Tag Archive for: bone marrow biopsy

Will Myeloma Patients Need Fewer Biopsies in the Future?

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Will Myeloma Patients Need Fewer Biopsies in the Future? from Patient Empowerment Network on Vimeo.

Is it possible multiple myeloma patients will need fewer biopsies in the future? Dr. Sikander Ailawadhi from the Mayo Clinic explains bone marrow biopsies, myeloma detection, and potential tests in development.

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Transcript:

Lisa Hatfield:

Okay, 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 plan.

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 maspect 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 survivable matter, 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.

Myeloma Expert Explains Diagnosis and Treatment for Newly Diagnosed Patients

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Myeloma Expert Explains Diagnosis and Treatment for Newly Diagnosed Patients from Patient Empowerment Network on Vimeo.

How can newly diagnosed multiple myeloma patients be oriented to their diagnosis and treatment? Dr. Sikander Ailawadhi from the Mayo Clinic shares key points he explains to patients about myeloma origination, tests, symptoms, treatment, and ongoing care.

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Transcript:

Lisa Hatfield:

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 tenants, everything was 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 on that cycle to recycle the two to three seconds have already got in 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 regiments are three weeks regiments, some regiments are four week regiments, 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.

What Is MRD-Positive Acute Myeloid Leukemia?

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What Is MRD-Positive Acute Myeloid Leukemia? from Patient Empowerment Network on Vimeo.

What do acute myeloid leukemia (AML) patients need to know about MRD-positive AML? Dr. Catherine Lai from Penn Medicine discusses minimal residual disease (MRD). Learn about the meaning of MRD, complete remission, and MRD testing methods.

[ACT]IVATION TIP from Dr. Lai: “Ask if MRD testing can be done on your bone marrow biopsy at the time at which you or after you’ve had your chemotherapy.” 

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Transcript: 

Art:

Dr. Lai, what is MRD-positive AML?

Dr. Catherine Lai:

So, that’s a really good question. And to answer that question, I’m going to actually answer a different question, which is, What is the definition of complete remission? So the definition of complete remission is when we do a bone marrow biopsy, and we have less than 5 percent of those blasts or leukemia cells in the bone marrow, and that is also in the setting of a relatively normal immune system or normal other blood counts have improved, so that your neutrophil count is above 1,000, and your platelet count is above 100,000. So, MRD, which stands for measurable residual disease, means that you’re in complete remission, so you have less than 5 percent blasts, but you’re more than zero.

And we, in general, when patients who are MRD-positive, we know that if you were to do nothing, that those patients have a high likelihood of relapse. We know for the patients who are going to transplant, if you’re MRD-positive before transplant, those patients also have a higher likelihood of relapsing after transplant. And so we tend to monitor it if possible…the tricky thing is, is that there is not a standard way to measure MRD testing as of yet, the common approaches are right now are with either flow cytometry or with PCR or next-generation sequencing, if you have a particular targeted mutation that we can follow.

So your activation from that standpoint is to ask if MRD testing can be done on your bone marrow biopsy at the time at which you or after you’ve had your chemotherapy. 

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What Experts Are Learning About the Hereditary Risk of Myeloma

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What Experts Are Learning About the Hereditary Risk of Myeloma from Patient Empowerment Network on Vimeo.

Myeloma experts Dr. Irene Ghobrial and Dr. Betsy O’Donnell share research updates on predicting the risk of developing myeloma, both from inherited genetics as well as environmental factors.

Dr. Irene Ghobrial is Director of the Clinical Investigator Research Program at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. Learn more about Dr. Ghobrial.

Dr. Betsy O’Donnell is Assistant Professor of Medicine at the Dana-Farber Cancer Institute specializing in Plasma Cell Disorders.

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Transcript:

Katherine Banwell:

Is there any research on predicting hereditary risk of myeloma? 

Dr. Irene Ghobrial:

Yes, so part of the PROMISE study is trying to understand what is the risk of developing myeloma? So, we’re recruiting people who are either African American, because they have a three times higher chance of developing myeloma compared to the white population, as well as people who have a first degree family member with a plasma cell disorder. 

Or even any blood cancer because now we see that CLL and lymphoma and myeloma can actually come together. And we’re now doing something called whole genome sequencing of all of the DNA that you inherit from Mom or Dad called the germ line. Basically, we try to see did you inherit the gene from Mom or Dad that increases your risk to myeloma? 

Now, it’s not as high as something like BRCA1 mutation or 2 mutation, where if you have that, you’re high, high chance of developing breast cancer or ovarian cancer and so on. We probably have several factors that need to be put together. You inherit something and then the environment adds something, and then as we get older, we get the hit. 

Or you inherit something that changes your immune system, and that allows the plasma cells to start proliferating faster because they are reacting as an immune cell, and that allows the hit of myeloma to happen. And we’re working on that, and we would really encourage everyone who has a relative with myeloma, sign up on PROMISE study. 

Because that’s how we can get the answer. That’s how we can say it’s not because you are an African American or you’re white. It’s not because you have a first-degree family member or not. It’s because of this gene. So, taking away race, taking away all of those factors, taking away age and trying to go back to the biology. Is it a certain gene, is it the certain immune cell that makes us go to that risk? 

And then Dr. O’Donnell is really taking it to the next level. Now what is in the macro environment? So, we talked about what we inherit, but it’s like nurture and nature, right? So, nature is the genetics and then nurture, what do we eat? What do we change? Obesity, health, all of those things change our inflammation level and change our ability to basically prevent those myeloma cells from starting or from continuing to progress. And she can potentially talk about her work on microbiome, on the tiny bacteria that are in our body from what we eat. So, maybe, Betsy? 

Katherine Banwell:

Okay.  

Dr. Betsy O’Donnell:

Absolutely. Yes, so one of the things that particularly interests me is the effect of lifestyle on our risk of getting cancer. 

And specifically within plasma cell disorders, and I think there have been other cancers, breast cancer and colon cancer, where they’re a couple steps ahead of us just in understanding the influence of things like obesity and the gut microbiome. So, the specific bacteria that are within your intestinal tract. It makes a lot of sense in colon cancer, but we think that that’s not limited to diseases like that. We actually think that these microbiomes, which are influenced by the foods that you eat, may have a relationship with your immune system. And remember, myeloma is a cancer of the immune system. 

