By Jennifer Ahlstrom | Posted - Apr 22nd, 2020

 

 

 

 

Full Show: COVID-19 Update with Ola Landgren, MD, PhD, MSKCC

C. Ola Landgren, MD, PhD
Memorial Sloan Kettering Cancer Center 
Interview Date: April 13, 2020

Thanks to our episode sponsor

Summary

Myeloma patients want to know how to manage their care, visits and tests during the COVID-19 crisis. Dr. Landgren has been treating myeloma patients in the midst of this intense situation and shares how he is caring for his myeloma patients at this time. He notes an incredible effort that includes telemedicine, social distancing and protecting the patient at every touch (or non-touch point). Treatments are remaining steady, although things like stem cell transplant are being delayed. Progress is continuing on upcoming approvals by the FDA, which is heartening news for myeloma patients. Learn more in this key update with Dr. Landgren. 

Dr. Landgren on Myeloma Crowd Radio

 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, Takeda Oncology, for their support of Myeloma Crowd Radio and this particular show.

Now with the COVID-19 pandemic ruling our lives these days, I thought it was best if we stay in tune with expert opinion about the latest findings on the coronavirus and how myeloma patients should be reacting.

In this show, Dr. Ola Landgren of Memorial Sloan Kettering Cancer Center will be sharing how he has treated myeloma patients who are both COVID-19 positive and negative and what he's finding in New York City, one of the key COVID-19 hotspots. The requirements for his and other New York City facilities has been extraordinary, and there's much to be learned from the head of the Myeloma Center. It's such an esteemed institution.

Dr. Landgren, welcome to the program.

Dr. Landgren: Thank you very much for having me, Jenny. It's really a great honor and a pleasure being on your show. Thank you.

Jenny: And it's been far too long since we've had you on, so we're excited to have you. And before we get started, let me introduce you.

Dr. C, Ola Landgren is Chief of the Myeloma Service and attending physician at Memorial Sloan Kettering Cancer Center in New York City. Dr. Landgren is also Professor of Medicine at Weill Cornell Medical College in New York. Dr. Landgren is a member of the International Myeloma Working Group, a board member NCI representative on the Myeloma Steering Committee, a lead for the Hematologic Malignancies Program of the NIH Clinical investigations branch, a member of the Association of Medical Research Charities Peer Review, a panel member of Myeloma UK, board member of the CCR Clinical Research Strategies Planning Committee, and Chairman of the Scientific Review Committee for Clinical Trial Development at the NIH.

Dr. Landgren was formerly with the NIH prior to his Memorial Sloan Kettering appointment and is originally from Sweden. Dr. Landgren performs significant research in myeloma on a variety of topics, including immunotherapy, MRD testing, precursor conditions, and the development of many, many new clinical trials to advance the field for myeloma patients. He's also the recipient of multiple grant awards, including a prestigious R01 grant.

So Dr. Landgren, we have a lot to talk about. This COVID-19 thing has really rocked everybody's world. Maybe you want to share the experience that you've had because now you've been in this hot spot treating many patients, a lot of whom are COVID positive that have myeloma. Do you just want to share what you've learned?

Dr. Landgren: Yes, I'm happy to share with you. Let's start with some of the high points. So I believe New York State, when we do this recording, the 13th of April of 2020, has almost 200,000 cases with COVID. I think, unfortunately, there are more than 10,000 deaths in the state. Many of these cases are here in the city, and it's really very sad. I think back when did we really start to realize the magnitude of this problem here in New York City? I think we started realizing this, really talking about it among the physicians for real probably, say, one and a half or two months ago. We started realizing that this is probably going to come here. I think we kind of all knew that earlier in the year, but I think there was like some kind of delayed processing. Maybe it won't come here, but about two months ago, people started talking that this is really going to come here.

And then about a month ago or so, we formally made decisions to start reprogramming our entire institution. I was assigned about three and a half weeks ago as one of the leaders for the hematology COVID team, and another doctor was assigned being the solid tumor COVID team lead, and a third doctor was assigned as the transplant COVID team lead. This is how we started off for the in-patient service. For the outpatient service, for every single disease area that we cover, we are a cancer center that only do cancer. We are one of the two largest cancer centers in the United States. So MD Anderson and Sloan Kettering are the number one. Number two, whoever is one and two, leading cancer centers with only focus on cancer.

So we started reprogramming all the outpatient care to telemedicine. So what we have done during this week is that we have ramped up the inpatient service to take patients, in my case, patients who came in with any blood disorder with COVID positivity. And as we have moved forward in this time window -- I'm outlining here -- we have been forced to open up additional COVID team services, so we have more than the one that we started off with. We now have four of them in the hospital, and we have more than that for solid tumors. The outpatient care has been converted, more or less, to telemedicine. We have done a lot of adjustments for the treatments, for the management of the different diseases. So for myeloma, including that, we have done very many changes. I'm happy to talk about exactly what we have done and share our experience.

