Tag Archive for: multiple myeloma
2022 ASH Meeting | Multiple Myeloma Takeaways
This is my 17th year attending ASH (American Society of Hematology), where typically over 30,000 attendees from all over the world (hematologists/oncologists, lab researchers, oncology nurses, scientists and 300 pharma companies) attend. This year ASH was set up as a hybrid meeting where some attended in person and many, including myself, virtually. I’m grateful to the IMF (www.myeloma.org) and their sponsoring pharma donors Takeda, Amgen, and Karyopharm for registering me for ASH so that I could learn and subsequently share my patient perspective with you.
My Takeaways
This year’s ASH continued to expand our knowledge on immunotherapies…more CAR-T’s and bispecific antibodies (“T-cell directing therapies”)…as well as more targets besides BCMA…and most importantly, side effects such as cytopenia (lower blood counts), cytokine release syndrome (CRS), neurotoxicity, and infections. At present, approved treatments in the area include CAR-T’s Abeca and Carvyti as well as the bispecific Tecvayli (Teclistamab), but these are currently only available for patients relapsed-refractory patients with >=4 lines of previous therapy. The good news is that all of these CAR-Ts and bispecifics are in clinical trials for patients with fewer prior treatments, even newly diagnosed patients in some cases!
Another area that needs better treatment options are Multiple Myeloma (MM) patients considered High Risk (HR) or ultra-high risk (>1 HR factor), as well as High Risk Smoldering Myeloma (HR SMM). Whereas some current studies show that media Overall Survival for MM is 10 years, HR patients are typically half that. And for HR SMM patients who have a good chance to progress to full blown MM within 2 years, is it possible that treatment at this pre-MM stage could delay progression or actually cure a patient from getting MM.
We know that if we achieve a Complete Response via blood tests which show no sign of an M-spike, that unfortunately the myeloma will still likely return, indicating that we still have myeloma but these tests are not sensitive enough to see it. Tests with more sensitivity are referred to as MRD (Minimal/Measurable Residual Disease) tests (Next Generation Sequencing and Next Generation Flow) from bone marrow biopsies and Mass Spectrometry tested via a patient’s blood. They are good prognosticators but typically not used to help guide treatment (for example, when to stop maintenance). If we knew when to stop treatment or change treatment, patients would more likely do better.
This leads to the discussion that we have many treatments available these days but what’s the best treatment for a patient being newly diagnosed, transplant-eligible or not, maintenance (for how long), treatment at first relapse, subsequent relapses? Many of the study results from ASH try to answer these questions via clinical trial results (but that’s still not a personalized treatment so it’s always important to ask your doctor questions and be part of that shared decision making).
Finally, the important topic of Diversity, Equity and Inclusion (DEI) was discussed more at this ASH than ever before and got its own Spotlight Education session. We need better representation of underserved populations in clinical trials. For example, 20% of MM patients are Black and yet they represent <5% of patients in MM trials. If we don’t improve upon this, trial results may lack internal validity resulting in poor external validity for the populations they are meant to serve.
For more patient information about ASH, there are many excellent webinars coming up from your favorite myeloma advocacy organization. And another great source are blogs written by patients (including myself) which you’ll find on the IMF website (https://ash2022blogs.myeloma.org/).
In summary, this year’s ASH continued to amaze me with so many studies in Myeloma, focusing on all stages from Smoldering Myeloma to MM Induction through Relapse. Clearly immunotherapy treatments, CAR-T’s and Bi-specific T-cell engagers were predominant among the oral presentations I attended, providing longer-term data on these new treatments. And importantly, other targets besides BCMA are being investigated.
For someone diagnosed with stage III MM 28 years ago with only 2 treatment options available (MP or VAD-SCT) and given 2-3 years expected survival, I’ve seen incredible progress since 2003 when Velcade was first approved followed by 14 more approvals and many combination therapies. While there continues to be unanswered questions, we now have many more effective treatments for MM, providing patients with better opportunities to manage their disease. Newly diagnosed MM patients can justifiably be more optimistic about their new diagnosis than at any other time in history. ASH2022 highlighted the tremendous advances we have made in treating this cancer for both the newly diagnosed and relapsed patient.
Patient Empowerment Network Board Emeritus
Jack Aiello is a former Silicon Valley high technology executive living in San Jose, CA. Jack was diagnosed with multiple myeloma in 1995 and has had three transplants for his condition. While the treatments have given him extended survival, he has had disabling side effects. After retiring, Jack has become a leading myeloma support group leader and traveled the US and overseas to attend medical conference, patient forums and inspire advocacy among patients.
Tools for Choosing Myeloma Therapy
Tools for Choosing Myeloma Therapy from Patient Empowerment Network on Vimeo.
