Is the COVID Vaccine Safe and Effective for Waldenström Macroglobulinemia (WM) Patients?

Is the COVID Vaccine Safe and Effective for Waldenström Macroglobulinemia (WM) Patients? from Patient Empowerment Network on Vimeo.

Dr. Shayna Sarosiek of Dana-Farber Cancer Institute discusses the safety and efficacy of the COVID-19 vaccine for Waldenström macroglobulinemia (WM) patients.

Dr. Shayna Sarosiek is a hematologist and oncologist at the Dana-Farber Cancer Institute where she cares for Waldenström macroglobulinemia (WM) patients at the Bing Center for Waldenstrom’s. Dr. Sarsosiek is also Assistant Professor of Medicine at Harvard Medical School. Learn more about Dr. Sarosiek, here.

See More From The Pro-Active Waldenström Macroglobulinemia Patient Toolkit

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Waldenström Macroglobulinemia Treatment Decisions: What’s Right for You? 

Waldenström Macroglobulinemia (WM) Treatment: Why Timing Is Essential

Waldenström Macroglobulinemia (WM) Treatment: Why Timing Is Essential

Exciting Advances in Waldenström Macroglobulinemia (WM) Treatment

Exciting Advances in Waldenström Macroglobulinemia (WM) Treatment


Transcript:

Katherine:

This is a question on many people’s minds these days. Is the COVID vaccine safe and effective for people with Waldenstrom’s macroglobulinemia?  

Dr. Sarosiek:

So, in general, we highly recommend the COVID vaccines for our patients with Waldenstrom’s. We think it’s very helpful; it’s usually very safe for patients. But the one caveat is that it’s sometimes not as effective for patients with Waldenstrom’s as it is for patients who are otherwise healthy. There are a lot of data coming out that the antibodies or the part of the immune system is not responding as well in patients with Waldenstrom’s as in other healthy patients.  

And so, Waldenstrom’s patients often need to get more doses of vaccines to get the same effectiveness as healthy patients might. And so, it’s really important to follow up with your provider to really get a good idea of how many doses you can have or should have. And the other really important part of that is making sure that those are time appropriately with your therapy. Because we know that the effectiveness of the vaccine is really related any recent therapies that patients might have had.  

So, making sure that’s an open conversation with your physician about if it’s the right time to get your next vaccine. And if its’ not the time for the vaccine or if the vaccine is not going to be effective for you, there are potential other options such as Evusheld, which is an antibody against COVID that can offer similar efficacy as a vaccine might in terms of giving you antibodies if your own body can’t make them. 

Katherine:

And when you refer to COVID vaccine doses, are you including the boosters? That people should be getting? 

Dr. Sarosiek:

Yeah. So, initially patients should have a core series of vaccines essentially. So, in most people – in healthy people – that’s generally two doses are considered the core before you start boosters. In patients with Waldenstrom’s or patients who are immunosuppressed, that initial core series is three vaccines. And then the ones after that would be considered the booster vaccines. 

Exciting Advances in Waldenström Macroglobulinemia (WM) Treatment

Exciting Advances in Waldenström Macroglobulinemia (WM) Treatment from Patient Empowerment Network on Vimeo.

What new therapies are on the horizon for patients with Waldenström macroglobulinemia (WM)? Dr. Shayna Sarosiek from Dana-Farber Cancer Institute reviews promising developments in WM treatment, including immunotherapy and BTK inhibitors.

 Dr. Shayna Sarosiek is a hematologist and oncologist at the Dana-Farber Cancer Institute where she cares for Waldenström macroglobulinemia (WM) patients at the Bing Center for Waldenstrom’s. Dr. Sarsosiek is also Assistant Professor of Medicine at Harvard Medical School. Learn more about Dr. Sarosiek, here.

See More From The Pro-Active Waldenström Macroglobulinemia Patient Toolkit

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Emerging Waldenström Macroglobulinemia Treatment Approaches

Emerging Waldenström Macroglobulinemia Treatment Approaches 

What Are the Treatment Goals for Waldenström Macroglobulinemia?

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Current Waldenström Macroglobulinemia Treatment Approaches

Current Waldenström Macroglobulinemia Treatment Approaches 


Transcript:

Katherine:

What are you excited about when it comes to Waldenstrom’s research? 

Dr. Sarosiek:

So, there a couple of things that I find really exciting right now. One thing in particular is currently for treatment for Waldenstrom’s, we often use BTK inhibitors. So, the group of medications that includes zanubrutinib (Brukinsa), ibrutinib (Imbruvica), acalabrutinib (Calquence). And that class of medications has really revolutionized treatment for Waldenstrom’s. But sometimes patients become resistant to those medications. And there’s a new group in that same class of what’s called BTK inhibitors.  

And those are non-covalent BTK inhibitors. And those drugs actually work often for patients who progress on initial therapy with ibrutinib or zanubrutinib. So that really, I think is game changing. There are some early Non-Covalent BTK inhibitors that are in trials. And I really think it’s going to lead to use of those medications very commonly in the future for Waldenstrom’s. So, that I think is exciting to have a next oral therapy to go to after progression on the current therapies. I’m also excited about new combinations that are being tried in Waldenstrom’s.  

So, using combinations of different oral therapies together that would offer deep responses and also offer a time-limited therapy. Because right now many of our treatments are given indefinitely. And so, offering a limited therapy. So, I think that, and there are many other things I could go on for a long time about this. But there are many things that I think are really exciting and we’re going to be changing the field in the coming years. 

Katherine:

Dr. Sarosiek, what is immunotherapy? Could you define that and also, how does it work to treat Waldenstrom’s? 