Jenny: Yes, that would be great. Let's talk about that now while we're thinking about it.

Dr. Landgren: So for myeloma, we started thinking through every single indication that we have patients in early on. So when we turned all outpatient program to telemedicine, more or less, we made decisions that we will continue to use combination therapies. We continue to use intravenous and subcutaneous drugs. We continue to use oral drugs. We had as a plan that we will try to minimize the encounters for the individual patient. So could patient come once a week instead of twice a week for infusions, that will be one encounter less to try to stay away from the virus. If patient could be treated once a month instead of twice a month, for example, same thing. For patients on oral regimens, instead of doing lab tests once a month, if that's what we used to do before COVID-19, we try to string that out to have, say, three or so months intervals.

So these are very simple principles on how we try to reduce the number of the visits for patients. When we looked at the overall program, for example, newly diagnosed patients, we had a lot of discussions and we were very quickly trying to come up with practical guidelines internally. All the faculty were behind these. We made immediately the decision to stay away from all the stem cell collection, to stay away from all bone marrow transplants. We did not want to expose people to extended immunosuppression because that could impose a major risk to these patients, of course. That being said, for newly diagnosed patients with younger myeloma, obviously, their myeloma is a real threat. So you couldn't just ignore the disease and just focus on staying away from the virus. You still have to move forward with that.

So we instituted very hands-on procedures for how to have a very transparent discussion on what the goal of care. So having a discussion with each and every patient between the doctor and the patient, what's the goal of the care? If you want to go after myeloma, there will be some risks with the virus, but the risks have to be handled in balance with the risk of the myeloma. So I think we have continued to give high-efficacy therapy for the majority of our newly diagnosed patients. Most patients are motivated to do that. We set out to do that. We have converted it to once-a-week dosing across the board. We have the bundle, the blood tests, with the visits for infusions. So for example, if a patient comes for an infusion, day 1, day 8, day 15, once a week for three weeks on, that third week, the third dose, that's the day we would draw the myeloma labs. There would not be any extra visit to come to the labs. It would be that same time. And then we would use those results and make decisions for next cycle.

We have discussed and argued. We were having an agreement early on that using good drugs up front would be also a way to hold off with the stem cell collection for transplant. So we have given, which is part of our standard default here in New York, that we have used a once-a-week KRd regimen for most of our newly diagnosed patients. For patients that are weaker, who cannot tolerate these therapies, we have used once a week VRd regimen. For patients who are not candidates with these therapies, who are non-transplant patients in the future, we have done either DRd with daratumumab-Rev-dex, or we have done just oral Rev-dex, and in some rare instances, we have done ixazomib-Rev-dex.

We have been holding off bone marrows. So normally, we would do six cycles of therapy and then determine the status. Right now, we have given these newly diagnosed patients six cycles as the default. So that will be 18 infusions. And then we have the check the blood work. We have been in close contact with the patient for telemedicine. And instead of doing a bone marrow to confirm MRD status, we have looked to see if the proteins could go down to zero. Then we have had a conversation again with the patient and then as a default, gone to maintenance, 10 milligrams Revlimid three weeks on, one week off.

For patients who are relapsed, we also have been holding off on the regimens that usually are given twice a week. We have given them once a week. If we have given Velcade based or carfilzomib based therapies, it has across the board been once a week. We have used the proteasome inhibitors with the antibody, Darzalex. We have used it in combination with both Pomalyst and Revlimid.

It has gone actually very well. If I go look across the board, these therapies have worked out very well. We have tried to stay away from old-school chemotherapy, not only the transplant with melphalan, but also like D-PACE and VTD-PACE for multiple reasons. One is that it can, of course, induce sustained immunosuppression for the individual patient, but also most of these regimens many times result in need for blood and platelet transfusion. So there's a shortage of blood and platelet transfusions in the United States at this time, so we have been very cognizant of that. So if we could use outpatient regimens, we have done that by default.

So these are like some very basic principles, but I think what I'm sharing with you here between the lines is that the same drugs that we use before the virus we still use. It works very well. We have not really seen a high rate of COVID in our patients. We have not. For a center of our size, in 2019, we have more than 10,000 myeloma visits at Sloan Kettering, more than 10,000 visits. At this time, I do think we have less than 30, 40 patients that have been positive with the virus, which is remarkable.

Jenny: Yes, totally.

Dr. Landgren: I cannot say that the outcome of our patients with myeloma on a statistical note is drastically different. I can just not give that message right now. I know there are a lot of other groups around the world. I follow the news. I follow the internet. I talk to a lot of friends and colleagues around the world. I know there are cases in Europe, for example, where the situation is quite different, but this is what we see here in the city of New York.

