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Tips for Joining Popular Multiple Myeloma Clinical Trials with Brian McMahon of SparkCures
Tips for Joining Popular Multiple Myeloma Clinical Trials with Brian McMahon of SparkCures image

Jul 30, 2018 / 11:00AM MDT
HealthTree Podcast for Multiple Myeloma

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Episode Summary

Brian McMahon
Interview Date: July 30, 2018

Why and when should multiple myeloma patients join clinical trials? Brian McMahon of SparkCures shares three steps patients can take to participate in clinical trials: awareness, understanding and action. SparkCures is a clinical trial finder tool specifically for multiple myeloma patients and can help you find personally relevant trials.  Brian shares the ins and outs of considering myeloma clinical trials, joining clinical trials and tips for getting into the popular CAR T trials. 

Thanks to our episode sponsor, Celgene Corporation.

Full Transcript

Jenny: Welcome to today's episode of Myeloma Crowd Radio, a show that connects patients with myeloma researchers. I'm your host, Jenny Ahlstrom. We'd like to thank our episode sponsor, Celgene Corporation, for their support of Myeloma Crowd Radio.

Today, I'm very excited to have Brian McMahon with us to talk about a very important topic for us as patients. Before I begin, I like to share what we've been up to over the last few weeks - some of you heard this on Friday when we had our little misstep - but I'm going to repeat it for those who haven't.

Our family has had a very busy summer. The Myeloma Crowd a team and my family personally have been on the 50 city tour across the United States hosting workshops on a new software tool we have called HealthTree. We've now hosted 36 meetings and it's been a really amazing experience to sit next to and meet so many of you and understand so many different patient situations. Everybody's myeloma experience is really different.

HealthTree is an online tool that really provides three key benefits to patients. First it helps you understand myeloma treatment options that are relevant to your specific situation. Second, it integrates with SparkCures and helps you final clinical trials that apply to you as well. We'll be talking a lot more about that today. And then third, it will allow us, as patients to really help accelerate a cure for myeloma researches and allow us as patients to see patterns and responses to care. It will help us find ways to live longer with myeloma. Why are we doing this? HealthTree really provides something that no other organization is doing today. This is a data problem and we don't think it's a problem that can't be overcome with the right technology and the right programs in place.

Over 450 patients are now participating in HealthTree. If you would like us to come to your area, we'd be happy to do that if we're invited in conjunction with the local myeloma support group or a cancer facility. We know that HealthTree will better help you navigate your disease and plan for the future. We've had many patients be very enthusiastic about this tool. As we've shown the product to myeloma researchers, we’re hearing that it will be a helpful tool for them to develop new hypotheses about optimal care for us. It's really what I wanted when I was diagnosed and I want everybody to have when you are making key decisions at diagnosis and then again at relapse.

Now, on to our show, I first met Brian McMahon at an American Society of Hematology (ASH) conference. After starting the Myeloma Crowd Radio Program, I decided that it was key that we needed to build the tool to help myeloma patients find clinical trials. We started building a clinical trial finder tool with our development team and I had shown it to some of the myeloma researchers and they were very excited to have that kind of tool built.

After I connected with Brian and he showed me what he had been working on with SparkCures, it was clear that what he had built was really superior to what we were building. We decided to shut down our project and decided to support what he was doing in every way. His mother has had an aggressive form of myeloma and he had the talent, experience, and motivation to really create something very useful and much needed for patients. With that, Brian, I will let you give any other introduction you would like, but we welcome you to Myeloma Crowd Radio.

Brian: Thanks, Jenny. Thanks for the awesome introduction there. It's amazing, I think it was ASH 2015 when we first connected. 

Jenny: It was a while ago.

Brian: Yes, it's been so long. But I'll tell you, the thing I love about HealthTree - and obviously we're biased, we've been working together for quite some time and we're big fans of Myeloma Crowd and HealthTree and a lot of the initiatives that both of us are working on together - but specifically a lot of the stuff that has been spearheaded through the Myeloma Crowd is that it was scratching your own itch, right? This wasn't some sort of theoretical exercise. It was how can we push this forward, give you said "It was the tool I wanted when I was diagnosed," which I think it's such a powerful statement.

It reminds me of why we started with SparkCures. My mom when she was diagnosed, she was really an anomaly because she was an oncology nurse with over 30 years of experience who at the time was actually on the clinical support team for Amgen. She was on the Neupogen-Neulasta team. Not only did my mom have the wherewithal, the understanding of clinical research as a nurse, she had the wherewithal with her pharmaceutical and hospital and nurse connections to quickly get into a clinical trial. Within two weeks of being diagnosed, we were down at the University of Arkansas with Dr. Barlogie and Dr. Tricot. My mom enrolled in a clinical trial down there.

That's a very uncommon occurrence when you think about how quickly she moved and was able to get into a clinical trial. For us, the question was how do we provide the same level of support? You shouldn't have to be a 30 plus year nurse to get that access. You shouldn't have to be to call up Dr. Stan Marks (who is the head of the UPMC Cancer Center). She worked there for a number of years. She called him up, "Stan, what are we going to do?" People don't have that access. What we want to do is break those barriers down to really provide that.

Jenny: That's very rare.

Brian: How could we scratch our own itch? I've gone through this process multiple times with family members. My business partner most recently passed away. We didn't have the same level of access that we had for my mom. That was really the genesis of why we wanted to provide this service into -- really, the cancer community but really niche-focused on multiple myeloma.

Jenny: I think it's really amazing. Her experience is so unusual and so rare. Most of us, I think the statistic is really the 80% of myeloma patients are being diagnosed and starting treatment inside of community oncology centers. We've talked about this a lot before, but the clinical trial process is so confusing. I was planning ahead for relapse and called eight different clinical trials to say hey, I'm interested in your clinical trial. I'd like to participate and learn more and only got a call back from two. It was really apparent that this system is pretty broken of how to understand the trials and then join the trials, which is why we created this whole Myeloma Crowd Radio Program in the first place.

Brian: I think it's unfortunate to say, but two out of eight is actually a pretty good hit rate. When we first started, we had even worse numbers in that in terms of actually hearing back when we were calling in for patients. You're absolutely right. It's why we need to look at how do we break down these barriers one by one and make this much more approachable for everybody. That's definitely a big challenge that we're facing. We tend to break it down within SparkCures into three real barriers. There's a barrier around awareness. We'll get into the details of what that is. But a lot of patients aren't even aware that a clinical trial was an option or what could be even worse is they think it's an option when there's no other option left. I'm not sick enough. I haven't gone through all my standard of care options. You made a great point, Jenny.