Dr. Sarosiek:

So, immunotherapy includes many different types of medications. But these are all medications that either use the patient’s immune system or use something from the immune system, like an antibody to help fight off a cancer. And this plays a huge role currently and I think it will continue to in the future. So, probably the most common immunotherapy that patients are familiar with, with Waldenstrom’s now is rituximab (Rituxan). So, that’s a monoclonal antibody.  

And that’s used in many combinations in Waldenstrom’s and is a very important therapy currently. And that antibody is essentially just goes into where the cancer cells are located and attacks that type of cell.  

But the other immunotherapies that are up and coming – which I think are important for patients to know about – one is CAR-T cell therapy. So, a lot of patients ask me about that. and that’s essentially, a T cell is part of the immune system that every patient has. And what CAR T-cell therapies do is patients can collect from their bloodstream – the physicians can collect T cells and then they modify those T-cells in a way so that they’ll recognized the cancer and attack the cancer.  

And so then, those T cells are given back to the patient and then that T  cell can go and work with the patient’s immune system to destroy the cancer. And that’s been very successful in a lot of other cancers and is being used in Waldenstrom’s now. And I think we’re going to be learning a lot about that and it’s going to be an important part of the future with immunotherapy involved in Waldenstrom’s. Another therapy similar is something called BiTE therapies. So, Bispecific T-cell engagers.  

So, that’s essentially two antibodies together. One antibody kind of pulls in the cancer cell and one antibody pulls in the immune system. So, when that treatment is given to patients it kind of brings the immune system close to the cancer cells. So, your own immune system can help fight off the cancer. So, those are just kind of two of the newer immunotherapies that are up and coming that I think will play an important role in the future in this disease. 

Katherine:

Who is this treatment right for? 

Dr. Sarosiek:

Immunotherapies in general currently we’re using them – currently immunotherapies are being used in patients who have had a relapsed disease. So, they have already had current available therapies, like BTK inhibitors or rituximab. And there are clinical trials that can use CAR-T cell therapy. And there are up and coming trials with BITE therapy. So, right now it’s being used in their relapse setting. But as we learn more about it, it’s possible those we moved earlier on to patients who are earlier in their disease course. 

Katherine:

What kind of side effects should patients be aware of? 

Dr. Sarosiek:

So, the side effects can vary depending on what the therapy is. So, patients who are getting rituximab, the currently available immunotherapy, patients can have infusion reactions. So, as your body is kind of getting used to that monoclonal antibody coming in, you can have a reaction. And in that case, we have to stop the infusion, wait for the side effects to settle down, and then restart.  

Katherine:

What type of side effects would they be? 

Dr. Sarosiek:

So, side effects from rituximab infusions can really vary. In some patients it can be similar to an allergic reaction. So, let’s say itchy throat or a rash or hives. Sometimes it can be pain in the chest or the back or trouble breathing. So, they can really vary. But most of the time, those can – when the infusion is stopped, we can give patients medications like Benadryl or Tylenol to help with symptoms. And then we can restart the Rituximab at a lower rate. And that lower rate allows the patient’s body to kind of get used to the medication and continue on the treatment. So that’s generally the things we watch for with Rituximab. 

Waldenström Macroglobulinemia (WM) Treatment: Why Timing Is Essential

Waldenström Macroglobulinemia (WM) Treatment: Why Timing Is Essential from Patient Empowerment Network on Vimeo.

Waldenström macroglobulinemia (WM) is a rare slow-moving disease, so immediate treatment isn’t always necessary. WM expert Dr. Shayna Sarosiek discusses the “watch and wait” period and what criteria may indicate a patient is ready for therapy.

Dr. Shayna Sarosiek is a hematologist and oncologist at the Dana-Farber Cancer Institute where she cares for Waldenström macroglobulinemia (WM) patients at the Bing Center for Waldenstrom’s. Dr. Sarsosiek is also Assistant Professor of Medicine at Harvard Medical School. Learn more about Dr. Sarosiek, here.

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Understanding Waldenström Macroglobulinemia and How It Progresses 


Transcript:

Katherine:

I understand that many people diagnosed with Waldenstrom’s may not be treated right away. Why is that? 

Dr. Sarosiek:

Yeah, so a lot of patients – actually, the majority of patients don’t need treatment right away for Waldenstrom’s. And even some patients, about 20 percent to 30 percent of patients a decade later still don’t need therapy. Because, as I mentioned, it’s really such a slow-moving disease that often patients will have no symptoms or very few symptoms for many years. And if that’s the case, we really don’t like to introduce treatments earlier than we need to.  

One, because you might introduce a therapy that adds toxicity or side effects that are making the patient feel worse than they currently feel. Two, the other reason we don’t want to treat too often if we don’t need to, is because it’s possible the Waldenstrom’s might become resistant to therapies and then when we truly needed something later, the disease might become resistant to things we used earlier.  

The other reason is, we don’t have any data that shows us that treating early improves survival. We know that patients with Waldenstrom’s have an excellent survival. And that’s only when treating when we need to. So, we don’t have any data that tells us we need to treat early. And so, really, the focus of Waldenstrom’s therapies is just to make sure that our patients maintain a good quality of life with their disease under good control. And we can do that in a lot of cases by not offering therapy early and just doing it when we start to see signs that there is something that needs to be addressed.  

Katherine:

Many of us have heard this term “watch and wait.” What does that mean exactly? 

Dr. Sarosiek:

So, watch and wait generally just refers to a plan to continue to monitor the patient. Often every three months or every four months in clinic, where we might just examine the patient to check for lymph nodes or an enlarged spleen. We ask about symptoms that might perk our ears up or make us think about progression of the disease. And we also check bloodwork.  

That can tell us what’s happening with the Waldenstrom’s. So, really, the exam, talking with the patient, getting labs every few months is a good way for us to keep track of what’s happening with the disease. So, we’re watching closely, but we’re waiting and holding off on therapy until it’s needed. 

