Renal Medullary Carcinoma (RMC) Archives

Renal medullary carcinoma, commonly known as RMC, is a rare cancer of the kidneys. RMC is known to nearly exclusively affect young people of African ethnicity who carry sickle cell disease, sickle cell trait, or other sickle hemoglobinopathies.

A Patient’s Perspective | Participating in a Clinical Trial

A Patient’s Perspective | Participating in a Clinical Trial from Patient Empowerment Network on Vimeo.

Colorectal cancer survivor Cindi Terwoord recounts her clinical trial experience and explains why she believes patients should consider trial participation.

Dr. Pauline Funchain is a medical oncologist at the Cleveland Clinic. Dr. Funchain serves as Director of the Melanoma Oncology Program, co-Director of the Comprehensive Melanoma Program, and is also Director of the Genomics Program at the Taussig Cancer Institute of the Cleveland Clinic. Learn more about Dr. Funchain, here.

Cindi Terwoord is a colorectal cancer survivor and patient advocate. Learn more about Cindi, here.

See More from Clinical Trials 101

Related Resources:

A Patient Shares Her Clinical Trial Experience

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

Are Clinical Trials a Logistical Nightmare?


Transcript:

Katherine Banwell:    

Cindi, you were diagnosed with stage IV colorectal cancer, and decided to participate in a clinic trial. Can you tell us about what it was like when you were diagnosed?

Cindi Terwoord:        

Yeah. That was in September of 2019, and I had had some problems; bloody diarrhea one evening, and then the next morning the same thing. So, I called my husband at work, I said, “Things aren’t looking right. I think I’d better go to the emergency room.”

And so, we went there, they took blood work – so I think they knew something was going on – and said, “We’re going to keep you for observation.” So, then I knew it must’ve been something bad. And so, two days later, then I had a colonoscopy, and that’s when they found the tumor, and so that was the beginning of my journey.

Katherine Banwell:    

Mm-hmm. Had you had a colonoscopy before, or was that your first one?

Cindi Terwoord:        

No, I had screenings, I would get screenings. I had heard a lot of bad things about colonoscopies, and complications and that, so I was always very leery of doing that. Shame on me. I go for my other screenings, but I didn’t like to do that one. I have those down pat now, I’m very good at those.

Katherine Banwell:    

Yeah, I’m sure you do. So, Cindi, what helped guide your decision to join a clinical trial?

Cindi Terwoord:        

Well, I have a friend – it was very interesting.

He was probably one of the first people we told, because he had all sorts of cancer, and he was, I believe, one of the first patients in the nation to take part in this trial. It’s nivolumab (Opdivo), and he’s been on it for about seven years. And he had had various cancers would crop up, but it was keeping him alive.

And so, frankly, I didn’t know I was going to have the option of a trial, but he told me run straight to Cleveland Clinic, it’s one of the best hospitals. So, I took his advice. And the first day the doctor walked in, and then all these people walked in, and I’m like, “Why do I have so many people in here?” Not just a doctor and a nurse. There was like a whole – this is interesting.

And so, then they said, “Well, we have something to offer you. And we have this immunotherapy trial, and you would be one of the first patients to try this.”

Now, when they said first patient, I’m not quite sure if they meant the first colon cancer patient, I’m not sure. But they told me the name of it, and I said, “I’m in. I’m in.” Because I knew my friend had survived all these years, and I thought, “Well, I’ve gotten the worst diagnosis I can have, what do I have to lose?” So, I said, “I’m on board, I’m on board.”

Katherine Banwell:    

Mm-hmm. Did you have any hesitations?

Cindi Terwoord:        

Nope. No, I’m an optimistic person, and what they assured me was that I could drop out at any time, which I liked that option.

Because I go, “Well, if I’m not feeling well, and it’s not working, I’ll get out.” So, I liked that part of it. I also liked, as Dr. Funchain had said, you go in for more visits. And I like being closely monitored, I felt that was very good.

I’ve always kept very good track of my health. I get my records, I get my office notes from my doctor. I’m one of those people. I probably know the results of blood tests before the doctor does because I’m looking them up. So, I felt very confident in their care. They watched me like a hawk. I kept a diary because they were asking me so many questions.

Katherine Banwell:    

Oh, good for you.

Cindi Terwoord:        

I’m a transcriptionist, so I just typed out all my notes, and I’d hand it to them.

