss, if there is no disease, if there are no active bone lesions and the person is in good health, they  are active…no bone-related issues. You’ve done imaging. Everything is good. I think it certainly it can be done that the bisphosphonate can be stopped. And, of course, this needs to be actively discussed with the patient, but frankly, other than having the side effect concern, if I can have a patient not come in for a treatment and they can spend that much extra time with their family doing what they want to…I think that’s a win-win.

Lisa Hatfield:

All right, thank you. So another patient asking, I was told I’m in remission, but my light chain numbers are going up and the lambda is low. Are small fluctuations common?

Dr. Sikander Ailawadhi:

Very good question. And very important to keep in mind, yes, small fluctuations in light chains can happen as the patient mentioned, they said their light chain are going up, but lambda is low, so I’m assuming they’re talking about their kappa light chains higher and the lambda low. For light chains, the most important thing is that we don’t want just an individual isolated value, we want to see a trend if there is an upward trend in one of the values, the abnormal light chain, that is certainly a concern if the involved or the higher light chain is stable.

But the uninvolved or the lower light chain continues to go down. Well, that is still of concern, but may not mean that the disease is coming back, it may mean that the immune system is getting affected a little. All said and done, light chains are very volatile, they are very…they can fluctuate, they can get affected by our kidney function, they can get affected by our hydration status. So if there is a concern with light chains, they should be re-checked and there is a persistent movement of light chains in a certain direction that is an important time to figure out, is the disease coming back or is there another reason that the light chains are changing.

Lisa Hatfield:

Okay, how often do you check those labs in your patients, their light chain?

Dr. Sikander Ailawadhi:

For somebody who’s on active treatment, we check the light chains, we do the whole panel of myeloma lab reassessment with? Electrophoresis, immunoglobulins, light chains, we do that on a monthly basis for somebody who’s on active treatment, that they are… Some patients who are on maintenance and who are doing perfectly fine, and they typically come every three months to clinic visits on maintenance over there, although I prefer to check them every month, but I certainly know logistic challenges and frequency, so sometimes in selected cases, we’ll check it every three months, but in a patient who has been diagnosed with myeloma on treatment or has been on treatment before, personally, I don’t go beyond three months in any case.

Lisa Hatfield:

Okay, those are good guidelines for patients looking forward, especially newly diagnosed patients. All right, what are we learning about monosomy 13 in myeloma, is it a high-risk marker for myeloma?

Dr. Sikander Ailawadhi:

So, Lisa I think that’s an extremely important question because there has been historically a lot of discussion about a deletion 13, monosomy 13 deletion 13, meaning a portion of the 13th chromosome missing. Monosomy 13 meaning one…so half of the chromosome missing, because everybody has two of each chromosome, one set from the father, one from the mother, so one set is missing, that is monosomy, or one arm is missing its monosomy if a portion of the chromosome is missing deletion. Historically, quite some years ago, deletion 13 or monosomy 13 was in itself a high-risk marker, then the drugs or called the pareso inhibitor family, in which one of them is bortezomib came about and it showed that whether the patient had deletion 13 or not outcomes were similar when they got bortezomib so, it was no longer a high-risk marker.

In current day and age, there are certain mutations that are considered high risk, monosomy 13 or deletion 13 by itself is not considered a high-risk marker, but the co-presence of deletion 13 or monosomy 13 with some other mutations is considered higher risk just because it is telling us about more widespread genetic damage in the myeloma genetic material.

So for example, if somebody has a mutation called 1-Q, as some patients may read in their FISH report, if that 1-Q co-exists with deletion 13 or month, the risk of that one can is even higher. So by itself modulators, but it’s co-existence, but some other mutations bring up the risk category higher.

Lisa Hatfield:

Okay, thank you. And just to clarify for maybe somebody who’s just learning about their myeloma diagnosis and the cytogenetics of that, when you’re talking about these mutations, are you specifically talking about these mutations are only in the myeloma cells, they aren’t all in their body, and they’re overall in any other cells, just the myeloma cell.

Dr. Sikander Ailawadhi:

Absolutely, you’re spot on. So these mutations that are tested in the abnormal plasma cells from the bone marrow, which the term used for that is somatic mutation, disease-related mutations in the disease cells, these are not mutations that we were born with or we inherited, so if somebody was to take a sample from a healthy blood cell or in my lumping shop from the mouth or a spit sample that is not expected to carry these mutations, it is only the cancerous abnormal plasma cells from the bone marrow or a myeloma cell that have these mutations.

Lisa Hatfield:

All right, thanks for clarifying that. Great, what are some of the clinical predictors for relapse in myeloma and when should patients speak up?

Dr. Sikander Ailawadhi:

Okay, so when we say clinical predictors of relapse, well, let me look at this from the standpoint of a patient’s been diagnosed, they’ve been treated, which patients are more likely to relapse is one way of looking at, and if we are looking for our following up, Iain, what are we monitoring to look for relapse. So I’ll address mutates very quickly. So when we say what are the predictors of earlier relapse, the most important things that we know of are on any of the high-risk mutations we’ve been talking about, the fact that it’s standard of care to look for any genetic mutations in the center diseased plasma.

So the myeloma cells, presence of any high-risk mutations, for example, there’s one called deletion 17p to certain chromosome mutations like 14;16 translocation, etcetera. Patients should be aware of what mutations their plasma cells have, having high-risk mutations, risk of early relapse or short duration of response. Similarly, if a patient does not get a deep response to their prior treatment, they are more likely to come out of that response state sooner. One of the tests that has recently been used over the past few years, there’s something called the MRD test, minimal residual disease test, looking for one myeloma cell out of 100,000 or even one million bone marrow cells. 

If somebody’s MRD-negative, they are more likely to have a longer duration of response. If they’re MRD-positive, meaning detectable disease on MRD test, comparatively shorter duration of response, etcetera. So these are predictors of earlier relapse, there are some other predictors like kidney dysfunction, and typically that happens if somebody has persistent kidney dysfunction because they don’t typically get access to all the drugs, typically relapse occurs sooner.

Now, when somebody is getting monitored for their disease, as I mentioned, we do labs every so frequently every month, every two months, every three months. That is what involves all the myeloma markers, serum electrophoresis is to look for M spike, free light chains, look for light chain changes. We know globules look for increases in immunoglobulins, and that’s what helps pick up the recurrence of the disease.

Lisa Hatfield:

Why do some myeloma patients experience chronic kidney disease?

Dr. Sikander Ailawadhi:

So Lisa, I think that’s a very important question. Kidney dysfunction can be seen in as much as 20 percent of patients at the time of diagnosis, and there are a significant number of patients who would have kidney dysfunction even as they go on with their myeloma journey. And something that I work on quite a bit, and I’m interested in this healthcare disparities. I just want to point out that patients who are African Americans do tend to have a much higher incidence of kidney dysfunction and need for kidney dialysis with myeloma at the time of diagnosis or even with treatment. Now, I mentioned that these…or we discussed previously that these plasma cells, that normally live in the bone marrow, they produce these proteins and these proteins, heavy chains, light chains are part of our body’s immune system. But when these plasma cells become cancerous, they produce a higher amount of those abnormal proteins, these proteins circulate in the blood, and they frequently get depositing the kidneys.

So when these proteins are very high in number, an amount, these proteins can circulate in the blood and clog up the kidney tubules, and that’s where some chemical reactions also happen and kidney damage can occur. When somebody gets diagnosed with myeloma and they have kidney dysfunction, we have the option of the opportunity to reverse that kidney dysfunction if we treat the disease appropriately and with the right kind of drugs fast enough.

In fact, there is some older data study data, which shows that within the first two months, we are able to reverse the kidney function, then it is no longer a prognostic significant marker. And it’s extremely important if somebody’s kidney function is getting affected by their myeloma, that they need to be treated very aggressively to try and salvage and save that kidney function because the longer the kidney dysfunction stays, it is quite possible that it may become irreversible.

Lisa Hatfield:

Okay, thank you. So this next question has to do with the sequencing of treatments, which again, speaks to the fact that it’s super important to see a myeloma specialist, but the question is what treatments are available for myeloma patients who relapse after care?

Dr. Sikander Ailawadhi:

Very, very important question, and unfortunately a tough situation that we are dealing with because CAR T initially has been used for later lines of therapy as it is currently FDA approved with time, hopefully it will start making it may sooner in the treatment also, but when a person…when a patient has had treatment with CAR T, generally, they have already had treatment with most of the standard available drugs prior to CAR T, because the way CAR T is currently FDA approved is the patient has to have at least four prior lines of therapy, and generally, at least in the U.S. system, with the first three to four regimens or lines of therapy, we’ve already seen and exhausted most of the available drugs.

So you can imagine most CAR T, there is less drug availability that the patient has not had before or may not be resistant to, but if the CAR-T response lasted long enough, sometimes we are recycling some of the drugs after previously used, and the patient may respond to them again.

Another thing to think about in that place is from my standpoint, clinical trials are extremely important and patients must seek clinical trial options, as you mentioned, again, important to see a specialized myeloma center, but one of the drugs that was approved in 2022 bispecific antibody, teclistamab (Tecvayli), and there are some other related by specific antibodies which have actually shown some benefit despite the fact that they also target BCMA, which art targets, but patients who had prior BCMA therapy still had a very good response rate to, for example, teclistamab or some other…bispecific antibodies in clinical trials, so I don’t say that everybody who’s been treated with a BCMA CAR T should go immediately to a BCMA and bi-specific may not be the best option in all cases, but sometimes recycling older drugs in certain different combinations, clinical trials or options promising options like bispecific antibodies. We do have more jobs today than even what we had a year ago for patients who are progressing after CAR T-cell therapy.

Lisa Hatfield:

And that is really promising, I think as more and more people get CAR T-cell therapy and perhaps start to relapse. It is great to know that there are other options out there. They’re even, like you said, recycling some of those prior regimes that were used, and even talking about CAR-T therapy or clinical trials, this next question has to do a little bit with the disparity and access for myeloma treatment.

So the question is, myeloma treatment is expensive, with quadruplet therapy options, what measures are being taken that can help patients to have equal access, and I think that we can also add clinical trials to that too. Is there anything being done, or how can you encourage patients to have equal access, whether it’s the drugs themselves or clinical trials?

Dr. Sikander Ailawadhi:

So absolutely, I think, Lisa, that’s an extremely important question as I mentioned, this area of healthcare disparity in health care, inequity, for example, is something I’ve spent a lot of time doing my research my career and publishing in this area. Unfortunately, in today’s day and age, we still have a lot of these disparities that exist, patients may not get access to the right drug or the  right time because of their geographical region, because of their insurance, their education status, socioeconomic status, and sometimes even in other…situations being similar, just their race and ethnicity. Age is an important factor.

Also, I would say there…I think the important part is that it is much more knowledge, awareness, and intent to do something about it now, there’s, for example, in the forthcoming clinical trial that should be opening for really diagnosed patients across the country, soon through NCI and CTAC where the trial has been specifically designed to do it in as close to real world setting as possible, and when we were writing that trial, there’s a specific racial, ethnic minority accrual plan that we are writing around it, and that’s not…I would say just that trial, there are trials that are now specifically going in trying to enroll patients as much as possible from the real world and all walks of life.

And that’s said. I think the bigger question comes, like you started the question by asking the trials are there…we are trying to make a difference for trying to make some changes, changing the inclusion criteria so that patients would even now our accounts can go in, etcetera, etcetera. What about the drugs that are already available, quadruplet therapy, which is a pretty, I would say, demanding approach, because the patient needs to get multiple drugs multiple times, frequent visits back and forth to the clinic, co-payments office visits, labs, etcetera. It’s not easy.

