Tag Archive for: myeloma expert
PODCAST: HCP Roundtable: Critical Clinical Trial Conversations in the Expanding Myeloma Landscape
Treatment options for multiple myeloma have increased substantially, mainly attributed to advancements in clinical trials. More than ever, HCPs having conversations about trials is critical. Given that underrepresented communities bear a disproportionate burden of multiple myeloma, it becomes imperative to shift this paradigm.
What are the optimal approaches to initiate these conversations early in the patient journey? How should HCPs effectively communicate information about clinical trials to patients and their families, including care partners? Myeloma experts Dr. Craig Cole and Charise Gleason lend their expertise, offering insights into best practices and guidance on the next steps to be taken.
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Transcript:
Dr. Nicole Rochester:
Welcome to this Empowering Providers to Empower Patients Program. I’m Dr. Nicole Rochester, founder and CEO of Your GPS Doc. EPEP is a patient empowerment network program that serves as a secure space for healthcare providers to learn techniques for improving patient-physician communication and overcome practice barriers. In this
Myeloma roundtable, we are tackling critical clinical trial conversations in the expanding myeloma landscape. Some of the things we’ll discuss during this program include, how to explain the sequence of myeloma treatment and how clinical trials fit in. Healthcare provider to healthcare provider, recommended strategies for initiating clinical trial conversations early in the myeloma patient journey, and how to effectively mitigate and manage concerns regarding clinical trials through education, and continuously encourage patients and their care partners to ask questions.
It is my honor and privilege to be joined by Charise Gleason, vice President and Chief Advanced Practice Officer for Emory Healthcare, and adjunct faculty at the Nell Hodgson Woodruff School of Nursing at Emory University. Ms. Gleason leads the physician assistants and nurse practitioners across Emory Healthcare, overseeing clinical practice, quality, safety, and education. Thank you so much for joining us today, Ms. Gleason.
Charise Gleason:
Thank you so much for having me.
Dr. Nicole Rochester:
We’re also joined by Dr. Craig Cole, a board certified hematologist. Dr. Cole leads multiple clinical trials in multiple myeloma, and has worked extensively with patient advocacy groups to empower, educate, and bring equitable care to everyone. Thank you so much for joining us today, Dr. Cole.
Dr. Craig Cole:
Yeah, and thank you for the invitation.
Dr. Nicole Rochester:
While this conversation can be broadly beneficial, in this program, we are speaking to the unique needs of myeloma patients and families. So let’s get started with how to explain the sequence of myeloma treatment, and how available clinical trials fit in. So I’m going to start with you, Dr. Cole. We know that there has been rapid advancement in the myeloma sphere. Can you speak to how the introduction of novel drugs, treatment combinations and therapeutic modalities may pose some challenges for healthcare providers as they attempt to explain the sequence of treatment in relation to available clinical trials?
Dr. Craig Cole:
Yeah, that’s a really good question, especially because so many things have been changing in myeloma, and such a rapid secession. It really, it’s been kind of not only an incredible transformative past 20 years in myeloma as we’ve moved away from using chemotherapy to using really targeted therapy, but really in the past five to 10 years, and us using immunotherapy and now T-cell directed therapy, it’s been transformative.
And it’s been very, very difficult for myeloma experts to kind of configure how these treatments are sequenced, and how the clinical trials are conducted. But basically, we have gone from using single drug therapies to using combination therapies for refractory patients to using multiple modalities and as upfront therapy for myeloma. Up until today, us using four-drug induction therapies with IMiDs proteasome inhibitors and now immunotherapy with anti-CD38 therapy being used upfront.
Now, we have…we’re on the fact we are past the horizon of using T-cell directed therapy for relapsed/refractory myeloma. Those are now being put in combinations. And at the last meetings, we saw data in combining talquetamab with the bispecific antibody with pomalidomide (Pomalyst) having incredible response rates to 99 percent to a 100 percent. The combination of using daratumumab (Darzalex)with teclistamab (Tecvidli) at ASCO a couple of years ago having very, very, very high response rates for relapsed/refractory patients.
And, of course, the combination of using two bispecific antibodies talquetamab (Talvey) and teclistamab together having, again, in these incredible response rates and for relapse refractory myeloma. So in very quick orders, we’re going to see those therapies moving further and further upfront, which is a huge benefit to patients.
But it can be kind of difficult to keep up with all the changes in myeloma, especially as we move from using these drugs as single agents, to using them in combination. And not only to speak to using some of the newer drugs like Mezigdomide in combination with daratumumab, having one of the CELMoDs having very, very high response rates.
And so it’s exciting, but it does, it’s a challenge to discuss clinical trials with patients, because so many things have changed. We now have clinical trials across the spectrum of myeloma, using bispecifics as upfront and smoldering myeloma, which was at the last ASH meeting to using again, more novel therapies upfront and relapsed/refractory space and in the maintenance therapy space.
Dr. Nicole Rochester:
Well, that’s all very exciting, and I appreciate you sharing that because as you’ve said, there’s been a really kind of an explosion for lack of a better word, in the numbers of treatments that are available as well as increasing improvements and results. But as you shared, having all of these different modalities available can definitely cause some confusion even among those who do this every day. Do you have anything to add to that, Ms. Gleason?
Charise Gleason:
No, I think, well, I think Dr. Cole described that perfectly. It’s an exciting time, and also a challenging time, which just really brings you back to that team care approach to your patient, and how all of us need to work hard to keep up to date on the latest information. Dr. Cole mentioned quadruplet therapy, and we’ve got two clinical trials that have essentially told us. if you add that quadruple therapy and add that antibody upfront, you drive that deeper response.
So we change our practice probably sooner in the academic settings. And it’s really how do we get this out to other healthcare providers in our referral basis that send patients to us? And then also, how do we do maintenance? And I think Dr. Cole would agree most of us risk-stratify for that maintenance setting too, whether it’s one drug or multi-drug, depending on our patient’s disease.
Dr. Nicole Rochester:
Wonderful. So certainly, this conversation alludes to the fact that the clinical trials regarding these medications are also increasingly complex. And so I’m going to go to you, Ms. Gleason, because we know that nurses and advanced practice providers provide understanding of these trials, including potential benefits and risks, and all of the things that are required as they consider participating in a trial. And then, as you all have both shared, there is some tailoring around the treatment with regard to the disease state, whether it’s relapsing, whether it’s refractory. So with that in mind, do you have any best practices around tailoring the trial conversation with regard to specific patient needs and situations?
Charise Gleason:
Well, I’ll start with, we bring that discussion with all of our patients about the potential of a clinical trial from the start. And so we’re all versed on that, we all look to what clinical trial could be available for this patient. So we’re used to having that conversation. So our teams all need to be educated, participate in our research meetings, so we are ready to discuss a trial on that. We sometimes get to spend more time with patients, and we get to know our patients. These are patients we see frequently, and so we can have those conversations.
You might have somebody who’s starting to have a biochemical progression. It’s not time to change their therapy yet, but we’re already thinking about what’s that next line of therapy. And so as we start to approach that with clinical trials and standard of care, and opening that dialogue, so it’s really that communication and that rapport and relationship you have with your patient, and that care partner. So an ongoing conversation about the different treatments that are available to them.
Dr. Nicole Rochester:
So we know that patients with myeloma are living longer lives based on everything that you all have shared, and with that comes a different set of options and challenges. And you also have alluded to this team-based approach, Ms. Gleason, and we know that there’s a critical role that advanced practice providers play in the myeloma clinical trial setting. So I’d love for you to speak to that..the role that advanced practice providers play in myeloma clinical trials.
Charise Gleason:
Yeah, the advanced practice providers have started specializing like our physicians do, and we have that collaborative relationship, and we are part of that team approach to take care of our patients. So we’re identifying patients for potential clinical trials. Our scope of practice does vary a little bit from state to state. So in some cases, we can also enroll patients. If we’re not able to do that, though, we can already have discussed the trial, discussed side effects, presented them with the consent. So when they do meet with the physician, they’ve already seen a lot of that information, and then they can ask further questions with the physician.
I think the other big role that we play in the clinic setting is we see these patients, we see these patients for follow-up. So we’re doing a lot of management of the side effects, supportive care through the trials. We might be a little more available during the week, so if a patient’s here on another day, and they’ve got something going on, we’re answering those portal questions, and calling patients back and just really collaborating with our physicians and also the research team.
Dr. Nicole Rochester:
Dr. Cole, I’m going to turn the conversation back to you. As a physician, I know that often, there are some barriers just as part of our everyday practice that can hinder our work. And so I’d love for you to speak to any unforeseen or outdated practice related barriers that you feel may hinder your work, and the work of your colleagues specifically as it relates to myeloma trials. And then if you could also share some potential solutions to those barriers.
Dr. Craig Cole:
Yes, super good question. I love this question. There are a lot that are out there that I…barriers that I hear providers talk about at other academic centers and in the community. One is that patients don’t want to go on clinical trials that they…and some of that is subconscious bias. Sometimes those are true, true bias. We know the FDA knows all the drug companies all, and I think every myeloma provider knows that there have been horrific disparities in the enrollment of patients in clinical trials based on race and age and ethnicity that the FDA looked at some of the data of trials that were going for FDA approval, and found that over the past 10 years, and that in those trials, that only 4 percent of the population of the trials were Black.
While in the United States, the number of Black myeloma patients is about 20 percent, over 20 percent of the myeloma population. So that’s a huge disparity. And what I hear is that while older patients and Black and Hispanic and Asian patients don’t want to go on clinical trials, and that’s not true. That’s been shown in multiple clinical trials that actually, the patients of different ethnicities and races actually are more likely to go on clinical trials than other racial groups. And so I think that it’s really important to keep that in mind that patients really…that really the ownership of getting a patient on a clinical trial is really on us to present the clinical trial option to them with every single conversation that we have.
Some of the other barriers to clinical trials is, and Ms. Gleason had mentioned this, what they do at through the Emory system is that, well, the nurses and the other staff in the cancer center aren’t aware of the clinical trials, that when a patient goes through the clinic, they talk to more than just the provider. They talk to the treatment nurses, they talk to the intake people, they talked to the MAs, they talked to the scheduling people.
And there was a study that was done a few years ago in looking at patients who were given consent forms and declined clinical trials. And they found that a lot of patients declined clinical trials, well, because they said that, well, their doctor didn’t want them on the trial. And when they looked further into that, they saw that, well, the doctor offered them a clinical trial, but when they discussed the clinical trial with a nurse practitioner, when they discussed that trial with a treatment nurse or the MA or any of the other staff, when they didn’t know about the clinical trial, that was considered well, if you don’t know about the clinical trial, it must not be good for me. And then they withdrew from the trial.
So just like what they do, what Ms. Gleason had said, we have an all-in approach. We make sure that the treatment nurses, the MAs, the intake people know what we’re doing, know about our clinical trials, because that’s the fun part about what we do. The fun part is when we say, look, my goodness, this four-drug therapy had a 100 percent response rate. That shouldn’t be left in the physician compartment. It really shouldn’t be left in the provider compartment. That excitement should be clinic-wide. And when you have that all-in approach where everybody’s involved, everyone’s excited about clinical trials, it produces a culture of clinical trials that everybody wants to be part of, and the patients then can jump on that bus and feel comfortable participating in the trial.
Dr. Nicole Rochester:
Wow. Thank you for elucidating that. Both the issue of the health disparities that we see in clinical trials and the need to diversify that clinical trial patient population, some of those biases that exist, as well as really lifting up this idea of creating a culture of clinical trials. I love the language that you use for that and the idea that everyone throughout the entire clinical encounter needs to be both aware of, and excited about the clinical trials that are underway. So I appreciate that.
That leads us nicely into our next segment, which is really focusing on strategies for fellow healthcare providers for initiating clinical trial conversations early in the myeloma patient journey. So I’m going to go back to you, Ms. Gleason. We’ve been talking about this team-based approach. We know that nurses serve as key coordinators of care in the myeloma trial setting, as well as other members of the healthcare team. So from your perspective, what are some recommended strategies that you can share to encourage advanced practice providers, specifically how to initiate the clinical trial conversation at the outset of care?
Charise Gleason:
First, we need to educate our advanced practice providers. So for new APPs coming into our system, part of their onboarding is the research mission, exposing them to the clinical trials, exposing them to what we have available. We have a weekly research meeting, I’m sure Dr. Cole has similar practices. And then our group has a separate meeting once a week, where we meet for two hours. The myeloma team, we have APPs who are off that day who call in for this meeting, because we go over our patients, we talk about what’s, clinical trials are available, that’s just how we practice and we think about that.
I would like to add to that, referring to a center early is so essential as well, and for us to start having that conversation. And I’ll talk a little bit to build on something Dr. Cole said with our patient population. In Atlanta, in our database, 40 percent of our data is based on Black patients. And we enroll about 32% to 33% of Black patients on clinical trials. And what our work on trials has showed us too, if you give the same access to every patient, you have good outcomes and good outcomes for Black patients, if not better, than white patients. So we all need to be versed on that, whether you’re the research nurse, the clinic nurse, the physician, the advanced practice. And so we really do bring that approach to taking care of our patients.
And then, managing those side effects and having that open dialogue. So patients aren’t surprised by things. And I’ll use talquetamab for instance. We have a patient who is still on the original trial, who relapsed on a BCMA targeted therapy. Early on, these side effects were new to everybody. And she wanted to come off the trial month end. And it was that education piece and working with her, holding the drug, that now almost two years later, she’s still in remission, tolerating the drug. And so those are the stories and these are the experiences we have. We’re giving really good drugs on clinical trials and patients are responding well.
Dr. Nicole Rochester:
That’s an amazing success story. Thank you for sharing that. What about you, Dr. Cole, with regard to potential strategies for healthcare providers, what are some things that they can implement for initiating these clinical trial conversations early in the journey, particularly in the current environment?
Dr. Craig Cole:
Yeah. And Ms. Gleason had mentioned this at kind of the top of our talk about having those conversations on day one. On day one of our patients coming in either as a second opinion, as a new diagnosis, as in whatever setting, we talk about…we have a list that we go through with the patient that talks about their stage or the disease, how we’re going to follow up. And there’s a line that I have to address, which is, clinical trials. So I mentioned our clinical trials, I mentioned on day one. And I think one strategy that other healthcare providers can take is that, even if you don’t have a clinical trial at that time, so right at this moment, we don’t have an upfront clinical trial.
We have one for maintenance therapy, post-transplant, but we don’t have an upfront trial. I mention that. I say that there are clinical trials that are available for your myeloma. Right now we don’t have a clinical trial for upfront myeloma, but we can refer you for a second opinion for an upfront trial if you’re interested or…and we have a clinical trial in maintenance. So that sets the groundwork that we’re going to talk about clinical trials on every visit. And that it doesn’t come as a surprise. Because the last thing you want to do is that someone is having a relapse and you say, “Oh, we’re going to talk about clinical trials today.” Because then it’s like, “Oh my goodness, this is a desperation.” This is a desperation move, and it puts a lot of anxiety when you frame it, and we need to do this now as opposed to having on day one.
The second thing that I think really helps is getting patients involved in the myeloma community, especially with the support groups having not only the patients, but their care providers and families involved in the myeloma community. Because the myeloma communities through a lot of the support agencies like the IMF, the MMRF, the HealthTree, they have a very strong clinical trial culture. And when patients get involved, not only is that empowering to see other myeloma patients doing well, but to hear other myeloma patients talk about their experiences in clinical trials really, really helps. And I think the last thing that we use to help patients, go through clinical trials, is a couple of other things, is one, every time we talk about treatment options, if that is maintenance, if that is smoldering, if that is a relapsed/refractory therapy, we always put clinical trials in that conversation.