Jenny: A last resort option.

Brian: Exactly. Look, a clinical trial may not be right for someone until then or they may decide not to join one. But I think for us, a clinical trial should be considered in every change of treatment - a diagnosis, at first relapse, at second relapse, at third relapse even if you're not going onto that. And we'll talk about why that is. The clinical trial process is really a continuing shifting landscape of trials for which you may or may not be eligible. It might make sense here to pause for a brief second. For anyone, for instance that maybe isn't aware of this, there's what's called inclusion and exclusion criteria.

A lot of people may be familiar with that, but it's really just a fancy way of saying there may be reasons you are eligible to join and there are reasons you won't be eligible. It could be anything such as your actual diagnosis. Do you have MGUS? Are you smoldering myeloma? Or myeloma? Are you high risk, intermediate risk, low risk? How many prior lines of therapy have you had? What have those prior lines of therapy consisted of? All those things that can go into these factors.

At every treatment point, every time you had a treatment, some clinical trials may go away forever and you may never be eligible for them ever again. By the same token, at every treatment point or when you have a new treatment, some trials are going to open up for the first time that you'll now be eligible for. It's this constantly shifting landscape that makes it really challenging to stay on top of.

Jenny:  Yes, absolutely. Why don't you give us an overview of these three different barriers and then let's jump into the awareness barrier.

Brian: Yes, great. The second barrier we really look at is all around understanding. Even if you are aware that clinical trials exists out there, what does it look like? What does it mean? How often are you going to have to travel in a trial? There's high level expectations both of the trial and of the patient that we really want to make clear. Not just that, but how do you go about it when there are over 90 treatments in active development for myeloma in the US alone? How do you go about -- even if you're aware of them, how do you understand which one of these is right for you? Is it an exercise of throwing darts against the wall and whichever it lands on you choose?

There are some real challenges around what this looks like. It's compounded by, do you have the ability, both the resources and the time and the help, to pick up and go somewhere if you're not near a large research center where maybe some of these are. Is it available in your local community setting? Sometimes, not always. There's an understanding aspect. Then the third is you hit on earlier, how do you ultimately take action? Once you can get past the awareness barrier, once you can get past the understanding barrier and you go okay, here is a trial that I may be interested in, how do you take action especially if you're calling and no one's returning your phone call? Or if you're put into the never ending phone mazes that exist out there? What does that look like? These are really the three things that we want to center our conversation on today and attack those one by one.

Jenny: Sure. That sounds great.

Brian: On the awareness side, if you want to just jump in there, you raised a really great point. You were planning ahead. You were looking ahead and we like to say that the best time to start looking for a clinical trial is when you don't need one.

Jenny: I completely agree.

Brian: When you have the energy and the wherewithal. The thing that's nice about that, Jenny, is that if you find something that you're interested in, you can just keep tabs on it. You can watch. You can see as the interim results come out, how well is it working? Did they shut down or satisfy the safety concerns? Are they starting to see patients really responding? A potential good example of this, really centering around of CAR T-cell side of things, would be looking at the data that came out on the bb2121 data that came out at ASCO in June which was showing the medium progression-free survival of 11.8 months.

Now, the challenge, and we'll get in this time for this later on is that some people are really pinning their hopes of CAR T on a cure. If you are thinking cure and you get nearly a year of progression-free survival, that can be a really hard thing to take. But when you look at the type of patient population that was included in these trials (the multi-relapsed/refractory patient), the thought would be, what other treatments out there are in development showing nearly 12 months of median progression pre-survival? 

Jenny: These were patients on 10, 11, 12, 13 lines of therapy. That's what you're saying.

Brian: I think there was a patient with up to 23 prior lines of therapy, if I can remember it correctly. When you look at this, part of the question is, when is the right time potentially for a clinical trial? That's really where you need to be actively involved with your doctor and talking through this. Because if we look at this, you can sit here and watch some of the data. Most of the CAR T-cell trials are  in Phase 1 and are testing dose escalations. There's a big logistical challenge around getting into these CAR T-cell trials. We'll address that in the action standpoint. But they're still looking to find the right dose.

Again, going back to the data from bb2121, it's really interesting because if you look at the medium progression-free survival at 150 million cells, the progression-free survival was 11.8 months. For the patients who got that at an earlier dose level of 50 million cells - and I know it's a lot of numbers, but it's important - they were seeing a medium progression-free survival of 2.7 months.

There's a lot of data that they're working through right now both on a safety standpoint and trying to figure out what's the right patient population? How much of an expression of BCMA (the B-cell maturation antigen which is the target that many of the CAR T-cells are looking at) do patients need to have? Is there a certain threshold of BCMA that patients need to have for this to be successful? Or is there is a certain dosing where they start to see this? You can see, they tripled the dose and they went from 2.7 months of median progression-free survival up to 11.8 months. It's a good idea to be aware of these numbers so you can start looking at this to be prepared if and when that day comes when you have to make a decision.

Jenny: I want to jump in for a second.  As we think about this, sometimes patients will say, especially some patients we've seen in these meetings for HealthTree across the country, they'll say "Well, I'm on a certain standard of care, a treatment protocol. So why would I ever want to consider a clinical trial?" And to me, the answer is because we don't have a cure yet. If the drugs we were using in the clinic were curative, then great. Let's all do that. But the clinical trial process is bringing new drugs like CAR T cell treatments or like even daratumumab or elotuzumab or some of these newer types of drugs into the clinic. Now, that's the only way they're going to get there.

At relapse, would I ever consider going to do a single stem cell transplant again? I had a good response to mine. So why wouldn't I just go and repeat that standard of care in the clinic? I would never do that. If I were going to do another stem cell transplant, (which I hope I don't do) I'd do a stem cell transplant that was part of a clinical trial, like with a vaccine to extend my remission, or something else that's going to get me further out the door. Anyway, that's just my passion as to why we support clinical trials or we participate - because there's no cure yet.