Unfortunately, there are certain groups within our society that would have difficulty getting those access, but there are lots of resources that patients and caregivers can access, and hopefully those…help share some of the burden. These are either from the pharma companies or they could be from foundations or societies like the The Leukemia & Lymphoma Society and several other such concerns whose goal is to try and provide an equitable and just access to the drugs and how to get the most evidence-based treatment to every single patient.

So there are quite a few of these efforts in our practice, what we strongly recommend is that the patients, of course, get this knowledge and information through support groups, through their physicians, but also searching for this information online or in a lot of the larger institutions, meeting with the social worker frequently helps gain access to our information about a lot of these resources. So I think a lot of work has been done there, but to bring it down to an individual patient’s level, how can I as a patient get access to something…

I think the patients will have to ask those questions either from their physician, their care team, a social worker, online resources, support groups, that information is out there, we are trying our best to get it to patients that hopefully patients can seek out some of that as well.

Lisa Hatfield:

Thank you for that. I think that’s a really important thing to bring up is the access to healthcare, we do have people in our local area, because we are a smaller community, were unable to seek out the care of a specialist and it has had a detrimental effect on their outcomes. And so I think having that discussion and being open to your patients so you can’t have a discussion or even refer them to the social worker is so important, so all patients get equal access, it’s one less thing that patients have to worry about when they’re already…stressed and overwhelmed with their diagnosis, so thank you for explaining that. Thanks for talking about that. We sure appreciate it. 

So for myeloma patients, even though our insurance companies, sometimes we have to argue with them a little bit as if we’re beating down doors to get a bone marrow biopsy, nobody loves those, I’m not sure why insurance companies think we would actually want that. But what do you see in the future, I know there’s talk about mass spectrometry. Every myeloma patient would love to hear the words, you’ll never have to have another bone marrow biopsy.

Do you see a future in that and some of these newer tests that are coming out?

Dr. Sikander Ailawadhi:

Sure, I think that’s absolutely important to know because…yes, that’s the bane of our existence, unfortunately, disease primarily lives inside the bone marrow, so to get the true information…that’s where you go. So there are some tests that are being developed or researched, patients may have heard about what’s being termed, the liquid biopsy or taking a blood sample to identify plasma cells or disease, there’s a lot of research going on around it. But, unfortunately, it has not panned out yet, because by nature, plasma cells do not circulate in the blood, or if they circulate, it’s a very, very small amount, so it’s hard to pick it up from the blood and do the tests on it. But there’s a lot of research going on for it to get the plasma cells, get the FISH testing, and all the genetic testing from the blood. So stay tuned, hopefully we’ll get in that direction.

What you also mentioned, a test that’s been developed and done at Mayo Clinic is what’s called m-aspect or looking at these proteins, these M spikes, these light chains, the IgGs, etcetera. Looking at them at a molecular level and separating them based on their weight, because IgG kappa, for example, from one patient may be different from the IgG kappa that came from a different patient, but they can be separated out based on the weight, based on the molecular weight…on the size, and that can sometimes be used that how the test has been developed to use that property to identify and almost catalog and tabulate and follow that patient’s protein, so that we can hopefully collect or detect a recurrence sooner, note a deeper response to the treatment.

And in the future, hopefully, use that depth of response and that earlier recurrence as…or earlier detection of the protein as a surveyable matter of recurrence. I still think that it’s two different things, one is to look at the protein and note it at a deeper level to know whether the patients responded or relapsing, but so far, if you want to do those rotation testing, the FISH testing, and look at some of the characteristics of the myeloma, unfortunately, we do have to go to the bone marrow, but down the road, I’m hoping that those liquid biopsies and the blood tests will hopefully make it happen.

Lisa Hatfield:

Well, that would be music to my ears, even fewer biopsies would be great, so that would be awesome. Well, this was a great conversation, Dr. Ailawadhi, thank you so much on behalf of myself, and I’m sure a lot of myeloma patients and family members watching this, they’re so thankful and grateful for the time that you spend with us answering these questions, so thank you very much for your time, thanks for your expertise and I hope you enjoy the rest of your afternoon.

Dr. Sikander Ailawadhi:

Thanks a lot, Lisa. Thanks for having me, and I hope this was beneficial and interesting for the patients and their caregivers.

Myeloma Research: What’s the Latest Treatment News?

Myeloma Research: What’s the Latest Treatment News? from Patient Empowerment Network on Vimeo.

Myeloma expert Dr. Rafael Fonseca shares updates from recent conferences and provides tips to help you stay up-to-date on myeloma research developments.

Dr. Rafael Fonseca is the interim director of Mayo Clinic Cancer Center and serves as the director for Innovation and Transformational Relationships at Mayo Clinic in Arizona. Learn more about Dr. Fonseca here.

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Transcript:

Katherine:

Dr. Fonseca, have there been any recent developments in myeloma treatment in research that make you hopeful?

Dr. Fonseca:

Absolutely. I would say that the one area of work that makes me most hopeful is what we’re seeing with immunotherapy. We have seen that both as the ASH meeting, as well as the ASCO meeting in this year, where people are presenting updates with the various clinical trials with either bi-specific antibodies or CAR T-cell therapy as a new avenue for the treatment of myeloma.

In fact, at the last ASH meeting, we had 14 presentations of different compounds or different constructs that are active.

I think the future is bright in that regard. We’re seeing their application right now. A lot of these updates have also been made at ASCO.

We’re seeing the update of the treatment of treatments with fairly advanced and aggressive disease where we can still show very significant responses. I participate in some of these trials. I can tell you in my institution, using some of the bi-specifics, I see patients who have previously exhausted all of their options and now are MRD-negative at 10 to the -6.

If we’re seeing that in the very advanced disease, I cannot wait to see what happens when we start using these treatments in either early relapse and why not in the near future as frontline part of our therapy? I think to me, that whole field of T-cell engagers, where there’s bi-specifics or the CAR T cells remains one of the most exciting areas for future research.

Katherine:

How can patients stay up to date on information like this?

Dr. Fonseca:

I think what we alluded to before is very important to work with groups like yours and other patient support organizations that can keep them up to date. I think they’re doing a very good job at also providing updates post some of the large meetings. I know there’s a lot of patients out there that are very sophisticated that will even join the medical meetings. That happens with some frequency; that they want to learn, and patients that go and ask me details about the statistics of the trial. That’s a whole spectrum, right?

But at the minimum, I would say a strong connection with a support group, or a patient support organization becomes an imperative as you deal with

this. Also, that would help you because with this whole concept of the information not always being complete and truthful, that can be scary as well, too.

If someone goes and just looks for, I would say even some of the resources that are out there in a textbook today, just keep in mind that textbook was probably written five years ago, and it represents the studies of about 10 or 15 years ago. How that relates to you, it’s very distant. So, it is because of this continuous process of research that we know better what’s going on at the present time.

How Will I Know If My Myeloma Treatment Is Working?

How Will I Know If My Myeloma Treatment Is Working? from Patient Empowerment Network on Vimeo.

How do multiple myeloma experts determine if treatment is working? Expert Dr. Rafael Fonseca explains factors that are examined when assessing treatment effectiveness and why it’s important for patients to speak up about side effects. 

Dr. Rafael Fonseca is the interim director of Mayo Clinic Cancer Center and serves as the director for Innovation and Transformational Relationships at Mayo Clinic in Arizona. Learn more about Dr. Fonseca here.

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Transcript:

Katherine:

Once on therapy, how is the disease monitored, and how do you know if the treatment is working?

Dr. Fonseca:

Well, fortunately, we use the same markers. Once a person is in therapy, we will be monitoring. We monitor at least on a monthly basis of those myeloma protein markers. Once a person reaches a great level of response, sometimes we complement that with an analysis of the bone marrow. Of course, it’s more invasive, so we don’t like to do a lot of them, but we do them as needed. As we go forward and monitor patients, we will be looking for signs that those proteins remain in a low level as stable as an indicator that the disease is under control.

Now, if I saw someone and then I start seeing that there’s an increased concentration of those proteins or we see something else clinical, we might need to do a little bit of a regrouping and test again in great detail to determine if the person is experiencing regrowth and the disease is so-called relapsed.

Katherine:

Why is it so important for patients to speak up when it comes to symptoms or treatment side effects?

Dr. Fonseca:

Well, that’s a great question. If you don’t speak about them, we don’t know about them. It seems very obvious, but then we cannot make the proper adjustments. I’ll give you a couple of examples. I already talked about dexamethasone, but a common drug we use is something called bortezomib. Bortezomib is a proteasome inhibitor.

That’s a mouthful, but it’s one of the key type of drugs we use. It’s given as an injection under the skin. Not to be confused, by the way, with daratumumab. Faspro is the name of that medication, so not to be confused with that is bortezomib, which we have been using for many years.

Bortezomib has a potential toxicity that is called peripheral neuropathy. If patients have peripheral neuropathy, that can go from very mild where you have some numbness and tingling, to the more extreme cases that it’s associated with pain, discomfort, even weakness and disability.

Well, if we don’t know that’s happening, then we can’t react to it and we can’t adjust doses or switch to something different altogether. You can imagine now we have more options, but in the old days, I always tell patients, “You might be tempted not to say anything about this because you might be thinking, boy, this is working. I don’t want to interfere with my treatment. I can live with the peripheral neuropathy.” But if it gets worse, despite the fact that the treatment is working, the person might have a very significant impingement on their quality of life.

More so now that we have so many alternatives, it’s important not to get us into a path that we might reach a point of an irreversible chronic complication from treatment.

What Can Newly Diagnosed Myeloma Patients Expect When Starting Treatment?

What Can Newly Diagnosed Myeloma Patients Expect When Starting Treatment? from Patient Empowerment Network on Vimeo.

As a newly diagnosed multiple myeloma patient, the thought of treatment can be overwhelming. Expert Dr. Rafael Fonseca shares insight about expectations when starting a new treatment, and what goals providers have in mind for patient care.

Dr. Rafael Fonseca is the interim director of Mayo Clinic Cancer Center and serves as the director for Innovation and Transformational Relationships at Mayo Clinic in Arizona. Learn more about Dr. Fonseca here.

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Transcript:

Katherine:

Dr. Fonseca, we have a question from a newly diagnosed myeloma patient. Barbara says, “I am just about to begin my first myeloma treatment. What can I expect?”

Dr. Fonseca:

I think if you start on treatment, first of all I hope they already went through a good description of what the treatments are, the frequency by which you’re going to have to go to the center, and also what are the toxicities to look out for.

One of the most common toxicities that we face and one of the most challenging parts of initial treatment is the use of steroids. So, we use dexamethasone as part of every single regimen we use for myeloma. I tell patients, “Dexamethasone is a simple drug at first glance, but it’s oftentimes the most complicated part of treatment.”

The human brain works at triple speed when you’re on dexamethasone. So, it’s hard to sometimes be able to sleep properly. People can become anxious and even the sweetest person in the world can become a little bit edgy on dexamethasone.

I always say Mother Teresa on dexamethasone would be an edgy person. Just be patient. Work with the team. Just know that on the other side of treatment there is a return to normal life.

Our goal as we embark on treatments and, for instance, is I see patients that are going to go through transplant, I tell them, “Our goal is you finish, you recover, and you go back to your life. You back to work. You go back to your family, your kids, your sports.” That’s really what we strive for when we treat patients with myeloma.

What Key Questions Should Myeloma Patients Ask About Treatment?

What Key Questions Should Myeloma Patients Ask About Treatment? from Patient Empowerment Network on Vimeo.

Myeloma expert Dr. Rafael Fonseca shares specific questions that patients should ask about their treatment plan, and explains how to ensure optimal care for specific myeloma subtypes.