Again, even if we don’t have that clinical trial at our institution, we talk about this as an option that we could refer you out to. And, and then we always talk about…I think one other little thing is that every visit that patients have, I somehow include some of the new things that are happening in myeloma. Now, my patients kind of expect it. They expect. They know when December and June is because when I see them after ASH and ASCO and sometimes they’re like asking, “So what’s new?” And once we get into that groove, they see, gosh. There are response rates that are off the charts with some of these new things. These patients are involved in clinical trials and the myeloma and multiple myeloma research is progressing at such a rate and things are getting better that patients want to be involved in it.
So we’re always talking about new things. Do I go into depth of detail with talquetamab and pomalidomide. I don’t go into depth of detail. And I say, where I was this clinical trials at our last ASH meeting that combined these two drugs for a relapsed/refractory myeloma, even patients who were refractory to some of the drugs you’re on now. And response rate was like 100 percent. And then when I talk about those clinical trials in the future, they’ll remember, man, that guy was talking, he’s all upset about these clinical trials. Maybe I want to be involved in them. So that’s kind of my few strategies that I use.
Dr. Nicole Rochester:
I love that. And what I really hear both of you saying is this idea of normalizing conversations about clinical trials and not introducing them as like a Hail Mary, so to speak, but really from the very beginning, letting patients and care partners know that this is a viable treatment option. So I think that is wonderful. And I can say like, your excitement is contagious for me, so I can only imagine how excited the patients that you work with feel.
So let’s move on to our final topic. How do we mitigate and manage concerns despite all these wonderful things that both of you have shared? I’m sure that patients and family members have concerns about myeloma clinical trials. And so I’ll start with you, Ms. Gleason. And as you hear concerns from patients and families over the years possibly related to fear of randomization, fear of getting the placebo, you all have mentioned some uneasiness about adverse effects. How do you effectively mitigate and manage these concerns with patients and their family members and care partners?
Charise Gleason:
Yeah, you just have to continue to have open communication. And if you’re, if a patient is accustomed to you mentioning clinical trials, then when you present one to them, right? They’re a little more open to it. But not everybody starts with us. And we get referrals in midway and different parts and different paths along the way. But patients we do hear, “I don’t want to get a placebo.” Or you’ll mention a clinical trial and somebody will say, “Am I ready for hospice?”
And it’s, you have to go back and start that education again that, no, you’re getting good treatment on this, a registry trial, for instance, you’re going to get standard of care treatment plus or minus something else, right? And so we really have to go back and educate that you are getting treatment. You’re going to be watched closer than any of our other patients actually.
You’ve got a whole team around you that’s talking about your trial and our patients every week. And so I think that our excitement and our being positive, we can get those patients to enroll on trials. I think something that makes me really happy is, we keep a list of every treatment line, and when you go through and it’s like standard of care, clinical trial, clinical trial, standard…it’s we’ve done the right thing then, right? Our patient has had full advantage of what’s available to them when we do that.
Dr. Nicole Rochester:
What about you, Dr. Cole? Do you have anything to add with regard to managing the concerns that come up?
Dr. Craig Cole:
Yeah. The one thing that I tell patients, and I tell patients one-to-one, and when I do talks for some of the efficacy groups that I tell lots of patients that. That in 2024, myeloma trials are incredibly competitive. And the only, the best, best drugs, now float to the top as part of our clinical trial portfolio. There were days I remember begging companies for clinical trials saying, “Please, please think about myeloma.” And we were struggling.
Now, it is incredibly competitive, and that competition does a fantastic thing for patients because what we see in the clinical trial portfolio are drugs that are safer and safer and safer, and drugs that are more effective and more effective. When you go to these meetings and the expectation is that our response rate needs to be over 60%, then you know that the clinical trial mail you, that we work with them, is of a super high quality, which you really can’t say for a lot of other types of cancer.
So I tell patients that their fears that they have are absolutely justified. And one thing we teach the fellows, the residents and the medical students, is that you validate those concerns and you listen to those concerns and you don’t ignore it or blow through it. That you absolutely…those are the most important parts of that conversation. And if you don’t validate it, the patient says, “Well, I have a fear of randomization.” And you go, “Hmm, there’s no such thing.” Then that’s not validating. And that’s not even listening. That’s just moving on because you don’t have that concern, but you’re not bringing that, you’re not validating the patient’s concern. And so you have to be very, very careful in doing that because there are multiple studies that have shown those are the big concerns.
Also, bringing up the things that are facilitators for clinical trials, that if there is an opportunity for reimbursement for travel or reimbursement for hotel stays or reimbursement that we say that this trial has a reimbursement program, or if we say that use other things that help facilitate clinical trials like speaking to the family, not just speaking to a patient, but speaking to the caregiver and speaking to the extended family that that patient will have a conversation with are really important conversation because the more people that you can talk to, that’s part of that patient’s decision-making group, which can be very different from patient to patient based on their culture, the more likely you are to get a consensus among that decision-making group for the patient to go on a clinical trial.
Dr. Nicole Rochester:
Those are great tips. Thank you both so much. It’s time to wrap up our roundtable. I must say I have truly enjoyed this conversation as always. I have learned a lot. I’m sure that our audience has learned a lot. In closing, I’m going to go to each of you just to share maybe one takeaway that you’d like to leave with the audience. So I’ll start with you Dr. Cole, one takeaway.
Dr. Craig Cole:
One takeaway. I actually thought about this, but I think that the biggest takeaway is, if I can squeeze two in.
Is that, is to remember that basically they’re all patients want to be involved in clinical trials and the ownership of having patients on clinical trials is really on us to really talk to them over a longitudinal period, to talk about clinical trials, to have them involved. To not look at a patient saying, “No, they don’t want to be on clinical trial.” That you really engage that patient to tell them about really the incredible progress that we’ve made, how competitive clinical trials are and how exciting it is to be part of that research environment. And that would be my one, my two sort of closing thoughts.
Dr. Nicole Rochester:
Thank you. And what about you, Ms. Gleason?
Charise Gleason:
Dr. Cole said it well. Please discuss this with your patient. Listen to them. Listen to their concerns. Don’t make decisions for them based on bias that maybe you’re bringing in. Don’t make decisions based on maybe it’s too far. Patients drive hours to go on clinical trials, and let’s give them the information and have that conversation.
Dr. Nicole Rochester:
Wonderful. Well, thanks again to both of you, and thank you all for tuning in to this Empowering Providers to Empower Patients program. I’m Dr. Nicole Rochester. Have an amazing day.
PODCAST | HCP Roundtable: Best Practices for Talking About Clinical Trials With Myeloma Patients
Clinical trials represent tomorrow’s medicine today, yet not every patient confronting a myeloma diagnosis is informed about all available care options. Surprisingly, some patients and their care partners are never introduced to the possibility of participating in clinical trials. How can we alter the course? What strategies can healthcare professionals (HCPs) employ to effectively communicate information about clinical trials and guide patients through next steps?
Experts Dr. Beth Faiman and RuthAnn Gordon share important insights into understanding the critical role of clinical trial nurses and how they educate and mentor nursing professionals around best practices for broaching clinical trial conversations.
Download Resource Guide|Descargar guía de recursos
Transcript:
Dr. Nicole Rochester:
Welcome to this Empowering Providers to Empower Patients program. I’m Dr. Nicole Rochester, pediatrician and CEO of Your GPS Doc. EPEP is a Patient Empowerment Network program that serves as a secure space for healthcare providers to learn techniques for improving physician-patient communication and overcoming practice barriers. Today we are tackling best practices for talking about clinical trials with myeloma patients. One significant challenge for some providers is initiating conversations about clinical trials and determining the appropriate timing of those conversations.
While clinical trials are often described as embodying tomorrow’s medicine today, not every patient facing a myeloma diagnosis is well-informed about all available care options. Astonishingly, some patients and their care partners are never even introduced to the possibility of participating in clinical trials. How can we shift this trend? How do we make these conversations a standard part of healthcare discussions at the outset of care?
What strategies can we as healthcare professionals employ to effectively convey information about clinical trials and guide patients and families through the next steps? We are joined today by RuthAnn Gordon, Director of Clinical Trial Nursing at Memorial Sloan Kettering. Ms. Gordon oversees clinical trial nurses, and develops and implements policies, procedures, standards, and systems to improve quality and compliance in the conduct of clinical research. We are also joined by Dr. Beth Faiman, a nurse practitioner and research oncology professional at the Cleveland Clinic. Dr. Faiman is an active author, presenter, and educator on the topic of multiple myeloma. Thank you both for joining me for this very important conversation.
Dr. Beth Faiman:
Thank you for having us.
Dr. Nicole Rochester: So we have a lot to discuss as it relates to best practices for talking about clinical trials with myeloma patients and their families. And I think this is always a topic that deserves so much conversation, likely more than we will be able to dedicate today. And while it can be a broadly beneficial conversation to have, in the program today we are speaking to the unique needs of myeloma patients and their families.
Some of the topics we’ll tackle today are understanding the critical role of clinical trial nurses, healthcare provider to healthcare provider recommended strategies to effectively communicate about pretrial eligibility determination and the consenting process, and how to educate and mentor nursing professionals in community hospital settings and beyond, guiding them to assist patients and families through the subsequent steps of participating in a clinical trial.
So let’s get started by talking about the role of clinical trial nurses. And, Ms. Gordon, I’m going to start with you. We know that research nurses are at the front line of treating patients. Can you speak to your role, and how you believe it has changed over time?
RuthAnn Gordon:
Absolutely. First, I can tell you that I’ve been doing research nursing for over 20 years and really love the work. I think it’s important for patients to have that support when they’re going through a clinical trial. And so we’ve done a lot of work to make sure that they have that support. So our role is to really be able to guide the patient through the journey, making sure that they’re educated on what they can expect on the clinical trial, and not only in terms of what maybe the drug might be doing them in terms of side effects, but what is their schedule going to look like? When are they going to have to come in? How long are they going to be here? What does that mean? And how do we support them with their quality of life while they go through all the responsibilities that they as patients have on a clinical trial, and what do they need to do to get ready for that experience?
And so we’re guiding them, we’re educating them, we’re ensuring that they do understand the potential side effects, but do understand also what their role is in the clinical trial and what they can expect. And I think that in terms of what has changed is that we have really put more value on the fact that having that nurse that has the expertise in the clinical trial and really can gate keep all of the patient care coordination that that involves from a clinician experience and from a clinician perspective, has really helped to ensure that our patients are ready, that we can do our very complex trials. Because trials have changed so much in the last decade.
There’s so many more expectations. There’s so many more things that need to happen while they’re on the trial that really having that clinician doing that with the patient has improved our ability to do those kinds of complex trials. And so I think that really recognizing that having that clinician perspective at the partner, at the bedside with the patient has really helped us to expand the kind of trials that we can do.
Dr. Nicole Rochester:
Thank you. And as a physician who acknowledges that the time that we are allotted with our patients is often very little, it really makes a lot of sense that you all are able to bridge those gaps in the patient education, and are critically important to this work. So thank you for the work that you do. Dr. Faiman, we know that patients with myeloma are living longer, and they’re dealing with a different set of challenges than perhaps they previously encountered. So can you speak to the critical role of nurses specifically in the myeloma trial setting today?
Dr. Beth Faiman:
Yeah, absolutely. You know, I must first start by saying that the successes in the treatment of multiple myeloma can be owed to the brave participation of the patients and the caregivers. So let’s not forget about the caregivers to support the patients with clinical trials. And I started as a clinical trials nurse in the 1990s managing these patients, and a nurse practitioner in 2002. And now my role is different also as a researcher. And so I have seen firsthand all these drug developments. And so the difference from before when we had very few available therapies to now we have an armamentarium of drugs, and so deciding whether or not to participate in a clinical trial is super important. And how can we support our patients who are now living a longer lifespan with all these cumulative physical and financial issues? How can the nurses support the patients to get the access to the drugs and access to the financial resources they need so that they continue living a good quality of life? I know we have a very robust program to talk about later on, but I think nurses can fill that critical gap of finding resources for patients to allow them to participate in clinical trials to live a better life.
Dr. Nicole Rochester:
Thank you. And thank you for acknowledging the role of the patients and their caregivers in all of the growth that we’ve seen in this field, in the research. Ms. Gordon, we know that diversity in clinical trials is lacking. Certainly there have been lots of reports about that. It’s gotten increasing attention over the last few years. There’s now regulations related to that. And while things are changing, we have a long way to go. And it’s also important that we celebrate the wins that we’ve achieved along the way. So my question for you is, do research nurses play a role in increasing diversity in clinical trials and also in trial innovation?
RuthAnn Gordon:
Absolutely. Absolutely. I think that one of the things that is important is community outreach, right? And so we have a lot of opportunities for research nurses. Well, as in large academic settings, a focus needs to be on exploring ways to have partnerships with our community organizations. And once those connections are established, the research nurses can play an extremely pivotal role in ensuring that we’re not only at point-of-consent educating, but way before that, getting involved in pre-screening activities in order to ensure that we’re looking at a diverse population.
And also to help with providers that are in the community that may have more advanced questions, and having the nurse being partners with those clinicians in order to help them get through the questions that they might have in a more timely manner. And so the research nurses that are attached to those academic centers have a pivotal role in ensuring that the community centers have support.
And in doing the pre-screening, I think is an important feature of having the research nurse also be involved in that process. And so I think that…we know that the community has needs, and we know that we need to increase that access. So looking at opportunities to partner with those settings, to me, with the research nurse, is really critical, and I think is an important way that we can do that.
Educating is, I’ll keep going back to that, when you get hands on that patient, making sure that they understand what they can expect. And any misconceptions. Clearing up misconceptions about being on clinical trials is really important so that when you have a patient that is eligible, that they feel comfortable and confident in joining that study.
Dr. Nicole Rochester:
Wonderful. Thank you so much. Dr. Faiman, I’m going to come back to you. And my question for you is, can you speak to unforeseen or outdated practice-related barriers that may actually hinder the work of research nurses?
Dr. Beth Faiman:
Absolutely. So I wanna preface this by saying in my mind. I think that both oncology nurses and advanced practice providers are highly trained professionals that should function within a multidisciplinary team. So that team, just as you mentioned before, Dr. Rochester, was the physician has limited time, maybe even the advanced practice provider has limited time. How can we harness all of our resources to provide the best care to that patient? And clinical trials are one of them. Clinical trials will offer support so that the patient can have access to a pharmacist, a social worker, a dedicated nurse, a dedicated line to call if they’re having a symptom. But to speak to some of the outdated procedures, again, it goes to scope of the practice. No matter how highly trained they are experientially or with credentialing, there are practice barriers within the hospital organization within state laws.
The nice thing about clinical trials though, is that nurses in most institutions are very able to watch that clinical protocol. They’ll look for who needs to hold a medication because of toxicity, consult with the provider, and then they’ll say, “Okay, hold your dose. And when your toxicity resolves, reduce it one dose level, and come back for labs,” or whatever that would entail. So while there are outdated practices historically, I think that within clinical trials nursing it provides some more autonomy for oncology nurses, again, as a part of that multidisciplinary team to enhance patient care.
Dr. Nicole Rochester:
That’s wonderful. Are there any additional solutions that you think are necessary as we continue to see advancements in myeloma?