Katherine:

Yeah. How do you know when it’s time to begin treatment? 

Dr. Sarosiek:

Great question. So, we have criteria that were designed. That physicians internationally follow to tell us when patients need treatment. Of course, those are just guidelines, so it’s often based on the guidelines and also each individual patient. But, for example, one of the main reasons why patients might require therapy is if a patient has anemia.  

So, we measure that with the hemoglobin. If the hemoglobin’s less than 10, and the patient has symptoms of anemia, then in that case we might need to offer therapy. Another common reason for therapy being initiated might be hyperviscosities. So, if the blood is getting thick, as Waldenstrom’s progresses and the IgM level is high, then in that case blood flow can’t happen appropriately. And so, in that case, we might need treatment.

Another side effect that patients with Waldenstrom’s can have is neuropathy. And so, that’s numbness, tingling, burning, loss of sensation. Usually starting in the toes and working its way up the feet and legs. If that’s progressing rapidly, if it’s causing the patient to not be able to do their usual activities, that’s another reason for treatment. So, we have these clear guidelines that tell us the things that we should be watching out for and then, it helps us to know when it’s an appropriate time to start treatment for patients. 

Why Should You See a Waldenström Macroglobulinemia (WM) Specialist?

Why Should You See a Waldenström Macroglobulinemia (WM) Specialist? from Patient Empowerment Network on Vimeo.

There are only 1,500 patients diagnosed with Waldenström macroglobulinemia (WM) each year in the United States. WM expert Dr. Shayna Sarosiek explains why patients should consider a consult with a WM specialist and advice for being proactive in their care.

Dr. Shayna Sarosiek is a hematologist and oncologist at the Dana-Farber Cancer Institute where she cares for Waldenström macroglobulinemia (WM) patients at the Bing Center for Waldenstrom’s. Dr. Sarsosiek is also Assistant Professor of Medicine at Harvard Medical School. Learn more about Dr. Sarosiek, here.

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Waldenström Macroglobulinemia (WM) Treatment: Why Timing Is Essential

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What Is the Patient’s Role in WM Treatment Decisions? 


Transcript:

Katherine:

Why do you think patients should consider seeing a Waldenstrom’s specialist? 

Dr. Sarosiek:

So, Waldenstrom’s is a rare disease. There are only about 1,500 patients per year in the United States diagnosed with Waldenstrom’s. And because of that, many providers – whether it’s an internal medicine provider, a surgeon, oncologist – most people don’t have a lot of experience, just because it’s such a low number of patients with the disease.  

And so, it’s not possible I think to really ever know everything there is to know about Waldenstrom’s. But that’s especially true when you’re working in the community, and you don’t get an opportunity to see a lot. So, if you have the chance to see a specialist, I think it’s really important. Because as a specialist, we really have the opportunity to get to know all of the data about the disease.  

We get to know the nuances of the data. We get to know a lot of different presentations of the disease and have a lot of experience with the unique things that can happen with Waldenstrom’s. So, we’re lucky in that way to really be able to see patients and continuously just be learning more and more so that we can be more helpful to patients. 

Katherine:

Right. What is your advice to patients who may feel like they’re hurting feelings by seeking a specialist or seeking a second opinion? Any advice for self-advocacy? 

Dr. Sarosiek:

So, I think in general I would hope that most physicians and all physicians would really be open to having their patients get a second opinion. Even as a specialist, we’re really open to that because we can never know everything and so it’s important to get more brains involved at all times, I think is always helpful. So, although it may feel that way sometimes, I think the vast majority of physicians I come in contact with are really more than willing to get help from other people who might have more experience with such a rare disease.  

And I think that patients should never be discouraged if they have a physician who’s not quite open to it [00:06:05], because they really – I think the patients are always their best advocate. They know their body the best, they know their symptoms, they know if something’s not right. And so, really pushing to get the right answers for themselves. I think being an advocate for yourself there’s no one who can do that better. So, patients should never be – should never hold back from getting a second opinion. 

Expert Advice for Newly Diagnosed Waldenström Macroglobulinemia (WM) Patients

Expert Advice for Newly Diagnosed Waldenström Macroglobulinemia (WM) Patients from Patient Empowerment Network on Vimeo.

What should you know if you or a loved one has been diagnosed with Waldenström macroglobulinemia (WM)? Dr. Shayna Sarosiek of the Dana-Farber Cancer Institute shares key advice.

Dr. Shayna Sarosiek is a hematologist and oncologist at the Dana-Farber Cancer Institute where she cares for Waldenström macroglobulinemia (WM) patients at the Bing Center for Waldenstrom’s. Dr. Sarsosiek is also Assistant Professor of Medicine at Harvard Medical School. Learn more about Dr. Sarosiek, here.

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Understanding Waldenström Macroglobulinemia and How It Progresses 


Transcript:

Katherine:  

Dr. Sarosiek, welcome. Would you please introduce yourself? 

Dr. Sarosiek: 

Sure. My name is Shayna Sarosiek, and I’m a hematologist and oncologist. And I work at Dana-Farber Cancer Institute where I see patients in the Bing Center for Waldenstrom’s. And really just focus on Waldenstrom’s and other IgM-related disorders.  

Katherine:  

Great. Thank you for joining us today. What three key pieces of advice would you have for a patient who’s just been diagnosed with Waldenstrom’s?  

Dr. Sarosiek: 

So, certainly being diagnosed with Waldenstrom’s can be incredibly overwhelming. So, a couple of things I try to remind patients of is one, in general, Waldenstrom’s is a pretty slow-moving disorder. And so, there’s a lot of time in most cases for patients to really get additional information, seek second opinions, learn really about the treatment options and make a really well-informed decision. And even in the cases where the patient might need treatment more urgently. We have some things that can kind of temporize or stabilize patients while we have time to make those informed decisions.  