Dr. Rafael Fonseca is the interim director of Mayo Clinic Cancer Center and serves as the director for Innovation and Transformational Relationships at Mayo Clinic in Arizona. Learn more about Dr. Fonseca here.

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Transcript:

Katherine:

What sort of questions should patients consider asking about their treatment plan?

Dr. Fonseca:

I think it’s important that patients understand a few things. They can be described in multiple ways. Number one is, of course, what? What is it that is being used? I think that includes a description of what to expect, the practicalities, the names of the medications, their side effect profile, and what to report when you use those medicines. I think that’s very important because if you’re empowered with that information, you’re going to be better off as you react for symptoms that may come along. I always tell patients when you have a cancer diagnosis, your self-awareness goes through the roof because we’re going to be paying attention to everything, every skin change, every pain we have.

So, I think having a bit of that proactive discussion becomes important as they think about the treatments that they want. I think the how-to on the practicalities are very important. The best where the nursing team and the pharmacists help us a lot too. Do you take the medicines at night? Do you take them with meals? Is there something that you shouldn’t be mixing? How much time would it take for me to get a refill? It’s different to get a medication from a specialty pharmacy versus your down-the-street Walgreens. So, all of those things are important that patients, again, participate in the understanding.

If not them, at least the caregivers that are a part of this team. I think it’s important that patients ask also some brief descriptions of (A) the biology of the disease. If I have myeloma, what type of myeloma do I have? Does that matter as far as what treatments I’m going to be using? What treatment options may be available to me because of my specific subtype? We have subsets of myeloma that have options that are not available to others.

Also, I think it’s important that patients also ask a sense from the physicians as to where they are. I’d like to describe this a little bit more. Sometimes, patients ask us specific questions about, am I in a complete response? Am I in a very good partial response? What is a PFS? Those terms work very well when we talk about clinical trials, but they don’t necessarily describe in a great way the situation for an individual patient. I’d use a lot more objectives than I’d use technical terms when I describe where patients are. I say, “You have an excellent response. You have a very deep response.”

Then I’d provide more details if they want. “Yes, you’re MRD-negative at 10 to the -6.” But sometimes I find that it’s harder for patients to understand where they are if they completely focus on the staging system or the response criteria, etc.

Because maybe a VGPR, a very good partial response, doesn’t sound very good.

But then you can be in a very good partial response for 15 years and it doesn’t matter. You my want to be in an MRD-negative status, but you still have a good outcome. That’s why the general description of the status by a physician becomes important.

Katherine:

Do you think patients should get a second opinion consult with a specialist?

Dr. Fonseca:

In general, my answer is going to be yes. This is not self-serving. I think myeloma has become so complex that trying to integrate at least once, or if not, in some infrequent basis, an opinion of a myeloma specialist becomes important. This is no one’s fault. If you’re a community oncologist somewhere where myeloma represents only a small fraction of your practice, I can guarantee you, you cannot stay on top of the literature. I cannot stay up with everything that goes on with myeloma, even though that’s what I do 100 percent of the time.

I get an email every week with all the articles, all the publications, and I have to integrate that. I have to think, okay, does this matter or not? I go to the professional meetings. I see all the abstracts and I still feel like I’m missing out. How could you do that if that is only a small fraction of your practice? I’m sure that the same applies for other cancers, breast and colon. You can’t move. You cannot uproot yourself and leave your community and your family, but I think there should be ways by which patients at least have an opinion from someone who has more expertise. Fortunately, there are many centers across the nation now that have that expertise for the management of myeloma.

Myeloma Test Results and Factors That Impact Treatment Decisions

Myeloma Test Results and Factors That Impact Treatment Decisions from Patient Empowerment Network on Vimeo.

Myeloma expert Dr. Rafael Fonseca reviews considerations that impact treatment choices, including the role of test results and how quality of life can factor in when choosing therapy.

Dr. Rafael Fonseca is the interim director of Mayo Clinic Cancer Center and serves as the director for Innovation and Transformational Relationships at Mayo Clinic in Arizona. Learn more about Dr. Fonseca here.

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Transcript:

Katherine:

What other factors do you consider when determining a treatment approach?

Dr. Fonseca:

The human experience that comes to the bedside as we consider treatments is so multi-factorial and multi-complex that all that needs to be brought into consideration. Whenever I walk into the room, I tell residents usually the medical part can be resolved pretty quick, but we’re reading how much we can communicate? What’s the level of understanding? What do I understand about the support system for this person? Is there someone who can drive to the treatment center? Is there someone perhaps whose other medical conditions would create certain challenges in how they’re going to be treated?

This person is telling me they do daily hikes for four miles. Well, that’s different from someone who I see comes into the clinic and has to use a cane. We try to integrate all of that information to make the right decisions. I’ve made a lot of my career in the early years working and showing how, for instance, genetic factors are important. I’ve come to realize later in my career and through some of the very elegant work that other colleagues have done, that these factors are just as important in determining the ultimate outcome of patients. Whenever I talk about that clinical experience, there’s two things I always tell the residents.

I use the residents a lot because I think it’s a good example of how we aspire to interact with patients. Number one is every single encounter is a final exam. You have to put your best foot forward. Every single encounter should be considered a final exam. Number two is when I walk into that room, there are three things I do, particularly the first time I meet a person.

Number one is connect, right? We cannot have a conversation and I’m not going to be able to move forward unless we have a human connection and I have gained the trust of the patient and the family members that are there. That’s number one. The second point is decide. That is usually okay, we’re going to do this treatment or that. That is a small part. Most of the time for me, that’s a very small fraction of the time and of the mental energy that I consume. There are cases that are more complicated, but most of the time it’s pretty straightforward. So, it’s connect, decide do very small, and then on the other end is explain.

So, that’s how I can connect. I propose we do this, and then why we are going to do it and what can you expect. If you can do those three things, I think that goes a long way in establishing a fruitful and a productive relationship with a patient and their families.

Katherine:

I would suspect that you also take into consideration the patient’s health, their age, maybe test results, side effects, things like that?

Dr. Fonseca:

Of course. So, we look at the medical record and with the advent, of course, of the electronic record and all the tests that we do, our consideration is quite complex. We have to look at all those factors, and the age, and comorbidities. It’s rare that we would take one factor alone that would trump everything else. We usually have to integrate the information. The same is true when we manage myeloma patients and we’re monitoring their protein levels and their response to treatment. I tell patients, they ask me, “What would you do? What’s the magic number for this or that?”

I say, “It’s a little bit like you’re flying a Cessna plane and you have all these dials in your dashboard, and that’s how we manage the situation is the integration of all of that information.”

Katherine:

Right. Can you help us understand, Dr. Fonseca, how test results may affect treatment options?

Dr. Fonseca:

Sure. Happy to do that. In myeloma, we are very fortunate in that we have, and it’s not the topic for today, but we have the best biomarker that exists for any cancer. That is that we can measure the proteins that are associated with the growth of the cells. We have multiple tests that we can do. We do them in the blood and we do them in the urine. They’re simple tests that have been done for decades now that allow us to monitor how a person is doing with regards to their disease. I use the following analogy. Myeloma cells live inside the bones, as I mentioned, in the bone marrow.

They don’t come out into the blood. So, we cannot measure them. Indirectly, we can measure how many they are and how they are behaving by measuring this protein. I use an analogy of imagine you’re walking in a street, and you see smoke coming out of a building. There are two things you can do. First is you diagnose that there is a fire inside the building, right? We see that with myeloma by measuring these abnormal proteins.

Then as a firefighting team comes on, you can gauge whether they’re making progress or not by the amount of smoke that comes out. That’s exactly what we do when we monitor myeloma. We monitor the M-spike, the serum free light chain, the urinary proteins. That’s how we make those determinations.

At the same time, we do that, we have to look indirectly at the rest of the body. We have to look at the kidney function. We have to look at the blood counts. We have to look at the hemoglobin and the red cell count because that can A) start on the wrong foot because of the myeloma itself, but B) can also suffer as a consequence of our treatment.

It is, again, that idea of having the multiple dials in the dashboard that allow us to reach our practice. We have to be adjusting. So, if we measure the proteins and we’re doing great, but then at the same time we see we’re suffering in blood counts, and we may need to adjust those as we provide supportive treatment. If we don’t see the proteins go down, then that may mean we need to change to a different form of treatment or that the person is unfortunately a refractory or relapsing to something.

So, that’s how we integrate the test results into our management.

What Are the Goals of Myeloma Treatment?

What Are the Goals of Myeloma Treatment? from Patient Empowerment Network on Vimeo.

Choosing a multiple myeloma treatment involves assessing and determining goals. Expert Dr. Rafael Fonseca shares insight about treatment goals and how decisions may be approached for the best care for each patient.

Dr. Rafael Fonseca is the interim director of Mayo Clinic Cancer Center and serves as the director for Innovation and Transformational Relationships at Mayo Clinic in Arizona. Learn more about Dr. Fonseca here.

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Transcript:

Katherine:

What are the goals of myeloma treatment from a clinical perspective?

Dr. Fonseca:

I’ve been very fortunate, also, to live through this era when we have seen a plethora of studies and new drugs being approved for the treatment of myeloma.

When I first started, I used to say no one wanted to do myeloma because we didn’t have good treatments. People wanted to study leukemia, lymphoma. It just turns out that this is probably one of the most vibrant areas of hematology from a science and from a clinical research perspective, of course. If I see young patients who have multiple myeloma, I have essentially two goals. The first one is to induce the deepest possible response I can do so in a safe manner. I also repeat, “in a safe manner.” But I really have the goal to try to induce the deepest response possible because that has translated and continues to translate, and in many ways proven to be associated with an improvement on their longevity and the time we can control the disease.

And it leads me to second goal, and that is that I firmly believe there is a subset of myeloma patients that are cured from their disease.

Now, this is possible because of the availability of these new treatments. I will only be able to say that in 10 and 15 years from now, when we have monitored patients for a long period of time, and we have been able to see that became true. But by all indicators, we have patients that are living many, many years without the disease coming back. I think that would be important. Now, we have patients that with more advanced age sometimes it’s difficult to propose some of the most intense form of treatments like stem cell transplants.

We don’t do a lot of that in individuals over the age of 72 just because the toll that it takes on a person is very high, and the risks become higher. But still, in that population, providing the best treatment possible becomes a goal because I think more and more, we’re seeing patients in that age category that can start to get close to what normal life expectancy would be. It’s not there. It’s not perfect, but you start to get close. Lastly, if someone asked me, I have that balance between quantity and quality, the good news in myeloma, if you do it right, quantity and quality go hand in hand.

So, effective treatment provides symptom relief and provides durability of responses

How Can Myeloma Caregivers Provide Support?

How Can Myeloma Caregivers Provide Support? from Patient Empowerment Network on Vimeo.

Some multiple myeloma caregivers may be unsure or overwhelmed in how to move forward in supporting a patient. Expert Dr. Rafael Fonseca shares advice for caregivers to assist in practical matters, decision-making, and providing emotional support to their loved one.

Dr. Rafael Fonseca is the interim director of Mayo Clinic Cancer Center and serves as the director for Innovation and Transformational Relationships at Mayo Clinic in Arizona. Learn more about Dr. Fonseca here.

See More From Engage Myeloma


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Transcript:

Katherine: 

We have a question from the audience. This one is from Sarah. Her question is, “What advice do you have for caregivers? How can I be supportive during appointments?”

Dr. Fonseca:

That’s a great question.