Dr. Beth Faiman:
Continuing education for these highly trained providers. And so those kind of…the education though, I’ll tell you, I think should focus a lot on the disparities in clinical research. One of the things I’m passionate about is highlighting the implicit and explicit biases that are in clinical research. Many of us will say, “Oh, that person won’t be a good clinical trial candidate because they live too far away or they don’t have a caregiver.” And so I’m really…I tell all of my nurses, nurse practitioners, even physicians, just ask a patient. Don’t think that because they live an hour away, they’re not going to want to participate in a well-designed clinical trial without even asking them. That doesn’t even allow them the opportunity to provide feedback.
And then not to mention all of the resources that are available to patients that provide, that participate in clinical trials. Many of the research studies will provide transportation or an overnight stay or some nominal, again, not trying to coerce the patients, but some nominal reimbursement for expenses to allow them to have access to that drug. So I can talk on and on, because I’m so passionate about this topic. But being aware that biases exist, through continuing education will hopefully enhance the diversity of clinical trials so that patients will be able to have access to care, and then that the clinical trial results are representative of the actual population of who we’re treating.
Dr. Nicole Rochester:
Thank you. I can definitely feel they’re both of your passion, and that’s why it’s so important that we have you here with us today for this conversation. So let’s shift focus a little bit and begin to talk about communication between healthcare providers to effectively communicate about pretrial eligibility determination and the consent process. So I’m going to go right back to you, Dr. Faiman. What do you think are the unique barriers that providers face when they’re speaking about myeloma trials to patients and their families?
Dr. Beth Faiman:
Right. So I think multiple myeloma is unique in that there are such an explosion of new therapies within the last decade. There hasn’t been such momentum in any other cancer such as multiple myeloma. But, unfortunately, there are challenges such as language barriers and communication problems that overarching with all the different specialties. The geographic I had already mentioned in a previous discussion about the geographic barriers to participate in clinical trials, not meeting inclusion criteria, I think it takes an astute nurse or advanced practice provider or physician to now sequence the therapy.
So for example, they have new therapies such as BCMA-targeted drugs that are available through cellular therapy trials or bispecific antibody trials. And without getting too specific into the drugs, you need a specialist to be able to say, “Okay, if I give you this drug today, that will exclude you from a clinical trial that might be very innovative and promising in the future.”
So those are unique barriers to accessing clinical trials or standard therapies for that matter because of the plethora of therapies that are available. So getting in, having patients get in with a myeloma specialist, they might not see them on a regular basis, maybe employ telehealth techniques, see them once and then virtually connect, share information about what might be available. Those are ways that you can provide access to patients, caregivers, and others throughout their disease trajectory because they’re living longer than ever.
Dr. Nicole Rochester:
Which is a wonderful thing.
Dr. Beth Faiman:
Yes.
Dr. Nicole Rochester:
Ms. Gordon, you’ve been doing this for a long time. In your experience, what are tried and true strategies that healthcare providers can implement to effectively communicate with their patients about clinical trials when speaking to pretrial eligibility determination and the consent process specifically?
RuthAnn Gordon:
Yeah. Thanks for the question. I think that an important thing whenever we’re talking to our patients is to really understand where they are with understanding and how they learn. So it’s important for us to know what their health literacy is so that we’re making sure that we’re talking in a language that they can understand and using words that are appropriate. And so that’s key. Clinical trials have a lot of comprehensive and complex assessments that are needed for pretrial eligibility, right?
So I think it’s really important to make sure that we are being transparent as to what they can expect. We don’t want them to have surprises later on and then not feel like they want to continue with that process. So I do recommend to my providers and my research nurses, sometimes get out the hard stuff up front. Know if they’re going to be there for 12-hour PKs. Let them know. It shouldn’t be a surprise. And I think that that really helps patients. First, they get involved in the process, they know what to expect, and you can really have more confidence in their adherence.
The other thing is to allow time for the conversations, right? We need to allow time for our patients to ask questions. And the consent process can be lengthy. There’s a lot on the document. Sometimes it’s quite long. So you wanna make sure that they’re in a state of mind to have the conversation, that you allow time for questions, and that you make it an exchange between the two of you. It’s a dialogue. It should be. And you should come with understanding where they’re at; understanding a little bit about what’s going on behind the scenes, right? What’s happening at home is important as you’re talking about pretrial eligibility, as you’re talking about what they can expect on trial, just to get a full picture of them.
So I think that those to me are very helpful. Providing take-home information to the patient so they have something to reflect on later is also really important, because they’re not going to grasp everything in that one session. And consenting is like an ongoing process, right? You have one conversation, you probably have 10 more.
Dr. Nicole Rochester:
That is wonderful. Thank you so much for sharing that. And I really appreciate that both of you have highlighted the importance of health literacy, and meeting our patients and families where they are and making sure that they understand, and this idea that it’s a continuum: That there may be multiple conversations that will be necessary. Dr. Faiman, as the myeloma treatment landscape continues to expand thanks to clinical trials, how are clinical trial conversations evolving, and what do you feel should be top of mind?
Dr. Beth Faiman:
That’s an excellent question. Over 20 different drugs are available in various combinations. And so we talked about sequencing very briefly about having patients that have access to clinical trials, making sure they’re not exposed to this class, or maybe they needed to be exposed to this class of drug before they can get drug B, for example. And so sharing mutual information through shared decision-making, again, the patients sharing information and goals of care, the provider and healthcare team mutually sharing information, bring in your social worker or pharmacist, etcetera, and then you can mutually agree on a treatment for the patient. And so that is something we did not have 20 years ago. There were very few effective agents.
I like to remind patients when we provide clinical trial consent forms, that the language is written by lawyers, but it’s intended to protect you. I overemphasize that this is voluntary, and you can withdraw your consent at any time. But I try to go back and highlight why there’s stringent, plus or minus one day, maybe you can’t take off three days to go on a holiday weekend, because we really need to dose this drug on that day and obtain this blood information. So again, having the patients understand what’s involved in the clinical trials and then being able to provide information.
I like to also offer handouts. So the International Myeloma Foundation has clinical trials and diversity handouts. And then another one that I really like is by the FDA that describes the importance of clinical trials. I give that to everybody. So at diagnosis, if you’re on a standard care treatment, you’re not receiving a clinical trial. Everybody that comes into my office that I see for myeloma amyloidosis and related disorders, I would say, “You are a candidate for clinical trial now, but if I or somebody else does not involve you or ask you to participate, then ask us. Just ask us about clinical trials.” I even have a pen that says “Ask me about clinical trials” so that everybody can see it.
Dr. Nicole Rochester:
I love the idea of a pen. Wonderful. Well, let’s move on to how to educate and mentor nursing professionals. Both of you are nursing professionals, and you’ve clearly highlighted in this program so far the importance of the role of nurses in this clinical trial process. So, Ms. Gordon, I’m going to go to you. We know that one significant challenge for some providers is actually initiating conversations about clinical trials and also determining the appropriate timing. Can you speak to whether care variation may pose challenges in community hospital settings, perhaps compared to academic hospitals?
RuthAnn Gordon:
Yeah, absolutely. I think one of the most important things about when to talk to the patient is every time, anytime, right? I think that we should be asking them if they’re interested in clinical trials. If they haven’t been engaged in that, we should be talking to them about, “You know, there’s maybe a chance at some time in our partnership together that we will be talking about clinical trials.” And introducing that up front I think is really important so that we don’t leave clinical trials sort of as a last thought and the patient have that feeling.
And I think that for the community setting, that’s one of the things that may be a challenge, is because it is hard to put a patient on a clinical trial and run it from a community setting. So it’s, how do we give them the support and resources so that it’s not so hard and that they do offer it and talk to their patients as much as possible about it? And I feel like that’s what we need to do more with these partnerships with academic settings, is that we have to give them support so that it’s not so hard, and that that clinical trials first of mind to them when they’re planning care for their patients.
Dr. Nicole Rochester:
I see a theme here: Partnership, collaboration. Dr. Faiman, as we continue on this topic, and as someone who has been a consistent figure in the continuum of care, how do you guide other nursing professionals when it comes to clinical trial communication? Do you have specific tips or tricks or things that you can share with the audience?
Dr. Beth Faiman:
Yeah, absolutely. So I think I have a unique perspective having been a clinical trials nurse, nurse practitioner, and now I conduct, independently, clinical trials. And so I, throughout that whole journey, so I share my experiences and some of the key tips that I like to share with other nurses and healthcare providers is just coming to the patient level. And as Ruthie had said a moment ago, at each encounter you have that opportunity to educate that patient about their labs, what’s their remission status, their disease status, what drugs are they on, what worked, what didn’t work? And the ones that are in remission for a while, one, two, three, five years, we have discussions about next therapy. So I say to them, “Okay, now, we have a great clinical trial. I think everything’s going very well with your disease remission status, but let’s make sure that you know what might be the next best thing for you.”
And I start planting that seed, giving them information about next therapy so that it’s not that, “Oh my gosh, I thought I was never going to relapse and now I need another treatment.” It’s okay, we have a game plan, we’re here in this together, let’s get some information. So disseminating this at this critical information to nurses at national conferences about the different drugs that are available, the toxicities, and how to offer them to our patients, I think is really important. But really just cheering in that partnership, as we just talked about, is really key to success, I think.
Dr. Nicole Rochester:
Great. Well, it’s time to wrap up our roundtable. And I have truly enjoyed this conversation. I have personally learned a lot. I’m sure that our audience will learn a lot as well. So I’d like to get closing thoughts from each of you. So I’ll start with you, Ms. Gordon. What is the most important takeaway message that you wanna leave with other healthcare professionals who may be watching?
RuthAnn Gordon:
Thank you. First, thank you for having me at this. This has been an amazing experience, and I want the providers out there to not be afraid of clinical trials, to look at opportunities to work with nurses to help support you in those clinical trials, to have the conversations with your patients early and often, and to work with your community partners.
Dr. Nicole Rochester:
And thank you. Thank you, Ms. Gordon. What about you, Dr. Faiman?
Dr. Beth Faiman:
Well, I guess I would say never underestimate for the nurses, nurse practitioners, physician assistants, social workers, physicians, anyone on the healthcare team. Never underestimate the unique role that you enact in the care of patients with myeloma or other disorders. Use your voice to speak up. If you think a patient is a candidate for a clinical trial but that physician or other provider hasn’t recommended it to them, then tell them why. You can refer them yourself as well. Ask patients about barriers to participation. Is it physical, financial, social? You can’t take time off of work. And then provide that assistance in counseling. It takes a big effort to support our patients, but we would’ve never gotten to where we are with treatment of multiple myeloma in 2024 without patient participation in clinical trials. So whatever we can do to enhance diversity, minimize bias, and support our patients, please try to do the best to do your part.
Dr. Nicole Rochester:
Well, thank you both, Ms. Gordon, Dr. Faiman, for this awesome conversation. We have learned a lot about how we got to where we are with myeloma. And thank you again for pointing out early on, it’s the patients and their caregivers and their participation in clinical trials that has led to the landscape where we are now with so many drugs available. And that really highlights the importance of clinical trials. We talked about diversity of clinical trials.
We talked about the implicit and explicit biases that all of us have, and that sometimes may preclude us from recommending trials for patients that can benefit from this therapy. And we’ve talked about the importance of having these conversations, not once, not twice, but every time that you are in the presence of a patient and their family. And also just the partnership and the collaboration that has already taken place, and that we hope to continue to foster as we move forward. So thank you both again, and thank you all for tuning in to this Empowering Providers to Empower Patients Program. I’m Dr. Nicole Rochester.
PODCAST: How Can You Engage in Your Myeloma Treatment Decisions?
Myeloma expert Dr. Benjamin Derman shares advice for partnering with your team when choosing a myeloma therapy, discusses important factors that should be considered, and provides key questions to ask your healthcare team to help you engage in your care. Dr. Derman also reviews research updates from the December 2022 American Society of Hematology (ASH) meeting.
Abou the Guest:
Dr. Benjamin Derman is a hematologist and oncologist specializing in multiple myeloma at the University of Chicago Medicine Comprehensive Cancer Center.
See More from the Empowered! Podcast
Transcript:
Katherine:
Hello and welcome. I’m Katherine Banwell, your host for today’s program. Today we’re going to talk about myeloma treatments, what the options are both current and emerging, and how you can play a role in your care and treatment decisions.
Before we get into the discussion, please remember that this program is not a substitute for seeking medical advice. Please refer to your healthcare team about what might be best for you.
Well, let’s meet our guest today. Joining me is Dr. Benjamin Derman. Dr. Derman, welcome. Would you please introduce yourself?
Dr. Derman:
Yeah. Thanks so much for having me. As you said, my name is Ben Derman. I’m an assistant professor at the University of Chicago. And I specialize in actually, plasma cell disorders, which is mainly multiple myeloma, amyloidosis, Waldenstrom’s. If a plasma cell is the problem, then I address it. So, that’s what I do. And that’s my clinical and research focus as well.
Katherine:
Excellent. Thank you so much for taking the time to join us today. Before we get into our discussion about available myeloma treatments, let’s talk about emerging therapies. And I know there are many.
The American Society of Hematology or ASH annual meeting took place in December. What are some of the highlights from that meeting?
Dr. Derman:
Yeah, ASH is always a very exciting time because it’s when we get to see all the latest and greatest of what’s on the way or what’s already here to stay.
I think the biggest focus in the myeloma field, if I could really pin it down, was more in the later stages of the disease and focusing on treatments in that setting. We already have two FDA-approved chimeric antigen receptors, or CAR T-cell therapies, in Ide-cel (Abecma), and Cilta-cel (Carvykti). Those are the brand names. And then more recently, we just had a bispecific antibody, which is another type of immune therapy that was approved. But there are actually many under investigation.
And so, at this ASH we heard a lot. Not only about the target that’s been most popular in this setting, which is something called BCMA or B-cell maturation antigen.
That’s what the CAR T-cell therapies that I mentioned are going after and the teclistamab (Tecvayli) bispecific antibody that I mentioned.
But there are a lot of other candidate drugs that are also targeting that same molecule. So, we heard a little bit about – more about those. We’ve been hearing about them pretty much at every conference these days.
So, there’s a lot of competition in that space. Which is good for patients because ultimately, what we’re trying to figure out is, is one of these better than the others? Or at least, if we have multiple options, there may be different side effect profiles that we have to think about.
But now as BCMA therapies are getting used more and more, one of the questions is, well, is there any other target that we could go after? And really, the one that was hot at ASH this year was something called GPRC5D, or G-protein coupled receptor 5D. This is expressed pretty strongly in myeloma cells, and not in many other tissues. Maybe the skin, nails, tongue. So, basically, that’s what you want, is you want a target that’s not going to be expressed elsewhere.
So, there were a couple of different types of therapies that were discussed. One was a CAR T-cell therapy going after GPRC5D, and the others were – there were two bispecific antibodies actually targeting the same GPRC5D. And that’s actually already in addition to another GPRC5D directed bispecific that’s in development.
So, basically, the idea is that if patients may experience progression on one of these BCMA targeting agents, we’re going to have another target to be going after. And I think that part is really, really exciting.
And as far as other highlights, I think the other thing is, how do we reduce the toxicity from these drugs? And exploring avenues in order to be able to decrease sort of the inflammatory effects of these drugs, which are important.
Katherine:
That’s great. It sounds so promising. And all of that information is going to be very helpful as we move through today’s discussion.
Let’s start with a general overview of treatment options. What types of treatment are offered for myeloma patients?
Dr. Derman:
Right. So, if you think about at the point where a patient is diagnosed with myeloma, unfortunately, always a tough – always tough news to receive and to share with patients as well, we start to think about dividing treatment into phases. And in part, some of it’s going to depend on, what is the fitness level of a patient in front of me? And not so much age per se, but really fitness level. And what I mean by that is independence in their activities of daily living, their ability to walk, go up flights of stairs, carry out just their daily life.