So, one, I would say there’s always time to make a well-informed decision about the next steps. So, although it can be overwhelming, that’s important to keep in the back of their minds. And the other thing for patients I would say is just to remember this is a constantly evolving field. And a conversation you have with your physician today, six months from now or a year from now is going to be totally different as things improve, more treatments are available. 

And that’s a really positive thing for patients to remember, is that things are honestly just really every day improving in the field. And the third thing I would say is that there are really incredible resources available for patients. Videos like this, educational material, patient support groups. And there are really just a lot of opportunities that patients should and could take advantage of in order to really improve their care, be educated, and really know what treatments are available to make the best decisions.  

What Do You Need To Know About Waldenström Macroglobulinemia (WM)?

What Do You Need To Know About Waldenström Macroglobulinemia (WM)? from Patient Empowerment Network on Vimeo.

What should you or your loved ones know following a Waldenström macroglobulinemia (WM) diagnosis? This animated video reviews symptoms of WM, current treatment options and provides key advice for becoming a proactive WM patient.

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Current Waldenström Macroglobulinemia Treatment Approaches


Transcript:

Waldenström macroglobulinemia, also called Waldenström or WM, is a rare, slow-growing type of non-Hodgkin lymphoma that starts in a person’s white blood cells. Healthy blood cells are crowded out when the bone marrow produces too many malignant white blood cells, and these produce an excess of a protein called immunoglobulin M or IgM.  

Waldenström can cause symptoms that may include: 

  • Fatigue  
  • Unintended weight loss 
  • Fever 
  • Swollen lymph nodes 
  • Enlarged spleen 
  • Unexplained bleeding 
  • And numbness in the hands or feet, which is called peripheral neuropathy 

It’s important to note that not all patients with Waldenström have symptoms when they are diagnosed, and so those patients won’t need treatment immediately. Instead, they are put on an approach called “watchful waiting” or “active surveillance.” This means patients are monitored regularly for indicators that it is time to begin treatment – such as the onset of symptoms.  

So, how is Waldenström typically treated? 

Every patient is different. When making treatment decisions, factors such as the extent of disease and symptoms can impact available options. And potential side effects, a patient’s age, health, and lifestyle are also taken into consideration. 

The good news is that there are several treatment options for Waldenström, including: 

  • Chemotherapy  
  • Targeted therapies such as proteasome inhibitors, BTK inhibitors and BCL2 antagonists; 
  • Immunotherapy  
  • And, clinical trials, which study emerging treatments for Waldenström. It’s important to ask your doctor if there is a trial that may be right for you. 

Less commonly used treatments for Waldenström are stem cell transplant and radiation. 

In the case of hyperviscosity or other IgM-related symptoms, plasmapheresis, also known as plasma exchange, may be used as a temporary measure to manage the issue.    

Now that you understand more about Waldenström, how can you take an active role in your care?  

  • First, continue to educate yourself about your condition. 
  • Understand the goals of treatment and ask whether a clinical trial might be right for you.
  • It also important to consider a second opinion or consult with a specialist following a diagnosis.
  • And, write down your questions before and during your appointments. Visit powerfulpatients.org/wm to access office visit planners to help you organize your thoughts.
  • Bring one or more friends or loved ones to your appointments to help you recall information and to keep track of important details.
  • Finally, remember that you have a voice in your care. Don’t hesitate to ask questions and to share your concerns. You are your own best advocate. 

 To learn more about Waldenström macroglobulinemia and to access tools for self-advocacy, visit powerfulpatients.org/WM. 

How Can Clinical Trials Be Accessed?

How Can Clinical Trials Be Accessed?  from Patient Empowerment Network on Vimeo.

Clinical researcher Dr. Seth Pollack and patient advocate Sujata Dutta explain the benefits of participating in a clinical trial. They review important questions to ask your doctor and share advice for finding a trial.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.

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Are Clinical Trials Safe?

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Transcript:

Katherine Banwell:    

Sujata, there’s clearly a lot of hesitation and misconceptions out there. What would you say to someone who’s considering a trial but is hesitant?

Sujata Dutta:  

I would say speak to your provider, speak to your doctor, and get all these myths kind of busted to say, “it’s going to be expensive” or whatever those questions are. And then, through that process also try and understand what is it that the study is trying to achieve? How is that going to be beneficial to you? So, in my instance, it wasn’t the last line of defense, it was just one of the processes or combos that would help me. And so, that was important for me to understand and then a little bit of education as well. So, I was asking, I have questions on my phone every time I meet my provider, and I did the same thing. So, I think that one of the good practices is keep your note of your questions and have those questions ready. And no question is silly, all questions are important. So, ask as many questions as you can and use that opportunity to educate yourself about it.

And maybe you realize, “No. I don’t think it’s working for me” or “I don’t think this trial is good for me.” But it’s good, important, to have that conversation with your provider, that’s what I would recommend highly.

Katherine Banwell:    

Excellent. Thank you, Dr. Pollack, if someone is interested in participating, how can they find out about what trials are even available for them?

Dr. Seth Pollack:       

Yeah. I mean, the best thing to do is to start just by asking your doctor if they know about any clinical trials. And a lot of the times the clinical trials are run at the big medical centers that may be closer to you, so you could ask your doctor if there’s any clinical trials at the big medical center even. Or I always think it’s good to get a second opinion, you could go get a second opinion at the big medical center that’s close to you and ask them what clinical trials are at your center.

And sometimes they’ll be conscious about some of the clinical trials that may be even run around the country. And you can ask about that as well.

Katherine Banwell:    

Would specialists have more information about clinical trials than say a general practitioner?