Katherine Banwell:    

That’s a great idea.

Cindi Terwoord:        

Here’s how I’m feeling, here’s…And I was very lucky I didn’t have many side effects.

Katherine Banwell:    

In your conversations with your doctor, did you weigh the pros and cons about joining a trial? Or had you already made up your mind that yes, indeed, you were going for it?

Cindi Terwoord:        

Yeah, I already said, “I’m in, I’m in.” Like I said, it had kept my friend alive for these many years, he’s still on it, and I had no hesitation whatsoever.

I wish more people – I wanted to get out there and talk to every patient in the waiting room and say, “Do it, do it.”

I mean, you can’t start chemotherapy then get in the trial. And if I ever hear of someone that has cancer, I ask them, “Well, were you given the option to get into a trial?” Well, and then some of them had started the chemo before they even thought of that.

Katherine Banwell:    

Mm-hmm. So, how are you doing now, Cindi? How are you feeling?

Cindi Terwoord:        

Good, good, I’m doing fantastic, thank goodness, and staying healthy. I’m big into herbal supplements, always was, so I keep those up, and I’m exercising. I’m pretty much back to normal –

Katherine Banwell:

Cindi, what advice do you have for patients who may be considering participating in a trial? 

Cindi Terwoord:

Do it. Like I said, I don’t see any downside to it. You want to get better as quickly as possible, and this could help accelerate your recovery. And everything Dr. Funchain mentioned, as far as – I really never brought up any questions about whether it would be covered. 

And then somewhere along the line, one of the research people said, “Well, anything the trial research group needs done – like the blood draws – that’s not charged to your insurance.” So, that was nice, that was very encouraging, because I think everybody’s afraid your insurance is going to drop you or something.  

And then the first day I was in there for treatment, a social worker came in, and they talked to you. “Do you need financial help? We also have art therapy, music therapy,” so that was very helpful. I mean, she came in and said, “I’m a social worker,” and I’m like, “Oh, okay. I didn’t know somebody was coming in here to talk to me.” 

But that was all very helpful, and I did get free parking for a few weeks. I mean, sometimes I’d have to remind them. I’d say, “It’s costing me more to park than to get treated.” But, yeah, like I said, I’m a big advocate for it, because you hear so many positive outcomes from immunotherapy trials, and boy, I’d say if you’re a candidate, do it. 

Katherine Banwell:

Dr. Funchain, do you have any final thoughts that you’d like to leave the audience with? 

Dr. Pauline Funchain:

First, Cindi, I have to say thank you. I say thank you to every clinical trial participant, everybody who participates in the science. Because honestly, whether you give blood, or you try a new drug, I think people don’t understand how many other lives they touch when they do that.  

It’s really incredible. Coming into clinic day in and day out, we get to see – I mean, really, even within a year or two years, there are people that we’ve seen on clinical trial that we’re now treating normally, standardly, insurance is paying for it, it’s all standard of care. And those are even the people we can see, and there are so many people we can’t see in other centers all over the world, and people who will go on after us, right?  

 So, it’s an amazing – I wouldn’t even consider most of the time that it’s a personal sacrifice. There are a couple more visits and things like that, but it is an incredible gift that people do, in terms of getting trials. And then for some of those trials, people have some amazing results. 

And so, just the opportunity to have patients get an outcome that wouldn’t have existed without that trial, like Cindi, is incredible, incredible. 

What Are the Risks and Benefits of Joining a Clinical Trial?

What Are the Risks and Benefits of Joining a Clinical Trial? from Patient Empowerment Network on Vimeo.

Why should a cancer patient consider a clinical trial? Dr. Pauline Funchain of the Cleveland Clinic explains the advantages of clinical trial participation.

Dr. Pauline Funchain is a medical oncologist at the Cleveland Clinic. Dr. Funchain serves as Director of the Melanoma Oncology Program, co-Director of the Comprehensive Melanoma Program, and is also Director of the Genomics Program at the Taussig Cancer Institute of the Cleveland Clinic. Learn more about Dr. Funchain, here.

See More from Clinical Trials 101

Related Resources:

You’ve Chosen to Participate In a Clinical Trial: What Are Next Steps?

