(Guest Lecture): June 2022 - Understanding the PROMISE and PCROWD Studies with Dana Farber

my best to keep track of those. This month, we're talking about understanding the PROMIS and P-CRUD studies with Dana Farber. We're actually even going to go a little bit more into myeloma and precursor conditions. Again, like I said, I'm really excited about the presentation today. These are studies that are meant to further myeloma research. I'm really excited about this because it's an easy way to participate in research, but also to get our families and friends involved in myeloma research as well, because it really takes a village and we don't want to wait for a cure. So I'm really excited to hear how we can participate in myeloma research and how we can spread the word to other people. Our presenters here today, we have Erica and as a clinical research coordinator with P-CRUD and impact studies, her main responsibilities are to manage the day-to-day operations, patient communication and assist in data management with our lab techs and PhD fellows. Her career goal is to become a physician and she joined the GOVRIO lab in August of 2020 because of the work that the lab is doing in order to increase awareness surrounding multiple myeloma and the importance of screening. Her family, like so many others, have dealt with the repercussions when diagnoses are discovered too late and their lab and the studies that she works on are trying to screen and treat patients before they even become symptomatic. She's thankful to be part of the team and work with the study participants. Maya is a clinical research coordinator on the PROMIS study and her primary responsibilities are to oversee the positive cohort and lead the Black community engagement effort. Her career goal is to work as a physician decreasing the current gaps in our healthcare system that disproportionately affect minority populations. She joined the PROMIS study in August of 2020 primarily because of the work the study is doing to decrease barriers of accessing care but also because people of African descent have two to three times more higher risk for multiple myeloma and its precursor conditions. She is grateful for the opportunity to improve patient care and experience and connect with wonderful study participants. Marjorie is a physician assistant at Dana-Farber Cancer Institute Center for Prevention of Progression. She graduated from the Yale School of Medicine Physician Associate Program and soon thereafter launched a career in oncology. Beginning in bone marrow transplant, Marjorie moved to a community oncology practice for many years before returning to focus again on hematologic malignancies and disorders. She joined Dana-Farber's precursor clinic in January of 2022 because of the exciting research opportunities to learn how we can intercept these conditions before they progress to malignancy and ultimately make impactful changes to the current standard of patient care. This is happening in your backyard in the northeast chapter and I wanted to make sure you were aware of it and I'm really excited to hear from these ladies today. With that being said, Marjorie, I will turn the time over to you. Okay and I think Erica is going to pull up the slide but you guys are from all over the country. I see Pacific Northwest and Tennessee and Connecticut. There are a lot of people I shouldn't say. We said come on and watch. That's great. There we go. So we all three work for Dr. Irene Govril who is out of the country right now. Sorry, I don't know how to get rid of the next slide. Go to display settings where you were before and then just click swap. There we go. Okay there we go. If you want to make that full screen so they can see it. It's full screen online. It looks strange on ours. Do you want to just stop sharing and try sharing again? Yeah, sorry it was working before. I know. When we test. Yes, sorry everybody. It's okay. Okay, what can you see now? Yeah, I still see things in front of the slide. Are you just sharing the window or are you sharing your entire screen? I'm sharing the entire screen. Thanks everybody for your patience. I'll use this time to make a plug for our movement challenge. If you're not a part of our movement challenge already with health tree moves, we are happy to be here. We are going to be doing a live stream of our movement challenge. So if you want to join us, please do so. We will be doing a live stream of our movement challenge. Okay, so that's it for our movement challenge. If you're not a part of our movement challenge already with health tree moves, we are having a great time. It's keeping me accountable for movement and I'll make sure to talk about that later in the meeting in case you're not already participating with us in that. Okay, that looks good. Excellent. Okay, thank you. Thanks, Maya. Okay, so I think again, my role tonight is just to kind of give the broad strokes again, a recap of kind of the spectrum of disease of plasma cell dyscrasias, which kind of encompasses all those plasma cell disorders. So that's MGUS, moldering myeloma and multiple myeloma. And then really the bulk of tonight is going to be Maya and Erica talking in detail about the PROMIS study and the P-crowd, which as was mentioned earlier, it's very easy to participate. So I think we can go to the next slide. Okay, yep, I think we can move on. Okay, so let's just take a step back again. Multiple myeloma is a blood cancer. And so all blood, I'm sorry, yeah, all the blood in adults is made in the bone marrow. And so that includes plasma cells. So plasma cells are a type of B cell that make antibodies and that's what helps you fight infection. So we all have, it's normal to have plasma cells and they secrete all different types of antibodies to help us fight infection. And that's normal and that's polyclonal. Sometimes some of these plasma cells can take on cancer-like features and then they secrete too much of the same kind of protein. And that's what we call monoclonal protein. And that is measured as an M spike and stands for monoclonal. So by definition, monoclonal is not normal. And there's a spectrum of change that goes along with that. So in the beginning, one may make just tiny bits of protein. But over time, if that protein starts to cause problems or damage in the body, then we say you have end organ damage or active disease. And that's at that point that we say you have multiple myeloma. So what makes people move from MGUS to myeloma and who are those people? And that's a lot of what these studies and Dr. Goebbriel's research is looking into. In terms of the damage, again, that can be caused once these cells, these proteins are causing problems. You may have heard the term CRAB criteria. So that stands for calcium, renal, anemia and bone. So if it is punching holes in the bones, that's the B, then people can be at risk for fractures. We can have an elevation in the blood calcium as calcium gets released into the bloodstream. If the proteins accumulate in the kidney, we can see renal failure, kidney damage or kidney failure. Sometimes that's a presentation for patients. Anemia is the A. So if these plasma cells are starting to proliferate more in the bone marrow, they