So, we’re all working together on our team here on a very scientific level to understand lifestyle influences and how they may cause or potentiate multiple myeloma. And so we’re excited to kind of bring this piece together. When you think about the spectrum of plasma cell disorders, not everybody goes on to myeloma, but a lot of people sit in these early precursor diseases, MGUS and early smoldering.  

And so are there things that people can do for themselves that might influence their gut microbiome, or if it’s the amount of body fat that we have that’s very involved in cell signaling? Can we modify those things, exercise more potentially, that will decrease our body inflammation levels or alter those pathways that have been set in process that, by altering them, may decrease the risk of going on to more advanced plasma cell disorders? 

Katherine Banwell:

That’s such great information.  

How Is Myeloma Treatment Response Measured?

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How Is Myeloma Treatment Response Measured? from Patient Empowerment Network on Vimeo.

Myeloma expert Dr. Betsy O’Donnell reviews the terms that define myeloma treatment response, such as complete remission (CR) and partial remission (PR). Dr. O’Donnell goes on to discuss the new tools that are being used to monitor treatment effectiveness, including MRD (minimal residual disease).

Dr. Betsy O’Donnell is Assistant Professor of Medicine at the Dana-Farber Cancer Institute specializing in Plasma Cell Disorders.

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Transcript:

Katherine Banwell:

Dr. O’Donnell, Alex wrote in with this question. “What is the difference between a complete response, VGPR, and PR as it applies to prognosis and maintenance after an autologous stem cell transplant?” And before you answer the question, would you define VGPR and PR for us?   

Dr. Betsy O’Donnell:

Sure. So, we have different criteria that help us understand how well a drug is working, and they’re uniformly used across clinical trials so that we’re all speaking the same language. And so we talk about a PR, a VGPR, and a CR. So, a CR is a complete response, which is 100 percent of that monoclonal protein that we initially detected is gone. We can’t measure it. Or if you have an elevated light chain, which is another piece of the protein, that has gone back down to normal. 

Taking that a step further, astringent CR is if we do a bone marrow biopsy and we can’t find any cancer plasma cells in there. A VGPR is where we see a 90 percent reduction in the amount of protein we can measure, and a PR is anything over – a partial response is anything over 50 percent. 

So, that’s a language we speak really just so that when we’re interpreting clinical trials, we all are using the same criteria. 

And so these are different terms that classify it. If the example that you gave, someone’s had a transplant, what would typically happen 100 days after that transplant is a patient would restart maintenance therapy.   

The classic maintenance is just lenalidomide (Revlimid), which is the pill that they were probably taking before that. And there’s a lot of controversy now but no good answers about changing therapy after a transplant, if you haven’t received a deep response. 

What we do know is that after a transplant, when someone goes on lenalidomide maintenance, they continue to respond. So, the greatest depth of response is not necessarily achieved in the induction phase or right immediately after transplant, but over time on maintenance. 

There’s another tool that we’re now using and incorporating, both in terms of how we assess treatment but also potentially in how we modify treatment, which is something called minimal residual disease, MRD, which goes a step beyond. When people have astringent CR, a CR, looking for really just traces of the disease on a molecular level.  

And all of those help us understand how well the patient has responded and how long that remission might last, but they’re not definitive in terms of how we should adjust treatment based on those right now. 

How Is Relapsed or Refractory Myeloma Managed?

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How Is Relapsed or Refractory Myeloma Managed? from Patient Empowerment Network on Vimeo.

Drs. Irene Ghobrial and Betsy O’Donnell discuss next steps if myeloma relapse occurs or the disease doesn’t respond to treatment. The experts review the necessary tests following a myeloma relapse and how a treatment choice is determined.

Dr. Irene Ghobrial is Director of the Clinical Investigator Research Program at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. Learn more about Dr. Ghobrial.

Dr. Betsy O’Donnell is Assistant Professor of Medicine at the Dana-Farber Cancer Institute specializing in Plasma Cell Disorders. 

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Transcript:

Katherine Banwell:

We know that relapse can happen. Dr. Ghobrial, how common is relapsed or refractory disease? 

Dr. Irene Ghobrial:

Yes, and, fortunately, we do have amazing remissions. We have very long remissions. Many people are living 10 years, 15 years and longer, which as Dr. Nadeem said, was not something we knew about years ago. I trained 20 years ago as a fellow, and myeloma was a survival of three to five years.  

We’ve come a long way, but we want to change that even better. We want a cure. We want to tell a patient, “You are done. You’re cured,” and we will not stop until that happens. So, when people have a progression again or relapse, then we want to consider what is the next available option. What is the best option to give them yet one more long, long remission? We are failing sometimes, and that’s because the disease is so bad, the biology of the disease is so bad, and the drugs that we’re using may not be the best drugs for that patient. 

And that’s why we need to understand better the biology and pick the right drugs for the right patient up front as much as we can, and also think about earlier treatment. We were just saying we probably have amazing drugs, but we’re waiting way too long until people have almost metastatic disease, and then we treat them. Why not think of an earlier interception when the disease is less mutated, when you have less cancer cells, a better immune system, and use your best drugs then? And hopefully we will achieve cure in many of those patients. 

Katherine Banwell:

What testing takes place after a relapse? Is it different than what has happened before, the testing that was done before? 

Dr. Irene Ghobrial:

No, the same tests exactly. We sort of say it’s restaging. We check everything again – the bone marrow biopsy, the FISH, because you may now develop a 17p that was probably there, but the very, very small number of cells that you cannot detect, and now it grows because of something called chrono selection. The drugs kill the sensitive cells, but they don’t kill the bad cells, and that’s how we can get all of those changes and mutations.  

Katherine Banwell:

Okay. Dr. O’Donnell, is the process for choosing treatment different for a relapsed or refractory patient? 

Dr. Irene Ghobrial:

So, that’s a great question. Yes, it can be. I mean, again, it always depends on how the person is doing at that time. It also depends, there are certain drugs that may not be approved in the front lines, something like venetoclax (Venclexta). If a person has a specific translocation, this 11;14, that’s something that we would like it in a second-line setting, for example. 

Usually one of the big questions people ask is if you’re on a specific class of drugs, should you change classes? So, this example is if you’re on lenalidomide (Revlimid), and you have evidence that your disease is progressing, should you change to a different type of drug? A proteasome inhibitor, monoclonal antibody? Should that include one of the same classes of drug, like pomalidomide (Pomalyst), which is the next generation? 