Brian:  Well, it's well said. That's it. I always say, my mom was given 30 days to live, and she ended living for just under two years. It's not the outcome obviously that we wanted. But it was two years that we never expected to have with my mom. The reason for that is because all the patients that came before her in clinical trials. My mom was diagnosed in 2005, a very different time frame. She was sent home with a Velcade pump. Revlimid wasn't approved by FDA until December of 2005. She was still approximately seven or eight months away from even Revlimid coming out on FDA approval.

It's a very different timeframe, but the patients that came before her helped her live longer just like she did for others. Her data set is part of the MyPRS genetic test which is a really cool thing. It's helping patients live longer. So we all add up to this accumulative whole of understanding this disease better and better, and we have to keep pushing that forward. Clinical research is the only way that happens. From an awareness standpoint, the number one thing that we think that anybody can do is to make sure they're seeing a myeloma specialist and make sure that a specialist is part of their team.

Jenny: Absolutely.

Brian: That is such a huge part of successful outcomes. You know this, you got to cover the Mayo study that came out showing the overall survival benefit. If you're being seen by a doctor that sees between three and ten myeloma patients in a year, the overall survival showed doubling versus those who see less than that. You want to make sure that you're going to a myeloma doctor at an academic facility. This doesn't mean, for someone that's in a community setting or that's seeing a local hematology oncologist, it doesn't mean that they're not good at what they do. It doesn't mean that you can't continue to receive care there because it might be convenient.

A good point might be in Florida. There are Florida cancer specialists spread out all over the state and then you may go to Moffitt, or you might go to Mayo in Jacksonville. You could go there to potentially see these docs there, but also go to the University of Florida and still receive treatment in the community setting. But it's bringing a myeloma specialist onto your team. Maybe you're connecting with them once a year. It depends on your needs individually. But that way, you have someone who's staying on top of the research and the literature that can help direct and guide the care that you're receiving. 

Jenny: I agree. The University of North Carolina study came out in the last six months that said, if you were treated by a myeloma specialist within the first year of being diagnosed, you live 39% longer. I think, if there were a drug that helped us obtain 39% more life, we would all be taking it and it'd be this mega blockbuster drug.

Brian: That's a great point. Going back so we get to the understanding barrier. We had a patient who gave us this analogy once. I really love that it hit really close to home. He said, "I feel like I'm a frog sitting on a lily pad." He said, "By working with you, I'm making sure there's always another lily pad that I can jump to." He said, "My job is to not run out of lily pads."

I love it for its simplicity. But it's right, we can't run out of options. There are only so many FDA approved options and clinical trials that can and will represent a number of potential lily pads that the patients can jump to. The idea is, how do you constantly stay on top of that so you always have plan A, plan B, plan C as you progress through, from MGUS to smoldering, smoldering to myeloma and to relapsed/refractory myeloma? We think that's a really, really important part.

Jenny: True.

Brian: Once you're aware there are trials available (and we always have a slide in our presentation that shows the number of active trials for every status and diagnosis), you can see that there are trials for newly diagnosed myeloma, first line relapse, second line, third line relapse, etc. There are also trials getting into the smoldering setting as we're all very well aware. But there is even a study for high-risk MGUS.

When we look at that spectrum, there are clinical trials for everyone and we should be aware that there are trials at every one of these phases. We are proponents of clinical trials. We are big believers in the research and advance in the science. But we also realize that a clinical trial isn't going to be right for every single patient every single point in time. That's where we circle back to the specialists, but it's really being aware.

Jenny: Well, I think the point you made earlier in the show needs to be stressed just a little bit. When you think about joining a clinical trial at every stage, it's better than saying, "Well, I ran out of all my options and now I'm going to go try a clinical trial," because at that point, you may not be fit enough to join a trial or you may have kidney damage or whatever you might have. There are things you can't control. It's just not a wise time to start thinking about a clinical trial. If you do your homework ahead of time and you're prepared, you can also understand the landscape and start assessing what looks more promising and what may be better for you personally as well.

Brian: I agree 100%. It's an interesting point to bring up. Sometimes you might think, maybe a CAR T-cell trial isn't right yet for me. Maybe I want to wait until it's in Phase 2 or Phase 3 when they know a little bit more about it. Okay, I can appreciate that viewpoint. There's always a double-edged sword around this. Maybe as it moves along in the clinical trials phases from 1 to 2, 2 to 3 and then to FDA potential approval, it will be more accessible. There will be more opportunities to participate. We'll know more. That's a good thing. But you run the flipside.  What happens six months from now or a year from now? Your blood counts, can they hold up to get into new trials? What about your creatinine levels? If any of these things change, would you be eligible and would you be a candidate for some of these experimental treatments if you wait?

There is never a definitive answer. We're always working essentially with incomplete information. It's only in retrospect. When we look back and we say oh, that was a good decision or maybe that wasn't the best decision based on what happened. But we don't often have the benefit of foresight when we're making some of these decisions. It goes hand-in-hand with the clinical research side of things. It definitely is some muddied water on that side, which is challenging.

Jenny:  Absolutely.

Brian: If we move into that next action barrier, it really comes down to how do we set expectations for the trial? What can you expect from the trial? Why is this research going on? Why do these people believe in it? Why are they pushing this forward? If it's a later stage trial, a Phase 2 or Phase 3, what are some of the results that you've seen that show that this could potentially make sense? For the patient, what is the trial going to expect of you? There's going to be travel commitment. There are going to be blood draws. There are going to be site visits. Financially, what does that impact look like?

We can say the trials are going to cover the treatment or maybe some of the things that are going into that trial that are experimental, and the other things are going to be billed into insurance, Medicare, Medicaid, different things. But what are the financial considerations? If you have to travel for a CAR T-cell trial, where are you going to stay? If you have to stay for 30 or 60 days, is it on you? There are some non-profits that actually do have funding available for patients in clinical trials. Some of the centers may have the Hope Lodge equivalent like outside of Dana-Farber. There’s I think 30-some of the Hope Lodges around there.

What are ways that you can go about this to actually participate? And how can you understand it in a way that it actually makes sense to you so you can have a viable conversation with your doctor to say, does this make sense, and really understand it. That's a big factor in this. We actually work really closely with pharmaceutical companies to actually gain access to their protocols and their informed consent. Anyone that's not familiar on the research side, there are documents, the protocol document is the master document. It's the instruction set of how this trial is going to be run. It gives you insights into the rational of the study and what things are going to be excluded, what things are going to be included, what is the research trying to accomplish?