crowd out the healthy cells. And then we see that they can't make the normal red blood cells that they should be making. And so we see a drop in one's hemoglobin. So I think we can go to the next slide. So this slide is a little bit dated, but it just talks about the continuum that is MGUS to smoldering to multiple myeloma. Not everyone that has MGUS goes on to develop myeloma. But those myeloma patients must have started with MGUS and then smoldering. And so why does that happen? That's a lot of what Dr. Gabriel's lab is looking at. And that's a primary driver of both of these studies. You know, what's happening, you know, what genetic changes are taking place in terms of mutations. We can have several clones. And I'm just doing a very broad stroke here on the several clones. There can be clonal selection and competition that changes over time. There's the bone marrow niche, kind of the cells that are bathing these plasma cells and all of the crosstalk that happens there as well. And so that's really what the meat of the P. crowd study is looking at is those details. I think we can go to the next slide. So again, multiple myeloma, it's the second most prevalent hematologic cancer. It's usually older patients in terms of, you know, 65 to 70 years old. Risks would be things like age. As we get older, it's more common. It's more common in men, people of African descent. And then there is an association with some of these occupational or I would say also hobby exposures. Next slide. So, this is just illustrating again, looking over time again, this is from, you know, 2005 to 2014 in terms of who is at risk. So roughly 50% of people of the age of 50 are having us. That's a huge number of people. But again, as I said, not everyone with them Gus is going to go on to develop myeloma. It's three times more common in people of African descent. It occurs when they're younger. And it's also three times more common if you have a family member with this disorder. Next slide. Sorry. And so this great, sorry, they updated the slide for me. So, again, what is the risk and that's something that if I have them Gus that's what I want to know is, what does this mean to me and there have been, you know, general models there's been criteria that have come out in terms of helping predict this but we need to do better. And so, if you have M Gus, again this is kind of all commerce. Sorry the comments didn't get moved I don't think so 27% will convert in 15 years so it's about 2% a year. You look at the upper curve smoldering myeloma. In the first five years, about half of the folks will go on to develop myeloma. So that's huge. Next slide. So, how are we going to intercept this so we think about mammograms people get a mammogram so that we can go find a lump. Take it out with surgery and keep you from having any further damage elsewhere in your body. You get a colonoscopy you go and you get a polyp removed before that can cause colon cancer or other complications of that. But for us, and myeloma we don't have we don't do that currently in terms of the standard of care, the standard of care now if you have them Gus is to just wait and watch. And we wait until you develop multiple myeloma to do something about it and so that's that's the driver of both of these studies is how can we identify who is more likely to go on to develop myeloma. And when, and how should we intervene to keep that from occurring. I think that's it for my slides. So I'm going to turn it over to Maya. Thank you, Marjorie. My name is Maya, as I mentioned in the beginning, I am the research coordinator for the promise study. So I'm going to give you a brief overview of the study today. And I'm going to start with a video that we have. Sorry. To know that promise was working on, you know, trying to figure out what might cause myeloma, whether or not early interventions could be helpful, you know, not just for our child but for other people's children. This study is amazing I can't promote it enough. And I hope everyone that has a patient or family member of multiple myeloma will look into participating in this study. I'm grateful for the opportunity. I'm grateful to be a part of this. It's amazing. Taking some control. Hello, my name is Irene Gabriel. I'm from Dana Farber Cancer Institute in Boston. The promise study started with a very simple idea. Why are we not screening for blood cancers, we screen for other cancers and we know that cancer screening saves lives. One of the things about the promise study is that no one ever develops active multiple myeloma that you never develop the real disease, we can detect it early, we can prevent it from progressing. And it isn't usually found unless something is going wrong. And by then, there's disease. So with something like promise, if you already know you have a family member that has had myeloma and that maybe your chances of getting myeloma are a little bit higher than your, your neighbor Sally who doesn't have any hematological cancers in her family. It makes it's the best thing you can do for yourself. I just hope that the study can find a way to prevent anyone from being in the kind of pain I was in. And, you know, the earlier you can be treated, the better. The fact that it can help prevent that pain, prevent those treatments, the related stress, the other conditions and problems that could come along with treatment or side effects. So just a lot of hope. It has made me more knowledgeable. I have children prior to when I met my wife, and it just helps me to also pass along the information of what should they look into to make sure that not only they stay healthy, but their children stay healthy. When I was diagnosed in February 2016, I really knew very little about multiple myeloma. It was a frightening, frightening experience. And I of course went to research, which is what we do in our family. Right, Carolyn? You can look up the promise study dot org, www promise study dot org, and you can just log in, see if you are eligible or not. And if you are, you sign the consent right there online. You don't need a physician. It's really direct to patient access. And once you sign up, we send you a kit at home and you can take that kit and go either to a quest diagnostic or go to any other place where you can get your blood drawn. And that's it. If you are negative and you do not have the monoclonal protein right now, we will re screen you again in three years so that we can see if you still are at risk or not. And then if the results are positive, we will call you either myself or one of our physician assistants or nurse practitioners will call you. I promise to help everyone who's at risk of myeloma, diagnosing it early and never having it happen. I promise to encourage folks to get an early diagnosis. I promise to give myself and my community a fighting chance. I promise to continue empowering myself and others. I promise to not stop fighting to advance our understanding of myeloma. My promise is to continue to support my sister, to support my family, and to support science. I promise to foster hope by encouraging people to participate in the promise study. I promise to never give up. Thank you for watching that short video. It describes the