So, there are a lot of different factors that we consider. The number of drugs. So, you know, as Dr. Nadeem said, historically – there’s a lot of history in myeloma therapy, and it’s been an evolution, and so now we’ve had people who were treated with the three-drug combination that are starting, after many years, to progress. So, we might choose a monoclonal antibody for those patients because it wasn’t available at the time they were diagnosed. Versus patients now, who are typically on a four-drug regimen that includes those monoclonal antibodies and all the different classes of drugs. 

We’re looking at different and, if available, novel agents to put those patients on. And again, I think Dr. Nadeem made a really important point that I want to underscore, which is that very often our best therapies are available in clinical trials. And so when and if there is the opportunity to be on a clinical trial, you may be then able to get something that would not otherwise be available to you. So, I encourage people to always have an open mind to being on a clinical trial at any stage in their disease treatment. 

Katherine Banwell:

What therapies are available for relapse or refractory disease? Are they different than other therapies? 

Dr. Betsy O’Donnell:

You know, so that’s a great question. So, yes and no. I highlighted one example that might be a little bit different, but in general, we’re very fortunate that we have multiple classes of drugs, meaning we have different drugs that work differently to kill your myeloma cells. And as Dr. Nadeem said earlier, we use those in combinations to increase the effectiveness of those medicines. Within each class we have a variety of drugs. 

You used the example of immunomodulators, and show that we have three different of those type of drugs.   

We have two different proteasome inhibitors. Beyond that, we have other classes of drugs that were mentioned. We have monoclonal antibodies, immunotherapies.  

And so very often we make, it’s almost like a mix where we pick what we think is going to be most effective, sometimes based on cytogenetics. The biology. Sometimes based on patient selection. What are their other medical problems, what are their current issues? And we pick the combination that we feel is going to be most effective from the different classes of drugs that we have together, usually trying to use multiple drugs in combination. 

Katherine Banwell:

Well, what newer therapies are available or in development for refractory and relapsed disease? 

Dr. Betsy O’Donnell:

So, I think that the greatest interest that I think we’re all most excited about is the immunotherapy space, and I think we’ve seen – for myeloma, we see that this is a relapsing and remitting disease. 

And what’s been so exciting about CAR-T cells and the bispecific antibodies is that in patients who have had, on average, five relapses, we’re seeing tremendous results. So, complete remissions or very good partial remissions that last. In fact, can last up to two years, on average, with one of our CAR T-cell products. 

So, this is really exciting, especially when you compare to what historically has been out there for patients who have had that many relapses. And just as Dr. Nadeem said, the way that drugs enter, they enter from the relapse refractory setting, ethically that’s what makes the most sense, and they march their way forward. And so that process is happening right now as we speak, and I think like Dr. Ghobrial talked about, is the importance in early disease of thinking about using these really exciting therapies in patients who have lower burdens of disease with a goal of cure. 

And so I think all of us on this call are committed to one thing, and that is curing multiple myeloma, and even the precursors that lead up to it so that patients never have to go through the process of years and years of therapy. And so I think we’re very excited about what immunotherapy might be able to offer as we move forward in myeloma treatment. 

How Are Patients on Myeloma Maintenance Therapy Monitored?

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How Are Patients on Myeloma Maintenance Therapy Monitored? from Patient Empowerment Network on Vimeo.

Myeloma specialist Dr. Omar Nadeem explains how a follow-up care and monitoring plan for patients on maintenance therapy is determined.

Dr. Omar Nadeem is the Clinical Director of the Myeloma Immune Effector Cell Therapy Program and Associate Director of the Multiple Myeloma Clinical Research Program at the Dana-Farber Cancer Institute. Learn more about Dr. Nadeem.

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Transcript:

Katherine Banwell:

Dr. Nadeem, many patients are on maintenance therapy following active treatment. So, how is a patient on maintenance therapy monitored? 

Dr. Omar Nadeem:

Yes, so, majority of the time just with blood work. We don’t necessarily need to do a lot of bone marrow biopsies and PET scans for a majority of patients that are on maintenance therapy unless we’re either worried about their blood markers or some symptoms. Generally speaking, any time – it depends on what maintenance therapy they’re on, of course. If they’re just on lenalidomide (Revlimid), which is the most commonly used maintenance therapy, a lot of times we check in with them every one to three months. 

Depending on how their disease status is and how they’ve been doing and whether there’s any side effects that we need to worry about. So, they still have to see their doctors, still have to get the blood work. Usually you can get away with having it done no more than once a month or so, unless they are on other medications along with Revlimid, where we then have to check in with them a little bit more frequently. 

And some of that changes, so patients can be on maintenance therapy for five plus years, and we get a very good sense of how they are doing and kind of how their disease is doing, and we can kind of be a moving target in terms of the frequency of the follow-ups. 

How Is Research Advancing Myeloma Treatment and Care?

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How Is Research Advancing Myeloma Treatment and Care? from Patient Empowerment Network on Vimeo.

A panel of myeloma experts, including Drs. Omar Nadeem, Irene Ghobrial, and Betsy O’Donnell, discuss how clinical trials advance myeloma research and share an update on promising therapies in development.

Dr. Omar Nadeem is the Clinical Director of the Myeloma Immune Effector Cell Therapy Program and Associate Director of the Multiple Myeloma Clinical Research Program at the Dana-Farber Cancer Institute. Learn more about Dr. Nadeem.

Dr. Irene Ghobrial is Director of the Clinical Investigator Research Program at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. Learn more about Dr. Ghobrial.

Dr. Betsy O’Donnell is Assistant Professor of Medicine at the Dana-Farber Cancer Institute specializing in Plasma Cell Disorders. 

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Transcript:

Katherine Banwell:

Where do clinical trials fit into a patient’s treatment plan? 

Dr. Omar Nadeem:

Yes. So, clinical trials as a term, a lot of times patients have a lot of questions about what that means. There’s a lot of misconceptions, I would say.  

Sometimes patients think they will get either a placebo and they won’t get the adequate treatment, or that they may not get the right treatment, right, because they’re taking a chance going on a clinical trial. It’s actually the opposite. So, all the trials are really designed to improve upon what we already know works in a particular disease, right? So, when we think about trials let’s say in relapsed myeloma, where the patient has already had some of the approved therapies, we’re looking at the most promising new therapies that have shown efficacy either in the lab or first in human studies and then moving them through the different phases and studying them in more and more patients.  