Understanding Common Clinical Trial Terminology

How to Find A Clinical Trial That’s Right for You


Transcript:

Katherine Banwell:

Why would a cancer patient consider participating in a clinical trial? What are the benefits? 

Dr. Pauline Funchain:

So, I mean, the number one benefit, I think, for everyone, including the cancer patient, is really clinical trials help us help the patient, and help us help future patients, really.  

We learn more about what good practices are in the future, what better drugs there are for us, what better regimens there are for us, by doing these trials. And ideally, everyone would participate in a trial, but it’s a very personal decision, so we weigh all the risks and benefits. I think that is the main reason.  

I think a couple of other good reasons to consider a trial would be the chance to see a drug that a person might not otherwise have access to. So, a lot of the drugs in clinical trials are brand new, or the way they’re sequenced are brand new. And so, this is a chance to be able to have a body, or a cancer, see something else that wouldn’t otherwise be available.  

And I think the last thing – and this is sort of the thing we don’t talk about as much – but really, because clinical trials are designed to be as safe as possible, and because they are new procedures, there’s a lot of safety protocols that are involved with them, which means a lot of eyes are on somebody going through a clinical trial.  

Which actually to me means a little bit sort of more love and care from a lot more people. It’s not that the standard of care – there’s plenty of love and care and plenty of people, but this doubles or triples the amount of eyes on a person going through a trial. 

Katherine Banwell:

Yeah. When it comes to having a conversation with their doctor, how can a patient best weigh the risks and benefits to determine whether a trial is right for them? 

Dr. Pauline Funchain:

Right. So, I think that’s a very personal decision, and that’s something that a person with cancer would be talking to their physician about very carefully to really understand what the risks are for them, what the benefits are for them. Because for everybody, risks and benefits are totally different. So, I think it’s really important to sort of understand the general concept. It’s a new drug, we don’t always know whether it will or will not work. And there tend to be more visits, just because people are under more surveillance in a trial.  

So, sort of getting all the subtleties of what those risks and benefits are, I think, are really important. 

Katherine Banwell:

Mm-hmm. What are some key questions that patients should ask? 

Dr. Pauline Funchain:

Well, I think the first question that any patient should ask is, “Is there a trial for me?” I think that every patient needs to know is that an option. It isn’t an option for everyone. And if it is, I think it’s – everybody wants that Plan A, B, and C, right? You want to know what your Plan A, B, and C are. If one of them includes a trial, and what the order might be for the particular person, in terms of whether a trial is Plan A, B, or C. 

RMC Patient Profile: Lamar Valentina Part 2

Read the first part of Lamar’s RMC journey here…

Part of Lamar’s cancer treatment occurred during the COVID-19 pandemic. He had to quarantine to keep himself safe, and it was scary to him at times. “But now that COVID-19 has subsided a little bit. It’s still around, I recommend doing some things that you enjoy. Don’t let cancer take away the joy that you still have. If you’re someone who’s active, maybe you just need to scale back on how active you are. Of course, you want to be safe. If you’re someone who likes to travel, find ways that you can still do it safely.”

Lamar found some activities that were helpful for him physically and mentally. “What helped me was being more involved in nature. I would do walks. I would sit outside and watch the clouds. I’d watch the stars at night. And I try to still continue to play basketball with my son. Obviously, he’s starting to get a little better than me. He’s getting bigger and faster, and I’m a little weaker. But I try to still do things that are fun and enjoyable.”

During part of COVID-19 restrictions, Lamar started missing the ability to do things, being self-sufficient, and even getting back into work. People asked why he was in such a rush to get back to work, but work helped him feel a sense of purpose. He felt like he had become a burden to his loved ones who had to cared for him. Lamar recommends striking a balance between accepting help and doing some things yourself. “Let others who want to help you actually help you. If you feel up to doing other things on your own, don’t shy away from that. Don’t let cancer take away a little bit of independence or a little bit of your purpose that you feel. I enjoy doing these PEN interviews, because I think we need that voice, and people shouldn’t shy away. Obviously, I’m not saying go out and be reckless. Be safe but try to do the things that bring you joy.”