So, assuming that all options are on the table, we consider those patients to sort of be what we call stem cell transplant-eligible.
And that picks a sort of variety of pathways that we can go down. And then the other variety of pathways we can go down are patients where either because of a comorbid conditions, there are other medical problems, or because of their fitness level, a stem cell transplant is not really going to be something that we consider.
But either way, in either case, we start with something called induction therapy, where we’re aiming to induce a remission. Or induce a response as we typically say more commonly in myeloma.
And usually that involves a combination of three or now possibly four drugs. And it’s really, really different the way that we treat myeloma than we treat other cancers. And what I mean by that is the traditional thought of using very harsh chemotherapy drugs that make people feel very sick, very ill, lose their hair, those kinds of things. Things that are maybe more outwardly associated with chemotherapy, we don’t see that with myeloma.
In fact, I often tell patients if they’re fortunate to not have the disease affect them so much at diagnosis, a lot of people may not even know that they’re on treatment. And that can be good and bad, because they don’t know that what you’re going through, which can be challenging in its own right.
So, really what we use are a combination of therapies. They can be oral drugs, they can be subcutaneous injections under the skin, or infusions. And one of the newer advances is using immunotherapy in myeloma. And this is a little different than it is in solid organ cancers like lung cancer or melanoma where immunotherapy is very popular as well.
One of the main targets that we go after is something called CD38 on the surface of myeloma cells. And CD38 can be targeted with a type of monoclonal antibody.
And there are two that are out right now, daratumumab (Darzalex) and isatuximab (Sarclisa). Daratumumab is actually approved to be used in the frontline setting, meaning at diagnosis. And that has really allowed us to augment the already – the backbone that we’ve been already using for quite some time in myeloma.
Dexamethasone (Decadron), which is a steroid, is typically employed in all of these cases. And then we use drugs that are in the class of what’s called immunomodulatory iMiDs, chiefly lenalidomide (Revlimid) is the main one that we use in oral drug, and that’s been approved since 2006 or so.
And then bortezomib (Velcade), which is something called the proteasome inhibitor, or its cousin carfilzomib (Kyprolis), can be used as well in the frontline. So, we’re usually combining these three or four drugs together in order to create this sort of symphony that really targets the myeloma from many different aspects.
Katherine:
Yeah. How do patients know if they have any of these targets, such as CD38?
Dr. Derman:
So, actually it’s interesting. CD38 is pretty much ubiquitously exposed on the surface and expressed on the surface of myeloma cells. So, it’s in a pathology report. It’s actually one of the ways in which we can identify what makes a plasma cell a plasma cell. But CD38 is one that is essentially ubiquitously expressed.
And I say that with the idea that that expression may go down if you use these drugs to target that specific – that target. So, as time goes on, it’s not a drug that you may be able to reuse over and over. Or at least there might need to be a nice long break.
Katherine:
So, obviously there are very – there are a lot of available therapies for myeloma. And I’m wondering what factors might impact treatment decisions. You did mention comorbidities. But what other factors are there?
Dr. Derman:
Sure. And I think in part, it depends on if we’re talking about induction therapy or in the relapsed refractory setting. Let’s focus on induction therapy, right?
So, there are some drugs that we’re typically going to employ pretty much universally. For those who are inclined to use that CD38 monoclonal antibody that I mentioned, it pretty much plays well with patients of all walks of life. So, that’s one where I feel really comfortable regardless.
Lenalidomide is a drug that we don’t necessarily know from the get-go if there’s going to be a patient that’s not going to tolerate it well.
We might reduce doses up front. But for the most part, that’s another drug that we’re typically going to use. I would say the one exception is for patients who have a simultaneous diagnosis of amyloidosis. And we know that in amyloidosis, lenalidomide may not be as well-tolerated.
But actually, one of the key decisions that I’m often making in clinic myself is around that drug class that I mentioned earlier called proteasome inhibitors. And I mentioned two different drugs. There’s bortezomib and carfilzomib. And they actually come with very different side effects that I think are important to mention.
Bortezomib is one that is typically associated with a high rate of numbness and tingling, what we call neuropathy in the fingers and toes. And about 75 percent of patients have been reported in the trials to get this. And most of it is what we call lower grade. But I’m not in the patient’s body, and I don’t know what that – what even a grade 1, which would be the lowest grade, really feels like. And if I have a mechanic, somebody who types for a living, a surgeon, somebody who uses their hands or their or rely on their feet for their day-to-day, that’s a scary prospect, right?
The flip side is this drug, carfilzomib, is one that does not really cause nearly as much neuropathy, but has been associated with cardiac effects. Heart issues. And so, that can scare people, right? Heart’s important I hear. So, we have to be really careful in how we pick these therapies and talk about it with patients.
Katherine:
Yeah. When we talk about making treatment decisions, it’s important to choose a therapy with your healthcare team.
Let’s share some tips for having that conversation. I’d like to start with induction therapy, which is the first line of treatment for patients. What questions should patients ask when choosing therapy early in their diagnosis?
Dr. Derman:
Yeah, that’s a great question. And it’s of course – it’s really the patient priorities I would say. So, one of the things that I like to discuss with patients is, number one, what are the things that they value? And that’s a hard question to ask without any qualifiers.
So, one of the things that I often ask patients to think about is the – first of all, the number of visits to the medical center. Certain therapies are weekly, certain therapies may actually decrease in frequency overtime. So, if that is something, it’s hard to travel, it’s hard to get someone to take you or to come yourself, or you just don’t want to be in the clinic as much – right? If that’s your number one priority, there are going to be certain therapies that are – or regimens that may be better suited for that patient. If somebody says, “I don’t care how many times I have to come, my goal is the deepest response possible,” you can think about things from that standpoint.
I mentioned side effects. What are the things that are scary to you personally, as a patient? Some people may look at that neuropathy, as I mentioned, and say “No way. That sounds horrible. I can’t do my job.” Other people would say, “I already have some cardiac issues. I don’t want to take that risk.” Right? So, there are different side effects that we have to take into account.
Especially when it comes to talking about transplant, there is not just the acute issues that we have to deal with in terms of side effects, but also long-term immunosuppression. Meaning the immune system is suppressed, and there’s a risk of infections, and it’s going to be higher than if you had not gotten a transplant. So, those are at least some of the things that I encourage patients to be thinking about.
I would also say, on top of that, patients may be approached about clinical trials. And I work at a university where we really value enrolling patients in clinical trials. But that they do come with some inconveniences as well, even though I think they really help to advance the field forward, and sometimes offer patients options they wouldn’t normally be able to get. But there are typically more visits associated with that, more evaluations, more blood draws, more bone marrow biopsies, so those are things that you really have to take into account.
Katherine:
That’s great advice, Dr. Derman. Unfortunately, relapse is common among myeloma patients. Or it may be that a treatment stops working, and so the person’s myeloma becomes refractory.
When considering a treatment for relapsed or refractory myeloma, are there different questions that patients should be asking their healthcare team?
Dr. Derman:
Yeah. I mean, that’s a great question. I think part of it is every patient’s journey with myeloma ends up being quite unique, in part because we don’t have a lot of consensus in terms of how to treat myeloma. So, I may choose one regimen, but the other doc down the street is going to recommend a slightly different one. And now, they all have efficacy. No one’s going to be recommending something that’s not good, right? But what it means is that the journey, the number of therapies, the types of therapies that a patient has received are all going to be quite different than the next.
So in part, sometimes the past therapies are going to dictate what options are available.
So, I mentioned some different classes of therapies. The proteasome inhibitors, there’s a certain number of those. The immunomodulatory iMiDs, there’s a certain number of those. The CD38 monoclonal antibodies, there are those. And then there are a few other drug classes as well.
And if we’re using three or sometimes four drugs at a time for each what we call line of therapy, meaning each time a patient changes treatment – right? Eventually, we’re going to have gone through a number of treatments that now the patient would be – their disease would be resistant to. And so, you don’t really – it’s not really going to be prudent or wise to go back to therapies that didn’t work previously.
And so, we start mixing and matching, and we come up with regimens that we think are going to hopefully throw a curveball to the myeloma to really try to get rid of it again. That’s what I mean by it’s dictated by past therapy.
Katherine:
Is research being done to determine the likelihood of relapse and when that might occur?
Dr. Derman:
Yeah. I mean, we can look at clinical trial data for regimens that have been tested in the relapsed or refractory setting and say, “Okay, we know that this three drug regimen typically gives patients a year before the disease comes back.” Or “This one gives two-and-a-half years or three years.” So, that’s one piece.
But when you think about who – if you wanted to know ahead of time, “Okay, a patient with high-risk disease, they’re likely not to have as good of a response.” But nobody knows ahead of time the exact amount that they’re going to relapse.
But one of the things that we focus on, part of the reason that patients get a good amount of blood work when they have myeloma and they’re on therapy is that we have a measure in the blood, or we have several measures in the blood, where we can monitor for relapse. So, we can look at the abnormal proteins, what we call paraproteins in the blood. Either as the M-spike, is what it’s called, or light chains. We look at both of those to see if there are increases in those numbers over time.
When a patient’s responding, those numbers come down. When a patient is losing response and their disease is progressing, that’s when we start to see those numbers go up. And that’s often an indication that we need to switch treatment, even before a patient develops symptoms related to their myeloma.
Katherine:
When a patient goes into remission, they’re often placed on a maintenance therapy. What’s the role of maintenance therapy in myeloma care?
Dr. Derman:
Yeah. So, maintenance, just to specify, is typically something that we call a long duration of usually, less intensive therapy after a more intensive schedule of therapy. So, the most common area that we talk about maintenance is after, let’s say, an autologous stem cell transplant, which came after induction therapy that I mentioned.
But for patients even who don’t go to a stem cell transplant, they can also go on maintenance therapy. So, when we think about the frontline setting, which in this case would be induction transplant maintenance, the most commonly used drug is a single agent lenalidomide. And that’s been shown to have survival benefits not just in keeping the disease away, but also helping patients live longer. So, maintenance therapy does seem to carry some real importance. One of the things though that we don’t know, is really how long patients need to be on maintenance therapy.
So, we can all accept I think in the myeloma field, if there’s one thing we can agree on, is that maintenance is important. But the question is, what makes up that maintenance therapy? And then how long? Those are questions we don’t really have the best answers to. And actually, one of the areas that I do quite a bit of research in is about this, how long do patients need to be on therapy?
So, we recently published some – we presented at ASH this year in 2022, some recent data, at least a preliminary data on patients who had really deep responses, and who we stopped their maintenance therapy after at least one year – but the average was about three-and-a-half years on maintenance therapy – to see if the disease would actually be at risk of coming back.
And so, what we’re finding is that even in the first year, about 85 percent of patients did not have their disease come back after stopping therapy. So, maintenance therapy is certainly important, but I think we still have to figure out how long patients need to be on that therapy.
Katherine:
Right. And I can imagine that each person, each patient is different, and some – the maintenance therapy would work really well for them for a long period of time. For others, not necessarily.
Dr. Derman:
Yeah. I mean, a lot of it comes down to the risk there of the patient’s myeloma. And what I mean by that is – so, somebody has explained to me previously, and I really like the analogy that myelomas are kind of like people. They have different personalities, and they give first impressions. And sometimes your first impression of a myeloma may end up being wrong. You thought it was going to be really hard to treat and you found out that it actually responded pretty nicely to therapy. And other times, it’s the other way around.
But for the ones that give us a bad first impression, we’re going to be treating those patients typically more aggressively. At least that’s my personal approach. And I take that all the way through from induction, to transplant, even into maintenance therapy where I mentioned already, most people will prescribe a single drug as maintenance therapy. But for those patients, I’m typically going to be prescribing more than that. Or I will continue more aggressive therapy for longer. So, that’s where you have to sort of adapt your therapy in some cases to the patient and their disease characteristics.
Katherine:
Related to maintenance therapy, we received this question before the program. How do doctors feel about maintenance breaks if you are MRD-negative? Or in a very good response?
Dr. Derman:
So, I want to be very careful about how I respond to this. Because what I’m going to say is, there’s currently no data to tell us that patients should stop. I mean, in part that’s, you should stop therapy. In part that’s what I’m hoping that we can answer with our study. There’s another large cooperative group study trying to answer this as well, about the duration piece and whether people can stop.
So, a very good partial response signifies at least a 90 percent reduction in the tumor, in the myeloma, but not 100 percent.
And there’s also a complete response, which means there’s no detectable disease by conventional methods in the bone marrow or in the blood, but that there can still be microscopic or low levels of cancer cells which we call minimal residual or measurable residual disease. Also called MRD.
So, MRD negativity is a not so nascent field now, where we are trying to quantify small amounts of cancer cells that may still be present. And the theory is that the presence of residual disease at a small measurable level is what’s ultimately responsible for myeloma relapsing.
We used to think like, “Oh, a patient is in a complete response. That’s amazing. Let’s clink our champagne glasses. Let’s celebrate.” And there’s still cause for celebration for that. That is a great achievement. But we know that that doesn’t mean we can rest on our laurels. If there is MRD-positive disease, then the disease, it can likely come back. And that’s where suppression of the disease with something like maintenance therapy with lenalidomide is probably helping a lot.
Katherine:
Yeah.
Dr. Derman:
But let’s say we have people who don’t have detectable disease, the question is, can they stop? And like I mentioned, we’re trying to answer that question. I would say right now, there’s no recommendation for that. I can’t say in good faith that you should be doing that, unless it’s as part of a clinical trial, which is what we’re hoping to answer.
Katherine:
Let’s get to a few audience questions, Dr. Derman.
Craig sent in this question prior to the program. “My primary side effect is fatigue.” And you just mentioned that. “What advice do you have for planning activities through the day?”
Dr. Derman:
So, this is a very common side effect that we see. In part, it can be from the disease itself. And if that’s the case, it’s going to get better as treatment works. In other cases, it’s due to the treatment itself. And sometimes there are controllable aspects. If it’s a pill, let’s say, where you can control the timing of when you take it. I often tell patients, “Take the drug at night. Because if it makes you tired, at least you’re going to be going to sleep at that point.”
I do think making sure that you have a good night’s sleep is important. I think making sure that you keep your day-night cycles. So, even if you feel fatigued and you’re at home, it’s not good to be having the windows closed and not being exposed to the outdoors at all. You need light during the day. That’s a normal human need. We do the same thing when patients are in the hospital, and it’s very easy to get your day and night cycles messed up.
And the other thing too is planning periods of the day when you know that your activity level is going to be, or your energy level is going to be higher, and planning your activities around those times. I think those are at least some important things that we can do.
Katherine:
Yeah. Lauren wants to know, what is the best way to measure current immunity status? And should we mix COVID vaccine and flu vaccine?
Dr. Derman:
Mm-hmm. This has become sort of a hot button issue all of the sudden over the last few years. Well, so, as far as immunity status, I wish there was a one good test that we could know.
I mean, there are some features. Patients who have low white blood cell counts, especially low neutrophil counts, are certainly going to be at higher risk for infection. And that can happen due to myeloma, or more commonly, due to therapies. We can look at immunoglobulin levels, especially the IgG level. Patients who have IgG levels typically less than 400 milligram per deciliter seem to be historically at higher risks of infections. So, something called IVIG, which is an infusion of donated antibodies from plasma from healthy donors, can be used for that.
There’s been a lot of discussion about, how do we know immune status related to COVID? And there are antibody levels that can be checked, but the truth is nowadays most people have high antibody levels, even if they’re on therapies because of the number of vaccines they received or natural infection. And it may not be a really good surrogate for understanding immunity to COVID. COVID’s outsmarted us time and time again, and probably will continue to do so.