That's what's presented to the FDA to get approval to move into the clinical trial process. There's a secondary document called the informed consent. It's like the clinical trials 101 document and breaks the study down into more accessible language about what the expectation are throughout this trial. We are working closely with a number of pharmaceutical companies and sponsors and hospitals to gain access to these documents so we could present them back on the SparkCures website.

What's currently out there and publicly available isn't really helpful. There's a lot of data and information missing and we're trying to improve that access so that people can go out there and learn about these trials and understand them in a way that up to this point has been very difficult, because you have to actually be in the pre-screening visit to get access to some of this information - which is a really difficult process.

Jenny: Right, and you'd be traveling everywhere just to read the informed consent document. That's driven the Myeloma Crowd Radio Program too. Let's hear from the investigators themselves, why they're running this and what the study is all about and who can join.

Brian: The fact that you can take that and bottle it up and get that out to all this patients at once, because these doctors don't have the time. We all have 24 hours in a day. To take that time to speak individually to patients is very difficult. If we can disseminate that information more efficiently and effectively, it's a win for everybody. The other thing too on the understanding side, this kind of bridges everything, but we'll get calls where maybe platelets are down and the threshold for some of the clinical trials may be 50, 75 or 100 or other cut-off. Patients say, "Well, my platelets are too low. I can't participate in the clinical trial. So I don't know what I'm going to do next."

In addition to clinical trials, there is off-label use. We can look at venetoclax. It's approved. It has FDA approval but not in myeloma. You can get it through expanded access before it is FDA approved in myeloma. Another use is selinexor which is by Karyopharm. If you're not eligible for some reason for the trial, you may be able to gain access to that through the compassionate use mechanism. One other one that may be worth discussing Idasanutlin which is by Genentech, and that's being geared towards the 17p deletion population is also potentially available through a compassionate use.

Even if there is a patient who maybe on paper isn't eligible or doesn't seem to be eligible for trial, it doesn't mean that there are still aren't options once you've exhausted prior FDA approved treatments. This is a really important point to make because doctors don't always bring that up or they'll say, well, we're going to go on a bendamustine regiment and we're just going to go on this. That could be fine. There could be reasons to do that. We're not advocating for or against that. What we're advocating for is options. Let's use the venetoclax or the selinexor or the idasanutlin. Let's get this on the table and help your doctor and you have this conversation to decide. Oh, maybe it does make sense to pursue a compassionate use regiment and what would that look like for all really important considerations.

Jenny: It's not fair that we have to self-advocate but we do. Just because of the complexity of the disease and Pat Killingsworth would say that all the time. It's not fair, but we still have to do it.  If we want good health, it's really a necessity.

Brian: It really is self-advocating. You're absolutely right. At the end of the day, we had a call just earlier today with this lovely woman. She was running, she was static and her doctor -- unfortunately, you're going to have to advocate for yourself. You're running into some road blocks here. We can help talk through this, but you're going to need to advocate if you doctor isn't maybe open or isn't able to provide the support that you're looking for.

If we look at the action component of this, that action barrier, that’s no better illustrated then you tried calling to stay ahead of the game and two of the eight called you back. It's unbelievable how difficult this is. Look, there's turnover. There are people that leave or maybe they get moved to a different department. All of that is understandable. But the challenge is when people are in a very acute situation, when they're looking to get this information, how do we do this as quickly and as effectively as possible? The first aspect of this is really to talk to your doctor.

Again, make sure there are myeloma specialists on the team. But self-advocate. If your doctor isn't telling you about clinical trials, ask about it at your next appointment. It could just be asking if there are any trials here that maybe make sense? Or, we're at a future relapse that we should be keeping an eye on. And you can also extend that and say, if it's not here, are there other trials running in other locations? Are there other trials maybe around the country that you're keeping an eye on that seem to be really interesting or that are showing some nice results? That's a good way to start that conversation with your doctor.

Jenny:  Depending on the doctor, they may or may not share clinical trials that are open at other facilities. I think patients just do need to be aware of that, that sometimes they may not share a clinical trial just because it's not at their facility. So they may want to focus just on the trials that they're running for their patients. As a patient, that's why the SparkCures tool is so good because you are able to see everything and geographically and in other ways.

Brian: That's right. For us, it doesn't matter to us. What we care about is helping the patient. The agenda is not this trial over that trial. That's the conversation to have with your doctor. Our agenda isn't this treatment center over that treatment center. What's more convenient for you? Are you getting along with your doctor? Your doctor may be brilliant. He might be great or she might be great. But is it part of the care team that you want? Are they interacting with you? Are you getting the supportive care that you need from your care team? If not, maybe it's time for change or maybe are there different ways that you can approach it. All those things come into play.  

I think it's talking to your doctor absolutely, but it's also making sure that you are prepared, self-advocating, having your records ready. Know what your latest lab results are. I know that Dr. Hofmeister is now down at Emory, a great myeloma doctor. He is one of our medical advisors. He gets so excited when patients show up and they have their M-spike or their free light chains mapped out. With either Microsoft Excel or if you're a Mac person, Numbers or Google spreadsheets, it's pretty easy to map those things out. It really helps to keep a handle on that. At least, so if you are looking at a trial and it's at another facility, you have access to this information and can get that over pretty quickly to see if something might make sense to one of these trials.

Jenny: This is really where HealthTree helps out as well, because that's what a lot of patients have said to us as we've travelled around the country. Now I have one place to put all my information. We have the ability for you to enter labs manually if you only have a printout. Or we will be working on electronic pulls from your patient portal or your electronic medical record. This just makes things so much easier and the doctors, we showed HealthTree to Dr. Hofmeister, and he just said, "Oh, this is just amazing that you have everything on a summary page." It's a really important thing to have everything together. You're right.

Brian: In most patients that are multi-relapse refractory, you might be at several centers. Jenny, how many centers have you been at? Huntsman, MD Anderson?

Jenny: Three.  

Brian: Now, all of a sudden, you are interested in getting in a trial. Well, guess what, you've got to go to all three of those for data release to get all that information over because we're going to have to do their due diligence, make sure they can follow you and prove that you have progressive disease and that you've had the prior treatments you say you've had. It gets really complicated. It doesn't get easier as the disease progresses. When you're at a point where you have more energy, chemo-brain isn't kicking in or any of that, it's best to stay on top of this to the best of your ability.

