Pod4Cure #5: Connecting to Clinical Trials

Brian McMahon, the founder of the multiple myeloma clinical trial finder tool SparkCures, joins us in this episode of Pod4Cure. As an experienced myeloma caregiver, Brian has witnessed the life-changing impact clinical trials can have on a patient firsthand. Hear him describe why he created SparkCures and how it can be a great resource for myeloma patients and their care teams looking for the best options for treatment.

Click here to visit SparkCures.com

Sara Lippert (Left) & Brian McMahon (Right)

Transcript:

Sara: Hello, and welcome to Pod4Cure, the podcast brought to you by All4Cure discussing health care for patients with myeloma, their caregivers, and everyone in between. My name is Sara, and today I am joined by Brian McMahon. Brian is an experienced myeloma caregiver and the founder of the patient resource SparkCures. Thanks so much for being here with me today, Brian!

Brian: Hey, Sara. Great to be here. Thanks for having me.

Sara: Before we get into the details about SparkCures and learning more about it, I'd love it if you could tell me a little bit about yourself.

Brian: Yeah, I guess it probably all boils down to sort of how we got started and how I joined the world of myeloma. Really, the short end of this is that when I was 21, my mom was actually diagnosed with myeloma. That was back in 2005. She was diagnosed in a time that was very different than it is today. Today we have bispecifics; we have CAR Ts. The treatment landscape is just a completely different world. And when my mom was diagnosed, not only did they catch it really late, but they caught it with two high-risk genetic mutations. So at the time of her diagnosis, they sent her home on a Velcade/Prednisone treatment regimen, and they basically said, "Get your affairs in order." They didn't expect her to live 30 days post-diagnosis. This is actually before Revlimid was even approved as a treatment option in myeloma.

Brian: So this is how different the world was back then on that side. So I was 21 years old. My mom's diagnosed, and the difference is my mom was a 30+ year oncology nurse who was working for Amgen. So, any cancer patient or any myeloma patient out there that has had Neupogen? My mom was a clinical support specialist on the Neupogen team. So not only did she have the clinical expertise to go through and understand clinical trials, but she also had this Rolodex that comes with working at one of the largest biotech pharma companies, right? So she had the ability to call around to these centers. And within two weeks, we had her at the University of Arkansas, where she ultimately enrolled in a clinical trial that helped her to live for almost two years with their disease. I always like to say it wasn't the outcome that we wanted, right? But when you're given 30 days, and you get two years, two years of living and knowing, and being with my mom, it really opened up my eyes to the power of clinical research and what that brings to both patients and their families.

Sara: Definitely, that's amazing. You were definitely right in saying that it's a completely different world. Now, the world of myeloma treatment is just changing every single day. Was this experience of being a caregiver and finding that clinical trial for your mother sort of the inspiration for SparkCures? How did you come from that experience to where you are now as an amazing patient resource advocate?

Brian: Yeah. Well, thank you. And you know, it's probably a good question. It's kind of hard in some ways to piece it together in hindsight. I know when I went through this with my mom, I can remember one of the most vivid memories I have of my mom going through this. We were at the University of Arkansas, and she was going through the screening process. So anytime you join a clinical trial, they're going to give you a document that could be anywhere from 20 to 40 pages, basically detailing everything that happens during the trial. It's the litany of everything that could go wrong, right? Side effects or bad things that could occur that they know of. And every patient has to sign that in order to go on. And I remember they put us into a room.

Brian: It was my mom and myself, and there was an older couple that was in there as well. The nurse would escort us into this room and gave us some time to read through it and sign everything. And I remember the nurse left, and this woman who was the patient was sitting there across the room. And you could just tell she'd been hit by a truck. She had no idea what was going on or where she was. I mean, her head was spinning, and my mom's sort of nurse mode kicked in. And she got up and walked over, and she started asking her these questions and walking through the document piece by piece by piece. She's that consummate patient advocate, right? Helping people. I got a chance from a very granular insight to see how disconnected and disjointed and confusing and difficult and challenging.