I have experienced this both as a physician, as well as a caregiver myself to someone who has had a cancer. I think I’m going to say that there are several roles that caregivers play. Some of them are obvious and I’m going to call them practical or perhaps even pedestrian, you know, organizing the activities of every day. That’s important, but a lot of people can do that. The second role is to be in assistance for the knowledge that is needed for some of this decision-making. Sometimes patients can be overwhelmed, and we need some support and some vetting and peer process from a trusted and loved person so you can go through that.

That is very helpful, but what is essential, and the number one thing is you are first and foremost the loving family member or friend of that individual who is living through a very profound human experience. I think the first role of a caregiver has to be to express that role.

I, myself, reflect on moments where perhaps in a quick, reactive way I wanted to solve some of the immediate practicalities and what was needed most was a direct support. Even if I face a situation today, if I was, again, a caregiver for someone with a serious diagnosis with cancer, I would start with that priority. Number one, you are the support and the loving person. Number two is I will try to provide information. And number three, hopefully you can help with meals and the driving and what have you. But there’s many more people who can come and help in that regard. Not a lot can do the first part.

How Can Myeloma Patients Take an Active Role in Their Treatment and Care?

How Can Myeloma Patients Take an Active Role in Their Treatment and Care? from Patient Empowerment Network on Vimeo.

Expert Dr. Rafael Fonseca explains shared decision-making, and encourages patients to take an active role in their care and treatment to aid in improved outcomes. 

Dr. Rafael Fonseca is the interim director of Mayo Clinic Cancer Center and serves as the director for Innovation and Transformational Relationships at Mayo Clinic in Arizona. Learn more about Dr. Fonseca here.

See More From Engage Myeloma


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How to Make an Informed Myeloma Treatment Decision

What Are the Goals of Myeloma Treatment?

Myeloma Test Results and Factors That Impact Treatment Decisions


Transcript:

Katherine:

Yeah. Lately, we’ve been hearing this term, “shared decision-making,” which basically means that patients and clinicians collaborate to make healthcare decisions, and it can help patients to take a more active role in their care.

I’d like to get your thoughts, Dr. Fonseca, on how best to make this process work.

Dr. Fonseca:

We are very fortunate to live in this time of medicine, where ultimately, we recognize that the patient is the person expert. It is the patient decisions that should drive what is to be done in a situation. Whenever I interact with patients, I tell them, “Listen, I’m going to be like your counselor. I will provide you with options of what I think is reasonable. I will go to different degrees of effort in trying to convince you one way or another for a particular intervention. But at the end of the day, I only do a good job if I present you with the options and the pros and cons of those various approaches.”

I weave that into my language on every single conversation we have with patients. I think we’re way past the time where a physician would come and say, “This is what you’re going to do,” or “This is what will happen.” My language always includes, “I would recommend this.”

“I think the next best step for you to consider would be X, Y, or Z.” But ultimately, I look at patients and not infrequently at the person next to them, a family member or a close friend, and I say, “You’re the boss and with the person next to you providing additional support, comment, and guidance, we can together reach the best decision of what should proceed.” I think we’re incredibly fortunate because patients have access to sophisticated information, especially patients that have serious conditions such as would be cancer and, in my case, myeloma.

As an example, when I work with general internal medicine residents that work with me learning about hematology, I sometimes tell them, “You’re going to walk into a room. Are you going to be seeing what I say, this is like a tennis match between professionals. Are you going to see the level of questions that patients are going to be asking me? They’re going to be asking me about the latest study that was presented at this meeting and the P value and this and that.”

“I can guarantee you that you would not have the tools to be able to address all those questions, simply because there’s such an in-depth understanding of the disease.” I realize this is not everyone. I’m giving you an extreme example. There are individuals that need additional support, more resources. But just to interact with someone who has such commitment to understand their disease and to help us by that understanding make the right decision makes my job so much more rewarding.

Katherine:

What do you think is the role of a patient then in their care?

Dr. Fonseca:

I think it needs to be … I’m describing in some detail and there’s a lot to unpack there. Of course, patients are dealing with a very serious diagnosis. It’s okay to have periods where they are in a pause moment and they’re reflecting of what their facing, and that they can gather information from close family members.

I think we, as providers and the medical team, need to deliver a message that provides clear options for them as far as what the best next phase of their treatment or their management might be, including observations or supportive care. But the patient ultimately is a person who has to make that decision. I frequently get the question, and this is not surprising, and it happens all the time. A patient tells me, “What would you do if this was a family member?” I always tell them, “I always talk to you as if you were my family member, as if you were my brother, my mother, my father.

So, I try to live deeply to that fiduciary responsibility I have to your well-being. I recognize that there are circumstances, and that’s part of the finesse and the art of medicine, that I have to help a little bit more walk you through that step. Sometimes, it’s just human that one may want to say, I just want to disconnect. Maybe I’m not the person that wants to go and read in detail. But perhaps I have my daughter or my son who are helping me and understand better where things are.”

I think one of the key aspects of my role is to make sure that I have a sense that the person has a good understanding to be able to make an informed decision. At the end of it all, if the person decides to proceed in such way that doesn’t necessarily align with what I’m trying to do, I’m deeply respectful of that choice. I will go to extra lengths. So, if someone is foregoing treatment, when I know their treatment has a high likelihood of improving their quality of life, relieve a symptom, or improve survival, I don’t think I would do a good job if I don’t present why that’s so important. But ultimately, it is the patient’s decision.

Who Is On Your Myeloma Healthcare Team?

Who Is On Your Myeloma Healthcare Team? from Patient Empowerment Network on Vimeo.

Myeloma patients have key team members involved in their treatment and care. Expert Dr. Rafael Fonseca provides an overview of the members of the healthcare team and how they play a role in providing optimal patient care.

Dr. Rafael Fonseca is the interim director of Mayo Clinic Cancer Center and serves as the director for Innovation and Transformational Relationships at Mayo Clinic in Arizona. Learn more about Dr. Fonseca here.

See More From Engage Myeloma


Related Programs:

How to Make an Informed Myeloma Treatment Decision

How Can Myeloma Caregivers Provide Support?

How Can Myeloma Patients Take an Active Role in Their Treatment and Care?


Transcript:

Katherine: 

When a person is diagnosed with myeloma, they usually have a whole healthcare team. Who is typically on that team?

Dr. Fonseca:

Absolutely. Let me start by saying the key to the successful management of myeloma is to have a well-organized team. It’s a disease that requires an integrated approach that usually brings around the patient a physician.

As part of my team, we also have advanced practice providers. We work with nurse practitioners that help us do the longitudinal care of patients. We have the nursing team. Every time I meet a new patient, I make it a point to bring my nursing team into the room so they can put a name and a face together, as patients will be interacting, of course, with a nursing team through the portal and the various visits. We have a team that is in charge of the chemotherapy administration. That is usually a separate a nursing team that is in charge of the administration of the medications. But we really don’t stop there.

We have pharmacists who help us review the medications for our patients. Very importantly, we have social workers that help us address psychosocial needs, as well as some of the practicalities that become inevitable when one deals with a serious diagnosis like multiple myeloma.

How Does Myeloma Begin and Progress?

How Does Myeloma Begin and Progress? from Patient Empowerment Network on Vimeo.

Myeloma expert Dr. Rafael Fonseca explains where myeloma begins, how it develops over time, and defines key terms for understanding myeloma.

Dr. Rafael Fonseca is the interim director of Mayo Clinic Cancer Center and serves as the director for Innovation and Transformational Relationships at Mayo Clinic in Arizona. Learn more about Dr. Fonseca here.

See More From Engage Myeloma


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How Can Myeloma Patients Take an Active Role in Their Treatment and Care?

Myeloma Treatment Decisions: What Should Be Considered?

Who Is on Your Myeloma Healthcare Team?


Transcript:

Katherine: 

Dr. Fonseca, to level set with our audience, can you help us understand myeloma?

Dr. Fonseca:

I’m happy to do so. Multiple myeloma is a cancer form of the bone marrow that arises when the cells that under normal circumstances protect us by the formation of antibodies. These are called the plasma cells. They become malignant. Myeloma is the last stage of a process where a plasma cell can go through a benign tumor or benign phase, if you may, something we call the monoclonal gammopathy, which by the way is quite common. About two percent of people over the age of 50 have this abnormality. Think of it like the colon polyp, a precursor condition.

There’s an intermediate stage that we call smoldering multiple myeloma, which is just more growth, but not quite at the level that it creates problems for the individual.

Then lastly, what we just simply call multiple myeloma, and that is when the growth of those cells becomes of such magnitude that a person starts having problems or starts having symptoms related to that. 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.

Lastly, the myeloma cells product proteins and some of the fragments of those proteins can be damaging to the kidneys. Occasionally, people will present with decreased kidney function and sometimes outright failure of the kidneys. Those are the common presentations. It is a disease that mostly affects people in their 70s. It is not something that you can detect through routine testing; it’s just indirectly we start seeing abnormalities and then we do the right testing. If anyone is hearing this, of course, they need to have a detailed discussion with their own provider.

Are COVID-19 Vaccines Effective for Myeloma Patients?

Are COVID-19 Vaccines Effective for Myeloma Patients? from Patient Empowerment Network on Vimeo.

Myeloma expert Dr. Rafael Fonseca shares what’s currently known about COVID-19 vaccine immune response and what he advises for his patients for their optimal protection.

Dr. Rafael Fonseca is the interim director of Mayo Clinic Cancer Center and serves as the director for Innovation and Transformational Relationships at Mayo Clinic in Arizona. Learn more about Dr. Fonseca here.

See More From Engage Myeloma


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NCCN Guidance on Safety and Effectiveness of COVID-19 Vaccines for Cancer Patients

Who Is on Your Myeloma Healthcare Team?


Transcript:

Katherine: 

We’re hearing that the COVID-19 vaccine is safe, but how effective is it for myeloma patients?

Dr. Fonseca:

Thank you. I think that’s a fundamental question. It’s hard to know precisely how to gauge effectiveness when it comes to vaccination because historically, we know that is done by measuring antibodies, and there are a number of publications that are addressing this.

The concern has been two-fold. One is that because the disease itself is something that starts from the person’s immune cells become cancerous, that perhaps that would prevent them from having a very good response. Number two, and perhaps more importantly, will the treatments that are used for myeloma, etc. or lymphoma, can they interfere with our ability to mount an effective immune response? I think the response is mixed right now. I think I tell all my patients the upside is much better than the downside. I think we have a good record now of the safety of this product. I encourage everyone to get their vaccination.

I think it’s important to discuss this with your healthcare provider because sometimes people say, “Should I stop a little bit so that I can get a better response?” While it’s theoretically possible, we don’t want people to stop treatment if they don’t have to do that. Just my very last quick comment, the good news is that the community transmission is clearly going down as more and more people have participated in the vaccination.

We have more people who now have participated in this level of immunity that we have in the community. Hopefully, for patients as well as for their families, the risk of contracting this will continue to decrease.

Tools for Living with Cancer and COVID-19

Tools for Living with Cancer and COVID-19 from Patient Empowerment Network on Vimeo

Breast Cancer Network Manager Mary Leer highlights the importance of a previous interview with Dr. Shaji Kumar focused on COVID-19 and cancer. In the original interview, Empowered Patient and Care Partner Ask the Expert: Addressing COVID-19 Concerns, vaccine concerns are also addressed and key factors are given for cancer patients, survivors, and care partners.  

See More From the Best Care No Matter Where You Live Program


Related Programs:


Transcript:

Mary Leer:

Hello, my name is Mary Leer, and I am the Patient Empowerment Network’s [PEN’s] Network Manager for the Breast Cancer Network.  