Jenny: Well, I think that's pretty amazing news considering how concentrated it's been in New York, and there's been such an amazing effort by everyone in healthcare in New York. It's truly stunning what you all have been able to accomplish. So I congratulate you for doing that.

Let's talk about these 30 to 40 patients that you've seen. And sometimes when you hear about comorbidity status for COVID-19, you hear about prior lung issues, you hear about prior diabetes, you hear about prior heart conditions. Are you seeing that independently as being consistent with what everybody else is seeing, or is myeloma adding another layer to that risk? 

Dr. Landgren: First of all, I would like to say that today is April 13, 2020, so it's a moving target, that we may see other things as we go forward. So everything is currently probably subject to change as needed here. But at the current time, if I look through what we have seen and I mentioned here, I've been responsible for the first launching of a COVID positive in service at Sloan Kettering and now we have additional of them. So we have four active service ongoing, but we were there from the very beginning, and we have seen patients coming to our service both in myeloma, with leukemia and lymphoma. We have some broader understanding of all the blood disorders in the setting of COVID, and also we know for all our patients that we treat for myeloma that not COVID positive, which obviously is the majority of our patients as I mentioned.

I don't really have a feeling that the myeloma patients stick out. They do not from what we see. There is no signal from what we have right now that there should be some obvious other risk factor. I think there are a lot of things that I've been thinking about that I don't have evidence to really prove. So one thing I think is potentially an explanation why we have a better outcome than I've seen in other parts of the world. I think we have been very, very, very cautious. We have really tried to have our patients staying at home. We have not had them coming in for unnecessary visits. We switched the program to telemedicine in 48 hours from the decision was made. We all had telemedicine

Sloan Kettering has 20,000 employees. In 48 hours, we all had access, all the doctors had access. The hospital made a decision right away. They implemented upfront testing for all the patients in the emergency rooms. The patients came to our emergency room before they move anywhere further into the hospital. They were tested, and they were assumed to be positive if they had any of the suspected symptoms until otherwise proven. So if they were found to be positive, they went right to a COVID-positive floor, and that floor was only staffed by people who are handling these patients. So there was no mixing, no mixing by invitations, no mixing with the doctors and nurses and mid-level providers. So very, very clear lines on how these things will happen. And also, when patients have been sent home, we very early on established an office in the hospital staffed 24/7 where patients were discharged with COVID diagnosis are being called every day by nurses that are stationed there, deployed into this office, to keep track and make sure that everyone is safe and doing fine.

So I think the front end, the back end, and the whole process in the middle has been rolled out very fast. And I think that has been one of the success factors. They really took great steps right away. It was like no wavering back and forth, just roll out right away,

Jenny: Well, the management has been totally stunning. I mean, it's unbelievable because you could have cycled for three weeks working through red tape or whatever to get some of those programs in place, and that would have impacted people's lives. So that's truly amazing.

Dr. Landgren: I do think that the rapidity of the response within the organization and the kind of thoughtfulness to look for all the things that needed to be taken care of and enact very fast was very impressive. So I mentioned when we started off three and a half weeks ago, we had never done this before, we were wondering, do we really have to have doctors and nurses and MPs going in to see the patients and examine them? That doesn't sound right. So of course, we didn't want to do it that way.

So within this 48-hour window, the hospital implemented iPads, so the team could round and have iPads and talk to the patient who had his or her iPad. They had iPads everywhere. You could talk to the patients from the hallway. You could still see each other. If someone had to go in, you had to go in. But if you don't have to, that's one less exposure. And all these different measures trying to avoid unnecessary encounters have been rolled out.

So I think in every kind of little aspect, there have been measures of caution and it happened very, very fast. It was consistent throughout the whole organization. I think that's important, the reason why the outcome looks the way it does.

Jenny: Amazing. Well, let's talk a little bit about actual treatments. So you're moving to weekly administrations. You're moving to oral. You're delaying stem cell transplant. Now that you're doing that or have done that for several weeks, what patterns are you seeing? Do you see any myeloma therapies making things worse, or do you see any myeloma therapies making things better?

Dr. Landgren: No, I really don't see any changes from what I'm used to. Being in this organization with very high volume, I think we use, obviously, all the different drugs every week all the time. Now, going to weekly dosing, going a little bit more towards oral and completely holding off both collection of stem cells and giving transplant, there was a little bit less of the aggressiveness, but I think one month into the game, it looks very similar. There was no drug that seems to be more dangerous on the other. There is no drug that I can tell you is a better drug.