As far as the vac – I mean vaccines are super important. We do this for all our patients after transplant as well, revaccination them for all of their childhood vaccines. As far as the COVID and flu, I personally – I’m happy and feel fine administering both at the same time. We’ve seen no real safety signals there in my anecdotal experience. But I’m perfectly fine if patients want to split them up. It’s not something that is a 10 out of 10 for me. It’s more that it is as long as they’re getting both, I think that’s really important.
Katherine:
Yeah. One final question for you. Jennifer asks, “Many new medications for treatment were mentioned. And I’m sure these could be expensive. What are the options to make these available financially for patients who need them?”
Dr. Derman:
That’s a really good question, and one that we don’t yet have great answers to. As a physician, I don’t receive compensation based on the drugs that I prescribe. And so, I do know – I often have a good sense of what these drugs cost. A lot of the costs that are passed along to patients typically revolve around oral therapies. Even patients who are on Medicare, or sometimes especially patients who are on Medicare. And looking at some of the policy changes that seem to be coming down the pike that include capping Medicare out of pocket costs for medications will be a huge benefit to our myeloma patients.
It’s important to familiarize yourself with different organizations and the financial support that may be available. Just to name a few, and you’re not limited to these, but The Leukemia & Lymphoma Society does a really great job in providing financial support to patients. But there are definitely other programs that can be contacted for this.
And also, a lot of the pharmaceutical companies will actually have patient assistance programs as well. Sometimes it’s as simple as asking your provider, and typically they will have their team look into this for you. But we’re fortunate to have a team of pharmacists and my nurses as well who are used to doing this kind of thing. So, it’s important to look into those as well.
Katherine:
Right. And so, there are lots of resources out there, it’s just asking your healthcare team what they are. Right.
So, these were all really great questions, and we ask our audience to continue sending in questions to question@powerfulpatients.org. And we’ll work to get them answered on future programs.
Dr. Derman, what advice do you have for patients? What would you like to leave the audience with?
Dr Derman:
You know, myeloma is a funny – it’s a funny disease in the sense that patients who were diagnosed 10 years ago, who I still see, they remind me of the action movie where the building is maybe blowing up in the background, blurred out, and they’re running out of the building just in time. And that is because the pace of progress is fast enough in myeloma that we have all these new therapies coming down.
So, really, I think maintaining hope and thinking about – don’t worry so much about what’s going to happen next. Figure out what you’re going to do now, and make sure that you’re living your best life now, and making sure that you’re doing what you can to treat your disease, I think, and help you feel good during that period too.
Katherine:
Yeah.
Dr. Derman:
So, I think it’s a message of hope mainly, that I feel really good about the future of myeloma. There’s a lot of innovation in this space that you can feel good about.
Katherine:
Yeah. Dr. Derman, thank you so much for joining us today. It was a pleasure talking to you.
Dr. Derman:
Likewise. Thanks so much.
Katherine:
And thank you to all of our partners.
To learn more about myeloma and to access tools to help you become a proactive patient, visit powerfulpatients.org. I’m Katherine Banwell. Thanks for joining us.
Questions and Considerations When Making Myeloma Treatment Decisions
Questions and Considerations When Making Myeloma Treatment Decisions from Patient Empowerment Network on Vimeo.
What should be considered when making a myeloma treatment decision? Expert Dr. Jeffrey Matous discusses key factors involved in choosing therapy and provides a list of questions to ask your doctor to guide optimal care.
Dr. Jeffrey Matous is a myeloma specialist at the Colorado Blood Cancer Institute and the assistant chair in myeloma research for Sarah Cannon Research Institute. Learn more about Dr. Matous.
Related Resources:
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Transcript:
Katherine:
What factors impact treatment decisions?
Dr. Jeffrey Matous:
Well, there are so many. One of the key ones is fitness, and fitness is a term that myeloma doctors use and rely on tremendously.
And fitness, more or less, falls into a couple different categories. It’s more complex than that, obviously, but generally speaking, it’s too old or too frail, or young and vigorous and I stress to my patients that vigorous or frail is not determined by chronological age. It’s determined by your physiologic age. That’s really critical, so determining what your patient’s overall fitness is, is really important in myeloma. And then, we have to assess the risk of myeloma. I think we’ll talk about this a little bit later, because not all myeloma is the same and we treat myelomas differently depending on risk, certainly. And then, patient preference is a huge part, because there are so many ways to treat myeloma these days that we explore options with the patients and sometimes patients have pretty strong opinions about, you know, one type of treatment or the other, for example.
Katherine:
What testing should take place following a myeloma diagnosis?
Dr. Jeffrey Matous:
Testing in myeloma is multifaceted, because myeloma can affect patients in so many different ways. For example, it involves radiology studies to look for bone disease, urine work to see if the kidneys are affected by myeloma, a lot of blood work, and then, we also do a lot of testing to make sure that we understand the whole health of the patient, because that comes into play so much when we’re making treatment decisions in myeloma.
Katherine:
What advice do you have for patients and caregivers related to working with their healthcare team in choosing a therapy?
Dr. Jeffrey Matous:
Yeah. I think the big thing is to do some research on your own, but really, ask questions when you see your physician. I mean, ask questions about, for example, what are my treatment options? Are there clinical trials that might be available to me? What’s on the cutting edge in myeloma? What are the standard therapies? What are the pros and cons? And a question I often counsel patients to ask when they’re seeking other opinions is if you had 100 people like me and you treated them this way, how many would do well and how many would not do so well, and prognosis, and so forth. And then, the other thing I think is really important sometimes is gauging how experienced your physician is in treating myeloma, because we actually have data that shows that patients who are treated in myeloma centers actually fair a little better than those who are not.
Involving a myeloma expert in your care doesn’t necessarily mean you have to get your care at that center. It just means you may want a myeloma expert on your team. Pretty much every doctor I know welcomes a myeloma person on their team, because the field is so rapidly evolving. It’s really hard to keep up with for a lot of people.
PODCAST: Myeloma Patient Expert Q&A: Start Here
In this myeloma patient expert Q&A, Mayo Clinic expert Dr. Sikander Ailawadhi provides highlights around the myeloma novel alphabet soup and actionable steps on how patients and care partners can start the treatment conversation.
About the Guest:
Dr. Sikander Ailawadhi is a Professor of Medicine in the Division of Hematology/Oncology at Mayo Clinic Florida.
See More from the Empowered! Podcast
Transcript:
Lisa Hatfield:
Hello and welcome, my name is Lisa Hatfield, your host for this Patient Empowerment Network program. In this important dialogue, we bridge the expert and patient voice to enable you and me as a myeloma patient to feel comfortable asking questions of our healthcare teams with more precision, more precision, the world is complicated, but understanding your disease doesn’t have to be. The goal is to create actual pathways for getting the most out of multiple myeloma treatment and survivorship. Joining me today is Dr. Sikander Ailawadhi, a respected multiple myeloma expert from Mayo Clinic. Thank you so much for joining us today, Dr. Ailawadhi, we really appreciate your time.
Dr. Sikander Ailawadhi:
Thanks a lot, Lisa, for having me, and I look forward to this program.
Lisa Hatfield:
Okay, so before we get started, please remember to download the program resource guide via the QR code, and we are going to jump right into a discussion about some of the novel therapies that there is much buzz about right now, and it’s kind of an alphabet soup these novel therapies. I actually was trying to digest all of this information and divide it into the general categories. And correct me if I’m wrong, but we have monoclonal antibodies, we have bispecific antibodies like the CAR-T therapies, and they target different things. We have BCMA, we have GPRC5D, FcRH5, we have things called antibody drug conjugates and cell mods.
So, Dr. Ailawadhi, if you can just give us kind of a broad overview of these therapies and how they may be used to harness our immune system, and how they come into play when you’re treating your patients, how and when they come into play when treating your patients.
Dr. Sikander Ailawadhi:
Surely, so I think thanks a lot for bringing up that discussion, this is extremely important, and I think it’s most important because if a myeloma patient goes online and wants to search for information or research, these things start coming up this term starts coming up. So it’s extremely important for a knowledgeable and empowered patient to learn about these, understand them, so that they are able to digest that information.
And I should mention that a lot of what we’ll talk about about these particular treatments may not be applicable to newly diagnosed patients or a recently diagnosed patient, but this is important enough and exciting enough that I would want every single patient to pick up this information. Learn it hopefully, and maybe park it for now somewhere, so that hopefully down the road it becomes important and handy. So you asked about monoclonals, bispecific, CAR-Ts, cell mols, etcetera. Let’s take a step back, let’s think about these as strategies to target myeloma.
Myeloma treatment is going through a change where immunotherapy and harnessing the body’s own immune system is becoming extremely important. And when we do that, the immunotherapy is typically very targeted, so what these drugs these agents, these terms, this alphabet soup is doing is it is targeting specific markers on the myeloma cell on the plasma cell.
For example, one of the markers is CD38. There is a monoclonal antibody. There are actually two monoclonal antibodies. Daratumumab (Darzalex), rituximab (Rituxan) that are FDA-approved, but there are other ways of targeting CD38, for example, CD38 targeting CAR-T cells, CD38 targeting antibody drug conjugates, etcetera. So CD38 is one important part. A very, very, very important thing in the past one year or a year-and-a-half has been what’s called B-C-M-A, B cell maturation antigen. BCMA is another target on plasma cells. Very effective, very specific.
So there are many, many drugs that are available and becoming available to target BCMA. Right now, there are three drugs that are FDA-approved that can target BCMA. Two of them are CAR-T cells, a particular way of going after BCMA in which the body’s own T cells are collected. These are not stem cells, these are T cells, T lymphocytes, these T cells are collected, they are actually genetically modified to go and fight against the BCMA, and then those modified T cells are multiplied in the lab and given to the person as a drug, they go and seek the plasma cells because of BCMA kill them harnessing the body’s immune system.
So there are two CAR-T cells against BCMA, one called ide-cel (Abecma) and one called cilta-cel (Avekti). There has recently been available a bispecific antibody against BCMA, we call it bispecific because it connects to BCMA from one end and from a second it connects to the body’s T cells again, bring the T cells close to the plasma cells to kill them. Then bispecific antibodies called teclistamab (Tecvayli). And until recently there was another drug available against BCMA which was what’s called an antibody drug conjugate. This drug is called belantamab (Blenrep) for the timing, belantamab has been removed or withdrawn from the market in the US, but there are ongoing clinical trials and down the road, it may come back again.
Now, antibody drug conjugate is another way of targeting something in which there is a seeker for the BCMA in this case, and it has a payload of some kind of a toxin, so that when the drug connects to the plasma cell through the BCMA in this case, that toxin is released, it can kill the cell, so either we harness the body’s immune cells, the T cells by CAR-T or bispecific, or we kill the cell by releasing a toxic payload from a drug, antibody drug conjugate, these are all different methods of targeting the myeloma cell.
So I talked to you about monoclonal bispecific CAR-T and ADC as different strategies, CD38 and BCMA, some of these strategies are available, but there are other targets which are very exciting and new drugs are being developed against them, two of the very interesting targets there one is called GPRC5D, and the other is FcRH5.
These GPR5CD or FcRH5 are two different targets on myeloma cells. No drugs are currently FDA-approved, but they are being developed very rapidly, and we have a couple of extremely promising agents which will be coming down the pipe. And you also mentioned something called cell mods. Cell mods are some newer drugs in the family of what’s called IMiDs or immunomodulators, in which our patients may be aware of thalidomide (Thalomid), lenalidomide (Revlimid), and pomalidomide (Pomalyst). The cell mods are kind of the same family, and there are a couple of them that are also being developed.
So why is this important for everybody, whether they are newly diagnosed or relapsed or long-term survivor with myeloma, because this tells you that not only are we getting newer drugs in the same classes, we are also getting brand new classes of drugs. And you can imagine that means that those brand new strategies are ways to target the plasma cell, we know cancer cells are smart, and they develop invasive mechanisms to become resistant to drugs. But every time something gets resistant if we have a brand new mechanism to go against the disease, but that’s exciting because that’s why we are seeing deeper responses, even in very heavily pre-treated patients, because we are using newer specific, relatively safe, convenient strategies to going after the plasma cell.
I know that was a lot of information, but I hope this helps our listeners learn a little bit about what you rightly said is an alphabet soup, but I would like us to think about it as an exciting time for being a myeloma doctor, and certainly a very hopeful situation for all our patients.
Lisa Hatfield:
Thank you so much for that great description. And one question comes to mind that I have heard from other myeloma patients, and you mentioned that we are seeing deep responses, or they’re seeing deep responses in clinical trials for some of these in refractory relapse patients.
Do you think that bringing these…do you think it’s possible to bring some of these therapies to the forefront of myeloma care, maybe an induction therapy or after first relapse, and if so, do you think that that could lead to even deeper responses in those patients because their immune system isn’t quite so tired and potentially cure?
Dr. Sikander Ailawadhi:
Again, Lisa, that is such an important and such a spot-on question that you’ve asked because absolutely, you can imagine, if we are thinking of harnessing the body’s immune system, the T cells, but we’re talking about patients who have had five, six, seven, then, prior lines of therapy. But that immune system is also a little exhausted, a little tired, but if you were to use the immune system of a newly diagnosed patient, patient who’s not been created that much…well, those T cells are going to be way more robust. Whether we use a CAR-T kind of strategy where we remove the T cells, train them and put them back, or we use a bispecific kind of strategy where we put in a drug that pulls the T cells closer to the myeloma cells and kills them using these smart thoughtful strategies which are not just dumb drugs that go in and kill everything, these are smart targeted drugs, using them early on in the treatment paradigm will certainly be more beneficial. In fact, there is some data showing up where some of these strategies like CAR-T cell are being used sooner in the treatment paradigm.
But again, as drug development goes, We first want to make sure it is safe, it is effective, and typically the starting point is patients who have exhausted other options, but very soon we will be seeing all of these strategies, and in fact, some of these strategies combined with each other coming in, early lines of therapy and hopefully providing excellent, deep responses, and you mentioned that term that has been very invasive for us cure, I don’t know if we are…
So we are not there yet. I don’t know how long it’ll take us to get there, but there is certainly much more hope today for getting to that cure than it was before.
Lisa Hatfield:
Thank you, and I think as a myeloma patient and on behalf of other myeloma patients, hearing about all of this research and how our immune system is being used to help us, does give all of us hope to keep continuing, and then you want a moving forward. And I think that was probably a good time to step into some questions here that we’ve received from other patients who have written in prior to this program. I will start with those, but I do want to take a step back, first of all, we’re going to kind of talk about a newly diagnosed patient and all of your explanation of all of these different therapies, these are things that typically are talked about later in therapy as of right now.
It also reminds me to tell everybody that there is great importance in seeking out the expertise of a myeloma specialist, I think everybody heard what Dr. Ailawadhi had to say about these therapies, really, even if it’s just when you’re newly diagnosed, going for a consult once and then maybe upon relapse going again, if you don’t live near it, a specialist, seeking out the expertise of a specialist is really critical.
I think I’ve had to do that and I’m so thankful I’ve been able to…we do have resources that we can guide you forward at Patient Empowerment Network, but I think it’s really critical to seek out that expertise of a myeloma specialist. So now we’re going to jump into our questions. So, thank you again, Dr. Ailawadhi.
So we have a patient asking for newly diagnosed patients, say a patient comes into you, maybe they were sent by their community oncologist or a family practitioner, something…I have myeloma, doesn’t know anything about it. Have even heard of it before. How do you start that conversation? How did you explain myeloma and the treatment and very importantly to the patient, how do you explain the prognosis when you know it’s not curable yet?