Brian: My mom was an anomaly, right? The reason we started SparkCures is because the thought was you shouldn't have to be a 30+ year oncology nurse working for one of the largest biotech pharma companies in order to navigate this right. In a 10-year period in my life, I was a caregiver on four different occasions. My mom was the only one to get into a clinical trial. I won't throw the hospital under the bus, but I remember we were at a major center in the Northeast. We were sitting there with my (at the time) girlfriend's father; she's gone on to become my wife, Melissa. Her father was diagnosed with pancreatic cancer, and we're sitting there. At that point, we had known enough; we were familiar enough with this to know and ask about clinical trials because they didn't bring it up at all.

Brian: And at the end of the meeting with the doctor, we said, "Well, what about clinical trials?" He said, "Well, there's nothing here he's really eligible for, but go on to clinicaltrials.gov, and do a search and bring the results back. And we'll, we'll help you figure out if there's anything that's appropriate." Well, we went back and researched and even geographically constrained it. We had over 300 options. What do you do? Do you go into a 15 or 20-minute consult or appointment printing out over a thousand pages of trial documentation, right? And you say, "Here, doc, what do we do?" I mean, it just doesn't work on that side. And you could see how my mom's expertise in her professional career and her connections helped to make this so that within two weeks, she was enrolled in a clinical trial. And no one else was able to do that. And it's not to say that other people can't do that, but it is kind of a more uncommon way of approaching going through that process. And I think it was going through that in such quick succession, with all these people in my life and seeing how my mom did it versus everybody else's inability to ultimately navigate and make that work, that had a really lasting impact.

Sara: Definitely, having that basis of knowledge just makes the navigation of myeloma and cancer in general so much easier. And it's definitely the minority. What I find a lot speaking to patients is that when they're diagnosed, it's the first time they've maybe even heard of myeloma. In thinking about that and seeing the contrast between how your mother was able to navigate clinical trials and the inability of people who didn't have that background, how is SparkCures designed to accommodate people who maybe haven't even entered the world of cancer clinical trials? How does it make it easier for them?

Brian: Yeah. It's such a spectrum. We've really designed this from the ground up. I like to say it's kind of a choose your own adventure, right? So there are people that come in, and they are so prepared for their docs. They read all the research, they know everything's coming out of ASH and ASCO (our big conferences). They know what the results look like. And then you have other people that aren't even familiar with the fact that a clinical trial exists. "They'll say, "Well, I know that once all my other treatments no longer work, then I'll start considering that." One of the things I want to get across early on is, unfortunately, the worst time to go looking for a clinical trial is when you need one. I think that we look at it almost like an insurance policy.

Brian: There's a reason why there's a standard of care, but we also know that standard of care will stop working at some point for virtually all patients. So the idea is the last thing you want to do is go searching for this and try to understand that when you're in the midst of a relapse. Because that's when it's really difficult to navigate and manage. I think the genesis (if we look at what happened with my mom and my life experiences as a caregiver), the one that kind of paints the picture most, is the very first patient we ever matched after my mom passed away. And after I went through all this process, I knew at some point that this is what I wanted to do. And I had a really great mentor. One of my best friends and business partner, he's like a father to me. We had a business radio program. A little bit of my background,

Brian: I've worked on Broadway, I've worked in radio- so all these like very old style or old school industries. When my business partner passed away from neuroendocrine cell cancer, we had to make the hard decision to shut down the company. I thought, "What am I going to do? What comes next?" For years, I'd been thinking that there has to be a way to help people. And that's when I really got on the path to starting SparkCures. The "pedal to the metal" kind of occurred. I started by calling support group leaders from around the country, basically saying, "Look, my name's Brian, here's my experience with my mom. I think there's a better way to navigate clinical trials. I don't know what it is, full transparency, but I want to talk to you and see if we can share what we're learning, understand your experiences," and the very first patient who came on board.