So we use all the drugs. We use the three-drug combinations. For up front, we use PI (proteasome inhibitor) IMiD (immunomodulator) and steroids. We use antibody (like daratumumab) PI,  steroid. We use Revlimid maintenance. All these work very, very well. We are trying to, as I said repeatedly, we are trying to minimize the number of encounters. Patients have also masks when they come in. All the staff have masks. Even when a patient comes in to get chemotherapy, we have screens like iPad-like screen in the room. So if I have a patient tomorrow or throughout the week, I can see the patient from the screen, but I don't have to go there and be interacting face to face with the patient. We still see each other through the screen, but we don't have to have that face to face encounter.

Jenny: So important. Let me ask some specific questions too about the steroids. Have you seen any difference between patients? Have you lowered doses on steroids? Do you see any more susceptibility to COVID-19 if a patient is on higher dose of steroids? Let's just talk about different drug classes.

Dr. Landgren: We have not seen any increased risks for patients with 20 or 40 milligrams of dexamethasone having any different factors for COVID. In general, we try to reduce dexamethasone. We liberally decreased to 20 milligram in a patient who cannot tolerate 40 milligram. We don't see any prognostic difference or benefit with higher dose. If a patient cannot tolerate 20, we would liberally use four-milligram tablets, go down to 12 milligrams on a weekly basis, but that's more for toxicity in general, but there is no pattern for the virus as far as we have seen.

Jenny: Okay, so you're not making any changes there. And what about immunomodulators like Revlimid or a Pomalyst? Patients who are in the immunosuppressed zone having more trouble than others, or is it almost protective if it's at a lower dose and they're using it as maintenance? What are you seeing with that?

Dr. Landgren: So just looking at high numbers of patients that we treat every day, there is no pattern in our database that the image imposes a higher risk for COVID-19. We don't have that information. Looking at the mechanism of action, the immunomodulatory drugs, for the most part, we don't really understand how they really work. We know that it blocks myeloma cells the IRF4, the NF-kappa B pathway, so that's in the tumor cell, but also we know from preclinical and from clinical translational studies also that there's activation of T and natural killer cells or NK cells. So you probably have an activation on the cellular immune system with more of the T and NK cells and more active T and NK cells.

So if anything, maybe the immune system is actually a little bit more active, that could help. But we also know in some patients, these drugs, in parallel with what I just said, they are a little bit bone marrow toxic, so some people tolerate them more than others. So some patients are a little bit susceptible. You can see drops, for example, in the neutrophils, and that would impose a slightly higher risk or typically a bacterial infection. And you obviously don't want to expose an individual for one infection that's unnecessary, and that could then lead to a coinfection with the virus, for example

So I think we pay close attention. We always do that. We follow very carefully the white cell count and the neutrophil counts. We don't like the absolute neutrophil count to go under 1.0 for sure. We will adjust the dosing. These are relatively rare to see. They are relatively rare to see, but there are some people that don't tolerate them so well. With 10 milligram Revlimid, I would say that the majority of people tolerate that very well from the standpoint of these aspects I'm outlining.

When it comes to the other side to the immune system, you have the humoral immune systems. You have the cellular immune system, and you have the humoral immune system. So these are the two parts of the human immune system. So the cellular immune system is activated the T and the NK cells through the immunomodulatory drugs. If you have suppression, a little bit of the marrow overall beyond suppression of the neutrophil cells, you potentially could also have a bit suppression, say, of the humoral side with the IgD. You could see also IgD suppression in other classes of drugs very commonly with daratumumab, but there is redundancy in the immune system, so you have two major sides. So I think if one is lower and the other one is higher, clinically it doesn't seem to make a big difference really. And we do not see increased risk of COVID-19 as I just said from what we have seen.

Jenny:  Yea, because I know daratumumab can affect NK cells, right?

Dr. Landgren: It can also suppress the humoral immune system with drops of IgD. So that would be the other side. But they could also impact the NK cells as well. Correct.

Jenny: Interesting. So you're not making any dosing changes necessarily.

Dr. Landgren: No.

Jenny: I know some people were thinking about, are you extending daratumumab doses? Like, let's say, you come in twice a month or something, are you extending that to once a month, or are you just maintaining?

Dr. Landgren: We are not doing any adjustments. There is no data to guide for that. So the only things we are doing is to be very practical, to minimize the exposure, meaning that every exposure could potentially result that the patient could contract the virus. So the fewer of those, the statistical risk goes down. That's the only principle we have.

So we actually have calls early in the morning. So we talk about a lot of the research and practical things. We had a call this morning at eight o'clock with the leadership. And I think we concluded that there are very many guidelines out there, but none of them are really based on data. So our take is that for the use of drugs to go after the virus will try to improve patient's outcome who have the virus, that clinical trials are preferred over empirical utility. There is no data to prove that any of these therapies that are proposed from the internet and elsewhere really work. So trials we prefer over empirical.