 As PEN’s Breast Cancer Network Manager, I was proud to sit down with noted Mayo Clinic expert, Dr. Shaji Kumar. The interview helped me think deeply about my own experience as a cancer survivor and how it relates to my experience living through the pandemic that is still around us all. As cancer patients, we’ve had to live with multiple uncertainties and make decisions that can quite literally and figuratively be painful. We’ve had to make decisions about cancer treatment with our medical team, and we’ve had to deal with the fact that it is in our own best interest to at times take a path that we do not want to take in the name of healing ourselves and living a healthier life. We have learned to live with options and making choices with outcomes that are not certain, our experience and roles as survivors and as caregivers can make it hard sometimes difficult to understand the decisions of others who are hesitant or resistant to getting a vaccine. So I listened and learned from Dr. Kumar discussion about the importance of getting vaccinated to reach a significant percentage of our population. He shows compassion for those whose fear of the pandemic has led them to a decision to turn away from getting vaccinated, perhaps out of fear, distrust of medicine and anger about government impinging on personal rights, or perhaps, of course, their own personal health journey, please implore others to listen to the interviews Jeff and I did with Dr. Kumar. 

Dr. Kumar gave us very clear advice.  He answers many of the questions about COVID-19 that cancer patients, and our community have been asking and frankly worrying about. As you listen to the interviews on PEN’s website, you will hear his voice of reason, make it clear how critical it is for cancer patients, indeed all of us to get vaccinated for the sake of our own and for others’ health. As he states there are uncertainties about aspects of vaccination, such as the strength and length of one’s individual protective immune response, but the bottom line is that cancer patients especially need to be vaccinated to protect their health, even if one is well post-treatment. If still in cancer treatment or if one has had the COVID-19 illness, he told us to discuss the optimum time to get vaccinated with your medical team. He truly gave a clear message that there is solid evidence for the efficacy, safety of approved covid vaccines. Listen carefully and share Dr. Kumar’s interview responses with your cancer community and with your family. His answers address lingering questions my family and I had about COVID and cancer, the bottom line, these interviews with Dr. Kumar are once again, a way of giving us the tools to compassionately help ourselves and others through this COVID-19 health crisis. 

How to Play an Active Role in Your Myeloma Treatment and Care Decisions

How to Play an Active Role in Your Myeloma Treatment and Care Decisions from Patient Empowerment Network on Vimeo.

How can you actively participate in your myeloma care and treatment decisions? Engaging with your healthcare team is essential and may lead to better overall outcomes. In this program, Dr. Rafael Fonseca provides tips for how best to advocate for yourself or a loved one, as well as tools for making treatment and care decisions.

Dr. Rafael Fonseca is the interim director of Mayo Clinic Cancer Center and serves as the director for Innovation and Transformational Relationships at Mayo Clinic in Arizona. Learn more about Dr. Fonseca here.

See More From Engage Myeloma

Download Guide


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Transcript:

Katherine Banwell:    

Hello and welcome. I’m Katherine Banwell, your host for today’s program. Today we’re going to explore how to engage with your healthcare team when diagnosed with myeloma, and we’ll discuss the patient’s role in care decisions. Before we get into the discussion, please remember that this program is not a substitute for seeking medical advice. Please refer to your healthcare team about what might be best for you. Let’s meet our guest today. Joining me is Dr. Rafael Fonseca. Dr. Fonseca, welcome, and would you please introduce yourself?

Dr. Rafael Fonseca:   

Yes, of course. Happy to do that. Thank you very much, Katherine.  

I am a hematologist/oncologist, but I specialize in the area of multiple myeloma. I work at the Mayo Clinic in Arizona. I currently serve also as interim executive director for the Mayo Clinic Cancer Center that is at large across the Mayo Clinic enterprise. But at heart, I’m a myeloma doctor and I love to take care of myeloma patients. I devote my research and the rest of my academic activities to the field of myeloma.

Katherine:                  

Excellent. Thank you so much for joining us today. Let’s start with a question that’s on the mind of many of our audience members. We’re hearing that the COVID-19 vaccine is safe, but how effective is it for myeloma patients?

Dr. Fonseca:               

Thank you. I think that’s a fundamental question. It’s hard to know precisely how to gauge effectiveness when it comes to vaccination because historically, we know that is done by measuring antibodies and there’s a number of publications that are addressing this.

The concern has been two-fold. One is that because the disease itself is something that starts from the person’s immune cells become cancerous, that perhaps that would prevent them from having a very good response. Number two, and perhaps more importantly, will the treatments that are used for myeloma, etc. or lymphoma, can they interfere with our ability to mount an effective immune response? I think the response is mixed right now. I think I tell all my patients the upside is much better than the downside. I think we have a good record now of the safety of this product. I encourage everyone to get their vaccination.

I think it’s important to discuss this with your healthcare provider because sometimes people say, “Should I stop a little bit so that I can get a better response?” While it’s theoretically possible, we don’t want people to stop treatment if they don’t have to do that. Just my very last quick comment, the good news is that the community transmission is clearly going down as more and more people have participated in the vaccination.

We have more people who now have participated in this level of immunity that we have in the community. Hopefully, for patients as well as for their families, the risk of contracting this will continue to decrease.

Katherine:                  

Yeah. We can only hope. Well, let’s learn a little bit more about the disease itself. Dr. Fonseca, to level set with our audience, can you help us understand myeloma?

Dr. Fonseca:               

I’m happy to do so. Multiple myeloma is a cancer form of the bone marrow that arises when the cells that under normal circumstances protect us by the formation of antibodies. These are called the plasma cells. They become malignant. Myeloma is the last stage of a process where a plasma cell can go through a benign tumor or benign phase, if you may, something we call the monoclonal gammopathy, which by the way is quite common. About two percent of people over the age of 50 have this abnormality. Think of it like the colon polyp, a precursor condition.

There’s an intermediate stage that we call smoldering multiple myeloma, which is just more growth, but not quite at the level that it creates problems for the individual.

Then lastly, what we just simply call multiple myeloma, and that is when the growth of those cells becomes of such magnitude that a person starts having problems or starts having symptoms related to that. 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.

Lastly, the myeloma cells product proteins and some of the fragments of those proteins can be damaging to the kidneys. Occasionally, people will present with decreased kidney function and sometimes outright failure of the kidneys. Those are the common presentations. It is a disease that mostly affects people in their 70s. It is not something that you can detect through routine testing; it’s just indirectly we start seeing abnormalities and then we do the right testing. If anyone is hearing this, of course, they need to have a detailed discussion with their own provider.

Katherine:                  

Of course, yeah. When a person is diagnosed with myeloma, they usually have a whole healthcare team. Who is typically on that team?

Dr. Fonseca:               

Absolutely. Let me start by saying the key to the successful management of myeloma is to have a well-organized team. It’s a disease that requires an integrated approach that usually brings around the patient a physician.

As part of my team, we also have advanced practice providers. We work with nurse practitioners that help us do the longitudinal care of patients. We have the nursing team. Every time I meet a new patient, I make it a point to bring my nursing team into the room so they can put a name and a face together, as patients will be interacting, of course, with a nursing team through the portal and the various visits. We have a team that is in charge of the chemotherapy administration. That is usually a separate a nursing team that is in charge of the administration of the medications. But we really don’t stop there.

We have pharmacists who help us review the medications for our patients. Very importantly, we have social workers that help us address psychosocial needs, as well as some of the practicalities that become inevitable when one deals with a serious diagnosis like multiple myeloma.

Katherine:                  

Yeah. Lately, we’ve been hearing this term, “shared decision making,” which basically means that patients and clinicians collaborate to make healthcare decisions, and it can help patients to take a more active role in their care.

I’d like to get your thoughts, Dr. Fonseca, on how best to make this process work.

Dr. Fonseca:               

We are very fortunate to live in this time of medicine, where ultimately, we recognize that the patient is the person expert. It is the patient decisions that should drive what is to be done in a situation. Whenever I interact with patients, I tell them, “Listen, I’m going to be like your counselor. I will provide you with options of what I think is reasonable. I will go to different degrees of effort in trying to convince you one way or another for a particular intervention. But at the end of the day, I only do a good job if I present you with the options and the pros and cons of those various approaches.”

I weave that into my language on every single conversation we have with patients. I think we’re way past the time where a physician would come and say, “This is what you’re going to do,” or “This is what will happen.” My language always includes, “I would recommend this.”

“I think the next best step for you to consider would be X, Y, or Z.” But ultimately, I look at patients and not infrequently at the person next to them, a family member or a close friend, and I say, “You’re the boss and with the person next to you providing additional support, comment, and guidance, we can together reach the best decision of what should proceed.” I think we’re incredibly fortunate because patients have access to sophisticated information, especially patients that have serious conditions such as would be cancer and, in my case, myeloma.

As an example, when I work with general internal medicine residents that work with me learning about hematology, I sometimes tell them, “You’re gonna walk into a room. Are you gonna be seeing what I say, this is like a tennis match between professionals. Are you gonna see the level of questions that patients are going to be asking me? They’re going to be asking me about the latest study that was presented at this meeting and the P value and this and that.”

“I can guarantee you that you would not have the tools to be able to address all those questions, simply because there’s such an in-depth understanding of the disease.” I realize this is not everyone. I’m giving you an extreme example. There are individuals that need additional support, more resources. But just to interact with someone who has such commitment to understand their disease and to help us by that understanding make the right decision makes my job so much more rewarding.

Katherine:                  

What do you think is the role of a patient then in their care?

Dr. Fonseca:               

I think it needs to be … I’m describing in some detail and there’s a lot to unpack there. Of course, patients are dealing with a very serious diagnosis. It’s okay to have periods where they are in a pause moment and they’re reflecting of what their facing, and that they can gather information from close family members.

I think we, as providers and the medical team, need to deliver a message that provides clear options for them as far as what the best next phase of their treatment or their management might be, including observations or supportive care. But the patient ultimately is a person who has to make that decision. I frequently get the question, and this is not surprising, and it happens all the time. A patient tells me, “What would you do if this was a family member?” I always tell them, “I always talk to you as if you were my family member, as if you were my brother, my mother, my father.

So, I try to live deeply to that fiduciary responsibility I have to your well-being. I recognize that there are circumstances, and that’s part of the finesse and the art of medicine, that I have to help a little bit more walk you through that step. Sometimes, it’s just human that one may want to say, I just want to disconnect. Maybe I’m not the person that wants to go and read in detail. But perhaps I have my daughter or my son who are helping me and understand better where things are.”

I think one of the key aspects of my role is to make sure that I have a sense that the person has a good understanding to be able to make an informed decision. At the end of it all, if the person decides to proceed in such way that doesn’t necessarily align with what I’m trying to do, I’m deeply respectful of that choice. I will go to extra lengths. So, if someone is foregoing treatment, when I know their treatment has a high likelihood of improving their quality of life, relieve a symptom, or improve survival, I don’t think I would do a good job if I don’t present why that’s so important. But ultimately, it is the patient’s decision.

Katherine:                  

Related to what you’ve just been speaking about, we have a question from the audience. This one is from Sarah. Her question is, “What advice do you have for caregivers? How can I be supportive during appointments?”

Dr. Fonseca:               

That’s a great question.

I have experienced this both as a physician, as well as a caregiver myself to someone who has had a cancer. I think I’m gonna say that there are several roles that caregivers play. Some of them are obvious and I’m gonna call them practical or perhaps even pedestrian, you know, organizing the activities of every day. That’s important, but a lot of people can do that. The second role is to be in assistance for the knowledge that is needed for some of this decision making. Sometimes patients can be overwhelmed, and we need some support and some vetting and peer process from a trusted and loved person so you can go through that.

That is very helpful, but what is essential, and the number one thing is you are first and foremost the loving family member or friend of that individual who is living through a very profound human experience. I think the first role of a caregiver has to be to express that role.