promise study very well and features some of our participants in Promise and Pea Crowd and their amazing stories. So I thought it would be great to share. To know that promise. So the promise study as described in that video is a national screening study for the precursor conditions to multiple myeloma. Our goal is to screen 30,000 individuals. And we're expecting about a 3% positivity rate. So that'll give us three or the about 3000 participants who screen positive and we will follow those participants prospectively. We have a great team of researchers. You saw Dr. Grobely on that video. And then we have collaborators at other institutions in the United States. The primary objectives of the promise study are to determine the clinical and genomic alterations present in individuals with monoclonal gammopathies who are diagnosed through our study. We also would like to determine the clinical, genomic, and epigenetic and immune environment predictors of progression to myeloma in patients with these precursor conditions. So also understanding why certain people progress and why others just stay at their precursor condition for the rest of their life. And then we have some secondary objectives as well. We wanted to define the prevalence and incidence of m. guss and smoldering myeloma in a high risk population of African Americans and individuals who have a family history. We want to define the drumline characteristics as well. Determine the natural history of screen detected versus incidentally detected. Meaning people who are specifically screened for these precursor conditions or other people who are getting routine blood work and determine that they have this condition. And then also determine the clinical and epidemiological risk factors for progression of m. guss and smoldering myeloma to multiple myeloma in our high risk population. A new screening technique that our study is using is quantitative multi-tough mass spectrometry. This is our study is the first to use quantitative mass spectrometry. It has been used in the past, but only quantitatively. We use an AI based software to detect the m spike in our data. Usually it's the data that we use to detect the m spike in our data. Usually it's interpreted by a person and we're using a machine to detect the peaks. We recently published some data and I wanted to give you a little bit of that information here. So we screened a little over 7000 participants. We use participants from our study, which is a prospective screening study. We also use samples from the mass general Brigham biobank, which is a retrospective study. This cohort included individuals who are high risk and that included people who are of African descent and then people who are not of African descent and have a family history. And then also people who were not at high risk for multiple myeloma. What we found from this study from this screening initiative that we did is we found that our machine was able to detect this increase in the monoclonal protein at lower levels than standard clinical measures. The standard clinical tests such as a serum protein electrophoresis assay or immunofixation can detect protein at 0.2 grams per deciliter, which you can see here with this pink line. And our machine could detect even lower than that. So that's all these samples here. We don't know what this means for these this increase in monoclonal protein yet, but we're still doing some more research to learn more. We also found that if we use the standard clinical lowest limit of the 10 of detection, which is 0.2 grams per liter, we detected on our machine 13%, a 13% positivity rate versus what is detected with standard clinical measures, which was 6%. So even using the standard lowest limit of detection, we found an increased positivity rate. So now I'm going to take you through how Promise screening works. As described in the video, you can enroll online. On our website, you'll be taken through our eligibility questionnaire and be invited to sign the consent form if you're eligible. Once you enroll, you will receive a blood kit in the mail that you can take with you to a local Quest Diagnostics, a local lab, or we can offer mobile phlebotomy through exam one that will come to your house. You'll get your blood drawn. It'll be sent back to our lab and we'll run the screening test on your sample. The people who are eligible for Promise are individuals who are over 30 years of age, who are either self identify as of African descent, or have a family history of myeloma or another blood cancer. People who are not eligible are individuals who are diagnosed with cancer of any type, who are currently requiring active therapy, and then people who have already been diagnosed with any blood cancer or precursor condition to a blood cancer. So myeloma, M. gastrointestinal myeloma, and the others. So far, we have enrolled 93% of our study population are people who have a family history of myeloma, and of those who screened positive 93% of the people who screened positive have a family history. And then the other 7% are individuals of African descent. And same with those who screened positive 7% of those are of African descent. Once you screen on Promise, we will return your results to you by a clinical member of our team. If you screen positive we move you into the positive cohort, where we function more as a bio banking study similar to the crowd which Erica will describe later. We ask you to fill out a few forms, and then we request serial samples, as you're being followed up clinically by a local hematologist or oncologist. If you screen negative, we will also inform you of those results, ask you to fill out some forms, and then And then we screen you three years after your baseline screening because you're still considered at a higher risk. Can I interrupt you just quickly. When you say test positive test positive for M. gastrointestinal myeloma. Yes, so if you screen positive for M. gastrointestinal myeloma. Okay, perfect. Okay. I'm sorry for not making that clear. If you do screen positive for one of these precursor conditions, we have our positive cohort which we like to make, which we call our myeloma care initiative. And so you will receive a phone call from a clinical member of our team describing your diagnosis what that means, and offering any support that you need. We will provide you educational materials, invite you into our positive cohort. And then we will establish care with either a local hematologist or oncologist, or if you're local to Dana Farber or want to travel, you will set up here with Dr. Gabriel, and then we will follow you throughout your follow up care, asking for research samples, but then also offering any support that is needed. If you do screen negative, we receive an email with their results. Their question, follow up screening questionnaire will become available, and then we'll continue to send them updates about study publications and other updates about our study and then invite them to restream for years. Now I'm going to turn it over to Erica to talk about that. Hi, I'm Erica. Like my said, or, I'm going to give you guys a little overview of the peak crowd study now, which Okay. So the peak crowd study is a clinical