I think there are more than 100 so-called guidelines, and none of them are based on high-number data. So they are written by people who just like to write guidelines, and there are a lot of those people out there. Some people have made a career writing guidelines without any data. We're not going to contribute to that

Jenny: Yes, you want to see the real numbers behind it. Well, what you're seeing so far is incredibly hopeful. I think for myeloma patients who are really concerned that being on therapy right now, this makes me feel like breathing a sigh of relief because if I'm on a current therapy, I can stay in my current therapy. I don't have to worry about myeloma growing out of control because I'm not getting treatment. So what you're saying is very relieving, I think, for patients.

For the patients that you've treated that are COVID positive, I know now clinical trials are open to test all these different types of things like tocilizumab or different antivirals. I know Selinexor just opened a COVID-19 study because they found it was partially antiviral and could suppress some of the cytokine storm. Do you want to talk about any particular therapies that you've given to COVID-positive patients that have myeloma? You mentioned using them in a clinical trial, so I don't really understand the trial landscape for those types of studies. Maybe you want to review what's happening there.

Dr. Landgren: Yes. I think it's important to emphasize right now that there is not yet any treatment for people who have COVID-19 that has been proven to be the breakthrough regimen that should be given that could either prevent or alleviate symptoms or shorten the health care duration. None of those endpoints have been proven for any drug at this time, unfortunately. We are hoping there could be a vaccine that could prevent the virus. We're hoping there could be treatment that could help and cool off the infection in those patients, the small proportion of patients who get very sick from the virus.

There are a lot of drugs that have been tested, and I think the first ones have been everywhere on the internet and in different other settings, the hydroxychloroquine with and without azithromycin. At this point, I would say we don't know. There are attempts trying to use steroids for patients who have more severe impact on the virus to see that will cool off the immune reaction. Again, we don't know. There are IL-6 inhibitors, we don't know. You mentioned Selinexor, we don't know. There are proteasome inhibitors, we don't know. There is also serum from people who have contracted the infection and collecting the serum and see if that could be given as a medicine for people with the infection and see if that could help. We don't know.

So there are a lot of things we don't know. So I think what we really need right now is to do these studies, to do them fast and figure out what really works. Right now it's a lot of anecdotal, empirical use. But people, of course, trust that when you're treating, when you're doctor, you treat the patient who is very sick, of course, it's very, very stressful and you try to do your best. So I'm not saying that don't use clinical best judgment. That's the best we can do in difficult situations. But I think to use that and say that this is not what everyone else should do, that's not right because we're still trying to figure out what the right thing is to do in kind of broader strokes.

Jenny: So are there clinical trials that are open at Memorial Sloan Kettering for some of these COVID treatments.

Dr. Landgren: We do have some of these drugs I mentioned in trial. And this is true across the board in the city here and across the United States and internationally as well.

Jenny: Right. We were talking about earlier in terms of limiting contact. Has any facility, including yours, been able to do any kind of home infusions? I know that that would change a lot with insurance coverage, and you'd have to create new teams of people to go do home infusions, but has that ever been considered?

Dr. Landgren:  I cannot speak for other institutions. I don't know exactly what they have done. And if there are already programs going or not, that I do not know. At our institution, we do not have that. What we have done is to have fewer visits as I mentioned multiple times, try to minimize all the invasive visits, no blood test every week or every month, do it less often if you can, minimize all the biopsies and things like that. So just fewer visits. All the staff have N95 masks. All the patients have masks when they come. We have very careful steps on people entering the buildings, they have to answer certain questions, whether they had any symptoms. We're trying to be just very, very, very careful. This includes patients and staff.  

Jenny: Well, it sounds like it's working. And you mentioned earlier about MRD testing, and I would assume that's something that you're going to space out a little bit further because of the bone marrow, or other reasons that you need to get a bone marrow biopsy might be spaced out a little more.

Dr. Landgren: Correct. So the bone marrow-based assays right now, we have the ability to do them. We can do them. We can do anything that we normally do, but we are holding off on things that really we don't have to do. So imaging and bone marrow biopsies, unless they're critical, we would not do. Therefore, we don't do the MRD testing there. We have filed in New York State, there is the so-called mass spec, the MALDI testing. So there are two platforms out there. There is one platform that's the one that I think is going to be the one that's going to go forward around the world developed by the Binding Site in the UK. We have that set up. We have it fully operational. We're waiting for New York State to sign off on it.

Mayo Clinic has developed their own local assay. They are also, I think, running that right now. We have the Binding Site assay. As soon as that gets signed off, we will start using that as the standard of care. So any person who do bloodwork at Sloan Kettering with a diagnosis on myeloma, that has to be done as a default. It takes 10 microliters of serum.

We are also trying to develop our -- we just published, it came out online last week, our ImmunoPET imaging where we have radiolabeled antibodies for PET CT. So we now have antibodies that we can inject less than 1% of a single dose of daratumumab. So very small volumes. And we can then see where the antibodies land, and we can see if there is residual disease. These are things we're trying to develop.