And that’s how all these drugs get started, right? So, they all get started at that point and then make their way to earlier lines of therapy.  

Then you’re trying to answer different questions as part of clinical trials. So, which one of these therapies can I combine, for example. Which ones can I omit, which ones – so, they’re all sort of getting the standard therapy and getting something either added on top of it or removed, depending on what the question that we’re asking. 

And then in the world that we currently live in with precursor plasma cell disorders, as Dr. Ghobrial mentioned, we have lots of patients that are at high risk of developing multiple myeloma in their lifetime, and that could be in a few years to a decade. And a lot of these therapies are so effective, and we’re now trying to really study some of these rationally in that patient population, so that’s a very different clinical trial, for example, than what I described earlier.  

So, it really depends on what you’re trying to achieve and where you are in the phase of your disease. 

Katherine Banwell:

This next question is open to all of you. Are there therapies in development that are showing promise for patients with myeloma? Dr. O’Donnell, let’s start with you.  

Dr. Betsy O’Donnell:

Yes. So, I think we are so fortunate in multiple myeloma to have so much interest in our disease and so many great drugs developed. So, as Dr. Nadeem was discussing, CAR-T cells are an immunotherapy, the ones that are approved now, we actually are fortunate to have two CAR-T cells approved, target something very specific called B-cell maturation antigen.  

We’re now seeing the next generation where we’re looking at other targets on the same cancer cell, that plasma cell, so those are evolving. 

Same thing is true in the bispecific antibody space. Again, those target BCMA now, but we have newer bispecifics who look at alternate targets, and really what this does is it gives us different ways of approaching the cancer cell, particularly as you relapse through disease.  

Dr. Irene Ghobrial:

I would probably say we’re also getting into targeted therapies and more of personalized, so if you have an 11;14 translocation, venetoclax (Venclexta) would be an amazing drug for that. And the more we can say my own personal myeloma, what’s the best treatment for me, that’s how we’re trying to do it. So, it may not be exactly precision medicine, but we’re getting closer and closer to precision medicine of my myeloma, my specific drugs. And even if people have a 17p deletion, then we would say let’s think of that immunotherapy.  

It is truly a renaissance for us, and we’re starting to get into trispecifics, into off-the-shelf CAR-T, into so many new things. Into two different antigens that are expressed for the CAR-Ts. I mean, we are really beginning the era of immunotherapy, and we’re excited to see how much we can go into that because it will completely change myeloma, and hopefully we will cure many patients. We think we have already amazing drugs. It’s a matter of when to use them and who is the right person for this right drug. 

Katherine:

What are you hopeful about the future of care for myeloma patients? Dr. Ghobrial, do you want to start? 

Dr. Irene Ghobrial:

I’m hopeful that we truly cure myeloma, and no one should ever develop end organ damage. 

We should identify it early and treat it early, and no one should ever come in being diagnosed with multiple myeloma. 

Katherine Banwell:

Okay. Dr. Nadeem? 

Dr. Omar Nadeem:

Yes, I think I definitely agree with what Irene said, and really having a more thoughtful approach to each individual myeloma patient. As I mentioned earlier, we have so many available therapies. I want to be able to know exactly which patients need which path in terms of treatment, and which ones we can maybe de-escalate therapy, right? So, thinking about which patients do well and maybe can get away with not being on continuous therapy, and those that absolutely need it. Identifying them better to give them the best therapy. 

Katherine Banwell:

Dr. O’Donnell, do you have anything to add? 

Dr. Betsy O’Donnell:

I think we all share a common goal, which is cure, and for those who we can’t cure yet, I think really working on making the experience as good as it possibly can be and focusing on the factors that we can control and optimizing those, both for patients and their caregivers who are in this journey together with the patient.  

What Are Currently Available Myeloma Treatments?

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What Are Currently Available Myeloma Treatments? from Patient Empowerment Network on Vimeo.

Dr. Omar Nadeem reviews myeloma treatment classes, including immunomodulatory therapies, proteasome inhibitors, and monoclonal antibodies. Dr. Nadeem also discusses how combining these therapies has boosted the effectiveness of myeloma treatment.

Dr. Omar Nadeem is the Clinical Director of the Myeloma Immune Effector Cell Therapy Program and Associate Director of the Multiple Myeloma Clinical Research Program at the Dana-Farber Cancer Institute. Learn more about Dr. Nadeem.

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How Is Research Advancing Myeloma Treatment and Care?

Transcript:

Katherine Banwell:

Dr. Nadeem, what types of myeloma treatment classes are currently available?  

Dr. Omar Nadeem:

Yes. So, we started over three decades ago plus with just having basically steroid medications and some older chemotherapy drugs that weren’t very targeted at all, and that was basically all we had up until about a little over 20 years ago, where immunomodulatory drugs were first discovered to be effective in multiple myeloma, and that included thalidomide (Contergan or Thalomid) and now a commonly used agent called lenalidomide, or Revlimid.  

After that, we had a next class of medications approved called proteasome inhibitors that work differently than the immunomodulatory drugs, and then we combined all of these therapies about a decade plus ago and showed that that was better than anything else that we were doing before that. So, combining the steroids with the immunomodulatory drugs and proteasome inhibitors became the standard of care. 

And then we had the next class of drugs approved in 2015 called monoclonal antibodies, and that’s the first time we have monoclonal antibodies approved for myeloma, and it first started in patients that had relapsed myeloma, and then they made it all the way up to front line therapy with a drug in particular called daratumumab (Darzalex).  

And now what we’re going is entering an era of combining all four of these therapies, just like we did 10 years ago with three drugs, and showing that combining four drugs is actually better than three. And the important thing there is that it’s not necessarily adding cumulative toxicity. These are targeted therapies; they all work differently, but they all work really well together. So, now combining these agents has allowed us to really treat the disease effectively and allow for patients to tolerate the therapies.  

And then over the last couple of years, we’ve now entered kind of the next renaissance in myeloma where you have immunotherapies, and these are sort of true immunotherapies, in some cases taking the patient’s own T cells and then genetically modifying them to recognize myeloma cells and putting them back into patients. This is called CAR T-cell therapy, and that’s now approved for patients with multiple myeloma.  