Another things is, don't move yourself out of a clinical trial. What I mean by that is, there was a Facebook question that popped up. I think about a week or so ago. There was a patient that said "I have non-secretory myeloma and I'm not eligible for any clinical trials." It may be true that you may not be eligible, but not necessarily for that reason. Clinical trials will have measurable disease thresholds where if you track your M-spike through serum, it might be 0.5 grams per deciliter or one or there'll be certain thresholds on your free light chains. But for patients that maybe are non-secretory, you can also look at bone marrow plasma cell percentages or a measurable plasmacytoma. Now, unfortunately not all trials will allow for that, but there are some that do. What I would advise is, don't lower yourself out until we can actually know for certain when we go through it because there are an awful lot of trials.

Jenny:  One other comment is, you need to know the criteria once you join the study. My my dear friend Liz joined a study. She didn't know that her iron level had to be a certain level. So she was eating vegetarian and then her iron level dropped and she had to leave the study. Once you're in a study, you need to understand what those criteria are so you can watch them and do whatever adjusting that you can do personally.

Brian: That's a great point, and it kind of blends into the next part of this which not ruling yourself out - there is a big difference between not eligible and not yet eligible. We've actually rewritten our entire software at the beginning of this year to allow for this new consideration of "not yet eligible". As an example, if we look at inclusion-exclusion criteria, many trials will say that if you've had a prior allogeneic stem cell transplant (which is a donor transplant) then you're not eligible for the trial. Well, that's a "not eligible". Unless the protocol is amended, unless there's a change, you are not going to be eligible for this trial at all, because you had a prior allo.

But  there a things like your lab values, like your creatinine or you GFR or your ANC or platelets, that if  you're below a certain threshold, if you GFR is below 45 or below 40, maybe you're not eligible, which is a measure how well the kidneys are working. But then we know what to look for. If you're really interested in that trial, then we know if your creatinine comes down, the GFR should be calculated a little bit higher. And we have the number where we can look at and say, oh, okay. Now maybe it does make sense. Now, we are aware of what things we have to keep tabs on.

Same thing with the CAR T-cell side. Most of the CAR T studies will say you have to have had at least 3 prior lines of therapy or be double-refractory (resistant to two different types of myeloma drugs). You're going to need at least two but most likely three prior lines of therapy in order to participate. Now, let's change and we're starting to see some of them coming up into the first line relapse territory. But it doesn't mean that you're not eligible. It just means you haven't gone through enough prior lines of therapy in order to be accepted into the study. By understanding those things, we know what to keep our eyes on, if and when that time comes to help make that connection.

Jenny:  That's great.

Brian: A lot of this comes down to asking a lot of questions. If you go in for a trial and you're told you're not eligible, ask why. Keep asking until you understand that. We had a patient that was told they weren't eligible due to their creatinine levels. They reported back to us. We looked at the protocol and their creatinine levels were within limits for the trial. They went back the next doctor appointment. They said, well, actually I think I am eligible. It ended up the doctor, the nurse coordinator, the trial coordinator had misspoke. Again, we're not going to know unless we're asking these questions - why am I not eligible?

More importantly, we had a patient who was told they weren't eligible because they had plasma cell leukemia, or PCL. We looked at the labs and there was a low percentage of circulating cells. Well, plasma cell leukemia is defined that 20% circulating plasma cell limit, they were drastically underneath that. We ended up going back and advocating through both the site and the sponsor of the study to say, if they're not eligible, that's okay, but help us understand this. Because as it stands, they're being excluded for a reason that we think doesn't match up with their labs. It ended up, there was some confusion. So they ended up being allowed to present for prescreening on the study.

We really have to ask a lot of questions. We're all human. Mistakes can and do happen. Again, that's probably another good point of self-advocating. Even if they say you're not eligible, don't just take that and walk away. Say, well can you help me understand why? Am I not eligible or am I not yet eligible, and what does that mean? The trial landscape is constantly shifting and changing. Patients with a prior allo five years ago didn't know that having an allogeneic stem cell transplant would make them an eligible for basically all the CAR T-cell trials. Not all of them, but most of them right now. Well, it's a hard thing to know, five years out.

One of the questions if you're considering a trial is, will this trial make me ineligible for future trials? If we look again at the BCMA protein, there's a lot of immunotherapy that's beginning to target BCMA. The CAR T-cells as well as the antibody drug conjugate and the bi-specific antibodies. They have targets that are looking at BCMA on the myeloma cells. Well, as it stands if you go on to one of these bi-specific or antibody drug conjugate trials targeting BCMA, you might be ruling yourself out for the CAR T BCMA trials at least as it's written right now. Maybe that will change six month or year, two years from now or when one of them receives potential FDA approval. But as it stands, you might be ruling yourself out.

So, you kind of go back to that double-edged sword again that we talked about, Jenny. Maybe you want to wait for the CAR T. But if you wait and don't do one of these trials, what if you're so sick or your disease has progressed, but you can't actually gain access to it. You are waiting for something specifically, and then you rule yourself out just because your disease has progressed. These are challenges that there's not really a very good answer to. It really comes down to an individual making that decision with their doctor. Knowing if you hold off, here is what could happen or knowing if you go onto a study, it could be removing some of these trials potentially forever. Even when the treatment is FDA approved, we don't know what that document going to look like. There's a lot of challenges around that.

Jenny: It looks like things are shifting in the CAR T environment also because will there be trials that test two CAR T's at the same time, not just the BCMA target, but BCMA plus something else. It's this game of strategy I think for myeloma patients. It's better to understand their disease, and then see what's available and what's optimal for them at a single point in time. That's why we built HealthTree and why SparkCures as a terrific tool to help with this.

Brian: Well, I appreciate that. If we jump into a little bit on the CAR T-cells, I know patients wanted to hear more about getting into these. I want to make clear that I don't think there's ever been clinical trials that are like these CAR T-cell trials. What I mean by that is they're so heavily publicized and so many people know about them and everybody is saying, "What about CAR T?" It seems like the bb2121 and CAR T are synonymous because it was the first out of the gate and the first to report their study data. We've had patients who are frontline, newly diagnosed, untreated, calling up and saying, "I want to get into this CAR T-cell trial."