Dr. Seth Pollack:       

So, I specialize in rare cancers, so a lot of the times the general practitioners they’ve got my cell phone number, and they text me, and they say, “Hey, do you have a clinical trial going on right now?” And that happens all the time, but yeah, the specialists will usually because frankly there’s so much to know. And the general practitioners really have a lot to keep track of with all the different types of diseases that are out there. Whereas at the big centers, the specialists, part of their job is really to keep their tabs on what’s going on with the clinical trials.

So, they’re good people to ask, either your local doctor could reach out to them, or you could go get a second opinion and ask.

Sujata Dutta:  

There’s also a lot of information, Katherine, on sites such as LLS, or PEN, or American Cancer Society that they also publish a lot of information. Of course, I would recommend once you have that information then vet it by your specialist, or whatever. But if you’re interested in knowing more about clinical trials in general and some that would work for you, then those are also some places to get information from.

Katherine Banwell:    

That’s great information. Thank you, I was going to ask you about that Sujata. Well, before we end the program, Dr. Pollack, I’d like to get your final thoughts. What message do you want to leave the audience with related to clinical trial participation?

Dr. Seth Pollack:       

Yeah. I think clinical trials it can be a very rewarding thing for a lot of patients to do, I think patients really like learning about the new treatments. And I think a lot of patients really like being a part of pushing the therapies forward in addition to feeling like sometimes they’re getting a little bit of an extra layer of scrutiny, because there’s a whole extra team of research coordinators that are going through everything.

And getting access to something that isn’t available yet to the general population. So, I think there’s a whole host of advantages of going on clinical trials, but you need to figure out whether or not a clinical trial is right for you.

Katherine Banwell:    

Yeah. Sujata, what would you like to add?

Sujata Dutta:  

Absolutely, I second everything that Dr. Pollack is saying. And in my personal experience I wouldn’t say everything is hunky-dory, everything is fine. I’m going through treatment, I have chemo every four weeks, I started with chemo every week. That’s when the logistics pace was really difficult because going to Mayo every week was not easy. But anyways, as the trial progress itself every four weeks, but as I said the benefits are huge because I have labs every four weeks. I meet my provider every four weeks.

So, we go through the labs and anything amiss, I’ve had some changes to my dosage because I’ve had some changes in the labs. And so, there’s a lot of scrutiny which I like, but the flip side, for maybe some maybe like, “I have to have chemo every four weeks. Do I want to do that or not?” Or whatever. In my case, I knew it, and I signed up for it, and I’m committed to doing that for two years. And so, I’m fine with that. So, I would say all in all, I’d see more benefits of being in a clinical trial. One, you’re motivated to give back to the community. Two, you are being monitored and so your health is important to your provider just as it is to you. And so, I highly recommend being part of a trial if it works for you and if you’re eligible for one.

Are Clinical Trials Safe?

Are Clinical Trials Safe?  from Patient Empowerment Network on Vimeo.

Clinical researcher Dr. Seth Pollack explains the safety protocols in place for clinical trials, including how data is reported and protected. Patient advocate Sujata Dutta goes on to share her experience in a clinical trial.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.

See More from Clinical Trials 101

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Is a Clinical Trial a Last-Resort Option?

A Patient Shares Her Clinical Trial Experience

If I Participate in a Clinical Trial, Will I Be a Guinea Pig?


Transcript:

Katherine Banwell:

Some patients feel that clinical trials aren’t safe, is that the case, Dr. Pollack?  

Dr. Seth Pollack:

No. I mean, we go through, as I was saying before, these clinical trials are extensively vetted. So, the safety is, of course, one of the things that we look most carefully about. But as I was saying before, like with any treatment’s cancer treatments have toxicity, that’s a common problem. So, and when you’re dealing with something brand new sometimes there is a little bit more risk. So, when you’re talking about these very early-stage Phase I trials you probably want to talk to your doctor about what sorts of toxicities you can expect and where they are in the Phase I trial. Are you the first ever to receive this new drug? And if you are nobody’s making you go in the clinical trial, so it can only help to get more information. Right? So, you should ask your team about it, you should find out. 

Most of the time there’s going to be a lot of patients that have been treated already, I mean, they can’t give you definitive data about how things are going but they can maybe say, “Hey. I’ve already treated a few patients on it, and they seem to be doing great.” 

Katherine Banwell:

So, you need to weigh the pros and cons of the trial. 

Dr. Seth Pollack:

You do need to weigh the pros and cons. Now, when you’re talking about these Phase IIs and Phase IIIs, I mean, these are drugs now that have really been vetted for their safety and we have a lot of data about it. And even the Phase Is, it’s not like these things are coming out of nowhere, they’ve been scrutinized, we really expect that they’re going to be safe but we’re doing the trial to prove it. So, it’s a good thing to ask about. 

Katherine Banwell:

Yeah, yeah. 

Sujata Dutta:

Yeah. I would also add that it’s so closely monitored that safety is a top priority, it’s front and center. So, the advantage, I think, with being on a trial is the close monitoring of the patient exactly for this reason. 

If something is amiss it’s going to be picked up as quickly as possible and you’re any issues are going to be addressed as soon as. So, I think, safety does get addressed pretty quickly.  

Katherine Banwell:

Good. 

Can data from trials even be trusted? Dr. Pollack, is that the case? 

Dr. Seth Pollack:

Well, of course, I mean, it can be trusted. Because the thing with the clinical trial data is that you really see the data and there’s all kinds of scrutiny making sure that the data is reported accurately. Now, there’s a whole other conversation we could have as to whether we could interpret the data differently. And sometimes that is an issue that comes up, but the data is reported very accurately. 