and translational research data and sample repository, which focuses on collecting sequential samples and data from patients with a variety of hematological malignancies, with the majority of which is moldering myeloma and M. We are open at Dana Farber Cancer Institute in Boston, as well as a few external collaborators, including Dana Farber Milford South Shore Hospital, London Dairy and Brigham and Women's Faulkner Hospital. The peak crowd study has been open since 2014. And since then we have consented over 3000 patients and collected over 9000 blood and bone marrow samples. Data and research from these peak crowd samples have contributed to dozens of publications that have helped doctors and their patients figure out how to treat precursor conditions and understand how they develop and why some people progress, while others remain in this precursor, in the precursor state. We have also been using this research to target future therapies and figure out how the disease affects the immune microenvironment. And then similar to the PROMIS study, the primary objective is to collect and study blood and other biological samples of participants to over time learn how these conditions develop and how they may progress into overt cancer, as well as stop that progression to overt cancer. All right, this is just a breakdown of all the samples we've collected through peak crowd. As you can see, we collect blood, mainly blood and bone marrow samples, while the majority diagnosis being smoldering, but we also collect with MGUS, active myeloma, and several other precursor hematological conditions that I will show you a list of in a few slides. All right, so quickly going to take you guys through how you can sign up for the peak crowd study. The website is on the screen, and I will add it into the chat later in a little bit. But yeah, so you go to the peak crowd slide and then you click enroll now, and it'll take you through a few questions just to ensure that you are eligible. And then it will allow you to create an email and password, where it will bring you to all the forms that you need to fill or to join the study. My thank you, Maya. You don't mind going to the next slide. Thank you. Okay, so once you create your username and password, you will see a page called my study documents. And then the forms that there are several forms on there that we ask that you do complete eventually. However, the two that are needed for us to enroll you in that study are the consent form, and then your participant information form, which just gives us a little bit more background on on you. It's another check to make sure that you're eligible and and able to participate in the study. Perfect. And then this is just a more complete list of all of the documents that you can fill out we have a baseline questionnaire COVID vaccine survey medical provider authorization, which allows us to contact your doctor and ask them for your medical records to use in tandem with to analyze in tandem with your samples when they come back to the lab. It avoids us having to go through you it's one less thing that you have to get from your doctor collection kit request. And that is for patients who are not coming to Dana Farber but getting their blood drawn through their local oncologist or hematologist, you let you fill out the form, let us know the date of your blood or bone marrow by our blood sample blood draw or bone marrow biopsy. And then we will indicate whether it is blood or bone marrow, and then whether or not you're going to a quest site, and then we will send you a kit in the mail to your house, you bring that to your appointment and they will draw that at the same time as they do that your clinical labs. We also have a form here that allows you to upload any lab results or medical records that you think would be pertinent to your precursor multiple myeloma. Next please. Thank you. Okay, so I already. So this is already what I spoke about with the collection kit but in the portal you can fill out any of these forms you can contact us our email and phone number or an address if you would like to send something through the mail are all on there, as well as the collection And then this is just the instructions for shipping your kit this comes with your kit so it tells you how to package everything up and then all of the materials to package your kit. After the blood has been drawn are also included. All right. So the inclusion criteria for P crowd is, you have to be over the age of 18, and be diagnosed with one or more the following precursor conditions, including clonal hematopoiesis of indeterminate potential or chip monoclonal B cell lymphocytosis, Myo dysplastic syndrome monoclonal gummopathy of undetermined significance, which is m Gus my own proliferative neoplasms, such as polycythemia Vera essential thrombocytemia or myofibrosis smoldering multiple myeloma smoldering Waldenstrom macro globulinemia or Waldenstroms Mac, or sorry, asymptomatic and untreated Waldenstroms macro globulinemia, As well as a variety of other precursor hematological conditions, the ones that I have listed, however, are the majority of our study. And then the exclusion criteria is just anyone who has been diagnosed with a hematological cancer that is symptomatic and requiring active therapy. So patients who are receiving therapy for a precursor condition are still eligible. It's your only ineligible if you're receiving treatment for active cancer. I have a question with that. Sorry. Yes, of course. But I did see on your previous slide there were some samples of active myeloma taken. Does that mean those were active myeloma and complete response that we're currently taking treatment, or in what situation were those active myeloma samples considered in the studies. Yes, so those were probably patients who had just progressed to active myeloma. I believe those were the blood samples that corresponded to the date that they did receive that active myeloma diagnosis from their doctor, and at which point they are not taken off study but we do stop collecting samples so that would be the last sample that we would receive on that patient. But we do keep them on study for a follow up. Awesome. Thank you. Of course. All right, you can go on to the next slide. All right. So now I'm just going to talk a little bit about CPAP, which is our clinic at Dana Farber, where anyone with a precursor multiple myeloma condition can be seen by one of our doctors, which is the Center for Prevention and Progression. Thank you. The Center for Prevention of Progression of Blood Cancers is a multidisciplinary clinic, which provides patients with hematological precursor conditions, a roadmap for clinical care and monitoring while aiding scientists in developing targeted therapies that could halt the progression of precursor conditions. Anyone who has any consultations with these conditions can see a physician who specializes in that condition as well as arrange consultations for social workers, genetic counselors, other practitioners that can help them manage their, manage their precursor condition. Anyone who is seen in the CPAP clinic will also be informed by their physician, if they are eligible for any interventional