People often tell Lamar that he looks so healthy and that he doesn’t look sick, which can be frustrating, since he wakes up with pains and has tumors all over. His biggest takeaway from this journey is how resilient he is. Lots of people tell him that he makes cancer look easy but don’t realize that it’s very difficult. “I just feel like life is short as it is. We all have an expiration date, and we don’t know when it’s going to come. And that’s the only thing guaranteed in life. For me, I really just feel like I want to live each day as if I’m trying to make a mark, at least be as happy as possible, chasing my goals and my dreams. I try to make sure with every encounter that I have with people that I’m not angry or bitter. I don’t want that to rub off on them, so I try to make sure that I greet everyone with a smile.”

If people don’t know specifically from his appearance since his eyebrows and hair are gone or know from someone else, Lamar prefers others to not know what he’s going through. “I don’t want people to feel sorry for me. Just treat me like a normal person, and hopefully I can pass on some positive energy and some happiness to everybody else regardless of what they’re going through to make it a kinder place here on earth.”

Lamar feels blessed about his overall quality of life. He’s at work and still travels for work as a flight chief in the Air Force. I’m not as physically active as I’d like to be. He’s doing chemo every three weeks, and will be starting radiation soon for a spot that’s remaining. The ultimate goal is to achieve no evidence of disease. He’s been in outpatient care for his entire treatment process and has been able to go to the hospital for chemo and then returns home and to work. “It’s been an absolute blessing that I cannot take for granted. But I still go through ups and downs. I have slight pains here and there. I’d love to be able to work out three to four days a week. But I’d rather take it easy and focus on my body healing from the inside out, and I’ll get back to working out more sooner or later.”

His biggest advice to renal medullary carcinoma (RMC) patients and cancer patients is don’t give up hope. “A lot of this fight is mental. Your body follows physically what you think mentally. So speak positive affirmations. Every day when you wake up even on the tough days, speak healing into your body. What you’re eating, whatever you’re drinking, it’s going to provide healing and substance. It’s going to rid your body of cancer. No matter how dark it looks or how dark it gets at any point, do not give up hope. Do not lose your spirit. Make sure you’re smiling and laughing and doing the things you love with the people you love.”  

Lamar looks forward to ongoing research of RMC. “This has been a huge purpose added to my life. Anything I can do while I’m here, I’ll do it. I’m a big advocate for more support and more research for RMC. I know each day we’re getting closer to a cure, and hopefully this won’t impact families as negatively as it has in the past.”

What’s Lamar’s parting advice to other patients? “When you come out of the storm, you won’t be the same person that walked into it, that’s what the storm is all about. When you can’t control what’s happening to you, control how you respond to it, that’s where your power is.”

RMC Patient Profile: Lamar Valentina Part 1

When Lamar Valentina shares his renal medullary carcinoma (RMC) patient journey, you can tell that he loves serving and helping others in his work and free time even as a cancer patient. As an active duty Technical Sergeant in the U.S. Air Force, Lamar has continued to work throughout his cancer treatment. When a lump on the side of his neck combined with extreme abdominal pain and flank pain concerned him, Lamar decided to have his symptoms checked out at the hospital. His RMC diagnosis came shortly before he turned 35, and his chemotherapy started about two weeks after his diagnosis.

Lamar is fortunate to have some friends who work in cancer centers, and they were connected with experts at Dana-Farber Cancer Institute, which is in Boston where his son also lives. The COVID-19 pandemic created a delay for some of his chemo, but it ended up as a benefit to give his body a break. Lamar recalls feeling some measure of relief about his tumor scans, “…we saw that there was a little bit of growth, it wasn’t alarming growth, but there was some growth, but it still hadn’t gone to where it was when I first was diagnosed, so that was the good thing that it wasn’t as aggressive as it’s known to be.”

After the things he’s gone through during his cancer journey, Lamar feels he has much to share to help other patients with what they’re going through. For newly diagnosed patients, he recommends that patients take advantage of resources and oncology therapists that most cancer centers provide. “Take the time to process the news of your diagnosis. I was sort of like a deer in headlights. Everything went blank, and I felt like I was in a nightmare of a dream, trying to wake up. So process your diagnosis and go through the emotions. You’re going to feel sad. You’re going to be depressed. You’re going to be angry. You’re going to be curious as to why you. But once you process those emotions, make sure you don’t compartmentalize those emotions and you express them to somebody whether it’s a friend, a caregiver.” 

Early after his diagnosis, Lamar decided to go full-on vegan and lost a lot of weight. “It was very frightening, because losing weight made my body become a lot more frail and weak. So I started to eat fish and chicken. His advice to other patients, “I think specific things like that definitely talk it over with your primary doctor, your medical team to make sure you’re doing what’s best for yourself and that you’re not going to hinder your treatment.”