Dr. Sikander Ailawadhi:
An extremely important question. And I agree that we should be starting at the beginning, so I think I had the privilege of working at an institution where we tend to spend a lot of face time with the patient, so typically in the outpatient, I have at least about an hour of time blocked is how we’re set up.
So at that visit, first of all, I’m hoping that a patient comes in with a caregiver, but if they don’t have a caregiver with them, I start off by asking them, Is there someone they would like us to call during the visit? Because it is always better to have a caregiver or an extra set of ears listening in, and once that has started, then I typically will explain to them literally from what is a plasma cell, what is the role of a normal plasma cell, because that tells us the type of proteins plasma cells produce.
And that leads us to how a plasma cell can become cancerous and lead to multiple myeloma, what are the signs and symptoms of multiple myeloma? What are the markers, these protein markers that come in the blood and are picked up as markers of disease for patients, because again, patients need to know what they’re looking for in the labs that are drawn, so very frequently.
We talked about the role of a bone marrow biopsy, a lot of times it has been done, sometimes it has to be done after that visit, we talk about the genetic mutations in plasma cells that can be seen because that is what helps determine the risk category of standard risk or high risk.
I do offer to patients about discussing the prognosis, again, it’s a good time where we know that the average survival of patients is close to about 8 to 10 years when they look at a general national data, U.S. data, but all the large centers, all of us who focus on myeloma, we have several patients who are living quite a bit in excess of 10 years, so more hopeful time, but it is important to put that prognosis in perspective with high risk or standard risk disease that can be determined based on mutation testing from the plasma cells from the bone marrow, something called the FISH test, part of it is to explain to the patient the prognosis, but other reason is also because sometimes that can determine the type of treatment, and this also importantly tells the patients about their disease much better, so they can be more educated, they can interact with other patients, they can ask the right kind of questions, and they can understand their disease process and follow-up better.
Now, after we have discussed all of this, we start talking about treatment, I can tell you when I talk to a newly diagnosed patient, I will tell them that in my way of thinking their treatment initially is broadly divided into three different discussions during three different visits. The initial visit is talking about any symptom or sign from the myeloma, increased calcium, kidney dysfunction and tumors, how are we going to tackle that? So we will come up with the right “induction regimen.”
I really don’t think one-size-fits-all, so based on the patient’s age, comorbidities, other diagnosis or the treatment drugs, family support system, financial situation, there are so many factors that go into it. We come up with an induction regimen, I’ll tell them that the second component is about controlling all the symptoms and manifestations of the disease, whether that means radiation therapy, bone-strengthening agents, multivitamins, minerals, whatever we need to do as supplements, then we’ll talk about…starting that treatment. What does it involve? Side effects, we will set that path, you will notice I have not even talked about transplant, and I’ll tell the patients that only thing I mentioned to patients in that first planning, visitors and down the road, we will be talking about transplant…
Today is not the time, because, in my experience at the moment, we start talking about bone matter, transplant, stem cell transplant everything goes out the window. That’s what patients think about…and I don’t want them to do that. The second part of my discussion comes around a month or so into the treatment, because by then we want to start seeing some responses, some symptoms turning around, but that month two to three is very importantly the time to rebuild things.
Does the patient need to go to physical therapy, pain control? Supportive or palliative care services? Lipoblasty or tuboplasty to strengthen their spine. I mentioned physical therapy, I’ll say it again, because I really think that’s very, very, very important for controlling the pain and supporting the movement and quality of life, managing any side effects, making sure that the dose is correct, do we need to tweak the doses, etcetera. And at that visit is tell them that, “Okay, very soon we will be talking about…we’ll be going into the details of a transplant, we will be passing along more information to you. But at your next visit, which would be probably at that two- to three-month mark, two- to three-cycle mark,” is when I will really sit and talk to them about our transplant…
So for me, the main transplant discussion comes at that cycle to recycle the two to three, two to three cycles have already gone and patients feeling better, they are much more receptive for the next phase of treatment, which is when we talk about transplant, that’s how I do it, typically. And then we’ll explain a lot about what this transplant need…what does it involve? Caregiver needs a supportive care, vital organ testing, bone marrow biopsy, response depth, MRD, all of that.
So for me, this is kind of the journey that a patient, newly diagnosed patient goes through for the first few months, then their transplant, then their maintenance and hopefully good long disease control state.
Lisa Hatfield:
Great, how often do you expect a patient will have to have appointments during that…talk about the induction phase, the first month to three months, how often do you think they will have appointments, whether it’s for treatment or to come see you? What should they expect that way?
Dr. Sikander Ailawadhi:
Sure, so the regimens that we typically use in myeloma, some of them, the drugs are given twice a week, a majority of the way we give the drugs, it’s once a week, so one to two times a week would be visits, we do the labs for the first month, we will do sometimes every week, but by the time the patient has gone to the second or third cycle, once every two to four weeks, labs are reasonable because by then things have stabilized, but the treatment still would, I think the once or twice every week depending upon the regimen that they have, we don’t typically see the patient for a clinic appointment every time, but a lot of centers do, so every time the patient comes, as I said, one to two times a week, typically that translates to about four visits in every three to four weeks they coming on the cycle, some regimens are three week regimens, some regimens are four week regimens, etcetera.
So patients come, I can say that the first one to two months are most intensive for follow-up for labs, we want to make sure everything’s been fine, been start reading the treatment, they are not having side effects it and etcetera, and then things can be spaced out a little bit for the next couple of months before we go into the transplant thing, if the patient is going for transplant.
Lisa Hatfield:
Okay, well, great. Thanks for that information. It helps patients plan a little bit better to their life around myeloma and myeloma treatment, so we have a pretty specific question here about amyloidosis, so how often does amyloidosis occur in myeloma patients, and does it change the treatment if they do have amyloidosis?
Dr. Sikander Ailawadhi:
Excellent question again. So I would like to clarify that amyloid is a specific kind of different kind of abnormal protein that can be produced by plasma cells. All of us have these proteins that are…these proteins that are developed as very…or produced in the body is very small molecules and then they fold upon themselves to make different building blocks for the body. If that folding process is misfolded or abnormal, these amyloid fibers can develop and they can deposit anywhere in the body, and whatever the deposit they cause their symptoms. Now, amyloid can be present in two different ways, either amyloid is the primary problem and is being produced by the plasma cells, or sometimes patients who have multiple myeloma and are on treatment for multiple myeloma can either start developing some amyloid protein or…or they can have amyloid deposited in certain organ, heart, kidneys, like the gut, etcetera, the occurrence of amyloid in a myeloma patient, it’s not a common phenomenon, I would say anywhere in 10 to 15 percent of cases that we know of, maybe this present, others that we don’t pick, but once even we find out that amyloid is present in a case of multiple myeloma.
If, for example, amyloid is present in the heart, if we are using any drugs that may have some heart-related side effects, we may need to adjust doses, if amyloid is present in the kidneys, if you’re using some drugs that have kidney-related implications, we may need to adjust the dose, etcetera, broadly, the treatment stays the same, but there is a higher risk to kidneys, higher risk to heart, etcetera in amyloid patients or patients who develop amyloid, so we have to take that into account, sometimes choice of treatment changes, sometimes dose of treatment changes sometimes impact on certain organs change broadly. For a myeloma patient who develops amyloid, the treatment can stay very similar to what would have happened even if amyloid was not present, except some small tweaks.
Lisa Hatfield:
All right, thank you. Another question from a patient since my diagnosis and bone marrow transplant, my teeth have been deteriorating, is there a connection between dental health and myeloma?
Dr. Sikander Ailawadhi:
Very important question because although this is not a very common finding, it is something that really affects quality of life, so myeloma itself does not always or frequently cause teeth problems or dentition problems, which you can imagine teeth are bones. Myeloma affects bones, Myeloma affects calcium deposition in bone so teeth can get damaged in two or three different ways in myeloma patients, first, if myeloma involves the job or you can imagine that the teeth in that particular area could become loose or they could become a little off because the structure is getting affected.
Sometimes if my novels present on the job, for example, and radiation is given, but that bone becomes weaker, so teeth can become weaker, another way myeloma and dental health can be connected is because we use certain bone-strengthening agents for myeloma. These drugs are called either bisphosphonates, for example, or zoledronic acid (Zometa) or pamidronate acid (Aredia), patients may know as Zometa or Aredia, or there’s a second category called RANK ligand inhibitors, one of the drugs there is denosumab or Xgeva, these are all drugs that are given for bone-strengthening for myeloma. Patients are recommended to take calcium and vitamin D, but a rare but definitive side effect that is known to happen or can happen with these drugs is what’s called osteonecrosis of the jaw, where basically the jaw bone is becoming necrosed or less viable.
And you can imagine if the jaw is less viable, the teeth that go into the jaw in that spot, they’ll become loose and hurt, painful…it’s not a good condition to have it very…it affects quality of life significantly. So while it is rare, this osteonecrosis of the jaw can occur maybe less than 10 percent of the cases, but it is a significant morbidity-causing issue.
What I recommend to patients is that one, if that is happening, first of all, we’re not…we typically don’t continue that drug that is causing it, like a bisphosphonate or RANK ligand inhibitor. Secondly, the patient needs to see a good oral maxillofacial surgeon or a good dentist, preferably someone who has knowledge and experience in handling osteonecrosis of the jaw. So different ways in which myeloma treatment can affect the jaw, there is not a direct correlation, but in about 10 to 15 percent of cases, there may be jaw or teeth-related implications in myeloma patients either from the disease or its treatment like radiation or bone-strengthening drugs.
Lisa Hatfield:
Okay, thank you, and that’s a great segue into the next question we have from a patient, so if a patient cannot take bisphosphates doesn’t explain the reason why, are there other bone-building therapies that are recommended to protect them?
Dr. Sikander Ailawadhi:
Sure, so I would say that while we talk about these drugs like bisphosphonates, RANK ligand inhibitors, there are some other drugs that can be used to strengthen the bones, because you can imagine these bone-strengthening agents are used in a lot of different cancer, breast cancer, prostate cancer, etcetera.
So this family of drugs can be used, there are some that are used less frequently, but can be used instead of bisphosphonates and denosumab, but I would bring the patients back to even more basic stuff, calcium, vitamin D, exercise, bone-strengthening exercise. These are the first steps. Then come the other bone-modifying drugs, so even if a patient has been told that they cannot get any of those drugs because of the side effects, they could certainly say calcium vitamin D after discussing with their doctors, and they can regularly do some bone-strengthening building exercises sometimes it’s as simple as swimming, as simple as spinning, but those are like on the stationary bike, but those are extremely important activities to help build bone mass.
Lisa Hatfield:
All right, thank you. Have you ever had a patient that has reached complete response that you said, Well, maybe you don’t need to continue on bisphosphonates, that ever an option for patients to not continue after a certain period of time?
Dr. Sikander Ailawadhi:
Again, excellent question. And, in fact, historically, all the bisphosphonate-related clinical trials had up to a two-year follow-up, so a lot of times we used to say, “Well, at two years we need to stop them because there’s no safety data beyond that.” But more recently, there are studies that have shown that even every three months of bisphosphonates is as good as every month. So if somebody has active bone-affecting myeloma, then their treatment can be given every month or every three months.
But if a person has gone into remission, and remember, the myeloma was the inciting event that was causing the bone loss, if there is no disease, if there are no active bone lesions and the person is in good health, they are active…no bone-related issues. You’ve done imaging. Everything is good. I think it certainly it can be done that the bisphosphonate can be stopped. And, of course, this needs to be actively discussed with the patient, but frankly, other than having the side effect concern, if I can have a patient not come in for a treatment and they can spend that much extra time with their family doing what they want to…I think that’s a win-win.
Lisa Hatfield:
All right, thank you. So another patient asking, I was told I’m in remission, but my light chain numbers are going up and the lambda is low. Are small fluctuations common?
Dr. Sikander Ailawadhi:
Very good question. And very important to keep in mind, yes, small fluctuations in light chains can happen as the patient mentioned, they said their light chain are going up, but lambda is low, so I’m assuming they’re talking about their kappa light chains higher and the lambda low. For light chains, the most important thing is that we don’t want just an individual isolated value, we want to see a trend if there is an upward trend in one of the values, the abnormal light chain, that is certainly a concern if the involved or the higher light chain is stable.
But the uninvolved or the lower light chain continues to go down. Well, that is still of concern, but may not mean that the disease is coming back, it may mean that the immune system is getting affected a little. All said and done, light chains are very volatile, they are very…they can fluctuate, they can get affected by our kidney function, they can get affected by our hydration status. So if there is a concern with light chains, they should be re-checked and there is a persistent movement of light chains in a certain direction that is an important time to figure out, is the disease coming back or is there another reason that the light chains are changing.
Lisa Hatfield:
Okay, how often do you check those labs in your patients, their light chain?
Dr. Sikander Ailawadhi:
For somebody who’s on active treatment, we check the light chains, we do the whole panel of myeloma lab reassessment with? Electrophoresis, immunoglobulins, light chains, we do that on a monthly basis for somebody who’s on active treatment, that they are… Some patients who are on maintenance and who are doing perfectly fine, and they typically come every three months to clinic visits on maintenance over there, although I prefer to check them every month, but I certainly know logistic challenges and frequency, so sometimes in selected cases, we’ll check it every three months, but in a patient who has been diagnosed with myeloma on treatment or has been on treatment before, personally, I don’t go beyond three months in any case.
Lisa Hatfield:
Okay, those are good guidelines for patients looking forward, especially newly diagnosed patients. All right, what are we learning about monosomy 13 in myeloma, is it a high-risk marker for myeloma?
Dr. Sikander Ailawadhi:
So, Lisa I think that’s an extremely important question because there has been historically a lot of discussion about a deletion 13, monosomy 13 deletion 13, meaning a portion of the 13th chromosome missing. Monosomy 13 meaning one…so half of the chromosome missing, because everybody has two of each chromosome, one set from the father, one from the mother, so one set is missing, that is monosomy, or one arm is missing its monosomy if a portion of the chromosome is missing deletion. Historically, quite some years ago, deletion 13 or monosomy 13 was in itself a high-risk marker, then the drugs or called the pareso inhibitor family, in which one of them is bortezomib came about and it showed that whether the patient had deletion 13 or not outcomes were similar when they got bortezomib so, it was no longer a high-risk marker.
In current day and age, there are certain mutations that are considered high risk, monosomy 13 or deletion 13 by itself is not considered a high-risk marker, but the co-presence of deletion 13 or monosomy 13 with some other mutations is considered higher risk just because it is telling us about more widespread genetic damage in the myeloma genetic material.
So for example, if somebody has a mutation called 1-Q, as some patients may read in their FISH report, if that 1-Q co-exists with deletion 13 or month, the risk of that one can is even higher. So by itself modulators, but it’s co-existence, but some other mutations bring up the risk category higher.
Lisa Hatfield:
Okay, thank you. And just to clarify for maybe somebody who’s just learning about their myeloma diagnosis and the cytogenetics of that, when you’re talking about these mutations, are you specifically talking about these mutations are only in the myeloma cells, they aren’t all in their body, and they’re overall in any other cells, just the myeloma cell.
Dr. Sikander Ailawadhi:
Absolutely, you’re spot on. So these mutations that are tested in the abnormal plasma cells from the bone marrow, which the term used for that is somatic mutation, disease-related mutations in the disease cells, these are not mutations that we were born with or we inherited, so if somebody was to take a sample from a healthy blood cell or in my lumping shop from the mouth or a spit sample that is not expected to carry these mutations, it is only the cancerous abnormal plasma cells from the bone marrow or a myeloma cell that have these mutations.