Brian: What we would ask of them is we'd say, "Look, we've been building out our own sort of database of all the clinical trials." And all we would ask them is to go onto clinicaltrials.gov, do a search and, and come to a meeting with us with their results. We interview them for over an hour, hour and a half. We poured through all their medical records, and then we would do a search. We wanted to see what can we do over what somebody could do on clinicaltrials.gov. We had a nurse who did nothing but clinical trial matching for myeloma patients. At the end of it, the patient that came had 156 results on clinicaltrials.gov that said, "These are the trials that you may be eligible for." We took four days of digging through everything because we didn't have a system in place yet.

Brian: We were doing everything there manually, so it was about four days. We were able to get it down to 16 trials. So 156 down to 16. We thought, "This is it. This is a way that we can really help people understand what the needs of the patient are and understand what the needs of the trial are." We can match that up and help them understand. So they don't have to go through throwing all of these ones out. I'll never forget. I was ready to call this a success and say, "Listen, we got down to 16; this is great!" And we thought, "Well, maybe we should call them. Maybe we should call the trials just to make sure they're still open and accepting."

Brian: This is no exaggeration. I started calling. It was when I still had, I didn't have an unlimited phone plan, so I still had a capped minutes. I blew through my capped minutes trying to call 16 trials. It was a week and a half of calling. I had to upgrade to the unlimited plan cause I ran through it. I heard stuff like, "Who are you?" "How did you get this phone number?" "What do you mean a clinical trial?" "I have no idea what you're talking about, honey. That trial was shut down two years ago." "Where on earth are you getting this information from?" It was so eye-opening and illuminating for me. And after that, it wasn't 156. It wasn't 16. Out of the 16 trials, nine were either shut down or never opened up in the first place. No exaggeration.

Brian: We got it down to seven. It wasn't a 156. It wasn't 16. It was seven trials that matched that patient and were actually open and accepting. They had a slot availability on that side. And once we realized that it took us four days of doing this and then a week and a half of calling, you think that you can use technology to help alleviate some of those pain points. How can we help people quickly and easily find this and then ultimately get connected? I feel like that's when we knew that there was really an issue. I think it was the fact that I was a caregiver, having seen this issue from a caregiver perspective with my mom. We were looking at it a little bit differently. We would talk when we were going out initially. Talking to some of the hospitals and doctors and they would say, "Look, that's what clinicaltrials.gov is for.

Brian: What do we need another clinical trial site for? We'll find it." But it doesn't work. And I can remember, you'll appreciate this Sara, I remember meeting with some of the pharma companies initially. They would say the same thing, "But we have plenty on clinicaltrials.gov. Why do the patients need another one?" And my response is always, "Have you ever gone to clinicaltrials.gov to find a clinical trial for you or someone you love?" And they would always kind of look at me and go, "Well, no." And I would say, "What would you do?" And they say, "Well, I'd walk down the hall and talk to our chief medical officer, and he would help." Well, how many people like my mom have access to people like that. It just doesn't work, and it doesn't translate. A lot of times, you can live in this bubble where you think, "Well, you just get the information until you really have to go and try and figure it out and discern and sort of work through that. You realize how difficult it is, and there's a lack of transparency on that side. I think that kind of illustrates the challenges. Once we saw that, we thought, "This is it, this is a go. This is how we can really help people."

Sara: That's an amazing story. The ability to identify the roadblocks in a broken system can be easily overlooked if you're not somebody who is actively trying to use it. I know even just speaking with people at All4Cure. Hearing the struggles that some of these patients go through to try to get into a clinical trial. Whether it be they go to this specific treatment center, so there's no way that they would be offered clinical trials that are at another treatment center. I think it's really amazing that you guys were able to build a network that's able to match people. Is the matching profile-based? Are you utilizing medical records? What is the process of somebody who wants to start using SparkCures?