I, myself, reflect on moments where perhaps in a quick, reactive way I wanted to solve some of the immediate practicalities and what was needed most was a direct support. Even if I face a situation today, if I was, again, a caregiver for someone with a serious diagnosis with cancer, I would start with that priority. Number one, you are the support and the loving person. Number two is I will try to provide information. And number three, hopefully you can help with meals and the driving and what have you. But there’s many more people who can come and help in that regard. Not a lot can do the first part.

Katherine:                  

Right, absolutely. Yeah, those are excellent points. Let’s talk about treatment goals. What are the goals of myeloma treatment from a clinical perspective?

Dr. Fonseca:               

I’ve been very fortunate, also, to live through this era when we have seen a plethora of studies and new drugs being approved for the treatment of myeloma.

When I first started, I used to say no one wanted to do myeloma because we didn’t have good treatments. People wanted to study leukemia, lymphoma. It just turns out that this is probably one of the most vibrant areas of hematology from a science and from a clinical research perspective, of course. If I see young patients who have multiple myeloma, I have essentially two goals. The first one is to induce the deepest possible response I can do so in a safe manner. I also repeat, “in a safe manner.” But I really have the goal to try to induce the deepest response possible because that has translated and continues to translate, and in many ways proven to be associated with an improvement on their longevity and the time we can control the disease.

And it leads me to second goal, and that is that I firmly believe there is a subset of myeloma patients that are cured from their disease.

Now, this is possible because of the availability of these new treatments. I will only be able to say that in 10 and 15 years from now, when we have monitored patients for a long period of time, and we have been able to see that became true. But by all indicators, we have patients that are living many, many years without the disease coming back. I think that would be important. Now, we have patients that with more advanced age sometimes it’s difficult to propose some of the most intense form of treatments like stem-cell transplants.

We don’t do a lot of that in individuals over the age of 72 just because the toll that it takes on a person is very high, and the risks become higher. But still, in that population, providing the best treatment possible becomes a goal because I think more and more, we’re seeing patients in that age category that can start to get close to what normal life expectancy would be. It’s not there. It’s not perfect, but you start to get close. Lastly, if someone asked me, I have that balance between quantity and quality, the good news in myeloma, if you do it right, quantity and quality go hand in hand.

So, effective treatment provides symptom relief and provides durability of responses.

Katherine:                  

That’s excellent. What other factors do you consider when determining a treatment approach?

Dr. Fonseca:               

The human experience that comes to the bedside as we consider treatments is so multi-factorial and multi-complex that all that needs to be brought into consideration. Whenever I walk into the room, I tell residents usually the medical part can be resolved pretty quick, but we’re reading how much we can communicate? What’s the level of understanding? What do I understand about the support system for this person? Is there someone who can drive to the treatment center? Is there someone perhaps whose other medical conditions would create certain challenges in how they’re gonna be treated?

This person is telling me they do daily hikes for four miles. Well, that’s different from someone who I see comes into the clinic and has to use a cane. We try to integrate all of that information to make the right decisions. I’ve made a lot of my career in the early years working and showing how, for instance, genetic factors are important. I’ve come to realize later in my career and through some of the very elegant work that other colleagues have done, that these factors are just as important in determining the ultimate outcome of patients. Whenever I talk about that clinical experience, there’s two things I always tell the residents.

I use the residents a lot because I think it’s a good example of how we aspire to interact with patients. Number one is every single encounter is a final exam. You have to put your best foot forward. Every single encounter should be considered a final exam. Number two is when I walk into that room, there are three things I do, particularly the first time I meet a person.

Number one is connect, right? We cannot have a conversation and I’m not gonna be able to move forward unless we have a human connection and I have gained the trust of the patient and the family members that are there. That’s number one. The second point is decide. That is usually okay, we’re gonna do this treatment or that. That is a small part. Most of the time for me, that’s a very small fraction of the time and of the mental energy that I consume. There’s cases that are more complicated, but most of the time it’s pretty straightforward. So, it’s connect, decide do very small, and then on the other end is explain.

So, that’s how I can connect. I propose we do this, and then why we are gonna do it and what can you expect. If you can do those three things, I think that goes a long way in establishing a fruitful and a productive relationship with a patient and their families.

Katherine:                  

I would suspect that you also take into consideration the patient’s health, their age, maybe test results, side effects, things like that?   

Dr. Fonseca:               

Of course. So, we look at the medical record and with the advent, of course, of the electronic record and all the tests that we do, our consideration is quite complex. We have to look at all those factors, and the age, and comorbidities. It’s rare that we would take one factor alone that would trump everything else. We usually have to integrate the information. The same is true when we manage myeloma patients and we’re monitoring their protein levels and their response to treatment. I tell patients, they ask me, “What would you do? What’s the magic number for this or that?”

I say, “It’s a little bit like you’re flying a Cessna plane and you have all these dials in your dashboard, and that’s how we manage the situation is the integration of all of that information.”

Katherine:                  

Right. Can you help us understand, Dr. Fonseca, how test results may affect treatment options?

Dr. Fonseca:               

Sure. Happy to do that. In myeloma, we are very fortunate in that we have, and it’s not the topic for today, but we have the best biomarker that exists for any cancer. That is that we can measure the proteins that are associated with the growth of the cells. We have multiple tests that we can do. We do them in the blood and we do them in the urine. They’re simple tests that have been done for decades now that allow us to monitor how a person is doing with regards to their disease. I use the following analogy. Myeloma cells live inside the bones, as I mentioned, in the bone marrow.

They don’t come out into the blood. So, we cannot measure them. Indirectly, we can measure how many they are and how they are behaving by measuring this protein. I use an analogy of imagine you’re walking in a street, and you see smoke coming out of a building. There are two things you can do. First is you diagnose that there is a fire inside the building, right? We see that with myeloma by measuring these abnormal proteins.

Then as a firefighting team comes on, you can gauge whether they’re making progress or not by the amount of smoke that comes out. That’s exactly what we do when we monitor myeloma. We monitor the M-Spike, the serum free light chain, the urinary proteins. That’s how we make those determinations.

At the same time, we do that, we have to look indirectly at the rest of the body. We have to look at the kidney function. We have to look at the blood counts. We have to look at the hemoglobin and the red cell count because that can (A) start on the wrong foot because of the myeloma itself, but (B) can also suffer as a consequence of our treatment.

It is, again, that idea of having the multiple dials in the dashboard that allow us to reach our practice. We have to be adjusting. So, if we measure the proteins and we’re doing great, but then at the same time we see we’re suffering in blood counts, and we may need to adjust those as we provide supportive treatment. If we don’t see the proteins go down, then that may mean we need to change to a different form of treatment or that the person is unfortunately a refractory or relapsing to something.

So, that’s how we integrate the test results into our management.

Katherine:                  

What sort of questions should patients consider asking about their treatment plan?

Dr. Fonseca:               

I think it’s important that patients understand a few things. They can be described in multiple ways. Number one is, of course, what? What is it that is being used? I think that includes a description of what to expect, the practicalities, the names of the medications, their side effect profile, and what to report when you use those medicines. I think that’s very important because if you’re empowered with that information, you’re gonna be better off as you react for symptoms that may come along. I always tell patients when you have a cancer diagnosis, your self-awareness goes through the roof because we’re gonna be paying attention to everything, every skin change, every pain we have.

So, I think having a bit of that proactive discussion becomes important as they think about the treatments that they want. I think the how-to on the practicalities are very important. The best where the nursing team and the pharmacists help us a lot too. Do you take the medicines at night? Do you take them with meals? Is there something that you shouldn’t be mixing? How much time would it take for me to get a refill? It’s different to get a medication from a specialty pharmacy versus your down-the-street Walgreens. So, all of those things are important that patients, again, participate in the understanding.

If not them, at least the caregivers that are a part of this team. I think it’s important that patients ask also some brief descriptions of (A) the biology of the disease. If I have myeloma, what type of myeloma do I have? Does that matter as far as what treatments I’m going to be using? What treatment options may be available to me because of my specific subtype? We have subsets of myeloma that have options that are not available to others.

Also, I think it’s important that patients also ask a sense from the physicians as to where they are. I’d like to describe this a little bit more. Sometimes, patients ask us specific questions about, am I in a complete response? Am I in a very good partial response? What is a PFS? Those terms work very well when we talk about clinical trials, but they don’t necessarily describe in a great way the situation for an individual patient. I’d use a lot more objectives than I’d use technical terms when I describe where patients are. I say, “You have an excellent response. You have a very deep response.”

Then I’d provide more details if they want. “Yes, you’re MRD-negative at 10 to the -6.” But sometimes I find that it’s harder for patients to understand where they are if they completely focus on the staging system or the response criteria, etc. Because maybe a VGPR, a very good partial response, doesn’t sound very good.

But then you can be in a very good partial response for 15 years and it doesn’t matter. You my want to be in an MRD-negative status, but you still have a good outcome. That’s why the general description of the status by a physician becomes important.

Katherine:                  

Do you think patients should get a second opinion consult with a specialist?

Dr. Fonseca:               

In general, my answer is going to be yes. This is not self-serving. I think myeloma has become so complex that trying to integrate at least once, or if not, in some infrequent basis, an opinion of a myeloma specialist becomes important. This is no one’s fault. If you’re a community oncologist somewhere where myeloma represents only a small fraction of your practice, I can guarantee you, you cannot stay on top of the literature. I cannot stay up with everything that goes on with myeloma, even though that’s what I do 100% of the time.

I get an email every week with all the articles, all the publications, and I have to integrate that. I have to think, okay, does this matter or not? I go to the professional meetings. I see all the abstracts and I still feel like I’m missing out. How could you do that if that is only a small fraction of your practice? I’m sure that the same applies for other cancers, breast and colon. You can’t move. You cannot uproot yourself and leave your community and your family, but I think there should be ways by which patients at least have an opinion from someone who has more expertise. Fortunately, there are many centers across the nation now that have that expertise for the management of myeloma.

Katherine:                  

Dr. Fonseca, we have a question from a newly diagnosed myeloma patient. Barbara says, “I am just about to begin my first myeloma treatment. What can I expect?”

Dr. Fonseca:

Thank you, Barbara, for the question. I think if you start on treatment, first of all I hope they already went through a good description of what the treatments are, the frequency by which you’re gonna have to go to the center, and also what are the toxicities to look out for.

One of the most common toxicities that we face and one of the most challenging parts of initial treatment is the use of steroids. So, we use dexamethasone as part of every single regimen we use for myeloma. I tell patients, “Dexamethasone is a simple drug at first glance, but it’s oftentimes the most complicated part of treatment.”

The human brain works at triple speed when you’re on dexamethasone. So, it’s hard to sometimes be able to sleep properly. People can become anxious and even the sweetest person in the world can become a little bit edgy on dexamethasone.

I always say Mother Teresa on dexamethasone would be an edgy person. Just be patient. Work with the team. Just know that on the other side of treatment there is a return to normal life.

Our goal as we embark on treatments and, for instance, is I see patients that are going to go through transplant, I tell them, “Our goal is you finish, you recover, and you go back to your life. You back to work. You go back to your family, your kids, your sports.” That’s really what we strive for when we treat patients with myeloma.  

Katherine:                  

Yeah. Once on therapy, how is the disease monitored and how do you know if the treatment is working?

Dr. Fonseca:               

Well, fortunately, we use the same markers. Once a person is in therapy, we will be monitoring. We monitor at least on a monthly basis of those myeloma protein markers. Once a person reaches a great level of response, sometimes we complement that with an analysis of the bone marrow. Of course, it’s more invasive, so we don’t like to do a lot of them, but we do them as needed. As we go forward and monitor patients, we will be looking for signs that those proteins remain in a low level as stable as an indicator that the disease is under control.