Jenny: Wow.

Dr. Landgren: We just published it. It came out in the Journal of Radiology. We just got another R01 grant for the extension of a new expansion phase for a large phase two study where we're going to compare bone marrow base with blood base with this new immunotest. It looks really, really promising. You can take pictures and see if there are residual myeloma cells.

Jenny: Wow, amazing.

Dr. Landgren: I think that imaging and the bone marrow tests are in development. The bloodwork is in development. So today is April 13th, we hold off on unnecessary things, but as soon as New York State signs off on the blood test, that will be implemented day one. When the COVID has cooled off, we will move forward with the bone marrow and the new immunotest.

Jenny: Well, we'll make sure to cover that on the Myeloma Crowd site to give patients a little more detail about what that is. And that's exciting, very exciting. A few more questions. So what's the status of current clinical trials? I know we're awaiting several approvals this year like the CAR T for bb2121 and the GSK antibody-drug conjugate and others. What's happening on those that look like they're about to be approved, and then what's happening on other clinical trials in myeloma in general?

Dr. Landgren: From all I know, the FDA is moving very fast forward. I do think they do a fantastic job. They are reviewing all the data they have been provided. I work with them quite a lot on different types of projects. We had a phone call just the other week, and they were working full speed on all these things we are collaborating on. I assume that all the data they have received from these drugs are expected to be approved soon. I think that is probably on track. I think for the trials that are still collecting data that then we'll go to the FDA, I would project there could be some unfortunate delays because the data may not be ready to be submitted. There could be some glitches, or there could be need for some cleanup or things like that.

So I think that probably could happen for some trials, but many of them are already completed for the purpose of collection of data. For example, subcutaneous daratumumab, it's with the FDA. I think they hopefully will sign off within a month or two months or so from now will be my guesstimate. We will see what the FDA does. I think for trials that are ongoing, if I look at our institution, all the trials are our company sponsored so unless the companies stop them, we still will have them open. But for myeloma, we are only offering patients we enroll if we don't think there is another good or better option. So if it's something that the patient is considering but there could be another option given the COVID setting, we will probably hold back till it cools off a little bit just for safety and for general kind of management purposes. But we still have them open.

As soon as we will reopen the city and we had again this morning this eight o'clock call, we talked about what the next step for opening up New York City, opening up Sloan Kettering and all the other institutions, when we start rolling back and we want to roll out, one of the top items we've discussed here is like to roll out our clinical trials. And we also concluded today actually that we have learned to run a lot of the trials through telemedicine. I think the research could come out stronger.

Patients probably could be monitored via telemedicine, and I think we probably could have an outreach that could even go outside of New York City. We could probably go across the United States for research monitoring of patients here. So when we are through this, I think we'll come back stronger with resource. That's what I feel right now.

Jenny: Well, you really have to look at how you change your approach, and sometimes those are blessings. They can turn out to be a blessing.

Let me also ask you about the portable tests. So a lot of the portable tests are coming out. There are the blood prick tests, and I think patients might have a lot of questions about these. Maybe you want to describe what they are. And then if patients can get access to them, should they use them?

Dr. Landgren: So first of all, I want to make sure when it comes to that particular question that I'm not a test expert, and I have no personal interest in any test or no conflict of interest. I'm just a regular doctor here. I'm trying to help patients. So when I look at all these things, I wonder, how can we test people as fast as possible in as optimal way as possible? I think if we have a reliable test, I think that is probably more important than just having access to a test. The reason I think that's important is because if you do some back of the envelope math, say that the infection happens in -- just make up a number -- say 5% of the population. If the test is only right in say 95% of the cases, which you could think it's a pretty good number, that means that it will be 5% to those positive people that will be told that they never had the infection. You could argue that that's not maybe as bad of a deal because if you're positive, you think you're immune and that would be 5% that when we told that they didn't have it, then they would feel have to be cautious.

I think the real drawback is the group of people that actually didn't have the infections or these tests or giving false positive tests. So again, only 5% have actually had the infection. That is the number. I'm not saying that is the number, but let's make that assumption. That means that 95% didn’t have it. That's the majority of people. So if there are a lot of false positives in that group, that will be people with such a test that are being told, oh, you had the infection, and they would think, oh, I'm immune and that's a false positive test.

So in the setting of a low prevalence, that will be more people given a false positive. If the infection is at a much higher prevalence, if say 50% of people had it, it's still a high proportion of people that will be given a false positive test. If the prevalence is 90%, which I don't think it is, but let's say if it were to be that, then the false positive group would be smaller.