And that again, just like the previous drug, sits in patients that have – you know, at a space where patients have had multiple relapses. But we’re now studying that earlier and earlier, and that along with another class of drugs called bispecific antibodies that also use your T cells via a different mechanism. A lot of exciting things going on, and we keep adding to the available agents for this disease.  

Understanding Personalized Medicine for Myeloma

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Understanding Personalized Medicine for Myeloma from Patient Empowerment Network on Vimeo.

Myeloma experts Dr. Omar Nadeem and Dr. Betsy O’Donnell discuss the personalized approach to treating myeloma and the factors that are considered when making care decisions.

Dr. Omar Nadeem is the Clinical Director of the Myeloma Immune Effector Cell Therapy Program and Associate Director of the Multiple Myeloma Clinical Research Program at the Dana-Farber Cancer Institute. Learn more about Dr. Nadeem.

Dr. Betsy O’Donnell is Assistant Professor of Medicine at the Dana-Farber Cancer Institute specializing in Plasma Cell Disorders.

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Transcript:

Katherine Banwell:

Dr. Nadeem, as we begin our treatment discussion, would you define personalized medicine as it relates to myeloma care? 

Dr. Omar Nadeem:

Yes. I think we’re getting better and better at really having a personalized treatment plan for each individual patient with multiple myeloma. I think Dr. O’Donnell defined before, we are identifying some of the markers where we have targeted therapy for, and we hope with time we’ll discover more and more targets that can truly lead to personalized medicine for individual patients. 

Right now, though, we have a lot of approved therapies for multiple myeloma, and that list is getting longer and longer basically every month, it seems, nowadays. So, when we have so many tools in our toolkit, we then have to figure out, well, which strategy works for which patient? And the fact that we have effective therapies, we’re able to tailor how much of one particular therapy a patient may benefit from. So, some of the decisions that come into play is which medication should I combine for this patient which will lead to obviously disease eradication? 

And then also, how much do I need to intensify that treatment? Do we need to think about doing a stem cell transplant or not? Yes or no?  

There are lot of pros and cons, right? So, it’s a very personalized decision that we have, looking at the disease factors, but also a lot of personal factors because transplant interrupts life, and then we have to make sure that that fits with that particular patient’s lifestyle.  

And then we talk about maintenance therapy. You know, that’s the therapy that is designed to kind of keep the disease away usually for many, many years for the majority of patients.   

But what does that look like, right? Does that include just pills? Is it going to be shots plus pills? Is it going to be a combination, etcetera? So, we have all the discussions at each phase of myeloma, and we discuss with them about what the pros and cons are and how that may fit into their particular lifestyle. 

Katherine Banwell:

Dr. O’Donnell, what factors do you consider when choosing a treatment approach? 

Dr. Betsy O’Donnell:

So, I think you’ve heard from all of us that we really try to have an individualized approach. When we’re talking about multiple myeloma, one of the main factors that I think about is really kind of the overall wellness of the patient. Historically, we had different categories of transplant eligible, transplant ineligible. 

And so that can influence some of the decisions. Really it comes down to what is it the person’s performance does? How well are they doing in their day-to-day life? And that really can dictate the intensity of the therapy. We know that age is just a number, it really is, so there are factors beyond that. What other medical problems do people have? What are the specifics of how well their kidneys are working? 

And so the biggest thing that we can work with is the dose. In fact, we’ve had work that shows that using lower doses from the get-go in older patients allows almost identical outcomes, but really gives patients a tailored dose to where they are at that juncture in their life.  

And so remember, myeloma is much more like a marathon, and so you have to set out at a pace that can be sustained. We treat people continuously. There’s an induction phase where we use a multiple drug combination, but beyond that, as Dr. Nadeem just said, they go on to maintenance, and that maintenance is indefinite. And so you have to set out at a pace or at a dose that you can sustain. 

Different medications have different toxicity profiles, so if someone had, let’s say, cardiac or heart issues, we might steer away from some medications that may exacerbate those. So, every decision is individualized. It’s based on who the patient is, where they are in their life, what other medical problems they have, and what we think they will do best with over time, not just in a short timeframe. 

How Is MGUS Monitored?

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How Is MGUS Monitored? from Patient Empowerment Network on Vimeo.

Myeloma expert Dr. Irene Ghobrial discusses how patients with monoclonal gammopathy of undetermined significance (MGUS) are monitored over time and shares an update on research being conducted to learn more about this myeloma precursor condition.

Dr. Irene Ghobrial is Director of the Clinical Investigator Research Program at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. Learn more about Dr. Ghobrial.

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Transcript:

Katherine Banwell:

Dr. Ghobrial, how are people with MGUS monitored? 

Dr. Irene Ghobrial:

Yes, so how do we even diagnose them, right? It’s a big question because it’s incidentally found. Someone will go to their primary care doctor and have a little bit of a high protein or slight anemia, and it may not be related, and then their doctor will check for serum protein electrophoresis, and that’s pure luck. We want to take away luck from this equation. We want to take away chance from this equation. 

And we want to start screening people who are at risk, and we are doing that with the PROMISE study. It’s online available to everyone nationwide, international now, where you can sign up on promisestudy.org and try to ask the question that we do for you research level, the serum protein electrophoresis, and a new test called mass spectrometry that is much more sensitive than SPEP to find it. 

Now, once we find MGUS, we want to know what is my own personal risk of progressing to myeloma? Because I could be 30 years old with MGUS, and likely I will progress to myeloma in the next 10 years, 20 years, and by the time I’m age 60, I would have been diagnosed with myeloma. Just a true case in many, many people. If people are diagnosed today with myeloma, they are going to their doctor because they had back pain or anemia, and they are diagnosed with myeloma. In almost all of the cases, they would have had MGUS and smoldering, but they didn’t know about it three years ago, four years ago because they never got tested for it. 

So, we want to change that completely and become proactive rather than being reactive and waiting for symptoms to happen. Once you have MGUS or smoldering, because we don’t know, we start looking for all of the things to help us identify your risk of progression. So, we look at the height of your M-spike. Is it small or big? And then we in many cases say okay, maybe you need a bone marrow biopsy if your M-spike is a little bit on the higher side because we don’t want to miss smoldering myeloma, which will change the prognosis. 

And then we start looking at do you have anemia? Do you have kidney failure? Do you have any of the other things that may predict that you may be actually going into myeloma? 

We also look at it more as a movie rather than as a snapshot, rather than a picture. If your M-spike is changing or your light chain is changing every three months, every six months, that’s an indicator that the cancer cells are doing something. They’re working in there and growing, and that’s why they’re increasing the M-spike and the light chain. 