Lamar feels fortunate to have connected with the Patient Empowerment Network (PEN) RMC Empowerment Lead Cora Connor through a Google search and found R.M.C., Inc. He also feels that the RMC community is a very tight-knit community, “I really like to pay homage to those we have lost. One of the first friends I met was Chad Alexander, Ava Cummings, Kai Penn, Da’Corey Kimbrough, Seth Calhoun, Caleb Wheeler, Feninna Vasilou, and there are so many other people I’ve met…they’ve since passed away. These are a few of the RMC warriors we have lost. I continue to fight for them and to everyone still battling RMC, I wish nothing but clear scans as we fight on the front lines together! Finding people who are going through this whether RMC or another form of cancer, I think you can relate more to cancer patients, because they understand what you’re going through.” 

Lamar advises patients to empower themselves. “You want to be able to at least know what questions to ask. And it starts with educating yourself. So I think you want to be able to go into those appointments and know what questions to ask, know if you get a certain answer to that question to know what a good follow-up question would be.” Early on in his care, he would record his conversations with his doctor to ensure he got all the information. Lamar also advises writing down questions before you go to your appointments to make sure you don’t forget about them. 

According to Lamar, being involved and learning about trial treatments are vital ways for patients to take part in their own care. “A lot of people have asked me about my treatment plan, but we’re all different. Our bodies are different. The way we can handle certain treatments are very different. So I try not to compare my care and the chemotherapy to what other people had. Because if you go based off that, you may turn down a treatment that may possibly work better for you with your genetics, and it may not have worked well for someone else, and you deny that based off their reaction to that treatment when it could be really helpful for you.”

Read the second part of Lamar’s RMC journey here…

Participating in a Clinical Trial: What You Need to Know Resource Guide

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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.

See More from Clinical Trials 101

Related Resources:

What Is a Clinical Trial and What Are the Phases? 

Are Clinical Trials Safe?

A Patient Shares Her Clinical Trial Experience


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

Related Resources:

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.

Could a Clinical Trial Be Your Best Cancer Treatment Option?

Could a Clinical Trial Be Your Best Cancer Treatment Option? from Patient Empowerment Network on Vimeo.

Is a clinical trial right for you? Cancer expert and researcher Dr. Seth Pollack is joined by PEN board member and empowered patient, Sujata Dutta, to discuss key information about clinical trials. The guests review clinical trial terminology, debunk common misconceptions about trials, and Sujuta shares her own story of participation 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.

Download Guide

See More from Clinical Trials 101

Related Resources:

Could a Clinical Trial Be Your Best Cancer Treatment Option? Resource Guide

Understanding Clinical Trial Phases

How Could Clinical Trials Fit Into Your Myeloma Treatment Plan?


Transcript:

Katherine Banwell:    

Hello, and welcome. I’m Katherine Banwell, your host for today’s program.

Today we’re going to discuss clinical trials, what they are and how they work, and debunk some misconceptions along the way. Before we get into the discussion, please remember that this program is not a substitute for seeking medical advice. Please refer to your healthcare team about what might be best for you. All right. Let’s meet our guests today. Joining me is Dr. Seth Pollack. Dr. Pollack, welcome. Would you please introduce yourself?

Dr. Seth Pollack:

Yeah. Thanks so much. It’s a pleasure to be here, my name is Seth Pollack. I’m a medical oncologist here at Northwestern University Medical Center.

And I specialize in treating patients with cancer, and I have a specific interest in patients with a type of cancer called sarcomas.

Katherine Banwell:    

Excellent. Thank you for taking the time to join us today. And here to share the patient perspective is Sujata Dutta, who is on the board of the Patient Empowerment Network and is currently participating in a clinical trial. Sujata, it’s a pleasure to have you with us.

Sujata Dutta:

Pleasure to be here Katherine. Hello, Dr. Pollack. And hi everyone, my name is Sujata Dutta, and I was diagnosed with a cancer called multiple myeloma in December of 2019. And I’ve been on a clinical trial since September of 2020.

Katherine Banwell:    

Thank you, for that information. And we’re going to go into that further in just a few moments. 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. Before we move onto safety and benefits of clinical trials, let’s hear from Sujata. 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.