So, and there are statistics that are very well understood, and the bar is actually pretty high to say one arm of the trial was better than the other arm of the trial. So, if patients have better survival on one arm, if we say that, usually it means they did considerably better. Enough better that it wasn’t a random chance that one extra patient did better on the treatment arm. No. There were enough patients that did better that the statisticians can go through it with a fine-toothed comb. And they can be absolutely sure up to exactly how many percent sure they can tell you, 0.05 percent or less chance of error that this was a real difference between the study arm and the standard of care arm. 

Sujata Dutta:

I think you mentioned too that one is trust, and one is data. So, Dr. Pollack mentioned a lot about the data, I think the trust is also a very important thing. I like to go with positive intent because I do not have a reason to believe my doctor has some ulterior motive to suggest a clinical trial. And so, I trust them wholeheartedly. The first hurdle is you have to trust the system or what is being proposed to you because, as Dr. Pollack said, it’s gone through a lot of vetting. A recommendation to be part of a trial itself is vetted by your doctor when they make the recommendation. So, have faith, trust, that they are making a good recommendation. And then, of course, the data, I don’t know much about that, but as I said, I trust it. So, I would trust the data too. 

Katherine Banwell:

Of course. Of course. Some patients feel like they’re going to lose their privacy. Sujata, did you feel that at all? 

Sujata Dutta:

No. Not at all. 

I mean, with everything else that is also taken care of, my information, or whatever, is not made available to anybody. And so, obviously there’s a lot of people will get those, and I had a huge pile of paperwork to go through, but I think that’s a good thing. For my peace of mind that I knew that my information was not going to be shared outside of the study, the trial, etc., and things. So, no, I don’t think that’s a problem. 

Katherine Banwell:

Beyond these misconceptions is there anything else you hear? Dr. Pollack?  

Dr. Seth Pollack:

No. I mean, look, in our crazy modern world there’s concerns everywhere, but the clinical trial is very, very careful. Whenever possible we use the medical chart.  

And then, we have a very stringently protected database that’s storing people’s information, but it’s deidentified. So, I mean, we have a separate key to figure out who the patients are and then we try to limit the use of the patient’s name or any identifying information about them beyond that. So, and your information is not shared. For example, if there’s a drug company involved in the trial, your information is not shared with the drug company, you have a new identifier that is unique and not traceable back to you that is provided to whoever, if there’s outside groups working on the trial with you. So, your information is very carefully protected, and everyone is very conscious about issues regarding privacy.  

Katherine Banwell:

That’s great to know.  

Are Clinical Trials a Logistical Nightmare?

Are Clinical Trials a Logistical Nightmare?  from Patient Empowerment Network on Vimeo.

PEN board member and myeloma survivor Sujata Dutta shares how her family managed the logistics of her clinical trial participation.

Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.

See More from Clinical Trials 101

Related Resources:

Is a Clinical Trial a Last-Resort Option?

Are Clinical Trials Safe?


Transcript:

Katherine Banwell:    

The logistics will be a nightmare and I don’t live close to a research hospital. Sujata, did you have that issue?

Sujata Dutta:  

Yeah. That’s a very interesting one, and actually I’ll share my experience. I did have this concern about logistics, because I got my transplant at Mayo Rochester, which is a two-hour drive from where I live. And so, when I got to know about it literally me and my husband were like, “Oh, my gosh. What are we going to do?” It’s not just me, my husband is my caregiver, he has to take the day off to drive me to Mayo, wait through my treatment, and drive me back. Then we have boys who were distance learning at the time, and so what do we do with them? Do we drop off a friends or take a favor from a friend? And so on and so forth.

So, the logistics was an issue and we literally said, “Thanks but no thanks” and we walked out of the room. And we came downstairs, and my husband was like, “What the heck?” My team understands everything, and I fortunately work for a very good employer, and they understand everything, people first. And so, he was like, “I can figure this out. Let’s do it if this is what’s going to help you, then let’s just figure this out.” And at that time, it was so good, and I have total respect for Dr. Pollack.

You and everybody in this medical community. My doctor who leads the trial at Mayo, she actually said, “Why don’t you check with your local cancer center? Maybe they are also approved by FDA, and they may be able to administer this treatment to you.” Unfortunately, at that time they weren’t but we were like, “We’re going to go ahead with the trial. It doesn’t matter.” My husband was like, “I’ll take the day off, you don’t worry about it.” And then, four months later my institute did get approved by FDA, and so I was able to transfer from Mayo to my local cancer center, Abramson Cancer Center, which is 20 minutes from home. And so, there are options, I know that it can be an issue and it can be overwhelming at the time which was the case with me. But I was able to overcome that, so maybe there are options available that the patients can consider.

Is It Expensive to Participate in a Clinical Trial?

Is It Expensive to Participate in a Clinical Trial?  from Patient Empowerment Network on Vimeo.

Is there a financial cost to participating in a clinical trial? Dr. Seth Pollack explains how clinical trials participation is billed and potential financial impacts.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

See More from Clinical Trials 101

Related Resources:

Is a Clinical Trial a Last-Resort Option?

Are Clinical Trials Safe?

Are Clinical Trials a Logistical Nightmare?


Transcript:

Katherine Banwell:    

Is this fact or fiction; it will be expensive? Dr. Pollack?

Dr. Seth Pollack:       

That’s fiction because the way the clinical trials work is we go through everything very carefully to figure out what things are standard and what things are unique to the clinical trials. So, if you are getting chemotherapy, you’re going to need blood work, you’re going to need the chemotherapy drugs, you’re going to need some sort of imaging, CT scan, or whatever your doctor would do.