And that evolving number is actually a very big predictor of telling us that there is a risk of progressing. Those are all clinical markers that we can do. When we look at the FISH, which we talked about, we can tell the certain markers are chromosomal changes that tell you that those cancer cells want to grow a little bit faster. So, 1q abnormality, 4;14, 14;16, 17p, all of those have been shown that when you have them, the cancer cells are not just sitting around and doing nothing. They’re actually starting to grow, and we want to catch them and understand what is the biology of the disease rather than just how many cancer cells you have. 

We do a lot of research level, and potentially now we’re going to give them back to the patients as clinical level, where we can give you more information about that prediction of your risk of progression. One of my colleagues calls it predicting the hurricane. We know that the hurricane will happen, and it’s a question of how precise could you be? We’re the Weather Channel men here.  

And we could be very precise and tell you it’s going to hit Miami at 2:00 in the afternoon tomorrow, and you could be prepared for it and get out of there. Or, you could be completely unprepared because we were not very accurate in our prediction and tell you it may hit the whole East Coast in the next two weeks. That’s not accuracy. So, we want to be more accurate in our prediction of myeloma because one person will never develop myeloma and can go have fun and enjoy life and not be worried and anxious about their risk, and another person we might say let’s watch you more carefully, or let’s think of interception preventing things. 

So, we do things called next-generation sequencing, taking all of those small numbers of cancer cells, even as little as single cells, and we can do whole genome sequencing and give back that information.  

We look at the immune cells and give back that information. We can do mass spectrometry. And with Betsy and Omar, we’re doing more and more tests so that when we have this prediction model, circulating tumor cells and so on, we can be more accurate in giving you that prediction. 

And help you make the next decision of are we watching carefully, are we preventing and intervening with behavior modification with other things? Are we intervening with therapy to intercept the disease? 

Katherine Banwell:

When are more in-depth tests necessary?  

Dr. Irene Ghobrial:

It depends, of course, on everything. I would probably say for every patient, it is a unique discussion. Some patients will tell me, “Let’s watch again in three to six months, and then I will do more testing,” and some patients want to know everything immediately. And we have those discussions with every patient, and we tailor our therapy as well as our diagnostics workup with every patient, depending on how much they want to know, how much their risk is, and how much they want to be involved in that discussion of how much to prevent myeloma. 

What Should Patients Know About Myeloma Testing?

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What Should Patients Know About Myeloma Testing? from Patient Empowerment Network on Vimeo.

Testing following a myeloma diagnosis, or relapse, can impact care and treatment decisions. Drs. Betsy O’Donnell and Omar Nadeem provide an overview of essential myeloma testing, how the test results impact staging, and discuss recent advances in testing that have changed myeloma care.

Dr. Omar Nadeem is the Clinical Director of the Myeloma Immune Effector Cell Therapy Program and Associate Director of the Multiple Myeloma Clinical Research Program at the Dana-Farber Cancer Institute. Learn more about Dr. Nadeem.

Dr. Betsy O’Donnell is Assistant Professor of Medicine at the Dana-Farber Cancer Institute specializing in Plasma Cell Disorders.

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Transcript:

Katherine Banwell:

Dr. O’Donnell, let’s move on to testing. What tests are necessary to help understand a patient’s specific disease? 

Dr. Betsy O’Donnell:

Absolutely. So, testing really does depend a little bit on the stage at which your disease is found. In general, we use a very specific blood test that lets us know that there is clonal protein present. Remember, plasma cells are a type of white blood cell, and they make something called antibodies. We use a test called a serum protein electrophoresis, which is a blood test – an SPEP, we call it – that can tell us the difference between normal, healthy antibody and clone that are made from the plasma cells that we see in MGUS, smoldering, and multiple myeloma. 

So, that’s a very important test, and sometimes your primary care doctor may notice that your total protein is elevated and send that test. 

Or there may be other things that tip them off. Perhaps the kidneys are not where they used to be. And so that test is sent, and that’s the first tip-off that someone might have a plasma cell disorder.  

Once we identify that there’s a plasma cell disorder, then that can set in place a workup, depending on the amount of clonal, monoclonal, M-protein that we see. So, sometimes that involves bone imaging. Historically that was a skeletal survey where we took lots of X-rays of your body. Now we have other tests we use. PET scans, CT scans, whole body MRIs. Sometimes it depends where you’re getting your treatment, and also it depends a little bit on your doctor’s degree of suspicion.  

Bone marrow biopsies are a procedure that we sometimes do. We use a thin, hollow needle to take out just a little piece of bone, about the size of an inchworm, and take some fluid with it. There’s actually fluid inside the bone marrow.  

And that can tell us, just as Dr. Ghobrial was defining the spectrum of plasma cell disorders, based on the percent of plasma cells, that can tell us where somebody belongs, which group they might belong in. So, we can use all of these tests to help give us a good sense of how much disease someone has and where in the spectrum or continuum a person is – MGUS, smoldering, or multiple myeloma. 

Katherine Banwell:

Okay, great. Thank you. I’m assuming these tests can help with understanding the stage of a patient’s myeloma. So, Dr. Nadeem, how is myeloma staged? 

Dr. Omar Nadeem:

Yes. So, myeloma is staged very differently than traditional cancers. Because this is a blood disease, we don’t really think about it like we may in other solid tumor cancers, where if it’s spread to multiple locations it’s IV, etcetera. That doesn’t apply to multiple myeloma. It’s actually staged out of three stages, and uses your blood work for the most part, some blood tests, to help identify which stage you are. Historically, that has correlated with how you may do. 

However, now we are learning that it’s far more to this story than just the blood work. So, we’re now using our bone marrow test results, particularly a test called a FISH test, which looks at the mutations that are present in examinable plasma cells, and if you have presence of some of these high-risk markers, that can actually either upstage you or downstage you if you don’t.  

So, we’re now I think becoming a little bit smarter how we think about this disease. It’s not just based on some blood test. We’re actually looking at the biology of some of these cells and the amount in the bone marrow. A lot of times patients ask, “Well, if I have 50 percent, 60 percent, or 80 percent involvement of the bone marrow, that actually does not have anything to do with staging, right?” So, I think it’s important to know that it’s actually a very unique staging system in multiple myeloma.  