Lisa Hatfield:
All right, thanks for clarifying that. Great, what are some of the clinical predictors for relapse in myeloma and when should patients speak up?
Dr. Sikander Ailawadhi:
Okay, so when we say clinical predictors of relapse, well, let me look at this from the standpoint of a patient’s been diagnosed, they’ve been treated, which patients are more likely to relapse is one way of looking at, and if we are looking for our following up, Iain, what are we monitoring to look for relapse. So I’ll address mutates very quickly. So when we say what are the predictors of earlier relapse, the most important things that we know of are on any of the high-risk mutations we’ve been talking about, the fact that it’s standard of care to look for any genetic mutations in the center diseased plasma.
So the myeloma cells, presence of any high-risk mutations, for example, there’s one called deletion 17p to certain chromosome mutations like 14;16 translocation, etcetera. Patients should be aware of what mutations their plasma cells have, having high-risk mutations, risk of early relapse or short duration of response. Similarly, if a patient does not get a deep response to their prior treatment, they are more likely to come out of that response state sooner. One of the tests that has recently been used over the past few years, there’s something called the MRD test, minimal residual disease test, looking for one myeloma cell out of 100,000 or even one million bone marrow cells.
If somebody’s MRD-negative, they are more likely to have a longer duration of response. If they’re MRD-positive, meaning detectable disease on MRD test, comparatively shorter duration of response, etcetera. So these are predictors of earlier relapse, there are some other predictors like kidney dysfunction, and typically that happens if somebody has persistent kidney dysfunction because they don’t typically get access to all the drugs, typically relapse occurs sooner.
Now, when somebody is getting monitored for their disease, as I mentioned, we do labs every so frequently every month, every two months, every three months. That is what involves all the myeloma markers, serum electrophoresis is to look for M spike, free light chains, look for light chain changes. We know globules look for increases in immunoglobulins, and that’s what helps pick up the recurrence of the disease.
Lisa Hatfield:
Why do some myeloma patients experience chronic kidney disease?
Dr. Sikander Ailawadhi:
So Lisa, I think that’s a very important question. Kidney dysfunction can be seen in as much as 20 percent of patients at the time of diagnosis, and there are a significant number of patients who would have kidney dysfunction even as they go on with their myeloma journey. And something that I work on quite a bit, and I’m interested in this healthcare disparities. I just want to point out that patients who are African Americans do tend to have a much higher incidence of kidney dysfunction and need for kidney dialysis with myeloma at the time of diagnosis or even with treatment. Now, I mentioned that these…or we discussed previously that these plasma cells, that normally live in the bone marrow, they produce these proteins and these proteins, heavy chains, light chains are part of our body’s immune system. But when these plasma cells become cancerous, they produce a higher amount of those abnormal proteins, these proteins circulate in the blood, and they frequently get depositing the kidneys.
So when these proteins are very high in number, an amount, these proteins can circulate in the blood and clog up the kidney tubules, and that’s where some chemical reactions also happen and kidney damage can occur. When somebody gets diagnosed with myeloma and they have kidney dysfunction, we have the option of the opportunity to reverse that kidney dysfunction if we treat the disease appropriately and with the right kind of drugs fast enough.
In fact, there is some older data study data, which shows that within the first two months, we are able to reverse the kidney function, then it is no longer a prognostic significant marker. And it’s extremely important if somebody’s kidney function is getting affected by their myeloma, that they need to be treated very aggressively to try and salvage and save that kidney function because the longer the kidney dysfunction stays, it is quite possible that it may become irreversible.
Lisa Hatfield:
Okay, thank you. So this next question has to do with the sequencing of treatments, which again, speaks to the fact that it’s super important to see a myeloma specialist, but the question is what treatments are available for myeloma patients who relapse after care?
Dr. Sikander Ailawadhi:
Very, very important question, and unfortunately a tough situation that we are dealing with because CAR T initially has been used for later lines of therapy as it is currently FDA approved with time, hopefully it will start making it may sooner in the treatment also, but when a person…when a patient has had treatment with CAR T, generally, they have already had treatment with most of the standard available drugs prior to CAR T, because the way CAR T is currently FDA approved is the patient has to have at least four prior lines of therapy, and generally, at least in the U.S. system, with the first three to four regimens or lines of therapy, we’ve already seen and exhausted most of the available drugs.
So you can imagine most CAR T, there is less drug availability that the patient has not had before or may not be resistant to, but if the CAR-T response lasted long enough, sometimes we are recycling some of the drugs after previously used, and the patient may respond to them again.
Another thing to think about in that place is from my standpoint, clinical trials are extremely important and patients must seek clinical trial options, as you mentioned, again, important to see a specialized myeloma center, but one of the drugs that was approved in 2022 bispecific antibody, teclistamab (Tecvayli), and there are some other related by specific antibodies which have actually shown some benefit despite the fact that they also target BCMA, which art targets, but patients who had prior BCMA therapy still had a very good response rate to, for example, teclistamab or some other…bispecific antibodies in clinical trials, so I don’t say that everybody who’s been treated with a BCMA CAR T should go immediately to a BCMA and bi-specific may not be the best option in all cases, but sometimes recycling older drugs in certain different combinations, clinical trials or options promising options like bispecific antibodies. We do have more jobs today than even what we had a year ago for patients who are progressing after CAR T-cell therapy.
Lisa Hatfield:
And that is really promising, I think as more and more people get CAR T-cell therapy and perhaps start to relapse. It is great to know that there are other options out there. They’re even, like you said, recycling some of those prior regimes that were used, and even talking about CAR-T therapy or clinical trials, this next question has to do a little bit with the disparity and access for myeloma treatment.
So the question is, myeloma treatment is expensive, with quadruplet therapy options, what measures are being taken that can help patients to have equal access, and I think that we can also add clinical trials to that too. Is there anything being done, or how can you encourage patients to have equal access, whether it’s the drugs themselves or clinical trials?
Dr. Sikander Ailawadhi:
So absolutely, I think, Lisa, that’s an extremely important question as I mentioned, this area of healthcare disparity in health care, inequity, for example, is something I’ve spent a lot of time doing my research my career and publishing in this area. Unfortunately, in today’s day and age, we still have a lot of these disparities that exist, patients may not get access to the right drug or the right time because of their geographical region, because of their insurance, their education status, socioeconomic status, and sometimes even in other…situations being similar, just their race and ethnicity. Age is an important factor.
Also, I would say there…I think the important part is that it is much more knowledge, awareness, and intent to do something about it now, there’s, for example, in the forthcoming clinical trial that should be opening for really diagnosed patients across the country, soon through NCI and CTAC where the trial has been specifically designed to do it in as close to real world setting as possible, and when we were writing that trial, there’s a specific racial, ethnic minority accrual plan that we are writing around it, and that’s not…I would say just that trial, there are trials that are now specifically going in trying to enroll patients as much as possible from the real world and all walks of life.
And that’s said. I think the bigger question comes, like you started the question by asking the trials are there…we are trying to make a difference for trying to make some changes, changing the inclusion criteria so that patients would even now our accounts can go in, etcetera, etcetera. What about the drugs that are already available, quadruplet therapy, which is a pretty, I would say, demanding approach, because the patient needs to get multiple drugs multiple times, frequent visits back and forth to the clinic, co-payments office visits, labs, etcetera. It’s not easy.
Unfortunately, there are certain groups within our society that would have difficulty getting those access, but there are lots of resources that patients and caregivers can access, and hopefully those…help share some of the burden. These are either from the pharma companies or they could be from foundations or societies like the The Leukemia & Lymphoma Society and several other such concerns whose goal is to try and provide an equitable and just access to the drugs and how to get the most evidence-based treatment to every single patient.
So there are quite a few of these efforts in our practice, what we strongly recommend is that the patients, of course, get this knowledge and information through support groups, through their physicians, but also searching for this information online or in a lot of the larger institutions, meeting with the social worker frequently helps gain access to our information about a lot of these resources. So I think a lot of work has been done there, but to bring it down to an individual patient’s level, how can I as a patient get access to something…
I think the patients will have to ask those questions either from their physician, their care team, a social worker, online resources, support groups, that information is out there, we are trying our best to get it to patients that hopefully patients can seek out some of that as well.
Lisa Hatfield:
Thank you for that. I think that’s a really important thing to bring up is the access to healthcare, we do have people in our local area, because we are a smaller community, were unable to seek out the care of a specialist and it has had a detrimental effect on their outcomes. And so I think having that discussion and being open to your patients so you can’t have a discussion or even refer them to the social worker is so important, so all patients get equal access, it’s one less thing that patients have to worry about when they’re already…stressed and overwhelmed with their diagnosis, so thank you for explaining that. Thanks for talking about that. We sure appreciate it.
So for myeloma patients, even though our insurance companies, sometimes we have to argue with them a little bit as if we’re beating down doors to get a bone marrow biopsy, nobody loves those, I’m not sure why insurance companies think we would actually want that. But what do you see in the future, I know there’s talk about mass spectrometry. Every myeloma patient would love to hear the words, you’ll never have to have another bone marrow biopsy.
Do you see a future in that and some of these newer tests that are coming out?
Dr. Sikander Ailawadhi:
Sure, I think that’s absolutely important to know because…yes, that’s the bane of our existence, unfortunately, disease primarily lives inside the bone marrow, so to get the true information…that’s where you go. So there are some tests that are being developed or researched, patients may have heard about what’s being termed, the liquid biopsy or taking a blood sample to identify plasma cells or disease, there’s a lot of research going on around it. But, unfortunately, it has not panned out yet, because by nature, plasma cells do not circulate in the blood, or if they circulate, it’s a very, very small amount, so it’s hard to pick it up from the blood and do the tests on it. But there’s a lot of research going on for it to get the plasma cells, get the FISH testing, and all the genetic testing from the blood. So stay tuned, hopefully we’ll get in that direction.
What you also mentioned, a test that’s been developed and done at Mayo Clinic is what’s called m-aspect or looking at these proteins, these M spikes, these light chains, the IgGs, etcetera. Looking at them at a molecular level and separating them based on their weight, because IgG kappa, for example, from one patient may be different from the IgG kappa that came from a different patient, but they can be separated out based on the weight, based on the molecular weight…on the size, and that can sometimes be used that how the test has been developed to use that property to identify and almost catalog and tabulate and follow that patient’s protein, so that we can hopefully collect or detect a recurrence sooner, note a deeper response to the treatment.
And in the future, hopefully, use that depth of response and that earlier recurrence as…or earlier detection of the protein as a surveyable matter of recurrence. I still think that it’s two different things, one is to look at the protein and note it at a deeper level to know whether the patients responded or relapsing, but so far, if you want to do those rotation testing, the FISH testing, and look at some of the characteristics of the myeloma, unfortunately, we do have to go to the bone marrow, but down the road, I’m hoping that those liquid biopsies and the blood tests will hopefully make it happen.
Lisa Hatfield:
Well, that would be music to my ears, even fewer biopsies would be great, so that would be awesome. Well, this was a great conversation, Dr. Ailawadhi, thank you so much on behalf of myself, and I’m sure a lot of myeloma patients and family members watching this, they’re so thankful and grateful for the time that you spend with us answering these questions, so thank you very much for your time, thanks for your expertise and I hope you enjoy the rest of your afternoon.
Dr. Sikander Ailawadhi:
Thanks a lot, Lisa. Thanks for having me, and I hope this was beneficial and interesting for the patients and their caregivers.
True Patient Empowerment: Bridging the Myeloma Patient and Expert Voice
Multiple myeloma can sometimes feel overwhelming and complicated, but what can patients and care partners do to help improve their care? With this question in mind, the Patient Empowerment Network initiated the START HERE Myeloma program, which aims to bridge the myeloma patient and expert voice to build empowerment.
START HERE Myeloma Program Resources
The program series includes the following resources:
- START HERE Patient-Expert Q&A Webinar with expert Dr. Sikander Ailawadhi moderated by a myeloma patient
- START HERE Library with a robust library of digestible video content that merges the expert and patient voice
- Your START HERE 90-Day Plan personalized 90-day plan with resources from trusted advocacy partners
- START HERE Activity Guide a downloadable, printable support resource packed with information to educate, empower, and support myeloma patients and care partners in their journeys through care
- START HERE Text Alerts to receive personalized support from PEN Empowerment Leads
Patient-Expert Q&A Webinar Topics and Key Takeaways
In the PatientExpert Q&A webinar, renowned multiple myeloma expert Dr. Sikander Ailawadhi from the Mayo Clinic shares his expert knowledge to help patients and care partners fortify their knowledge and confidence, while myeloma patient and Empowerment Lead Lisa Hatfield moderates the discussion and shares some of her views as a patient. Dr. Ailawadhi and Lisa provided some in-depth discussion along with key takeaways. Some of the discussion covered:
- Diagnosis and treatment topics covered for newly diagnosed patients
- Overview of novel myeloma therapies and research updates
- Mutational markers in myeloma and clinical predictors of relapse
- Access to multiple myeloma clinical trials
- Recommended bone-building therapies for patients
- Fluctuations in light chain numbers
- The outlook for frequency of biopsies
- Treatment response with myeloma therapies
- Treatment options for myeloma patients who relapse after CAR-T therapy
- Frequency and treatment considerations with amyloidosis
- Incidence of kidney dysfunction and healthcare disparities
- Outlook for the future of multiple myeloma care
Among some key points, Lisa shared her perspective about seeing a myeloma specialist, “There is great importance in seeking out the expertise of a myeloma specialist, even if it’s just when you’re newly diagnosed, going for a consult once and then maybe upon relapse going again, if you don’t live near it, a specialist, seeking out the expertise of a specialist is really critical.”
Dr. Ailawadhi provided his expert perspective about recent developments in multiple myeloma research and treatments. “Myeloma treatment is going through a change where immunotherapy and harnessing the body’s own immune system is becoming extremely important. And when we do that, the immunotherapy is typically very targeted, so what these drugs these agents, these terms, this alphabet soup is doing is it is targeting specific markers on the myeloma cell on the plasma cell.”
Dr. Ailawadhi also shared his excitement about the future of myeloma care. “So why is this important for everybody, whether they are newly diagnosed or relapsed or long-term survivor with myeloma, because this tells you that not only are we getting newer drugs in the same classes, we are also getting brand new classes of drugs. And you can imagine that means that those brand new strategies are ways to target the plasma cell, we know cancer cells are smart, and they develop invasive mechanisms to become resistant to drugs. But every time something gets resistant if we have a brand new mechanism to go against the disease, but that’s exciting because that’s why we are seeing deeper responses, even in very heavily pre-treated patients, because we are using newer specific, relatively safe, convenient strategies to going after the plasma cell.”
Dr. Ailawadhi has also been very involved in researching and working to improve healthcare disparities, and he shared some of this knowledge during the webinar. “Kidney dysfunction can be seen in as much as 20 percent of patients at the time of diagnosis, and there are a significant number of patients who would have kidney dysfunction even as they go on with their myeloma journey. I’m interested in these healthcare disparities. I just want to point out that patients who are African Americans do tend to have a much higher incidence of kidney dysfunction and need for kidney dialysis with myeloma at the time of diagnosis or even with treatment.”
Some program participants provided valuable testimonials about the START HERE Myeloma Patient-Expert Q&A webinar.
- “I have been a myeloma patient for 8 years. This was one of the best webinars I have listened to. The speaker was excellent and the questions presented were great! Thank you for a wonderful session!”
- “This program was well thought out and I felt like Lisa was reading my mind! Super job. It makes living with a serious condition a little less scary when you see so many people have the same questions as you.”