I empathize and say, "If I were in your shoes, I'd be looking at the same thing," but it's just not yet available in that setting. It's going to take some time to get there. Not only is it heavily publicized, but there's an issue of supply and demand. There are a lot of patients that want to get into these studies but, there's very few spots available. There's a lot of interest without a lot of ability to get these patients in, which makes it challenging in and of itself. If we compound it with the fact that these CAR T-cells are really personalized medicine. They're taking out your T-cells from each individual person in the case of a CAR T-cell trial. They're reengineering it to target that BCMA protein or in the case of one, there is one CD38 CAR T-cell trial.

So they're reengineering it and then they have to grow or expand these high quality T-cells to infuse back in. That could take upwards of a month. Few spots are available in these trials.  They have to be eligible right at that moment of the spot opening, which is oftentimes very tricky. Patients typically go through a preparatory regiment and then they wait a month for those cells to grow. Then, the T cells are re-infused back and then it could be upwards in another month where the doctor is waiting to see how the patient responds before the next patient goes into the study.

It's a lengthy process with very few eligible slots on the CAR T side. It's very tricky. If you look at what can you do as a patient or caregiver to help maximize that, there are some thoughts to this, knowing that not everyone has the same resources, not everyone is able to pick up with a drop of a hat and fly across the country when a spot opens up. Not everybody has the luxury of time off from work or can leave immediately without other considerations.

All those things being pushed aside for second, you want to spread your name on the waiting lists as far and wide as you possibly can. There's a number of centers that are running CAR T-cells trials. A lot of times we'll say, "What's the way that we can maximize the exposure to CAR T-cell trials?" For example, there may be two or three CAR T-cell trials at one location. Sarah Cannon has I think four at this point.

If we look at Sarah Cannon and then other facilities like Moffitt or the University of Chicago or Emory, there may be a little bit of overlap. They each may be running the same study.  Instead, maybe we can get you considered for five or six completely different CAR T-cell trials. Some of these places will actually allow you to call and be placed on the list without actually traveling to their site and getting a consult at that center. Fred Hutch is one them.

At the Fred Hutchinson Cancer Center in Seattle, you can call the immunotherapy phone number and you can actually get placed on that wait list. They have two CAR T-cell trials running right now. So you can go through that route. You could call the NIH and be evaluated. There's a hospital up in Rhode Island, Roger Williams, that you can call to be considered for the CD38 CAR T trial and they'll at least look at your profile remotely. For patients that maybe don't have the wherewithal to get up and travel to all these centers, there are places that they can call, send their records up and at least have some sense of whether they could be potential candidates.

Once your name is on the waiting list,  you've got to be persistent. Again, self-advocating. The squeaky wheel gets the grease. Follow up every month. Send them your latest lab values. Let them know you're still interested. Maybe you have stable disease or maybe your M-spike (your monoclonal protein) is going up but it hasn't gone up enough to be considered progressive disease yet. That's okay. Get out there, and make sure that these coordinators aren't going to forget your name, your email, and your voice when you're calling. 

Jenny: Let me ask you a question, Brian, because when I was talking to Dr. Noopur Raje about the CAR T trials and this was probably six months ago. She said, if you're applying to get into a specific CAR T trial and it's being run at multiple centers, please don't call each center for the same trial because then that kind of messes with our waiting list and somebody might be on five lists for the same study. What you're saying is you could put your name on the waiting list for five different trials. So I want to make that clarification because it's just a challenge for them to pick who is going to be taking care of next. These are patients who are really in need.

Brian: It does and you're right. I don't think this is easy on anybody. The centers are struggling because they're getting so many requests to go into the CAR T studies. But I can point to number of examples where patients that we've been working with have been on the waitlisted at both their home center and to a remote location. And they've gotten on to the trial to a remote location instead of at their home center. Unfortunately, we don't want to create more complexity and more issues for the centers. But we're big proponents at SparkCures of what we call "patients first". It's the first thing you see when you walk in our door.

For us, that means we do what's right by patients. If spreading the net maybe makes it a little bit more cumbersome, we're sorry for that. But we are seeing patients who are getting in at the same trial when they couldn't even get at their own center. It's hard to say just sort of sit back and wait and see what happens. I think this will change as time goes on. As more trials are opening up, we're seeing more and more CAR T-cell trials opening up later in Q3 and Q4 of this year as well as in 2019. As these centers open more trials and get availability and get slots for the CAR T, we're going to start to see this even out a little bit.

It's still kind of the Wild West when we're in Phase 1 studies with an awful lot of patients looking to get in. If patients are looking at other trials outside of CAR T, they're not going to see the same logistical issues that exist. This is not in any way sort of a tell-all of how getting into a clinical trial looks. This is not represented of the typical process. The CAR T studies are really an outlier.

Making sure again that one of your action components on the CAR-T cell side in is to get out there and join support groups whether that's in person, on Facebook or the new program Myeloma Crowd is creating. Advocates like Dana Holmes and Bonnie Falbo help with those great groups out there that patients can go in and connect and learn from others who are going through this process.

People are also getting into CAR T-cells and are then sharing their experiences. It's a really incredible thing. Cheri Rineker is out there and sharing her story and really open to telling what that was like on the bb2121 study that she was on. But one caveat - as great as these community connectors are and it's great to hear about their experience, it may not be your own experience.

We'll have patients who will call in about the trial and say well, I saw someone on Facebook and they were on it and they didn't do well so I don't want to go on that one. That's everyone's right to say that, but work backwards to make sure you have the whole story. What if it was a dose escalations study and the patient you're talking to is one of the first patients to go on and they didn't see a response because of a low dose? But now, the study is increasing the dose they think they will use in a Phase II study and they're looking for more patients.

That can be a very different conversation. If you look back at the bb2121, the dose of 50 million cells was very different in outcome of the dose of a 150 million cells. Make sure you have the whole picture and then talk to your doctor. Don't dismiss this out of hand. We can hear this sort of anecdotal information, but at the end of the day, you're a sample of one. There's one Jenny Ahlstrom. It's unfortunate, I wish we could clone you and do this for more patients. Everyone is a sample of one.

I remember when they told my mom there's less than a 5% chance that she'll pull out of this. On one hand, I can appreciate setting expectations for us as a family. On the other, I remember being so angry, probably angry at the situation of losing my mom. But angry  -- don't take away hope. Maybe only 5% of people do, but that means there's five people out of 100 that can pull out of this. I know that's kind of difficult but I remember thinking my mom isn't one of those hundred people. My mom is my mom and we'll see if she's going to pull out or not.