Katherine Banwell:

Okay. Dr. O’Donnell, the landscape of myeloma has changed significantly in recent years. How have advances in testing changed care from myeloma patients?

Dr. Betsy O’Donnell:

So, I mean, the landscape has changed incredibly just in terms of the treatments we have, and I think that Dr. Nadeem was talking about something really important. 

In that when we look at FISH, which allows us to know the biology a little bit more, sometimes it helps us to decide kind of the risk that a patient is. We aren’t really at the point now where we do truly tailored therapies, like you see in some cancers, where we can detect specific mutations and pick drugs that align with that, but there are some that we do use. An example would be a drug called venetoclax (Venclexta), which works very well in patients who have a specific translocation, 11;14. 

So, there is some degree in which we use that FISH and those cytogenetics to help define our treatments, but also really we’re just fortunate that we have new and evolving therapies. We’ve changed how we treat myeloma in the up-front setting, and then at the back end we have an exploding field of immunotherapies, CAR-T cells, bispecific antibody that we’re now using that really have tremendously benefited our patients.  

Katherine Banwell:

Dr. O’Donnell, should all patients undergo in-depth testing, like cytogenetics?  

Dr. Betsy O’Donnell:

Yes, so if you’re doing a bone marrow biopsy, absolutely. The question in terms of who needs bone marrow biopsies, if someone has a low risk MGUS, those patients don’t necessarily require a bone marrow biopsy. It’s an invasive procedure, it’s an uncomfortable procedure. But if we’re doing a workup for multiple myeloma or smoldering myeloma that includes a bone marrow biopsy, then absolutely. 

Katherine Banwell:

Okay. Dr. Nadeem, what are you looking for with cytogenetics, and how might test results affect prognosis and treatment? 

Dr. Omar Nadeem:

Yes, so as mentioned earlier, there are some mutations that are considered high risk, I will say with the caveat that we don’t fully understand every single mutation yet or have identified every single mutation yet that may be high risk or low risk.  

But there are roughly five that we have identified that if a patient has one or two or several of those abnormalities, then their disease may behave a little bit more aggressively or may not respond as well to treatment. 

However, I think myeloma is just very complicated, so we look at a lot of these results in the beginning, both whether they may be good or bad. But I think, ultimately, we have to see how patients do, and that by far is the most important prognostic factor, in my opinion. So, if we look at some of these tools, including staging, some of the bone marrow results and cytogenetics, and try to give some prediction in terms of what we may see from this person’s disease, but ultimately the treatments that are so effective now really dictate the course for the majority of the patients. 

Katherine Banwell:

Are there specific tests that patients should ask for that could impact their care decisions? 

Dr. Omar Nadeem:

Yes, I think it depends on where they are in their disease state. So, if we’re looking at whether a patient has a precursor or plasma cell disorder or multiple myeloma, then they need all the testing to help us figure that out. 

So, that includes a bone marrow biopsy, the FISH testing as we just talked about. Advanced imaging like a PET scan or an MRI is now critical to identify patients that may have multiple myeloma versus those that have a precursor condition. So, we used to count on X-rays, as Dr. O’Donnell mentioned, but now really we do prefer one of those advanced imaging techniques for patients to undergo so that we can know. 

So, I think if they have basically those tests completed, that gives us most of the information that we need. 

Understanding MGUS & Smoldering Myeloma: What’s the Difference?

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Understanding MGUS & Smoldering Myeloma: What’s the Difference? from Patient Empowerment Network on Vimeo.

Myeloma expert Dr. Irene Ghobrial explains the difference between the precursor conditions, MGUS (monocloncal gammopathy of undetermined significance) and smoldering myeloma, including how these conditions are detected.

Dr. Irene Ghobrial is Director of the Clinical Investigator Research Program at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. Learn more about Dr. Ghobrial.

See More From INSIST! Myeloma

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How Is MGUS Monitored?

How Is MGUS Monitored?

 How Is Research Advancing Myeloma Treatment and Care?

How Is Research Advancing Myeloma Treatment and Care?

 What Experts Are Learning About the Hereditary Risk of Myeloma

What Experts Are Learning About the Hereditary Risk of Myeloma

Transcript:

Katherine Banwell:

Dr. Ghobrial, what is MGUS? 

Dr. Irene Ghobrial:

So MGUS, or monoclonal gammopathy of undetermined significance, is a precursor or the stage before myeloma happens, and it’s actually a very common disease or entity in many, many of us as we get older. In fact, maybe 5 percent of the population over the age of 50 would have this early MGUS. 

It doesn’t mean that it’s cancer. It’s a precursor to cancer, and we can talk more about it as we go on. 

Katherine Banwell:

All right. Is it the same as smoldering myeloma, or is that something different? 

Dr. Irene Ghobrial:

It’s not. It’s an earlier stage than smoldering myeloma, and it’s hard to actually make the right definitions. But currently what we say is if you have more than 10 percent cancer cells or plasma cells in your bone marrow, then it’s smoldering myeloma. And by the name, smoldering, it’s almost myeloma. It’s ready to go on fire, but it’s not there yet.  

MGUS is before that, and the difference is that the chance of progression from MGUS to myeloma is only 1 percent per year, so many, many people will never progress to myeloma. While smoldering myeloma, just because there are more cancer cells in the bone marrow, has a higher chance of progressing, which is 10 percent per year. And in some people, a very high chance of progression of 50 percent in two years. 

And we want to make sure that we catch those cases early and not wait for myeloma to happen. 

Katherine Banwell:

How would you define myeloma? 

Dr. Irene Ghobrial:

So, myeloma is currently defined as the same thing. The number of plasma cells in the bone marrow could be above 10 percent or more, or you have a protein in the blood. But the problem is that you’ve already had problems. You’ve had symptoms of end organ damage, so we have either high calcium, bone lesions, or bone fractures, anemia, kidney failure.  

And then now or more recently, we added a few more things to tell us these people are going to really develop myeloma soon. So, it used to be part of smoldering myeloma, now it’s part of the definition of myeloma, so that we can treat patients earlier, which is if your light chain level is very high, above 100 for a ratio, or if you have multiple lesions by something called an MRI or a PET CT scan instead of the traditional X-rays, or if your bone marrow has a lot of the plasma cells, more than 60 percent. 

And these were new definitions to make sure we don’t wait too much until people have an organ damage or symptoms and then we treat them. And you’ll hear from us that we think we should be treating people even earlier than that. 