- “Thanks for a great discussion. It felt like it wasn’t a lecture, but a conversation. Lisa is an inspiration to our support group members in South Carolina. We will be sharing this when we meet next week.”
We hope you can use these valuable multiple myeloma resources to build your knowledge and confidence toward becoming a more empowered patient or care partner.
Myeloma Expert Explains Diagnosis and Treatment for Newly Diagnosed Patients
Myeloma Expert Explains Diagnosis and Treatment for Newly Diagnosed Patients from Patient Empowerment Network on Vimeo.
How can newly diagnosed multiple myeloma patients be oriented to their diagnosis and treatment? Dr. Sikander Ailawadhi from the Mayo Clinic shares key points he explains to patients about myeloma origination, tests, symptoms, treatment, and ongoing care.
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Transcript:
Lisa Hatfield:
So now we’re going to jump into our questions. So, thank you again, Dr. Ailawadhi. So we have a patient asking for newly diagnosed patients, say a patient comes into you, maybe they were sent by their community oncologist or a family practitioner, something…I have myeloma, doesn’t know anything about it. Have even heard of it before. How do you start that conversation? How did you explain myeloma and the treatment and very importantly to the patient, how do you explain the prognosis when you know it’s not curable yet?
Dr. Sikander Ailawadhi:
An extremely important question. And I agree that we should be starting at the beginning, so I think I had the privilege of working at an institution where we tend to spend a lot of face time with the patient, so typically in the outpatient, I have at least about an hour of time blocked is how we’re set up. So at that visit, first of all, I’m hoping that a patient comes in with a caregiver, but if they don’t have a caregiver with them, I start off by asking them, Is there someone they would like us to call during the visit? Because it is always better to have a caregiver or an extra set of ears listening in, and once that has started, then I typically will explain to them literally from what is a plasma cell, what is the role of a normal plasma cell, because that tells us the type of proteins plasma cells produce.
And that leads us to how a plasma cell can become cancerous and lead to multiple myeloma, what are the signs and symptoms of multiple myeloma? What are the markers, these protein markers that come in the blood and are picked up as markers of disease for patients, because again, patients need to know what they’re looking for in the labs that are drawn, so very frequently.
We talked about the role of a bone marrow biopsy, a lot of times it has been done, sometimes it has to be done after that visit, we talk about the genetic mutations in plasma cells that can be seen because that is what helps determine the risk category of standard risk or high risk.
I do offer to patients about discussing the prognosis, again, it’s a good time where we know that the average survival of patients is close to about 8 to 10 years when they look at a general national data, U.S. data, but all the large centers, all of us who focus on myeloma, we have several patients who are living quite a bit in excess of 10 years, so more hopeful time, but it is important to put that prognosis in perspective with high risk or standard risk disease that can be determined based on mutation testing from the plasma cells from the bone marrow, something called the FISH test, part of it is to explain to the patient the prognosis, but other reason is also because sometimes that can determine the type of treatment, and this also importantly tells the patients about their disease much better, so they can be more educated, they can interact with other patients, they can ask the right kind of questions, and they can understand their disease process and follow-up better.
Now, after we have discussed all of this, we start talking about treatment, I can tell you when I talk to a newly diagnosed patient, I will tell them that in my way of thinking their treatment initially is broadly divided into three different discussions during three different visits. The initial visit is talking about any symptom or sign from the myeloma, increased calcium, kidney dysfunction and tumors, how are we going to tackle that? So we will come up with the right “induction regimen.” I really don’t think one-size-fits-all, so based on the patient’s age, comorbidities, other diagnosis or the treatment drugs, family support system, financial situation, there are so many factors that go into it.
We come up with an induction regimen, I’ll tell them that the second component is about controlling all the symptoms and manifestations of the disease, whether that means radiation therapy, bone-strengthening agents, multivitamins, minerals, whatever we need to do as supplements, then we’ll talk about…starting that treatment. What does it involve? Side effects, we will set that path, you will notice I have not even talked about transplant, and I’ll tell the patients that only thing I mentioned to patients in that first planning, visitors and down the road, we will be talking about transplant. Today is not the time, because in my experience at the moment, we start talking about bone matter, transplant tenants, everything was out the window. That’s what patients think about…and I don’t want them to do that.
The second part of my discussion comes around a month or so into the treatment, because by then we want to start seeing some responses, some symptoms turning around, but that month two to three is very importantly the time to rebuild things. Does the patient need to go to physical therapy, pain control? Supportive or palliative care services? Lipoblasty or tuboplasty to strengthen their spine. I mentioned physical therapy, I’ll say it again, because I really think that’s very, very, very important for controlling the pain and supporting the movement and quality of life, managing any side effects, making sure that the dose is correct, do we need to tweak the doses, etcetera. And at that visit is tell them that, “Okay, very soon we will be talking about…we’ll be going into the details of a transplant, we will be passing along more information to you. But at your next visit, which would be probably at that two- to three-month mark, two- to three-cycle mark,” is when I will really sit and talk to them about our transplant…
So for me, the main transplant discussion comes on that cycle to recycle the two to three seconds have already got in patients feeling better, they are much more receptive for the next phase of treatment, which is when we talk about transplant, that’s how I do it, typically. And then we’ll explain a lot about what this transplant need…what does it involve? Caregiver needs a supportive care, vital organ testing, bone marrow biopsy, response depth, MRD, all of that.
So for me, this is kind of the journey that a patient, newly diagnosed patient goes through for the first few months, then their transplant, then their maintenance and hopefully good long disease control state.
Lisa Hatfield:
Great, how often do you expect a patient will have to have appointments during that…talk about the induction phase, the first month to three months, how often do you think they will have appointments, whether it’s for treatment or to come see you? What should they expect that way?
Dr. Sikander Ailawadhi:
Sure, so the regimens that we typically use in myeloma, some of them, the drugs are given twice a week, a majority of the way we give the drugs, it’s once a week, so one to two times a week would be visits, we do the labs for the first month, we will do sometimes every week, but by the time the patient has gone to the second or third cycle, once every two to four weeks, labs are reasonable because by then things have stabilized, but the treatment still would, I think the once or twice every week depending upon the regimen that they have, we don’t typically see the patient for a clinic appointment every time, but a lot of centers do, so every time the patient comes, as I said, one to two times a week, typically that translates to about four visits in every three to four weeks they coming on the cycle, some regiments are three weeks regiments, some regiments are four week regiments, etcetera.
So patients come, I can say that the first one to two months are most intensive for follow-up for labs, we wanna make sure everything’s been fine, been start reading the treatment, they are not having side effects it and etcetera, and then things can be spaced out a little bit for the next couple of months before we go into the transplant thing, if the patient is going for transplant.
Is MGUS More Prevalent in BIPOC Communities?
Is MGUS More Prevalent in BIPOC Communities? from Patient Empowerment Network on Vimeo.
Does the multiple myeloma precursor of monoclonal gammopathy of undetermined significance (MGUS) occur more frequently in minority (BIPOC) patients? Expert Dr. Sarah Holstein from the University of Nebraska Medical Center shares information that myeloma studies are researching on Black, Indigenous, and People of Color patients and how to improve myeloma awareness and care.
See More From the Myeloma TelemEDucation Empowerment Resource Center
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Transcript:
Dr. Sarah Holstein:
: When we look at data sources like the SEER (The Surveillance Epidemiology, and End Results) data source, it’s not necessarily so granular that we can always distinguish whether the population is Black/Hispanic, Black/non-Hispanic, but really where I’ve seen the increased risk is whenever there are population-based studies and they describe the population at least in the U.S. as Black. I will admit I don’t know the details as to further sub-division amongst the category of Black and whether or not it’s appropriate to use the term BIPOC in this setting with respect to why do Black Americans have higher risk of plasma cell disorders than white Americans? I think that’s still a question that we can’t completely answer. There are a lot of really good research teams in this country and really worldwide that are trying to understand the different genetic-based risks, and it’s clear based on some studies that there’s some differential with respect to for example, what the frequency is of particular genetic abnormalities that happen in the plasma cells as they go from normal to abnormal. So, one example that I’ve seen is a higher frequency of translocation 11;14 in patients who are Black compared to patients who are white, but ultimately, I don’t think there’s an easy, easily understood answer to that very complex question right now with respect to why the risk is two to three-fold higher in Black individuals compared to white individuals.
And then that’s a little bit of a separate—I mean it’s related, but in some ways, and that’s somewhat separate from the issue of when Black individuals actually get diagnosed with myeloma, whether that’s at a more advanced state of the disease than in white people that I think is a little bit more dependent on access to care as well, as knowledge of the disease. I would say that in general, myeloma is not a cancer that most Americans are actually that familiar with, and that’s regardless of white, Black, race or ethnicity, it’s still a relatively rare cancer and most people have never heard of it and don’t know other people who’ve had it. But I think what is key in the Black community is to really increase awareness of not only myeloma, but the precursor condition MGUS just like there have been enormous efforts to increase awareness of the risks of high blood pressure and diabetes, and how that can affect health later on, there’s also… I think sometimes a decreased frequency of access to primary care, sometimes myeloma is picked up just because of routine blood work, and that can be done sometimes on an annual basis by a primary care provider. And if individuals aren’t getting their annual physical and annual labs drawn, then by the time myeloma presents itself, sometimes it’s at the point where it’s presenting, because bad things have happened, like bones are breaking, or patients are very anemic, or there are serious infections, etcetera, as opposed to being found in a more asymptomatic stage when abnormalities such as high protein levels in the blood are noted that patients are otherwise feeling well. So I think you raise some really excellent questions, and I think there’s a lot of room for improvement in this country for not only improving the research so that we understand what the genetic bases are for developing plasma cell disorders, but also increasing education throughout this country, but specifically in the Black population, and then making sure that everybody has access to care.
Is the COVID-19 Vaccine Safe for Myeloma Patients?
Is the COVID-19 Vaccine Safe for Myeloma Patients? from Patient Empowerment Network on Vimeo.
Should myeloma patients get the COVID-19 Vaccine? Dr. Joshua Richter encourages all patients to get the vaccine but notes important considerations around treatment.
Dr. Joshua Richter is director of Multiple Myeloma at the Blavatnik Family – Chelsea Medical Center at Mount Sinai. He also serves as Assistant Professor of Medicine in The Tisch Cancer Institute, Division of Hematology and Medical Oncology. Learn more about Dr. Richter, here.
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An Expert’s Take on Promising Myeloma Treatment and Research |
Transcript:
Katherine:
Is the COVID-19 vaccine safe for patients with myeloma?
Dr. Richter:
Absolutely, 100 percent yes. Everybody with myeloma should absolutely get the vaccine. What’s a little more complicated is the timing of it. So, one is in relation to stem cell transplant or CAR T-cell therapy. If you’ve had one of these, obviously, consult with your provider. But the general recommendation is to wait about 60 to 90 days after a high-dose therapy like that. And it’s not a question of safety, it’s a question of efficacy. Vaccines are like vegetables, seeds, you have to put them in the ground to grow. If you give yourself a vaccine right after a stem cell transplant, well, your bone marrow is not ready to work with it. It’s like planting a seed in the desert.
You want to make sure your immune system can take in that vaccine and give you immunity. So, you have to wait at least 60 to 90 days. The other question is, what happens if you’re getting continual therapy? And we don’t know the answer for most of these drugs, but one of the things is dexamethasone (Decadron), which is a steroid. Almost all myeloma therapy comes with some steroids. And we like to separate the vaccine from the steroid dose by a little bit if we can. Again, always important to talk with your care team as to risk/benefit about holding certain treatments.
An Expert’s Take on Promising Myeloma Treatment and Research
An Expert’s Take on Promising Myeloma Treatment and Research from Patient Empowerment Network on Vimeo.
Myeloma research is advancing quickly. Dr. Joshua Richter, a myeloma expert, shares his excitement about emerging treatments in development.
Dr. Joshua Richter is director of Multiple Myeloma at the Blavatnik Family – Chelsea Medical Center at Mount Sinai. He also serves as Assistant Professor of Medicine in The Tisch Cancer Institute, Division of Hematology and Medical Oncology. Learn more about Dr. Richter, here.
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Myeloma Treatment: When Should a Clinical Trial Be Considered? |
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Transcript:
Katherine:
When it comes to myeloma research and emerging treatment options, what are you most excited about, specifically?
Dr. Richter:
So, I think the big thing that I’m excited about from myeloma that we’re on the cusp of is T-cell engagers and T-cell based therapies. And, essentially, we all have T cells in our body, and T cells are a part of our immune system. They attack bacteria, viruses, and cancer.
And one of the best cancer fighters that exists is our own immune system. And the old way of treating cancer and blood cancers like myeloma was just to give medicines that suppressed all of the immune system, the good and the bad. Now, we’re trying to be more precise, and there’s certain parts of the immune system that we don’t want down, we want up. So, they help attack the cancer.
And the two biggest technologies are something called CAR T and something called bispecific antibodies. CAR T stands for chimeric antigen receptor T cells.
And, basically, what that is is we collect your T cells, we engineer them in the lab to rev them up and target the cancer. And we can put them back into you and they attack the cancer, very exciting. And then we have something called a bispecific antibody that has two arms. And as we infuse this medicine into you, one arm grabs onto the cancer cell, the other arm grabs onto your T cell and makes that T cell activate and attack the cancer cell.
And a lot of these drugs are in clinical trials as well. So, we’re very excited about moving from, you know, just lowering everything, the good and the bad, to being more precise and saying, no, no, no. There are some cells that we want way, way up.
Katherine:
Right. Right. So, you’re – you’re being much more specific now.
Dr. Richter:
Mm-hmm.
Myeloma Treatment: When Should a Clinical Trial Be Considered?
Myeloma Treatment: When Should a Clinical Trial Be Considered? from Patient Empowerment Network on Vimeo.
At what point should a clinical trial be an option for myeloma treatment? Dr. Joshua Richter shares his perspective on the appropriate time to weigh clinical trial participation and the potential benefits.
Dr. Joshua Richter is director of Multiple Myeloma at the Blavatnik Family – Chelsea Medical Center at Mount Sinai. He also serves as Assistant Professor of Medicine in The Tisch Cancer Institute, Division of Hematology and Medical Oncology. Learn more about Dr. Richter, here.
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Which Myeloma Patients Should Consider Stem Cell Transplant? |
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Transcript:
Katherine:
When should a clinical trial be considered for myeloma treatment?
Dr. Richter:
So, clinical trials are an extremely important component of how we manage myeloma. And I think there are a lot of myths and misconceptions about trials. Trials are not always things to do after everything else failed. From my standpoint, at every point along the way, we should always consider clinical trials, because they offer something really amazing. They offer us access to drugs way before they’re approved.
And the benefit of not waiting until the end, after you’ve been through everything else, is two-fold. One, in order to get on a trial, you need to fit certain criteria, inclusion, and exclusion criteria. You need to have myeloma, but you can’t be so sick from other medical problems that you’re not going to tolerate that treatment well. As such, unfortunately, some patients after they’ve been through all the other therapies may not qualify for a clinical trial, and that can be really upsetting.
The other benefit of doing a clinical trial early on is if you go on a new drug and it doesn’t work, you have all of the other standard of care options available at a moment’s notice. But if it does work and you gain access to a drug way before it’s approved, and it happens to work extremely well in you, you can have an unbelievably long remission and still have all of the drugs that are available. And, potentially, in that time on the drug, new standard of care drugs are approved. It even deepens the well that you can reach into to grab more options. So, at all times along the way, it’s always important to weigh the risks and benefits of what we call standard of care treatment versus clinical trial options.