Unfortunately she didn't and again so I can appreciate the setting expectations in having those difficult conversations. But that's the big part of it and we look at getting out there and sharing these experiences. We're based out of Pittsburg, Pennsylvania. For anyone that knows Mr. Rogers, Fred Rogers, he had this great quote. He said, "When I was a boy and I would see scary things in the news, my mother would say to me, look for the helpers. You will always find people who are helping."

I think it hits so close because the myeloma community is so open in welcoming and so great to share information and news. In the midst of the incurable cancers today, we don't want to look at that. We want to look at there's all this hope and there are these people who are putting up time and energy - the myeloma docs, researchers, patients, caregivers, husbands, brothers  and kids. I think it's such an amazing thing to be a part of. Joining those groups and being part of that access to these helpers is so critical for everybody.

Jenny: I completely agree. It really speaks to the power of the individual patient. I mean we're powerful as an individual when we self-advocate. But we're also powerful when we get together in our collective about moving things forward. That applies for the clinical trials and the participation that we have in terms of joining these trials.

But when we use tools like SparkCures and HealthTree, we are helping each other and we're going to be developing a program called Myeloma Coach which will become a mentoring program to help patients with the clinical trials, with HealthTree and with other myeloma resources. We've run into many people who say, I want to help other people. I've been given lots of blessings and I want to give back. You see people like that in the Facebook groups. They're terrific and wonderful and they want to help other people and we all I think just want a cure for myeloma.

Brian: I love it.  It's such a powerful way for patients to give back. A lot of them, that we talk to, do want to get back. You had a great point. When patients are calling us and we're talking to people, the nice thing about this too is, SparkCures is spreading our net wide too.

We have many individuals around the country reporting back and saying "here is what's just happened on this CAR T-cell trial"  or "here's how I got in," or "I just came from my doctor and the trial is open but it's not listed publicly yet." Let's make sure we let people know. We got one of those calls today. So that we were able to update the database, get that setup there and alert patients that maybe eligible that something has changed so that they're always kept up to speed on it. 

Jenny: That's great. Well, I want to leave sometime for questions. We don't have a lot of time left, but we have a little bit. If you have a question for Brian about joining clinical trials and maybe navigating those steps you can call 347-637-2631 and press 1 on your keypad. If you have any specific questions about the CAR T-trials also, I'm sure he'll be happy to answer those.

Brian: Yeah, absolutely. 

Jenny: We have a caller, go ahead with your question.

Caller: Hi, Jenny and Brian. It's Jack. Hello.

Jenny: Hi, Jack.

Brian: Hi, Jack.

Caller: I have enjoyed your interview. You do great things helping patients get into clinical trials. Brian, I'm wondering, do folks ever ask you about their financial responsibilities in trials?  That's usually not laid out until they've seen the informed consent, but I'm always concerned if they skip that part of it in case there are any kind of financial responsibilities.

Brian: Yes. One, Jack thank you for your question. I appreciate it. The financial considerations are so imperative. Part of the challenge, Jack, and you know this is that there's as many answers to that question as there are patients and  insurance plans in terms of what they cover. We suggest first seeing if there's a trial that even make sense. Let's see if there's one that you may be eligible for. Let's talk through this with your doctors, see what they think. Then let's get over there and talk to the center itself. Let's get in touch with the social worker. What sort of resources do they provide - housing, financial support, etc? Are there some non-profits that we connect them with to help with the financial aspects. We like to at least to have something definitively that we can point towards because that really helps to have that conversation. I would say it's one of the most critical questions that's going to come up. But we have to work backwards from the trial in mind to see how that's going to work.

Caller: Sure that makes sense, thanks.

Brian: Yeah. Thank you.

Jenny: Thanks, Jack. Another caller, go ahead with your question. Go ahead. 

Caller: Hey, Brian. It's Paul. How are you?

Brian: Hey, Paul. Good to hear from you.

Caller: Good to hear from you too. Great show. Thank you for taking the time. It's just an amazing job you've done at demystifying the clinical trial process and providing real access to patients. This is like a dream. Actually, I can't think of another example of any other cancer having this level of access. Thank you for your time and your commitment to this.

Brian: Yeah, absolutely. Thank you. I appreciate that.

Caller: Also, I just wanted to highlight this collaboration between SparkCures and HealthTree and Myeloma Crowd. It's also kind of one of this other unprecedented areas where both of you have taken this really abundant, patient- centric approach and saying we're just kind of focused on the outcomes. You have lots of other things you could be doing with your time and your energy. You have gone so deep in the space. How do you justify just keeping SparkCures focused on myeloma? It's an amazing resource for the community, but is this sustainable? Will this be a resource that's going to available to patients for years to come? As patients are committing to this, this is an amazing resource. It's really unheard of.

Brian: Thank you. I appreciate that. I think it's a really great question. We've batted this around too with different events that we've been at. What we have to remember is that there are a lot of places that patients can go to get information. They could say well, I'm happy and have talked to my doctor about my situation. That's okay. Or I'll use and I'll go through that. We have no problem with that.

I think if there's a setting the patients are comfortable with, they should continue to use that. But when we look at it, like Jenny said, there's not a cure. And there's a lot of roadblocks and barriers to patients getting access to clinical trials. I think that we're taking a very centric approach on this side to really solve this problem. I think we've done a really nice job and in a lot of ways, but there are still a lot of work left to be done. We ask ourselves, how do we create a model that can be replicated in other cancers?

Even the blood cancer side leukemia, lymphoma, MDS, we'll get there and that's part of the plan. But for us right now, we're looking at how do we really work directly with patients? How do we do this? We've seen a number of competitors, one in particular who I don't want to throw them under the bus or anything, they raised close to $20 million and went out of business a year-and-a-half later almost two years later trying to do this because they were doing it for every indication.

The reason we can speak so definitively and we can really help through this process is because we understand myeloma. There's a deep understanding. But more importantly than that, I think at the end of the day, we have built trusted relationships. We want to be connected with people on a deeper level than that. We have patients that will call to say, "I just was offered this trial by my doctor, but I didn't want to do anything until we spoke with you and your team first," which is really amazing. 