So these are just like simple examples of how different tests could impact people's kind of perception whether they are immune or not. I do think we need to have good tests with very high accuracy. We certainly need to test people. Ideally, we test the whole population to see who actually had it, but we do not know how to maneuver where we are until the test or better. I think it's a problem that we will tell people that they had infection although it's false positive.

Jenny: So these little tests look like they have this IgM line, which means you may be having an active infection. You need to go get further testing. And IgG line that shows that you may have had it already, so you have an antibody against it and then at this control line that shows you haven't had anything. So even if somebody says, I have had it, but they might still be contagious, right?

Dr. Landgren: Well, I think if you if you have these tests that show antibodies, because that some of these tests are not specific for COVID-19, they could show up positive if you had another infection. There are a lot of other coronaviruses that are around for years. So some of these tests would be positive if you had such a coronavirus. So that's an example that fits with what I was just trying to say, that if a person wants to do this test and this shows up positive, he or she would think, oh, I had a virus. I'm safe. I mean, that's a false positive signal here.

I can tell you at our institution, we have currently looked through several of these tests. We have done head-to-head comparisons and we have been holding off. We don't really know what to make out of it. So we are still basing all our monitoring on the sequencing-based tests that have their own drawbacks, so they require presence of the virus in real time. So you won't be able to see if someone had it before. So the sequencing based are only possible to do in a person who carries the virus.

We would ideally like to have a serologic test with antibodies, but right now, I think there's still work to be done to identify the optimal antibody test. There are maybe tests that I'm not aware of, but we are still looking.

Jenny: Right. So it may give you a piece of information, but we don't know fully until things get a little further along. But the test can be used reliably and all that. That's amazing. There's a lot that we don't know, isn't there?

Dr. Landgren: There's certainly a lot we don't know. When it comes to the testing, so what we started doing, we started this Sunday night. The decision was made that we now have so high capacity of internal testing that we will now start testing the entire hospital. So we tested until Saturday. We tested anyone who had any sign, including both staff personnel of any kind and patients who came into the hospital or developed symptoms in the hospital. But just this Sunday night, the decision was made to test every individual every 72 hours. So now we are testing every three days. Everyone is being tested in order to see what is actually the true prevalence in people who don't have any symptoms and what is also the incidence, if there is an increase in the uptake. So I don't know the answer to this yet, but this is something that we had just started.  

Onto caller questions. I know one of these questions is from Gary. He emailed the question prior. So while we're waiting for the software to work, I'm going to ask his question for him if that's okay. So he said he understood that COVID-19 blood tests are now 40% New York covered blood test for now 40% positive. So what is that percentage in myeloma? And we talked about the outcome a little bit already. And he also talked about -- yeah, that was that -- well, the European versus the American experience, I guess, was part of his question

Dr. Landgren: So I don't know -- I have not seen the number. So I don't know what the true prevalence is. I actually saw online here very recently they have done a population screening in Iceland. Every place is different, obviously. But they have screened 5,500 individuals, and they found that in the population screening, they found about 1% of the people to have it. And they also in Iceland have screened almost 5,000 people in multiple high-risk individuals, and I'm not sure exactly how they define that. I would assume it's people who work in healthcare or things like that, and the rate there was 11.6%.

We have tested our people who have worked in our hospital, and I think the numbers are being more in the range of about five or so percent. The majority of our people who have been tested now have recovered and come back to work, tested negative. So I don't know. It seems to me that if the ratio between symptomatic and asymptomatic could even be one to 10, say that one person is symptomatic and the other nine are asymptomatic, for every 10 people who actually have the virus, maybe a 5% prevalence in a high-risk population, maybe that is equal to actually a true 50% prevalence of people in that group maybe. I don't know. It seems very high than the 40% of New York should have it. So I don’t know. I'm questioning what is really the true prevalence? I would say that we actually don't know. So because we don't know, we cannot answer what prevalence is in myeloma. We don't know if it's higher or lower because we don't know what to compare with. All these questions that I don't have the answer to, there is no data guide at this time. We need more information.

What I do have the answer, that's what I started off saying here is that about a month into the game here with a lot of activity at our center, my interpretation is that myeloma patients do not have in New York at our institution, Sloan Kettering, do not have a different prognosis. The patients we have seen who have come in with the virus, many of those patients have been there for 3, 4, 5 days and been discharged. That's good news.

Jenny: Great news. It's fantastic.

Dr. Landgren: There are some, unfortunately, who have come in and being sicker, but that's true for the general population and that's true for other diseases as well. But what I can say is that it is not the majority or high number of the myeloma patients who have had a lateral -- the majority of them have been similar to what we have seen in the general population.

Jenny: Well, let me ask one more question because my software seems like it's not working to allow caller questions. It's just keep cycling. So where do we go from here? What do you see happening from here? I know you're having these preparatory meetings in terms of how to open things back up. What can patients do that is the most effective thing to protect themselves in addition to what you've already mentioned? What can their family members do? And then where do we go from here in myeloma care?