clinical trial that is that we are currently occurring for at Dana Farber. And then I've also included the link to the CPAP website. So, Dr. Omar Nadim, Dr. Robert Seufer, Dr. Irene Gobriel and Dr. Benjamin Ebert are the, the leaders of the CPAP, however, we do have many other doctors who work in our clinic that are listed below. And this list is not fully encompassing as we have new doctors being added to our team all the time. All right. We did want to include a slide on whether or not you are eligible for PROMIS or PCOUD as we do get a lot of questions about this and it is a little bit confusing. So for PROMIS, you are eligible if you have not been diagnosed with any precursor condition, myeloma or any other blood cancer. PCOUD is if you have already been diagnosed through your hematologist, your primary care or any other, any other way that you've been diagnosed. If you already have a diagnosis, PCOUD is where you are. If you don't have a diagnosis, you're eligible for PROMIS. All right. Well, that was the last of my slides. Now we can- Will you actually go back to the, will you go back to the slide before? Yeah. I think I want to just clarify with everybody, just action steps because I'm all about action steps. So if you have, and correct me if I'm wrong, but if you have a precursor condition, your action step hopefully would be to go to the PCOUD website and register if you are interested in participating in myeloma research this way. If you have active myeloma, which I would say are the majority of people on this call, your action step is to tell your parents, your siblings and your children about this study and give them the chance to enroll in this to further myeloma research. Is that- Yes. Are we all on the same page? Because often I know I get active myeloma and they're like, well, I guess I can't do anything, you know, and spreading the word, I guess, is a really good action step. So you can stop sharing now. Thank you so much. And I'd love to get questions. I have several questions in the chat that I see already. I'll start with those, but while I'm talking and while we're entering in these questions, feel free to submit your own questions in the chat as well. So one of the first questions that we got, we know that the PROMIS study used to be 40 and now has dropped down to 30, which is exciting. It says 30 and older. How much older are we talking about? Are we talking about like, they just had their birthday so they're not eligible because they're only 30? Or is it like 30 in one month is eligible? 30 in six months? You know what I mean? Yes, yes, I do. So it's 30 years on the day. So the day someone turns 30, they are eligible. Great. That's great news. There you are, Mary. Mary asked that question and she has twin boys that just turned 30 so she is going to get on them about participating in the study, which is exciting. Okay, another question that somebody had was regarding the mass spectrometry. Is mass spectrometry used for pre-crowd participants as well as the PROMIS study? So the mass spectrometry is used mainly for PROMIS. I think we may be working on a project to include the P crowd in that cohort as well, but mainly for PROMIS right now. Yeah, I know there's a lot of excitement around using things like mass spectrometry instead of a bone marrow biopsy, but that's exciting. Thank you. And then another question was asked about medical data and health tree. So we have health tree care hub where people keep track of their blood draws and their lab results and things like that, and how we could connect health tree care hub with your study so that instead of, you know, trying to send a test here, there, everywhere, we can connect that. That's an excellent point. I don't know if we've talked about it before. I know Dr. Gabriel is aware, but that would be something good for us to talk about offline as a way of partnership and a way of accelerating my own research in that way to make it simpler for the patient. So I loved that comment. Thank you. Linda is wondering, at one point there were supply chain issues for the PROMIS study having been delayed. Have these been resolved, those supply chain issues? Yes, they have. So we, there was a national shortage of some of the tubes we included in our kits. We now are stocked in our office right now and I have a huge stack next to me. So we are stocked back up on those tubes. We do now require an appointment scheduled before you get your kit. Because of the shortage, we want to make sure that they're going to be used when we send kits. So you, if you're a participant, you should get an email from our team asking you to schedule an appointment. You can also give us a call or an email once your appointment is scheduled and we'll send you a kit right away. Perfect. Awesome. That's exciting. Linda mentions, you know, she's really grateful and wishes this study was available when she was diagnosed with Kappa-free light chain in 2012. She has a family history of myeloma and lymphoma on her dad's side. Her brother enrolled in the PROMIS study and tested negative, but because of her history of light chain myeloma, she's wondering, you mentioned you test for an M-spike, but what about the possible non-secretory or light chain myelomas that might be out there as well? We also check light chains as well. Awesome. All right. Jan is wondering, is saying, three sisters and brother took part in the PROMIS study. Thank you to you and your family. After diagnosed with multiple myeloma in 2021, thankfully none had M-gussers smoldering myeloma. She has high risk, all-ego secretory, non-secretory, like we said. So again, she's just wondering, is it accurate without a bone marrow biopsy? You do check for light chains. Non-secretory is a little bit more difficult, and so is all-ego secretory because it shows just a little bit of M protein or no M protein at all. It might not even really show on the light chains. So without a bone marrow biopsy, how confident are you in these results? You know what I mean? Even though non-secretory is so rare, right? It's a concern for these patients. That's a great question. I'm not a clinician, so I don't know if I'm the best person to answer this. I know we use the standard blood test because we don't want to ask all of our participants to get a bone marrow biopsy. Understandably so. Yeah. But I don't really have a good answer for the other part. Yeah. It's just, yeah, it's okay just knowing that bone marrow biopsies aren't being currently used right now. Maybe it's something I can talk to Dr. Garbreau. Wonderful. And just another story of being diagnosed only after renal failure, and we see that so often. This is why I'm so excited. Just that something's even being done in this field. I love when Dr. Garbreau always says, we always screen for breast cancer. And obviously, with the whole MGUS not even being treated right now, I understand the complications, but I'm excited to see what happens in the future because of the work you guys are doing. So thank you very much. So, once somebody has a question about once being diagnosed with smoldering myeloma, can that be treated outside of a clinical trial? So I'll take this question again. I'm not a medical