Brian: We try to make it as easy. Just as a brief aside, I think you were well-spoken in terms of "If you've never had to go through the jungle, you don't know how to bushwhack." Once you see that and you realize how inefficient and sometimes backward and inaccessible it really is, it gives you a different way of looking at it. I guess as a quick breakdown, every clinical trial has what's called inclusion and exclusion criteria for anybody listening who maybe hasn't heard that. I think sometimes we try to break down these medical words. This basically just means there are reasons why you can join or not join a clinical trial. What we do is we have the ability to ingest all that information in the system and to bring that in, you know, it could be everything from "What are your platelet counts?"

Brian: "What's your percentage of bone marrow plasma cells?" "Do you have a measurable disease?" "Does your disease present?" "Do you track it through M-spike in your blood spike or in your urine, through your free light chains?" "Have you had certain types of treatments or not had certain types of treatments?" All of these things will give us an understanding of if a trial may be a fit and would allow for you to join it. It is very easy for our patients. We try to make this as simple as possible. While we don't look at the historical aspect of this, we don't need to know what your platelets were like three years ago, two years ago, or even three months ago. What does today look like? If we're looking for a clinical trial, what things are going to get in the way?

Brian: So oftentimes, platelet requirements for trial could be 50, 75, or 100. If a patient is at 60, our system can tell them which ones they might be eligible for now. We could also say, "You could potentially be eligible for this in the future. If your platelets increase, it goes from 60 to 75. Here's the next trial." I think one of the things that we did early on was we broke down the list of trials and sorted them into three broad buckets. We call it Current, Future, and Past. Often, patients will call and say, "My doctor told me I'm not eligible for that." It's a little bit of a misnomer. It's not that you're not eligible; it's just you're not yet eligible. And there's a difference if you can say, "You could be eligible, but you need another line of therapy," or "You would be eligible once you have a CD 38 monoclonal antibodies such as Daratumumab." I think the idea of helping them understand what things have to change in order to change the landscape of available options from a clinical trial perspective is critically important.

Sara: I feel like whenever I hear about patients getting hung up on clinical trials, it's the very specific inclusions or exclusions. SparkCures makes it a lot easier for sure. Something else that I noticed just going through and looking around the resource, there's a lot of really great imagery of this idea of being a "spark" or having a patient "become a spark." What does that mean for you?

Brian: To me, the reason why my mom lived as long as she did was because of all the people that came before her, whether or not they joined a clinical trial. If you're in a clinical trial, if you're being seen by a specialist, it helps us to understand the disease more. My mom's doctors understood more about that disease because of all the patients that came before. It's the idea of "we stand on the shoulders of giants." In some small way, my mom, having gone through a clinical trial, is helping patients to live longer and have a higher quality of life. There's this great quote from Dante's Inferno. And it says, "A mighty flame followeth a tiny spark." If you look at the patients that were on, Daratumumab or Darzalex and 120 people in the registrational trial that ultimately got that role. If you think about Revlimid, Velcade, Kyprolis, Daratumumab, Pomalidomide, any of those things, a patient that goes onto a clinical trial has the ability to be a spark. We never know what spark is going to ultimately set up that mighty flame, which, to me, is the cure. A functional cure, a chronic cure. However, we look at this that still has yet to be seen. And we're starting to see these incredible results pouring out of the CAR T and the bi-specific clinical trials. The idea is that patients who participate are a spark. Our goal for SparkCures is the more people, the more sparks that we create, the higher likelihood and the quicker that this can occur.

Sara: That is a similar theory at All4Cure. I feel like they're siblings; All4Cure and SparkCures. It's all for one and one for all at the end of the day. I really liked your analogy of standing on the shoulders of giants. It's not going to be a one size fits all solution, but hopefully, the snowball effect will lead to a really big breakthrough one day.