Dr. Landgren: Well, I don't know if I have facts on top of what we have already discussed. I think my answer is to basically reiterate what I said. We don't just go back to normal tomorrow. I wish we could, but I think we have to be a little bit more cautious here. I think the next step based on what we know and what we have discussed here is to have some form of a plan going forward along the lines of opening up stepwise. So what we will do at our center, we will reopen for new visits and for patients who want to transfer care. For a while, we have been a little bit more cautious on that too. We didn't want to have people coming over and making existing patients sick, but we will start reopening that

We will also continue to open up more existing clinical trials that we have and start enrolling again because it's important that we move that forward. We will then continue to have more and more patients coming for second opinions again. We know that a lot of patients have been waiting and want to come, so we will start doing that. And we have developed a four-step model. So the four-step is to resume all the health and inpatient activities and also to start opening new clinical trials.

I wish I could tell you when the start date for the four-step is. I don't have that. But I can tell that you're about to roll out. Probably in the coming two weeks or so, I think we will start rolling out the first step. And then we will start seeing how things go and we monitor on an hourly basis all these things. If everything follows the plan, we will then go into the next step and then the next step and then the final step. If we see any signs of anything, we will put a break and we will reassess. So that's the best we can do for now. I think be patient. Wash your hands. Be careful. Don't do unnecessary things. If you come in for treatment, have masks. Try to minimize unnecessary things. There's no need for collection of stem cells for transplant. There is no need for biopsies or imaging unless it's really needed. Have fewer visits. That would be my advice. That's the recommendation for Sloan Kettering.

Jenny: Okay, great. Another question that was messaged to me is, are your COVID patients in active myeloma treatment? And are they newly diagnosed myeloma patients or relapsed refractory patients or both who have tested COVID positive? And are you doing the convalescent plasma trial?

Dr. Landgren: We have, as I mentioned, like, say, 30 or so patients in that range, so it's not very many. But out of those individuals, it would include people who are relatively recently newly diagnosed. We actually had one patient that transferred from one of the other hospitals who was newly diagnosed and came with kidney failure and myeloma. And we have had some patients who have a few cycles and then contracted the virus, but also patients who have relapsed refractory. So all the different spectrums. And yes, we do participate in this study where we are collecting serum from people who have had the infection.

Jenny: My last question is on telemedicine. I think you've seen something that we were talking about how this really changes things. You have to operate in a different way, and you're doing all this wonderful telemedicine. You want to continue that for clinical trials in the future. Some restrictions have been opened up about crossing state lines to be able to do that. Do you think that will continue in a status tool that you'll continue to use as things move forward, even post-COVID-19?

Dr. Landgren: I think this technology would allow all of these things to happen. I think it's a lot to do when it comes to legal and reimbursements and the insurance companies. Right now a lot of these things have been approved overnight because there are no other options. So I think patients will also have to put pressure on the different stakeholders here, together with the healthcare professionals. I think this is also a time where we actually can get things better. Access through telemedicine I think it's a fantastic addition to office visits. Office visits are great for very many things, but many things probably can be done through telemedicine.

So I look at this in a very positive way. I mentioned the research probably can benefit from it, but I think also standard of care for sure. I'm very optimistic and I think this is -- I think this terrible crisis, one thing, it will kind of give us, when everything is over, is that will give us a lot of new tools and new opportunities. I think we'll come out of it stronger with a lot of new positive ways to do things.

Jenny: Well, I totally agree and that's a great way to end the show. I think you can come through adversity stronger and smarter and doing things in new and different ways that you would have never considered before.

So Dr. Landgren, thank you so much for joining us and giving us this amazing update. It's really totally inspiring actually to know that as a myeloma patient, I'm not necessarily at a huge higher risk and that I can get my treatment and I can visit with my doctor. So this show is a lot of good news. And I think we've all needed a lot of good news, especially as we're stuck at home. So thank you for taking the time at such a busy time for you. And we just really appreciate you and all you're doing.

Dr. Landgren: Thank you very much for having me, and thank you for everything you do. We will get through this together. We will be stronger when we are through this.

Jenny: Well, thank you again and hang in there with all you have to do. So we thank Dr. Landgren. And thank you so much for calling in and listening to Myeloma Crowd Radio. And we invite you to tune in next time to learn more about the latest in myeloma research and what it means for you.

 
Jennifer Ahlstrom
About the Author

Jennifer Ahlstrom - Jenny A - Myeloma survivor, patient advocate, wife, mom of 6. Believer that patients can help accelerate a cure by weighing in and participating in clinical trials. Founder of Myeloma Crowd, Myeloma Crowd Radio, HealthTree and the CrowdCare Foundation.

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