professional, Marjorie, if you want to also answer this question, you're welcome to. It really depends on what kind of smoldering myeloma you are diagnosed with. We highly recommend that you go see a myeloma specialist and yes, that is a specific doctor that is working on pretty much only myeloma or maybe some other things like Dr. Garbreau does, for example, but someone that's very well versed in myeloma and aware of the new and changing things. I normally only treat high risk smoldering multiple myeloma and a clinical trial is a great way to be treated. Occasionally, doctor specialists, it's complicated, especially occasionally they're treated outside of a clinical trial. I've even seen oncologists start treating smoldering myeloma when they really shouldn't have. So that's why it's really important to go to a specialist and have them assess your personal case. Marjorie, do you have anything to add to that? Perfect. Okay, wonderful. Thank you. Jeff wants to send a link to the PROMIS study to all his siblings in an email. Do you guys have an email template explaining the program or like even a little flyer or something? Yes, we do. And I can send it to you, Audrey, so you can share it with the whole group. Perfect. Thank you so much. Jones wondering when do you think screening for MGUS will become a standard blood test at your annual exam with your PCP? I mean, we saw that statistic. We saw how many people have MGUS, right? Like, it's kind of mind blowing that it's not already standard screening with the sheer significance of people that have MGUS. Like, I'm a little bit floored. I think it's because we don't know yet who are those people that are going to progress. And I think that's why these studies are so important, because once we can show who those people are, I think that will really guide how we will use the screening test. Yeah. And just to be clear, because this obviously I'm passionate about this and excited about this, what we're testing for is it this genetic population progresses? Are we looking for a genetic sequence? Are we looking for certain characteristics? What exactly is the end goal of? Do you know what I'm trying to say? Yes, yes. And I can speak a little bit and then Erica can add as well because she works more with the participants who have pre-gursor conditions than I do. Like, as you know, currently, there's not a lot known about myeloma, why people get it, why others don't, why people progress, why some don't. So we are looking for like germline characteristics, but we're also looking for general risk factors, like from people's social history, from their health history. And we have a pretty comprehensive post-screening questionnaire to gather all this information from our participants so that we can create a big picture and understand when we're looking at doing the tests in our lab, what risk factors are, but then also looking at like social and health and life history. Yeah, that's helpful. Erica, anything to add? Yeah, I'd like to add that, like you said, we are looking for certain genetic markers. Obviously, we can't say for certainty that this is like a genetic disease, but that is the question that we're asking and that we're hoping to, with more patients and more samples, have a better understanding so that when we see these certain genetic biomarkers, those are the patients that we think are going to progress faster. Progress quicker. But we are also obviously looking for other markers in the blood and other reasons why patients may progress. Yeah, it's fascinating. And that change, that can change over time as well. Exactly. In terms of clonal selection and competition. And so that's the other important piece of this is there's serial collection of samples over time. Yeah. So in terms of the really meat and potatoes of the details on how those tests are run in the lab, I can't speak to that, but we're really looking for, you know, like Erica said, you know, what are those markers and how do they change in those individuals? Yeah, it's fascinating, right? Because we know that, well, I don't know. This is again, not an expert here, just sharing my passion as a my little advocate. But we've heard, you know, Agent Orange has a connection to myeloma and then we hear like my boss, Jenny, her and three of her neighbors got myeloma. Like what in the world, you know? And then you hear like Jen was saying earlier, she has a history of myeloma on her father's side. So, you know, lots of people say, well, it could be genetic, but it could be that families also share environment, right? Which would explain maybe the neighbor thing. There's just so much that we don't know. And I just want to reiterate, I'm so excited that something is being done about this so that we can start to get answers. So thank you. I'll just add one more thing. I think that's the other wonderful piece. I think when I came to this practice is that there's human beings, you know, that are helping run this study and they're looking through your history and your answers to the questionnaires are very important because we're not just looking at a number, right? We're looking at more than just your value, how much, you know, protein did you have, but kind of all the other things that can contribute. Yeah, yeah, I love that. Several people asking for the link. I did include them in the chat. I will also include them in the follow up email that we send out with the recording, as well as the other resources mentioned. So we will make sure that all of you will have the chance to enroll in these studies, but look further up in the chat in case you didn't see it. I can repost it as well. Marisol or Maru, if you want to just copy and paste again because if somebody entered later, they wouldn't have seen those chats. Let's go back to the questions. Several wonderful, wonderful questions. Another question for the P crowd. Oh, so are the blood tests different? Like when they get normal blood draws at the lab from their hematologist, is it any different than the blood like draws that they're going to get in order to submit them for the P crowd study? No, so what we do is we collect a small amount of blood at the same time that you're getting these tests done. So it's not any additional tests that your clinician isn't ordering. This test is purely a research sample. It's sent back to our lab. And then we at this time do not return any results, but it isn't anything that would affect that should affect your clinical care. Your doctor will test for all of that separately. You're you're just harboring secret results in your lab. Okay. Yeah, that was just another question that somebody had. Is it is what's being tested for P crowd different than what local hematologist does for EMGUS? So the goal is not to make it any more burdensome on patients. It's just going to be however often your checks for EMGUS, even if it's annually, semi-annually, it would just be the same as long as you're getting blood drawn. You just take a little bit. Is that correct? Yes, no additional draws are needed just whenever you're already going in to get your clinical tests will ask for a sample as well. Perfect. Um, Marjorie, this is a good question. I don't I don't actually know this. I'm going