And all those sorts of things are considered standard, so your insurance company is built for those. Then there’s a bunch of things that are considered research. For example, there’s special research bloodwork, maybe there’s an investigational agent that’s being added to standard chemotherapy. Those things are billed to the study, so you don’t actually have to pay anything extra, it’s just like you’re getting the normal treatment as far as you’re concerned. I mean, that’s the way it always is, and I haven’t had any of my patients ever get into real problems in terms of the finances of these things. It always works very straight forward like standard therapy.

Is a Clinical Trial a Last-Resort Option?

Is a Clinical Trial a Last-Resort Option?  from Patient Empowerment Network on Vimeo.

Are clinical trials only meant as a last-resort option? Dr. Seth Pollack debunks this common clinical trial misconception and explains why he feels patients should participate when the opportunity arises.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

See More from Clinical Trials 101

Related Resources:

Is It Expensive to Participate in a Clinical Trial?

Are Clinical Trials Safe?

Are Clinical Trials a Logistical Nightmare?


Transcript:

Katherine Banwell:    

Right. And another concern that people have is; clinical trials are my last resort treatment option. What do you say to that Dr. Pollack?

Dr. Seth Pollack:       

Yeah, no. That’s a common misconception. So, we like to have clinical trials for every phase of the patient’s cancer journey because we’re trying to make every single part of the cancer journey better. So, I think a lot of people think that, okay, when they hit their last resort that’s kind of the time to try something new. Even in the very earliest parts of the cancer journey, even in the diagnosis phase sometimes we’ll have clinical trials where we’ve tried different images, modalities, or look at things in a different way in terms of the biopsies.

But then, in terms of the cured-of treatments, when somebody is in the cured-of setting we don’t usually try something very brand new. But a lot of the times we’ll try something that is very affective for patients at the end, and we want to try and make the cured-of strategy even better. So, a lot of the times for those patients we’ll have new therapies that are very safe and established that we’re trying to incorporate earlier into patients’ treatments because we know they work really well, right? And then, even in patients who have incurable cancer a lot of times it’s better to try a clinical trial earlier on just because sometimes the clinical trials have the most exciting new therapies that are bringing people a lot of hope.

And a lot of the times you want to try that when you’re really fit and when you’re in good shape. So, that’s why I think that you really want to think about doing a clinical trial when the opportunity arises.

Katherine Banwell:    

Yeah. Beause it could be beneficial to you and it’s certainly going to be beneficial to other people.

If I Participate in a Clinical Trial, Will I Be a Guinea Pig?

If I Participate in a Clinical Trial, Will I Be a Guinea Pig?  from Patient Empowerment Network on Vimeo.

Does participating in a clinical trial make you a “guinea pig” for new treatments? Clinical researcher, Dr. Seth Pollack, provides a clear explanation of clinical trial safety protocols.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

See More from Clinical Trials 101

Related Resources:

Is It Expensive to Participate in a Clinical Trial?

Are Clinical Trials Safe?

Are Clinical Trials a Logistical Nightmare?


Transcript:

Katherine Banwell:    

Well, I’d like to address a list of common concerns about clinical trials that we’ve heard from various audience members prior to this program.

And this is probably the most common; I will be a guinea pig. Dr. Pollack, how do you respond to that?

Dr. Seth Pollack:       

Yeah. I know that is a common concern. I mean, I think the thing that people have to understand about clinical trials is there is just so much oversight that happens for these clinical trials. Every document, every procedure, is scrutinized by multiple committees. There’s a scientific review committee, there’s a review board, IRB, that reviews these. Many of these trials are reviewed by the FDA and they’re reviewed by your doctor and your doctor’s colleagues that are also participating in the trial. So, every detail is discussed at length.

In fact, a lot of the times there’s a lot more structure to being on the clinical trial than just routine clinical care because they’ve thought so thoroughly about when everything needs to be done and what the right timing of is for the various procedures.

A Patient Shares Her Clinical Trial Experience

A Patient Shares Her Clinical Trial Experience  from Patient Empowerment Network on Vimeo.

Sujata Dutta, an empowered patient advocate, explains why she felt participating in a clinical trial was the right decision to treat her myeloma.

Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.

See More from Clinical Trials 101

Related Resources:

If I Participate in a Clinical Trial, Will I Be a Guinea Pig?

Are Clinical Trials a Logistical Nightmare?


Transcript:

Katherine Banwell:    

Sujata, I understand that you went through a series of treatments for your multiple myeloma, which is a type of blood cancer, including a stem cell transplant.

At what point did you and your doctor consider a clinical trial might be best for you?

Sujata Dutta:  

Yes, you’re right. I was diagnosed with multiple myeloma in December, and so the line of treatment or the standard protocol is that you go through what is called an induction therapy. Which is like a few cycles of chemotherapy which get you ready for a transplant. And the transplant, the hope is that it kind of washes away, or cleans off all the cancer cells for you, or at least brings the cancer to a very, very minimal level. And I did go through six rounds of chemo which got me ready for the transplant, and I went through the transplant in June of 2020. However, I’m amongst the very few, small percentage of people that just did not respond with the transplant. So, I was at the same point as where I started. So, it was a little bit disappointing, but my doctors were there to help me understand the situation. It was a hard pill to swallow.

But anyways, there were options. And that’s what I feel very hopeful about with multiple myeloma is that there are so many options available today through treat, or to at least bring the disease under control to a very large extent. And I expressed a desire to be in a trial very earlier on, so my doctor did know that I would lend a year or two listening to what the trials were. And it just so happened that there was a trial that was very apt in my situation, somebody who had gone through a transplant. They have some criteria, and I was able to meet that criteria. And so, for me, it seemed to be the right decision to make. And so, that’s how I agreed to be part of the trial.

Katherine Banwell:    

Can you go into some detail about why you thought a clinical trial was a best thing for you?

Sujata Dutta:  

Yeah. So, initially before knowing much about the strain that I’m a part of, I just had the desire to be part of a trial because I was always in awe of patients who had been in trials before me.