Brian: It's an interesting point, Sara, because a treatment that works for one patient might not work for another. Let's remember that the benchmark for approval is that 30% overall response rate, meaning that three out of every 10 patients are going to have a response, and seven out of 10 won't. I always like to say, if I'm talking to a patient, "We can't take you and clone you five different times, and clone one goes and does standard of care 1, clone two does standard of care 2, clone three does clinical trial 1, 2, 3, right?" I guess there are some companies right now that are looking at doing that through these precision medicine testings, but there's nothing standardized right now where we can do this. I think the most important thing is making a decision that you're comfortable with and having a team that can help support that decision.

Brian: You're not looking in the rearview mirror saying, "Should I have done something differently?" There is no right or wrong here. We just need to find something that you're comfortable with. There's a patient who told us once, "I feel like I'm a frog on a Lily pad." I remember going, what in the world are you talking about? He said, "Well, you're helping me to make sure there's always another lily pad to jump to." That's when we talked about the insurance side of it. If this stops working, how do we make sure that there are two or three other options at the ready that could be a potential option for you? The worst thing in the world was when you get to that last lily pad, and you're looking at nothing else out there. That's what I think clinical trials give. And that's what I think the awareness and the understanding, and the preparation beforehand helps make sure that we're always keeping something in front of us to jump to.

Sara: I think that's amazing. I am just so grateful that SparkCures is around to help patients. Thank you so much for being willing to chat with me about it today. I'd love to open the floor for any closing thoughts that you have or any advice for myeloma patients or their caregivers that are seeking clinical trials. Anything that you would like to close out with?

Brian: I think two quick things. Number one, Tony [Blau] is such an amazing guy. I know there's a great team offered here. I've known Tony for quite some time, and I think you talked about sort of being in simpatico or whatever wording you used. I think that it takes a community. It takes all of us. There are the support groups, there's the advocacy, there are the hospitals, there's the pharma, and, most importantly, there are the patients. I think it takes all of us working together to really move the needle on this. I'm just so appreciative of that. I know there's a lot of things that maybe aren't publicly known about how deeply Tony and the rest of the All4Cure team care and support patients outside of things that maybe are seen on a day-to-day basis.

Brian: I just think that's an amazing thing. It's been a really great friendship over the years, so thank you for having me. And I think, two, if I leave anybody with any thought, it's that we're here to help, and we'll do that in any way that we can. If there's a place where you're getting your information already on clinical trials, we're not here to say, "We're the best thing in the land, come over here." If you have help or if you need help and you're having trouble, we're here to support that. I think the idea (number one) is if you're not seeing a specialist go see a specialist, and if you don't know how to do that or how to navigate that, go to All4Cure, go to SparkCures, call somebody, ask, talk to patients on Facebook.

Brian: There's a lot of really great support and resources out there. And (number two) the worst time to go looking for a clinical trial is when you need one. Sometimes when people are doing well on treatment, the last thing they want to do is think about myeloma. I can appreciate that; I saw that with my mom. But an ounce of prevention is a thing to think about. I think that what we can provide for patients is that we're doing the heavy lifting. Our system is re-evaluating every patient profile against every clinical trial around the US. It's something that is constantly working in the background for the day that you need it. Anytime I talk to people, I always say, "The longer we go without talking, the better off it is." As much as I love the people that we connect with, it means they're doing well, and it means they don't need us, and that's an amazing thing. So just be prepared, be at the ready, and whether it's today, tomorrow, or a year from now, we will be here to help support that. We'd love to hear from you, that's how I would end that, Sara. So thank you for the time and for letting me tell some of those stories here today. I appreciate it.

Sara: Thank you so much. I am really excited for people to be able to hear about you, and I'm excited for the advice to get to the people that need it. Thank you again, Brian, and I hope you have a really great rest of your day.

Brian: Thank you. You too!

Sara: Thank you all for listening to this episode of Pod4Cure. If you or someone you know has multiple myeloma and would like to register with All4Cure for free, you can visit All4Cure.com.