to take a little bit. So this question said does P crowd test for extra medullary or plasma cytomas. From what I understand if it's extra medullary or plasma cytoma, it's already active myeloma at that point right because there's there's end organ damage in the body. I think sometimes people can be treated a little bit differently if there are solitary plasma cytoma, but I'm going to guess that does not come under the purview of P crowd. Erica, can you do you know the answer? Yes, that is correct. If it's active disease that would not be considered P crowd. Okay, yeah and solitary plasma cytoma like you're saying Marjorie is a little bit different than than MGUS, smoldering myeloma and active myeloma. I love it so complicated. I don't love it. That was sarcastic. I don't know. It's very complicated. But good questions. I believe when it's so extra medullary plasma cytomas are when there's tumor like growths and other parts of your body that escape the bone marrow. Therefore, I believe once that happens it's it's classified as active myeloma. And I don't know if he would be able he wouldn't probably be able to find that through a blood test you would need to get a PET scan in order to find those plasma cytomas if I'm totally not giving medical advice at all I promise. So, Donna said after her multiple myeloma diagnosis younger brothers PCP ran tests and diagnosed him with MGUS so other brother got tested and also had MGUS on last visit with Dr. Nadim he asked if we were part of the study at Dana Farber. This is the study that she thinks he was talking about so she's going to get sister and children tested. Love love love to hear it and thank you for participating in research. So, that is all the questions that I see right now however I'm totally open to more questions. Steve's going to unmute and ask his question or share his thought. See if I didn't ignore you just wanted to bust through the chat. This is a tough time for me during dinner time so, but I wouldn't miss I wouldn't miss you. I just have a comment about this. You know, all you guys are such experts in the new field of multiple myeloma. But there is one topic, an adjunct to what you guys have been discussing. I was discovered with it. Two years ago I'm in remission I said I'm 79 years old I was 81 years old now. Father and grandfather, and I was pretty much healthy my whole life on and on and on. And I'm in remission. I have to because of your expertise about genetics. I had to make a decision about my two sons and my six grandchildren. And you guys have a second. Please, I had to make a decision about discussing this new field of genetics, and I feel horrible. This is not fun and games for me. I feel for the first time in my life that I may have given my next generation, and the next generation. The kiss of death, and that's how I feel. I think they have passed on this gene to my little, I have grandchildren from the college age to five years old and my kids are my baby is 51. So, um, I had to make a decision knowing that when I tell them, it's going to, they're all healthy, completely healthy. I'm going to change their life. Because from now on, they're going to have to be checked and rechecked and have in some way cope with living with this shadow over them. After I'm long gone to me. I'm the American dream. I'm 81 started with nothing. An amazing amazing life. It's okay for me I'll get whatever. And this seems to mention this psychological or whatever you want to call it. This terror I feel this guilt that I feel of passing this gene on to my, especially my six little grandchildren. I cry about that. And I dealt with it, I told my two sons, one's a physician and. Because it's the right thing to do but I held my breath. And I told them, knowing how badly I feel. So, you most of the experts in this field are too are much younger than me they're all everybody in the world seems much younger than me. But, you know, you don't have grandchildren. And you don't have to, I don't think, have this option of having to tell them that for the rest of their life they have to be tested. It's a horrible thing to go through I've given them my whole life and everything. And now I have to leave this earth, at some point, with a cloud. And, you know, they have to know, I know that all the medical stuff, I know they'll be protected and their treatment and they get it early I know all this stuff but that doesn't seem to erase my guilt and feeling horrible about this. Thank you for giving me the time to say that. Yeah, I, yeah, thanks for sharing with us Steve and again you know while we want to educate you in this group, this is also a group where you can feel validated in your feelings you can feel supported in your feelings. I mean, totally understandable feelings that you have Steve. I have a lot of thoughts but I'm not sure any of them would help you and I, if you don't want to hear them I'm not going to share them if it just is to get No, no, no, no, I'm always hoping for anyone's expertise and experience. Well, it's definitely my expertise or experience since I only have one child who decided to burn his hand on the stove. This morning, which is absolutely traumatic for me. But I will, I'll say a couple things, even then if anybody else wants to pipe in or ask a different question. You're more than welcome to. Number one, I wouldn't put all the blame on yourself. I mean you. This is not a genetic disease in the, in the sense from what we know so far of it's going to be guaranteed passed on to your next and next and next So again, like, I get where you're coming from. I'm not trying to say you shouldn't feel validated in those feelings but at the same time, you. It's, it's silly to put the entire blame on yourself. Second, This sounds rude I promise I'm not trying to say there's nothing you can do about it now they're already here they're already living their life. And the most you can do is help them feel loved and then participate in my own research. And third thing that I wanted to say, even though you said not to say it. If it's so be that your grandchildren grow up to have my Loma. I'm pretty sure we will have a cure by then, with the amazing research that's being done with the crazy passionate people in the field. If not a cure, even better treatments than there are today which we know are getting better and better and better and more effective and more effective and more effective. It's easy for me to say I don't have my Loma, I'm 27, but I talked to my Loma specialist, every single day. And they have hope, so I share hope. Do you know what I mean, Jeff, do you want to say anything, so you have your hand up. I would only pass on Steve that try not to think of this as passing it down to your, to your kids or your, or your grandkids but now's the opportunity to pass on to the chance to find out early. If they have it or not. So this promise study as scary as it might be to find out that they've got them Gus. It's better to find out early than to find out too late, like we all did. So, again, think of it as not passing it on but now you've got an opportunity to help cure them. Love that. Thank you, Mary, do you want to share something. Yes, thank you. Hold on the dog. By the way, I