And because of whom I was benefiting. But whatever regiments, medications, combos, whatever was happening. And so, from that perspective I always wanted to give back in some way. Unfortunately, we are having more people being diagnosed with cancers, with multiple myeloma, and so I was very motivated to do something for the community that I was now part of. And so, I had my transplant at Mayo, and I knew that they had a whole bunch of trials and had access to different types of trials. So, that was my first motivation and it just so happened that, as I said, my experience with transplant didn’t go the desired way. And so, when I heard that there was a possibility that I could be part of a trial, I kind of leaned into actually agreeing to be part of that.

Katherine Banwell:    

Yeah. It sounds like that was the next step for you.

Sujata Dutta:  

Yup.

What Is a Clinical Trial and What Are the Phases?

What Is a Clinical Trial and What Are the Phases?  from Patient Empowerment Network on Vimeo.

How do clinical trials work? Dr. Seth Pollack, a clinical researcher, defines clinical trials and explains what occurs in each of the phases.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

See More from Clinical Trials 101

Related Resources:

A Patient Shares Her Clinical Trial Experience

Is It Expensive to Participate in a Clinical Trial?

Are Clinical Trials a Logistical Nightmare?


Transcript:

Katherine Banwell:    

Let’s start with a basic question, Dr. Pollack. What is a clinical trial?

Dr. Seth Pollack:       

Yeah. It’s a basic question, but actually, sometimes, it can be harder to answer than you might think.

I think everybody has an idea in their mind about what a clinical trial is, you’re going to test a new approach. But actually, there’s a whole variety of different things that can be a clinical trial, right? A clinical trial a lot of the times is testing a new drug, could be testing something for the very first time, could be testing something in combination with other drugs for the very first time. It could be testing a standard approach but doing it in a new way. It could even be giving less treatments than we usually do. For example, if there’s a very intense, harsh, standard of care treatment we might even have a clinical trial where we try a little bit less and see that patients do just as well. So, all of those things are clinical trials, but really the clinical trial in its heart is a very organized and careful approach to testing a new treatment strategy for patients.

Katherine Banwell:    

Okay. What are the phases of a clinical trial?

Dr. Seth Pollack:       

Yup. So, the Phase I clinical trial is usually when we’re testing something for the first time in however we’re doing it. So, it could be the first time we’re testing a new drug, or the first time we’re testing a drug in combination with other drugs. And the real thing about a Phase I trial is that the main goal of the trial is to look at the safety and tolerability of the regiment. That doesn’t mean that we’re not really trying to figure out if the regiment works, I mean, that’s also one of the most important things. But the most important thing for a Phase I trial is making sure that it’s safe and tolerable. A Phase II trial is where we, sort of, shift and we’re still making sure, and double checking, that the drug is, but now our main focus becomes on the efficacy of the strategy.

So, now we’re trying to really figure out if this is a strategy that seems affective enough to go to a Phase III. And a Phase III is a big multi-center trial. Frequently those will be placebo controlled where a lot of the times there’ll be randomized trial where we really try to absolutely prove, beyond a shadow of a doubt, that, that strategy is affective. And those are most of the types of trials that patients will encounter.

Katherine Banwell:    

Okay. Thank you for providing clarity around the phases.

Five Ways the PEN Empowerment Lead Program Can Support Your Cancer Journey

Our Empowerment Lead program is here to support patients and families around important topics and to provide navigation for the path to empowerment. Our Empowerment Leads are highly passionate empowerment ambassadors volunteering from around the U.S., engaging with the PEN network of cancer patients and care partners, and serving as a direct channel of empowerment.  

1. Utilize the PEN Text-Line

By texting EMPOWER to +1-833-213-6657, you can meet someone with your same condition  and  receive personalized support from our Empowerment Leads. Whether you’re a cancer patient, or a  friend or loved one of a cancer patient, PEN’s Empowerment Leads will be here for you at every step of your journey.

2. Watch PEN Videos

Taking a proactive role in your well-being as a patient is of utmost importance for optimal health outcomes. And PEN videos are a trusted source when seeking out information from cancer experts, patients, care partners, and PEN Empowerment Leads. Whether you’re a newly diagnosed patient, care partner, long-time cancer patient, or other concerned patient advocate, PEN videos provide a valuable way to learn about cancer patient stories, testing information, questions to ask your cancer specialist, how to support and be supported as a care partner, ensuring that your patient voice is heard, and more.

3. Read PEN Blogs

Our PEN blogs are a rich source of support information on a wide range of topics for cancer patients and care partners. The blogs serve as another way to gain knowledge and advice for navigating and coping with your cancer journey. Some recent topics have included mental  health advice, financial support resources, nutrition and exercise tips, COVID-19 vaccine guidelines, patient stories, caregiver advice, genetic testing, and cancer news updates.

4. Download and Use Our Activity Guides

Initiated as a patient and care partner tool at the beginning of the COVID-19 pandemic, our PEN-Powered Activity Guides continue as a way to stay connected and to relieve stress during your cancer journey. Packed with information and support resources, the Activity Guides provide content including clinical trial information and experiences, patient stories and lessons learned, advice from care partners, healthy recipes, music playlists, coloring pages, and more. If you’re a busy cancer patient or care partner, the Activity Guides are easy to print to take with  you to read during travel and waiting room time for cancer care appointments.

5. Learn About Our PEN Empowerment Leads

If you don’t have time to watch a video or to read a blog right away, you can browse our list of PEN Empowerment Leads. You can easily see the community that each Empowerment Lead serves  and read a short bio about their experience as a cancer patient or care partner.

By taking advantage of our PEN Empowerment Lead resources, cancer patients and care partners can gain knowledge and confidence to navigate their own cancer journeys.