Caller: I think it's a fact that you've gone so deep that you have built this trust at every layer of the network. And so it's just astonishing.

Brian: Well, thank you. For us, we're sustainable and we haven't taken investor money. I self-funded everything myself for the first two years of the company. The nice thing about this is there's no shot clock on us as it were. There's nothing that we have to do. We're going to grow when we're ready to grow. We're going to jump in to other indications when we're ready and we think that makes sense for patients and for us, which really is a nice thing because it keeps us really in control of our destiny. We don't have to do things that maybe don't make sense if we can't deliver the high quality service in matching and everything else that we've been doing and we've been building up to. In that sense, it puts the future in our hands as to how and when we're going to do that.

Caller: Well, the commitment and the quality really shows. Jenny, I have a quick question for you. How do patients and caregivers become myeloma coaches? How can they get involved and help facilitate it? Because to really make this work, there needs to be a broader community of people that are going to be providing that coaching and guidance that you guys are providing through digital means. But sometimes, they just need people that may not have access to the technology sitting next to them and helping them out.

Jenny: Right. We are working on building that program right now. Right now, if you want to become a Myeloma Coach and you have some hours to volunteer every month and you're willing to help others, you can email us at and we'll start that conversation with you. We have a small set of people who are working with us right now on that to help us expand this program. That's really the first way to start. You'll be seeing some information shortly on the Myeloma Crowd site about this program - how to sign up, how to set your hours and things like that, all the details behind it. But before we end, I just want to explain also how we've integrated with SparkCures, because some people might say "Well, if I have already have a SparkCures account, then do I really need to log in to HealthTree or if I have a HealthTree account what's the integration there?"

SparkCures is focused on finding clinical trials. As you can hear from what we've talked about already, it's a really incredibly valuable tool and goes amazingly deep on that. Some people want to also understand their existing treatment options as well - what's currently available and FDA approved. Now, inside of HealthTree, you're basically creating a SparkCures account at the same time. If you don't have one already, you don't have to go to SparkCures and create and account. You can create it from within HealthTree. But if you already have a SparkCures account, you could also log in to SparkCures and just go look at clinical trials separately. 

Brian: Jenny, if I can just throw in one thing real quick. If you do have a SparkCures account and you sign up for HealthTree under the same email, our system acknowledges that and we don't worry about creating another account or duplicate entries or anything. We'll link those two together and show you. So if you're in HealthTree, you'll see everything. If you're in SparkCures, you're going to see everything. So we've made that really easy on the backend side of things to connect accounts.

Jenny: Brian, I just want to thank you for participating. We really appreciate your time. We appreciate that you've dedicated your life to doing this. It's truly amazing. We just are so grateful.

Brian: Jenny, just a quick recap. You know, it goes both ways. The things that you were doing specifically in  Myeloma Crowd, we've been big fans for a long time and we're really excited to continue this relationship. At the end of the day, the only way we're going to make end roads is by everybody working together. We all have to partner together in the best ways that we can and share information and help make these connections and help raise awareness and understanding around all of this. Thank you for everything that you're doing.

We did get some Facebook questions. Can I have two more minutes? Is that okay to talk through in this smoldering side of things?

Jenny: Yes, sure. Go ahead.

Brian: We did get some questions on the smoldering side of things. It's a really interesting and perplexing dilemma that a lot of smoldering patients who end up going into clinical trials are facing at this moment in time. What I mean by that is, if a patient goes on and do a smoldering clinical trial and they're high risk and they tip over in the symptomatic myeloma, what does that mean for their clinical trials that, if that initial myeloma diagnosis, are they now considered untreated, newly diagnosed? Will that smoldering clinical trial count against them? Even also, there's another way to look at it. If you're in a smoldering clinical trial and maybe it ends or you drop out of that, is there another smoldering trial that you could get into?

I just want to address the fact that these are all really great questions. We're not going to have definitive answers on every one of them because they're going to be a little bit different. We've seen -- there are some trials that are newly diagnosed that'll say no myeloma treatment, no prior myeloma treatment and they'll consider smoldering treatment as part of that. Even if you're newly diagnosed myeloma, some of those things would happen. It's a very complex situation. What I would say is if there's any smoldering patients listening, because there are trials in this smoldering setting that you can go from one to another, we're happy to talk through that and kind of address those question one by one.

We know there's less of a population out there of high risk smoldering that are on trials but it's getting larger and larger. It's important if you're going to start treatment in this early phase, in this precursor stage to understand what does that mean down the road? For instance, we had a patient who was in a smoldering trial, progressed to active myeloma that had been on two additional therapies as a myeloma patient when we first connected with them. The way we would interpret that is three lines of therapy, the smoldering clinical trial and then the two lines that they had as a myeloma patient.


We could not get them into this clinical trial that will acquire three more prior lines of therapy. The medical monitor on the study would not accept a smoldering trial or a smoldering treatment. It very specifically had to be "active myeloma treatment." Some of those things were left going, I mean we can't do anything. If they decide to change that, that's okay. But there's not a clear cut answer to what happened yet. I think if anyone is smoldering or MGUS and they're considering going into this, we really need to ask some questions with these docs. What does this mean if -- would I be able to go and do another clinical trial? What would happen if I'm merely diagnosed and I didn't want to do the RBD plus transplant? Would I be eligible for another clinical trial or what would that look like?


So these are really great questions. I want to make sure that if anyone has those, let's talk. Let's figure out what the interest lies and we can help map some of these things out on a more individualized basis. But to kind of recap all that together, I think the biggest thing, Jenny, is be aware of your options, see myeloma specialists. Make sure you bring the myeloma specialist on your team. Number one most important. If we can help anyone sign up through HealthTree, you'll also create through us as well.

You can call us at any point. Our direct number is 888-828-2206 and this will be in the show notes. Please don't hesitate to call or email. Any question big or small is welcome and we'll do what we can to help out. But thank you for the time here, Jenny, and thanks for everything you're doing to help spread this information out there.

Jenny:  Thank you so much Brian for participating. We're glad that you helped some people understand some tips and tricks and, especially for somebody who wants to get into really popular clinical trials. Thank you so much.

Brian: Absolutely.

Jenny: Thank you for listening to Myeloma Crowd Radio. We hope you'll be listening this Friday with Dr. Paul Richardson for a mid-year review on myeloma and an update there. Thank you so much.

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