just wanted to say that my family has diabetes. And that that that knowledge is power to me. So throughout my life, I've always checked for diabetes and been conscious of that. So knowing that I did a, I went into ancestry.com and I did a general, genealogical breakdown of my life and my family. And I found that many, many relatives have passed on mostly men of hematological cancers. So it all connected for me it all made sense. So I'm not presenting this to my sons as you better get this done, you're going to die. No, no, it's like, make it part of your routine yearly checkups. And just, it's that simple. If only it were that simple right so my son went to his doctor and he said, there's no proof that it's a genetic cancer so your insurance won't pay for it. That's another that's another question, isn't it. So my answer to this is knowledge is power. As much as we overuse that phrase, we need to make sure that our tool belt is loaded with as much information as possible. And, yay, I'm so excited my sons will be able to test for this. And now I didn't even think about my brothers. I love them don't get me wrong, but I didn't even think to include them. So thank you. This is a. Thanks Audrey this is a great presentation. I hope that conscious somewhat Steve will never become really. Thank you. Thank you. Never never never never. Wonderful. George I do see your question here I think that question is a good one, but for my own specialists. I don't. And it's probably for a different session as well regarding when it's a good time to stop maintenance therapy. Once you've tested for MRT negativity. Stay tuned we're going to be continuing to talk about minimal residual disease in our, in our upcoming And then just another plug for consideration of mass spectrometry in the P crowd. So, just thank you so much to Marjorie Maya and Erica for coming here today for presenting. It's been a really productive session. I'm feeling really excited about these studies and just the future of my Loma thanks to these studies and other conditions as well as we saw this That awesome word that I always feel cool saying because it's like a big word. Anyway, we are going to finish up. If there's any other unanswered questions, make sure to pop them in the chat. I'll look one more time before we close out the session today but thank you thank you for coming. We're going to be talking about moving forward after COVID-19. Now I say after because COVID-19 is a very important one. So, I'm going to be talking about moving forward after COVID-19. And we're going to be talking about moving forward after COVID-19. Now I say after because obviously there's very, there's still a risk of COVID-19. Are we in it? Are we out of it? Kind of unclear, but it seems that the world as a whole, America, United States seems to be moving on. and how can we as an immunocompromised community find balance in safety and sanity. So I want this to be a group discussion. I want you to be thinking about what's worked for you, even what your fears are. I'm going to have a couple people come and share their experiences, their advice, different resources that has helped them. And we'll just be kind of talking about as a group, no right or wrong answers, but validating each other's feelings that it's stressful to be in the MyLemma community right now. And how can we again find balance in safety and sanity. Another plug for our Northeast MyLemma Moves Challenge. So if you haven't downloaded the app, there's still time to join us, whether you have an Android, a Google Pixel phone, or an iPhone or any other kind of phone, you can download the Health Tree Moves fitness app, and then track your movement. It doesn't even have to be exercise. It can be gardening. It can be pushing your granddaughter on her bike. Just little things like that. If you're out moving, that counts as minutes. And if you track your minutes, you help us get to the goal. If you get to the goal, you qualify for prizes with us, Amazon gift cards, we're doing a drawing for an Apple watch, we're getting merch that's exciting. I love it. Again, it's keeping me accountable. Love getting to know you guys a little bit more on the app and connecting. And again, it's not too late to join. So make sure to download Health Tree Moves app. It's just called Health Tree Moves. I said fitness because I wanted to give you an idea of what it is. The app is just called Health Tree Moves. And then it's called the Northeast Myeloma Community Challenge. So join us. You might be interested in other upcoming events. On the 14th, we're going to be talking about fish and chromosomes. So that fish tests, not like salmon, but like fish, tests and chromosomes, risk status in multiple myeloma. What does it even mean? You hear us talk about it a lot. Translocations, deletions, et cetera. And this is an excellent presentation that will kind of go into the nitty gritty of all of that. It will not be recorded. So make sure that if you want to attend, you attend live. There will be resources sent out for those that can't make it live, however. On the 15th is our Mountain West Myeloma chapter. We're going to be talking about equity, diversity and inclusion for myeloma at the Huntsman Cancer Institute. That's at 1 p.m. Mountain. And then on the 16th, we've rescheduled the Myeloma financial chapter. It's going to be the medical appeals insurance workshop for myeloma patients and caregivers. Several, like I'm making up the statistic, but 60% or something crazy like that of medical bills have errors in them. And we can save financially if we recognize those errors and fight them. So this workshop I'm really excited about. The link to sign up for these events and even more events I did not mention is found at the bottom of the slide and will be sent out in the follow up email. One of the questions was when was the PROMISE study started? So Maya, I'm not sure. Yes. Yeah. We officially launched in 2018 and we started screening participants in 2019. Awesome. And then the P crowd study, Erica, was earlier than that, right? Yes. The P crowd study started in 2014. Okay. Awesome. And we're only going from here. I'm so excited. I also saw a question in the chat about sharing information with insurance companies. So I just wanted to clarify that we do not share any information with doctors or insurance companies without the, well, we'd never talked to an insurance company, but we don't share information with any physicians or start a referral process without the patient requesting that first. Awesome. Thank you so much. Cause I know privacy is super, super important. So thank you. All right. We'll finish up just thanking our sponsors, Bristol Myers Squibb, GSK, Genentech, Janssen Oncology, and AbbVie. And a big thank you to each of you for our Dana Farber team, for our myeloma patients and caregivers that joined us today. Thank you for helping us build the strong Northeast myeloma community. I really appreciate you. Hopefully you all have a rest of good rest of your evening and remember sign up, tell your family and friends and post it in your social media groups. We want to let people know about this and further myeloma research. Thanks y'all. Take care. Thank you. Bye. Thank you.