Katherine Banwell:    

Yeah. 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.

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. 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.

Katherine Banwell:    

Okay. That’s good to know. 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.

Katherine Banwell:    

Yeah. Dr. Pollack, do you have anything to add?

Dr. Seth Pollack:       

No. I think the logistics and the location are real concerns with clinical trials.

Clinical trials do sometimes require you to have an extra visit, sometimes they’re a little bit less flexible in terms of when you can get your medication. If you’re getting a standard treatment your doctor may say, “It’s probably okay for you to wait an extra week.” Whereas sometimes on a clinical trial, not always, but sometimes they could be a little bit more strict about when you’re supposed to get certain things. And likewise, with the travel for some people that can be an issue. I mean, the clinical trial is not available everywhere. I mean, Sujata was very lucky that she was able to do the clinical trial she was doing close to home, but that doesn’t always happen. So, I think that’s an important thing to talk to your clinical team about.

Katherine Banwell:    

Yeah. 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, good. Okay. That’s good to know. Another concern is; I’ll get a placebo. Dr. Pollack, what is a placebo first of all? And is that true in a clinical trial setting?

Dr. Seth Pollack:       

So, there are clinical trials with placebos, it’s a real thing. And what a placebo is, it’s a pill and it’s made to look just like the real pill, but it doesn’t have any active drug in it. Sometimes people say it’s a sugar pill, but it may or may not be sugar, but it’ll probably be something without a taste. But it’s an inert substance that is not going to affect you at all.

And your doctor won’t know whether you’re getting a placebo or not, so a lot of the times they’ll call these things double-blind because your doctor doesn’t know, your pharmacist doesn’t know. And to unblind you they have to go through special procedures to find out whether you’re on the studied drug or not.

Katherine Banwell:    

Would a placebo be given solely? Or would it be given in addition to this new drug that’s being tested?

Dr. Seth Pollack:       

Yeah. So, it’s unusual for a placebo to be given solely. Usually there’ll be a clinical trial where you’re getting the standard treatments plus the new drug or standard treatment plus the placebo, so no matter what you’re getting the standard treatments. There are still some trials where, and these are usually for patients with very advanced cancer, who there’s not really any treatment options that are good. Where they will randomize people to just be on the standard drug versus the placebo.

Sometimes what they’ll do is if they want to do a trial that’s the standard drug versus a placebo, they’ll do the imaging very frequently and they’ll have a crossover. So, a crossover means that everybody gets to be on the new drug, but some people will have to go on the placebo first. So, and then they watch you very closely. So, if you get randomized to go on the placebo and your cancer starts to grow, they figure it out very quickly and then they give you the opportunity to go on the new drug.

Katherine Banwell:    

I see, okay. I’ll be stuck in the trial forever and I can’t change my mind. Sujata, did that happen to you?

Sujata Dutta:  

No. I mean, when I finally agreed and signed the dotted line it was made very clear to me that it was voluntary, I was volunteering to be part of the trial and I could get out of the trial at any point of time. So, in my case I’m in Phase III of a trial, the first commitment was for two years and then the next was five years.

So, again, it sounds daunting to me right now, two years is coming to an end in July of this year. I’m like, “Wow! Two years are over already?” And then five years, I’m not thinking about that, but again, it was at any point I could just say that I’ve had enough, or whatever be the reason, I could get out of the trial. So, no. Yes. There’s an option.

Katherine Banwell:    

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:       

Well, I hear a lot of people really interested in clinical trials. I mean especially, I treat some patients with rare cancers or with unusual presentations and I think people are very excited to be a part of something that could be new, that could be the next wave. A lot of times the clinical trials have new things with the most exciting science that could be the future of treatment.

So, I think a lot of people are excited about clinical trials. And I also hear some of the reservations that you’re expressing. I think usually when patients ask their questions are very straightforward and easy to address so that people can make their own decisions.

Katherine Banwell:    

Dr. Pollack, I’d like to go back to you and ask you the same question about privacy. Do patients need to be worried about that?

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. 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.

Katherine Banwell:    

Yeah. Sujata Dutta, and Dr. Pollack, thank you both for taking the time to join us today.

Sujata Dutta:   

Thank you.

Dr. Seth Pollack:       

Thank you.

Katherine Banwell:    

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