Now, if I saw someone and then I start seeing that there’s an increased concentration of those proteins or we see something else clinical, we might need to do a little bit of a regrouping and test again in great detail to determine if the person is experiencing regrowth and the disease is so-called relapsed.           

Katherine:                  

Why is it so important for patients to speak up when it comes to symptoms or treatment side effects?

Dr. Fonseca:               

Well, that’s a great question. If you don’t speak about them, we don’t know about them. It seems very obvious, but then we cannot make the proper adjustments. I’ll give you a couple of examples. I already talked about dexamethasone, but a common drug we use is something called bortezomib. Bortezomib is a proteasome inhibitor.

That’s a mouthful, but it’s one of the key type of drugs we use. It’s given as an injection under the skin. Not to be confused, by the way, with daratumumab. Faspro is the name of that medication, so not to be confused with that is bortezomib, which we have been using for many years.

Bortezomib has a potential toxicity that is called peripheral neuropathy. If patients have peripheral neuropathy, that can go from very mild where you have some numbness and tingling, to the more extreme cases that it’s associated with pain, discomfort, even weakness and disability.

Well, if we don’t know that’s happening, then we can’t react to it and we can’t adjust doses or switch to something different altogether. You can imagine now we have more options, but in the old days, I always tell patients, “You might be tempted not to say anything about this because you might be thinking, boy, this is working. I don’t want to interfere with my treatment. I can live with the peripheral neuropathy.” But if it gets worse, despite the fact that the treatment is working, the person might have a very significant impingement on their quality of life.

More so now that we have so many alternatives, it’s important not to get us into a path that we might reach a point of an irreversible chronic complication from treatment.

Katherine:                  

No, and that would be awful.

Dr. Fonseca:               

Absolutely.

Katherine:                  

Before we end the program, Dr. Fonseca, have there been any recent developments in myeloma treatment in research that make you hopeful? 

Dr. Fonseca:               

Absolutely. I would say that the one area of work that makes me most hopeful is what we’re seeing with immunotherapy. We have seen that both as the ASH meeting, as well as the ASCO meeting in this year, where people are presenting updates with the various clinical trials with either bi-specific antibodies or CAR T cell therapy as a new avenue for the treatment of myeloma.

In fact, at the last ASH meeting, we had 14 presentations of different compounds or different constructs that are active. I think the future is bright in that regard. We’re seeing their application right now. A lot of these updates have also been made as ASCO.

We’re seeing the update of the treatment of treatments with fairly advanced and aggressive disease where we can still show very significant responses. I participate in some of these trials. I can tell you in my institution, using some of the bi-specifics, I see patients who have previously exhausted all of their options and now are MRD negative at 10 to the -6.

If we’re seeing that in the very advanced disease, I cannot wait to see what happens when we start using these treatments in either early relapse and why not in the near future as frontline part of our therapy? I think to me, that whole field of T-cell engagers, where there’s bi-specifics or the CAR T cells remains one of the most exciting areas for future research.

Katherine:                  

How can patients stay up to date on information like this?

Dr. Fonseca:               

I think what we alluded to before is very important to work with groups like yours and other patient support organizations that can keep them up to date. I think they’re doing a very good job at also providing updates post some of the large meetings. I know there’s a lot of patients out there that are very sophisticated that will even join the medical meetings. That happens with some frequency; that they want to learn, and patients that go and ask me details about the statistics of the trial. That’s a whole spectrum, right?

But at the minimum, I would say a strong connection with a support group, or a patient support organization becomes an imperative as you deal with this. Also, that would help you because with this whole concept of the information not always being complete and truthful, that can be scary as well, too.

If someone goes and just looks for, I would say even some of the resources that are out there in a textbook today, just keep in mind that textbook was probably written five years ago, and it represents the studies of about 10 or 15 years ago. How that relates to you, it’s very distant. So, it is because of this continuous process of research that we know better what’s going on at the present time.

Katherine:                  

Dr. Fonseca, thank you so much for taking the time to join us today.

Dr. Fonseca:               

Oh, it’s my pleasure. Thank you for the opportunity.

Katherine:                  

And thank you to all of our partners. To learn more about myeloma, and to access tools to help you become a proactive patient, visit powerfulpatients.org. I’m Katherine Banwell. Thanks for joining us.

Empowered Patient and Care Partner Ask the Expert: Addressing COVID-19 Concerns

Empowered Patient and Care Partner Ask the Expert: Addressing COVID-19 Concerns from Patient Empowerment Network on Vimeo.

With COVID-19 infection and vaccine concerns, what are the key points for cancer patients and care partners to know? Expert Dr. Shaji Kumar from Mayo Clinic shares valuable information about protective measures against COVID-19 infection, vaccine side effects and effectiveness, working toward herd immunity, and cancer research benefits that have emerged from the pandemic. 

See More From the Best Care No Matter Where You Live Program

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How Can Cancer Patients Protect Themselves During COVID-19


Transcript:

Mary Leer:

My name is Mary Leer. I’m the Breast Cancer Network Manager.

Jeff Bushnell:

And I’m Jeff Bushnell, the MPN Network Manager at the Patient Empowerment Network. I’m a caregiver.

Dr. Shaji Kumar: I

’m Shaji Kumar, a hematologist at Mayo Clinic.

Mary Leer:

Jeff and I are proud to be part of a strong team of compassionate volunteers, helping health communities adapt to the realities of living with a serious illness, living with cancer during a pandemic certainly presents another layer of challenges. So, Jeff and I will drill down to ask the important questions from the community. For this production, Empowered Patient and Care Partner Ask the Expert, we are very lucky to be joined by noted expert, Dr. Shaji Kumar, a consultant in the division of hematology at Mayo Clinic. Thank you for taking the time to join us, Dr. Kumar.

Dr. Shaji Kumar:

Thank you for having me, Mary.

Mary Leer:

Let’s start with the top of mind questions for so many of us right now, what should every patient and care partner facing a cancer diagnosis know during the pandemic?

Dr. Shaji Kumar:

I think it’s a challenging time for everyone, and it’s obviously more challenging for patients dealing with cancer at the same time, thankfully, we have a vaccine at hand that will certainly make the situation a lot better, but I think from a cancer standpoint, I think what we need to keep in mind all the precautions we talk about in terms  of social distancing, masking, hand washing and all those measures apply equally to everyone, even more so to patients with cancer. And the reason why we say that it’s even more important for several reasons, one, and we continue to learn more about the pandemic and its impact on cancer, one thing that has become clear is that patients with underlying conditions including cancer are to other folks were more affected by the infection, more likely to have more severe interactions and poorer outcomes. Now, patients with cancer appear to be at a higher risk of getting the infection and then they get the infection having a more serious disease. Now, it’s hard to know how much of this is also related to the fact that patients with cancer often have to go into the hospital or the clinic, and hence are more likely to get exposed to the infection than someone who is able to just stay at home.

So that’s one thing. And second, we know that the ongoing treatment for cancer definitely suppresses the immune system, and hence places people at a higher risk of the infection itself. Now, even patients who have their past history of cancer, this appears to be some increased risk, even though this is a little bit, unclear how much more it impacts those individuals. But I think the bottom line is keep the awareness that you might be at a higher risk of getting the infection, more serious infection, and the need to take those precautionary measures in a more strict fashion, and getting the vaccination when you can get it is all things that one needs to keep in mind.

Jeff Bushnell:

Well, that’s wonderful, Dr. Kumar, you mentioned the vaccinations, I am a strong proponent of that, I happen to have been involved in the Moderna vaccine trial, which is and still enrolled, they’re doing the follow-up. I guess they’re checking the last time I was in last week, they took 8 vials of blood, I think they’re checking to see whether I have the antibodies and how long it will last, but I was very happy with the way it was conducted, they were very forthcoming with information.

It was very interesting. And out here in San Diego, where I am, we have done pretty well as a county in vaccinating people and Summer got the vaccine as well with myelofibrosis and she feels a lot better. But for cancer patients who have tested positive for COVID, are there notable consistencies amongst that group of people, and have we learned anything from those patients yet about maybe their chances of getting it more, or their reaction to it? That kind of thing.

Dr. Shaji Kumar:

We know that there’s a wide spectrum of reaction to the vaccine. The majority of the people would not notice any symptoms related to that except for some pain at the injection site.  Not there are some folks, number of people who might have more or just myalgia, muscle pains, just feeling fatigue, some low-grade fevers, just feeling blah for 24-48 hours, and it seems to be not too uncommon. The reactions to the vaccine in terms of the side effects or the symptoms, there doesn’t appear to be much of a difference between cancer patients and normal individuals. Now, in terms of the efficacy of vaccination, you just mentioned Jeff, about you being checked for the antibodies, obviously, that is something that we hope will happen to all individuals who get the vaccine, but we know that is not going to be the case, there’s going to be a wide variation in terms of how strong an immune response one might develop against vaccines. Now We know from, not necessarily the COVID vaccine, but the vaccinations that have been used in the past, whether it be flu vaccines or pneumococcal vaccines, that we all get patients with cancer or patients going through treatment for cancer that can suppress the immune system, tend to have a lower response. But again, that varies quite widely from patient to patient now, there are some vaccines where we can clearly look at the antibody response and say, “Oh, this is not adequate, and we need to maybe give an extra shot.”

We just don’t have that information for COVID vaccines yet. So the way I would look at it is, even though the response to the back in a given person might be less than what we eventually would identify to be optimal, it’s likely to be better than not having to see the vaccine, so I would encourage obviously, everybody to get the vaccine. Now, what about someone who has already had an infection, what would be the response? Should we vaccinate those people? We certainly should. Again, we don’t know the immunity from a natural infection, how long would that last? That is still something that is unknown, and the vaccination dose is likely to make the responses more relevant and more durable, so I would recommend the vaccines for everyone. We don’t think one vaccine is any different from another in terms of your underlying cancer or lack thereof. So in terms of assessing for the antibodies, there is no clear guideline in terms of what one should anticipate from  the vaccine, so there is really no way to say, check the antibody, and they can go ahead and get one more dose or you’re fully vaccinated. So I think the bottom line is, get the vaccine, you don’t need to necessarily test for a response, and then we continue with the usual measures for prevention.

Jeff Bushnell:

And so what would you tell the… I guess that’s pretty much the answer to the next question I had. What would you tell the patients who are in active treatment and who planned to get the vaccine just continue as normal after they get it, with all the appropriate precautions?

Dr. Shaji Kumar:

Yeah, no, I think there’s one other important aspect, Jeff, to that question you just raised, which is, what is the right timing to get vaccinated, the vaccine, and that is a question that often comes up. So patients who are not getting active treatment, there is obviously no concern whenever the name comes up, go ahead and get the vaccine. And the second is what if someone is actually getting active treatment for their cancer, is there any role in terms of trying to find the vaccination, with respect to the doses of the medications and for most of the treatment we are using for cancer, there are no clear guidelines in terms of the when they can get the vaccine, that having several guidelines that have been put out by different organizations. The bottom line is, if there is an ability to space out or give sometime between the vaccine and the dose of the medication, do that, don’t modify your treatments, just so that you can get the cross at a particular time. The only place where we would recommend specific guidelines within the context of somebody who may have had a bone marrow transplant or had some other kind of cellular therapies, in those contexts, we often recommend that you wait for a couple of months after the stem cell transplant, before we get the vaccines. But for all the other treatments that we are getting right now, we want to just within the schedule of the treatment that’s already on going, try and get the vaccine in between two doses.

Mary Leer:

For those who have been vaccinated and are living with cancer, you spoke to that in great depth, but I’m also wondering about people that are perhaps in post-treatment and let’s look at social distancing measures or other restrictions, are those different for patients versus the general population?