Understanding Relapse in Myeloma

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Understanding Relapse in Myeloma  from Patient Empowerment Network on Vimeo.

What are indicators that a myeloma patient has relapsed? Dr. Mark Schroeder explains how relapsed and refractory myeloma are monitored and treated. 

Dr. Mark Schroeder is a hematologist at Siteman Cancer Center of Washington University School of Medicine in St. Louis. Dr. Schroeder serves as Associate Professor in the Department of Medicine. Learn more about Dr. Schroeder.

See More from Engaging in Myeloma Treatment Decisions

Related Resources:

Expert Perspective Advances in Treating Relapsed and Refractory Myeloma

 Expert Perspective Why Myeloma Patients Should Weigh in on Their Care Decisions

Transcript:

Katherine Banwell:

What are the indicators that a patient’s disease may have relapsed?  

Dr. Mark Schroeder:

Yeah, so we would typically be following a patient about every three months. Somebody that has gone through the initial induction, consolidation, maybe they’re on maintenance therapy, or maybe they’re on active therapy for after they have relapsed from a myeloma.  

Each of those visits every three months, we are monitoring bloodwork, we’re monitoring the monoclonal protein that the myeloma produces.  

Or if it doesn’t produce much of that protein, we’re monitoring other parameters, so urine testing or maybe even imaging like a PET scan. And we’re looking for consistent rises in that number, and we’re looking for, not necessarily a little rise in the protein, but incremental continuous rise – that suggests that the myeloma is starting to grow again, and it’s growing on the current treatment, and we need to switch gears and try a different treatment. There are some patients who – that protein, the myeloma or the myeloma cancer doesn’t die to treatments – that’s refractory. So, we try a treatment, and there’s just no response. We don’t see a drop in the protein in the blood, we still see a good burden of the myeloma in the bone marrow biopsy. And those patients, that’s also an indication to try a different treatment.  

Katherine Banwell:

You mentioned that myeloma often returns, so how typical is it for a patient to relapse? 

Dr. Mark Schroeder:

Yeah, I would say that’s the norm for patients with myeloma. There are reports in patients who undergo things like stem cell transplant, that maybe 10 percent of patients might be out 10 years without detection of their myeloma, but that’s not the norm. So, most patients who are diagnosed with myeloma will go through periods of treatment and hopefully periods of remission – the majority go into periods of remission to myeloma where it’s not very active, but the myeloma tends to come back. 

Katherine Banwell:

I think you’ve already answered this, but I’m going to ask you in case you give different or more information. If a person is relapsed or refractory, how are they typically treated? 

Dr. Mark Schroeder:

So, when they relapse, it depends on their prior treatment. So, if the myeloma is not responding to a drug, then it is, from the physician’s perspective that’s treating you, a good idea to change the type of chemotherapy drug that you’re on. Any time, whether it’s diagnosis or relapse, clinical trials are appropriate to engage with and potentially even use as primary treatment. All clinical studies in myeloma or for cancer in general are typically engineered around active treatments for the cancer. And so, those studies in myeloma when you’re having the cancer relapse, say, early in the course of your cancer, those studies typically are geared to use drugs that are approved by the FDA. Later in the lines of treatment, maybe you’ve had to progress after four lines of treatment, but trying to move them earlier, and they’re very active in the fourth line.  

So, you could potentially have access to an active treatment moved earlier in the treatment through a clinical trial. There is also a long list of other approved myeloma therapies. There is a good handout, I think, through the NCCN for patients for myeloma that lists a lot of the approved myeloma therapies and kind of guides patients. It’s a good resource book that I would point any of the listeners to. 

Does Maintenance Therapy Have a Role in AML Care?

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Does Maintenance Therapy Have a Role in AML Care? from Patient Empowerment Network on Vimeo.

Acute myeloid leukemia (AML) expert Dr. Farhad Ravandi-Kashani discusses the role of new and developing maintenance therapies that may improve remission and how this treatment phase may fit into the future of AML care.

Dr. Farhad Ravandi-Kashani is professor of medicine and Chief of the Section of Developmental Therapeutics in the Department of Leukemia at The University of Texas MD Anderson Cancer Center in Houston, TX. Learn more about Dr. Ravandi-Kashani.

See More From INSIST! AML

Related Resources:

How Does the Presence of Molecular Markers Affect AML Care

 Diagnosing and Treating AML_ What Testing Is Essential

 Advances in AML Research _ Where Do Clinical Trials Fit In

Transcript:

Laura Beth:

Dr. Ravandi, does maintenance therapy have a role in AML?  

Dr. Ravandi:

Maintenance therapy is something that has been used in other leukemias for a long time, and other types of cancer, particularly in ontological cancers. In AML, it hasn’t been normal practice, traditionally, mainly because in AML, we haven’t had many good relatively nontoxic, easily taken drugs.  

So, about 30 years ago, some groups, for example, a German group actually tried to do maintenance with cycles of chemotherapy, and you can imagine if a patient is in remission, and somebody says to you, “I’m going to give you cycles of chemotherapy for the next three years,” most patients wouldn’t take it because they say, “Well, you know, maybe I have three years to live. I want to go to Bahamas and be on the beach rather than getting cycles of chemotherapy.” But over the last several years, in a number of effective, highly effective oral agents that have been developed, and one specific agent that has been developed for maintenance. Now, this specific agent is not curative, as it’s not that if you take it, you will live forever.  

But it does improve survival, and it’s relatively well-tolerated. And there are other clinical trials of maintenance. Agents are being developed, and I think it’s a very important area in AML. And I think in the next several years, it will actually become common practice to do maintenance regimens.  

Laura Beth:

That’s good news. So, once an AML patient is in remission how are they monitored? 

Dr. Ravandi:

So, I mean, I usually tell my patients that once you’re in remission, you’re in remission until something goes wrong with your blood counts. So, in my opinion, it’s not important to do – definitely not important to do weekly blood counts, for example.  

Depending on patient’s anxiety levels and comfort, we do check their labs maybe once a month, once every two or three months, depending on how far they are from their remission. And in my opinion, routine bone marrows are not necessary during remission, unless the patient is a part of a clinical trial that they have accepted to participated in, because we do get a lot of information by doing those bone marrows. So, some studies have follow-up bone marrows, but that’s really as a part of a clinical trial and to help further the knowledge in therapy.