When faced with choosing a myeloma treatment, what should be considered? This animated video reviews factors that impact treatment decisions, provides a list of questions to ask your healthcare team about therapy and advice for engaging in your myeloma care.
See More From Innovative Myeloma Therapies
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Transcript:
Whether a patient is newly diagnosed with myeloma or is facing a relapse, choosing a treatment approach can feel overwhelming.
Shared decision-making is a process where patients and healthcare providers communicate and collaborate to make care decisions. This approach encourages patients to take a more active role in their care and treatment and can help them feel more confident when choosing a therapy.
So, what can impact myeloma treatment decisions?
- There are patient-related factors, such as a patient’s age, fitness level, and pre-existing conditions.
- And, disease-related factors, including the aggressiveness of the patient’s disease and its location in the body.
- And, treatment-related factors, such as past treatments a patient has received or if they are refractory to medicines.
How can you play a role in making treatment decisions?
You can start by making a list of questions in advance of your appointment. This can help you to organize your thoughts before you meet with your healthcare team.
And, when working with your doctor to choose a treatment, consider asking the following questions:
- What type of myeloma do I have?
- Are there test results that may impact my treatment choices?
- What are the risks and benefits of each treatment option?
- What approach do you recommend and why?
- How is the treatment administered, and what side effects might I expect?
- What are my options if this treatment stops working?
- Are there newer treatment options available to me, including immunotherapy?
- And, is there a clinical trial that might be right for me?
It’s also a good idea to bring a friend or loved one to your appointment for support to take notes and help you recall information. Afterwards, discuss the appointment together – you can use this time to talk about your care plan and do your own research to learn more about your options.
The patient portal is another useful tool in your care. You can use it to view lab and test results. And you can use the messaging feature to communicate with your healthcare team when you have more urgent questions to address before your next visit.
Now that you know more about how to make myeloma treatment decisions, how can you take action?
- First, consider a second opinion or a consult with a specialist.
- Then, ensure you have had all relevant myeloma testing.
- Next, understand and participate in treatment decisions. This includes learning about your options, so you can weigh the pros and cons of each approach. And be sure to speak up and share your personal preferences and goals with your care team.
- Communicate regularly with your healthcare team – don’t wait to share information only when you have an appointment.
- And finally, bring a friend or loved one to appointments and always write down any questions or concerns in advance.
Visit powerfulpatients.org/myeloma to learn more about myeloma and access tools for self-advocacy.
What Is CAR T-Cell Therapy for Myeloma?
What Is CAR T-Cell Therapy for Myeloma? from Patient Empowerment Network on Vimeo.
How does CAR T-cell therapy work to treat myeloma? This animated video provides an overview of the CAR T-cell process, explains which patient this treatment could be appropriate for, and reviews potential side effects.
See More From Innovative Myeloma Therapies
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How Is CAR T-Cell Therapy Changing the Myeloma Treatment Landscape? |
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Transcript:
CAR T-cell therapy is a type of treatment in which a patient’s own immune system cells, also known as T cells, are reprogrammed in a laboratory to attack cancer cells.
The process involves removing T cells from the patient’s blood. Then, the T cells are sent to a laboratory where a gene for a special receptor that binds to a protein on the patient’s cancer cells is added to the T cells. The special receptor is called a chimeric antigen receptor.
When this process is complete, the cells are put back into the patient’s body by infusion. The altered T cells then attack and destroy cancer cells in the patient’s body.
In myeloma patients, the FDA-approved CAR T-cell therapies recognize a protein called B.C.M.A. on the surface of myeloma cells.
Now that you know how CAR T-cell therapy works, who is CAR T-cell therapy right for?
- While still a new treatment, CAR T-cell therapy is currently approved for people with relapsed or refractory multiple myeloma who have already received four or more lines of therapy.
While every patient reacts differently to CAR T-cell therapy, some of the potential side effects may include:
- Cytokine Release Syndrome, which occurs when the immune system responds to infection or immunotherapy drugs more aggressively than it should. Symptoms may include fever, nausea, fatigue, and body aches.
- Another potential side effect is neurotoxicity, which may cause negative effects on the nervous system such as confusion, difficulty speaking or understanding, loss of balance or consciousness, tremors and seizures.
- And blood count recovery can be slower following CAR T-cell therapy.
So, what should you ask your doctor about CAR T-cell therapy?
- Is CAR T-cell therapy available at this cancer center?
- Is CAR T-cell therapy an option for me now or in the future?
- What is the cost of this therapy?
- What are the risks and benefits of this approach?
- What can I expect during the recovery process?
To learn more about innovative myeloma therapies and to access tools to help you become a pro-active patient, visit powerfulpatients.org.
What Experts Are Learning About the Hereditary Risk of Myeloma
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.
Related Programs:
Understanding MGUS & Smoldering Myeloma: What’s the Difference? |
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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.