Dr. Shaji Kumar:

No, I think the proportions are the same, I think the social distancing and the masking should continue to be observed the same way, and I think the only other word of caution I think may be particularly relevant for the cancer patients would be, again, trying to avoid again those kind of being outdoors and larger groups of people, even if when you maintain the social distancing, try and not do that. The outdoors are probably a little better than smaller indoor gatherings, and it’s mostly the common sense proportions, and I think the cancer patients are probably more tuned to this because they have been following some of those things even before the COVID came on and post-vaccination, I would recommend that these steps don’t change at all, partly because we gain for a given person, we don’t know how robust the immune response that those patients have after the vaccination and the lack of good testing to say that, okay, now you’re fully vaccinated, your response is great, you don’t need to worry about getting infected.

Mary Leer:

Wow, thank you so much. That’s so helpful. I’m going to shift to vaccine hesitancy. This is an important topic for many. Drug development takes years, sometimes decades. Can you speak to those who might be hesitant about the speed of vaccine development around COVID. I’ve heard this often from other people saying, “Well, they develop this so quickly, how can we trust it?”

Dr. Shaji Kumar:

Yeah, no, I think those concerns are quite valid, I think vaccines have always been a very controversial topic and not just COVID vaccination but even for childhood vaccinations. There have been long-standing concerns that some of those vaccinations may be responsible for some of the issues that we see in the children and even in the late adulthood. I think what we really want to get across is, again, taking that question apart, and there are multiple different aspects to it, one is the whole concept of how we created the vaccine so quickly, we kept telling everyone from the time that it started that it takes five to 10 years to develop a good vaccine, and now we have something in a year, so obviously that raises concerns amongst people. I think it’s just a testament to how far technology has come. In the past, we had to isolate the protein and use that protein to develop the immune response, and what has been really unique about the COVID situation has been the Pfizer vaccine and the Moderna vaccine, both of which uses a new technology called the mRNA-based technology. And this is something that has been developed over the past decade to decade-and-a-half, and I would say this is a platform that was perfect, just waiting for the right opportunity to come along.

And the COVID situation really presented that. And even though it was the speed with which this was developed, is just because the technology has come along so much and we can actually do that, and the second is how fast the clinical trials have been done, and I think that speaks to, again, the infrastructure that they have been developed over the years to rapidly develop and implement a clinical trial. So the clinical trials, both Pfizer and Moderna trials had 40 to 50,000 people enrolled in a quick phase and the community transmission that was happening at a very high rate. We could get these trials done in a very rapid manner, so the patients or the people who enrolled in this clinical trial the fact that they were not getting infected could be determined in a much, much faster fashion than what you would have done in the past with any of the other vaccines. So I think the technology is robust. The [COVID]  trials are very well-conducted and the end point in terms of efficacy has been very well-determined or very accurately determined.  And given the size of these trials and the number of people who have been a goal, I think we can feel fairly confident that the risk associated with this vaccine is pretty low, so you can argue that one of the risk of a particular side effect is only 1 in 80,000. So maybe to the 40,000 people enroll in the trial, they may not have adequate numbers of that and that was certainly a concern when they started vaccinating. And we just know a couple of days ago, there was a publication that looked at almost like 63 million vaccination doses that have been given, and overall the risk of vaccine related side effects have been very, very minimal.

So I think that should also boost our confidence.

But on the other hand, we all heard about what would happen with some of those vaccines and the blood clots, and I think that even though…yes, it is, as it is a risk. It is a very, very small risk. And the fact that you were able to identify them right away again, I think tells us that should there be rare side effects, you’re going to find it, and we are going to figure out the mechanics of why those side effects happen. And we’re going to figure out how to avoid those things.

So, I think the information flow is so fast and all the data related to vaccines and the side effects are being captured in a real-time fashion that we would be… You’d immediately be of avail of side effects should that happen.

Mary Leer:

Wow, that’s so reassuring. Thank you.

Jeff Bushnell:

Another question kind of along the same lines, doctor is the last few days, especially, it’s Vaccine hesitancy has really become sort of the issue to the potential of achieving herd immunity, and how can everybody in the medical community, you guys are facing those stuff in a different way, but the average person, how can we help overcome hesitancy and increase the people’s trust in the vaccine, and also increase the equitable distribution amongst all populations? Some populations are hesitant to take it, others have distance problems for being able to get it. What can we do to sort of push ourselves over the hill to get to that herd immunity?

Dr. Shaji Kumar:

Yeah, no, You bring up a very important point, and I hope we are in a much better place than many parts of the world right now because we have one of the few countries where a significant proportion of the people have been vaccinated, but we are not quite at the point where we can claim herd immunity, I think we still need to continue to pursue this, and I think the ideal goal is to get everyone who’s eligible to get a vaccine vaccinated. Now, you bring up some of the very important points, because even though vaccine hesitancy is a real problem, the underlying reason behind this is manifold, and the only way to tackle that is we have a multi-front approach that will take into account what is the reason behind it.

So for the people where it’s hard to get to populations which can live in far from the areas, it may be more the ability to use those vaccines, which does need the complicated storage, for example, the J&J vaccine. You only need one dose. It’s easy to store. So that may be one of the approaches to be taken. And people who believe that this is a vaccine is going to create side effects, or it’s part of some grand scheme to introduce a variety of things. I think it’s a person of education, and I think they really need to tell them what can happen with. Not really just to them, but the fact that if you continue to allow these infections to proceed on stuff, there are going to be increasing numbers of mutations, and that in turn is going to make the pandemic much more difficult to control in the long run. So it’s totally an individual benefit, but it’s on to the society’s benefit to have everyone be vaccinated. And then definitely, I think knowing that should anything unto it happen, there’s going to be medical care that’s going to be available to these individuals, and I think that’s also an important point, so who are near and dear to them is going to be the key thing.

Mary Leer:

Here’s a question many cancer patients are unclear about if antibodies are present or if I have tested positive before, there’s a wondering, “Should I still get the vaccine?”

Dr. Shaji Kumar:

Yeah, I know the recommendation right now is to go ahead and get the vaccine, partly because we don’t know the natural immunity from the infection, how long does it last. So it seems like the antibodies can start to wane off the infection. And again, we don’t have a lot of data on it, but it looks 3 to 6 months, it might start waning at least to the level that they can detect. Now, whether that is sufficient or even the undetectable levels is protective against a future infection, we don’t know. There have been some reports of people getting a second infection even though they have been infected before again, scattered reports, we don’t know how widespread that phenomenon is going to be, so given all these, I think the current recommendation would be to go ahead and get vaccinated. We generally tell people to wait for two to three months after the infection to go ahead with the vaccination.

Mary Leer:

Alright, thank you

Jeff Bushnell:

Should people… Is the idea of pre-screening, especially for cancer patients, maybe who may be at risk, I guess, to see whether they have antibodies or whatever, be an effective thing to decide which vaccine they should get? or I know, as I say, I was in the trial and they were very forthcoming to the participants with what the numbers were, and I was flabbergasted at how effective the vaccine was, it was just amazing to me, and that kind of information that I guess is not available publicly maybe it should be. Does it help to decide which vaccine you get? All I hear on the TV is get the first one you can. What are your thoughts on that?

Dr. Shaji Kumar:

Yeah, no, I completely agree with you. I think even those numbers may mean… You look at the Moderna and the Pfizer trials, and they said, now over 90 percent effective. Look at the AstraZeneca trials, you know, it’s like they recorded 70 to 80, 85 percent, and the J&J about 80 to 90 percent effective. Do these numbers mean much? It’s really hard to know, I think, partly because they have been tested in, again, different countries, different times, as the virus was continually changing its characteristics. So it does it mean… So one could argue that maybe the vaccines that were tested later on when this will be some of the mutants were already there might be more effective, but we don’t know.

I think at the end of the day, 80 versus 90 is not something we would decide a vaccine on. The fact that, yes, if something was only 10 percent effective versus 90 percent, it’s a probably different story. So based on the numbers we have seen, I would say whatever you can get to first, if you don’t want to get jabbed twice, maybe you go with something that goes, it’s only one dose, but that may be the only distinguishing factor here, but nevertheless, I think we have to just get the vaccination, the first vaccine that we can get our hands on.

Mary Leer:

So let’s hope there is some good that comes from the bad. Are there any noticeable trends born out of the pandemic that will be or could be a benefit to the future of cancer care or research?

Dr. Shaji Kumar:

Mary, That’s a very important question, and I think we always learn from adversity, and I think this is going to be no different. I think, especially when the pandemic hit back in the spring of last year, we all had to think fast on our feet to figure out how best to continue to tell about the best care for the cancer patients without compromising the care in any way. And we knew that bringing the patients back into the clinic at the same rate we did before the pandemic would expose them to significant risk for infection, so how do we continue with treatment? There have been very different things people have tried…one of them is to try and get the medications to patients at home. If they are on IV medications, they can be changed to something that’s comparable that can be given by mouth. We already did that for some patients. For some patients who used to come to the clinic very often, so we figure out is there a way for them to get some of those testing done in a clinic much closer to home, so they can avoid the travel, they can avoid being in a bigger city, they can avoid being in a bigger institution, again, reducing the risk of exposure, and then you look at those numbers and then decide on the next course of treatment. We converted many of the clinic visits to video visits. Nothing is as good as having the patient right in front of you, but this is the best we could do under the circumstances.

And I think that helped. So I think the clinical trials was a big problem because in many of those trials were done in a very rigid fashion with very little variability allowed within the protocols. And everybody loosened from the clinical trial sponsors, the pharmaceutical companies, the institutional review board, the investigators to try and build flexibility into those clinical trial structures to allow patients to continue to be on those trials, many of which are important and both helping. So what does that mean for the future? I think the video visits are here to stay, I think we will continue to utilize that and bring patients back to the clinic only when it’s absolutely needed. I think the clinical trials will have in-built flexibility so that patients can enroll on clinical trials remotely, they can potentially be given some of those medications at home, maybe it would be something where we would check into the patients on a regular basis to make sure things are proceeding in the right way. I think there are increasingly technologies that will allow the patients to communicate in real time with the care team and also provide many of the data that we need through iPads or iPhones, Apple watches, whatever we end up using.

So that is that I think that technology will rapidly take off in the next few years, I think. So I think a lot of the care of the patients with cancer in general, and particularly cancer patients, I think is going to look very different five years from now, because of all these things that we have always thought of and we thought, “Yeah it will take time to implement, it’s difficult.” Now we figure it out in a year. We can do a lot of those things.

Mary Leer:

Yeah, thank you.

Jeff Bushnell:

For the final question, you’ve given tremendous information here, Dr. Kumar w What’s the final takeaway for the average cancer patient and caregiver, how to get through this? What’s your bottom line for us all?

Dr. Shaji Kumar:

Bottomline is, I think Your cancer treatment comes first, let’s not compromise on it, let us do it as safe as we can by observing all the instructions in terms of social distancing, masking, avoiding gatherings, getting vaccinated, and make sure you keep connected with your care team. You don’t have to be in the clinic to do that. There’s a variety of different tools, I think every hospital has options to either through their medical records to message their care team, or set up video visits and so forth.

So we want to be in a state where it was before the pandemic in terms of your communications, but use the technology, so we can decrease the risk of exposure without compromising the quality of care.

Mary Leer:

Alright, well, thank you so much, Dr. Kumar, that you have just given us such valuable information, and I want to thank Jeff as well, and the Patient Empowerment Network for putting this together.

Jeff Bushnell:

Thank you, Dr. Kumar, appreciate it.

Dr. Kumar:

Thank you, Jeff.