Expert Perspective: COVID Vaccines and Treatment for Myeloma Patients
Expert Perspective: COVID Vaccines and Treatment for Myeloma Patients from Patient Empowerment Network on Vimeo.
Myeloma expert Dr. Irene Ghobrial shares an update on COVID vaccines, treatment, and advice for myeloma patients on how to help protect themselves from the virus.
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.
Related Programs:
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Understanding MGUS & Smoldering Myeloma: What’s the Difference? |
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Transcript:
Katherine Banwell:
Many prominent doctors claim the COVID vaccines suppress the immune system. How can boosters be justified in an already immune deficient myeloma patient?
Dr. Irene Ghobrial:
Yes, so we think that protecting yourself and preventing COVID infections is so essential and so important.
Especially in a patient with myeloma and especially when you’re receiving therapy: daratumumab (Darzalex), bispecifics, CAR-T. We want to make sure everyone is protected from COVID infections, and they are real. They are serious, and they cause death in our patients. So, every step, not only getting the vaccine but also sometimes we give tixagevimab co-packaged with cilgavimab (Evusheld) to protect our patients and protect further problems and reinfection.
Katherine Banwell:
Remind us, what that is, the Evusheld?
Dr. Irene Ghobrial:
Oh. It’s an antibody to help us prevent the COVID infection, so as a prevention method rather than as a treatment method.
The other thing that we think of is the immune system is already altered in myeloma. It’s even altered or changed even as early as MGUS and smoldering myeloma. So, when we’re walking around and thinking, “Oh, I have only a benign design of MGUS,” that’s not true. The immune system has already started to change as early as MGUS, and in many of us as we get older.
So, we have to be more protective and we have to be more careful with our patients. But as we get to even myeloma, before we even treat it, before we use the drugs that kill plasma cells, good and bad plasma cells, which secrete antibodies that fight infections, we are already at risk for COVID infections.
And then our drugs, unfortunately, don’t only kill the malignant or the bad plasma cells, they also have a small side effect of killing also your normal plasma cells, and these are the ones that make antibodies to fight infections. So, you are at risk, and you have to be very protective and careful with yourself.
How Is Myeloma Treatment Response Measured?
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.
Which Myeloma Patients Are Candidates for CAR T-Cell Therapy?
Which Myeloma Patients Are Candidates for CAR T-Cell Therapy? from Patient Empowerment Network on Vimeo.
Myeloma specialist Dr. Omar Nadeem discusses which patients are most appropriate for CAR T-cell therapy and explains cytokine release syndrome (CRS), which may arise following this treatment approach.
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:
“How is it determined as to which patients might be the best candidates for clinical trial CAR T-cell treatment?”
Dr. Omar Nadeem:
So, CAR T-cell therapy is already approved. It’s FDA-approved for patients that have had four or more prior lines of myeloma therapy. So, when we think about a patient coming to us for that particular treatment that have relapsed myeloma, we’re always looking to see how much of the previous therapy they had.
Whether they meet the indication, the labeled indication for that particular product. And then now, as we’ve discussed today, we’re studying this CAR T-cell therapy in various different phases of myeloma. Earlier lines of therapy, even thinking about studying it in high-risk smoldering myeloma, right? And then kind of looking about how we can best study this therapy in so many different phases.
So, it all depends on where a patient is in their disease state, and then we kind of look to see whether a commercial approved CAR-T product makes sense for them, or we think about one of our several relapse CAR T-cell trials that are looking at BCMA target, which is what the approved one is, but also looking at newer targets like GPRC5D that we’ve brought up before.
So, it encompasses a lot of different things, that question, but I think in terms of the candidacy of the patient itself, we do know that these CAR T-cell therapies have some toxicity, so we have to then weigh in terms of what medical problems they have whether they’ll be able to tolerate what the majority of patients with CAR T-cell therapy get, which is this syndrome called cytokine release syndrome, where patients will get a fever.
And in some cases have changes in their blood pressure or oxygen levels. We have to make sure that the patient’s body can handle that. I will say we’ve gotten better and better at managing a lot of toxicities as it comes to CAR T-cell therapy. When this was first approved, it was all pretty new, but now what we’re learning is if patients are developing a fever, which the majority do, we’re intervening earlier and earlier to prevent them from getting sicker.
So, these are things we’ve learned now, and the majority of patients get through CAR T-cell therapy toxicity period much better than they did when it was first approved.
How Is Relapsed or Refractory Myeloma Managed?
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.
Related Programs:
What Tests Are Essential Before Choosing a Myeloma Treatment Approach? |
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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?
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.
Related Programs:
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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?
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?
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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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
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?
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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Understanding MGUS & Smoldering Myeloma: What’s the Difference? |
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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?
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.
