When it comes to myeloma treatment options, where do clinical trials fit in? Dr. Melissa Alsina of Moffitt Cancer Center discusses the role of clinical trials in a myeloma treatment plan at every stage of a patient’s care.
Dr. Melissa Alsina is an associate professor of medicine in the Blood and Marrow Transplant Program at Moffitt Cancer Center in Tampa, Florida where she also serves as head of the Multiple Myeloma Transplant Program. Learn more about Dr. Alsina, here.
When it comes to myeloma treatment options, where do clinical trials fit in?
They fit everywhere, essentially. They fit everywhere because myeloma – even though we have many, many advances, it’s a disease that we cannot cure, so there’s still a lot, a lot of work to do, so we have trials for newly diagnosed patients, improving what we do at newly diagnosed, bringing in some of those therapies, for example, like CAR-T up front, and then we have trials for early relapse/late relapse, because again, yeah, we’ve done a lot and we feel very encouraged by that, but we’re short because we have not been able to cure myeloma.
So, it’s super important, and it’s super important that patients reach out to myeloma centers to see what is available for them because participating in a clinical trial, number one, gives a patient a unique opportunity to get something more than standard of care, something that might make their response better or their survival better.
That’s one thing, and the other thing is the only way we’re able to move the field forward is doing clinical trials and having patients participating in clinical trials, and the reason today I can sit here and tell you that the treatment of myeloma has evolved dramatically in the last 20 years, and now we have these responses that are amazing that were unheard of, is thanks to the many patients that have participated in clinical trials.
Without that, obviously, we would not be here with these results. But that needs to continue. I think we cannot rest because there are still patients that die from myeloma. We cannot lose the perspective that this is still an incurable disease and there’s still a lot of work to do, and the only way to get there is to continue doing the research.
It sounds like clinical trials are also available for patients who have already been treated with another therapy. Is that right?
Absolutely. Clinical trials are available for all the different stages of the disease – when you are newly diagnosed, when you have your first relapse, when you have your second relapse.
Anytime through the process.
Anytime, anytime, and there are clinical trials – the clinical trials not only help us test new drugs or new combinations of drugs, but it also helped us understand the disease better. The majority of clinical trials, we do what we call correlative studies, where we get a sample of the patient, the bone marrow of the patient, for example, before and after therapy, and we see what are the changes that we see there and what are the genes that dictate that response or lack of response.
So, clinical trials not only help us improve outcomes in patients, but it also helps us understand the disease better that leads to other new therapies and other clinical advances. This can translate into new clinical advances.
The Patient Empowerment Network (PEN) is fostering change toward achieving equitable healthcare for all. One resource, the Myeloma TelemEDucation Empowerment Resource Center is to significantly improve multiple myeloma patients’ and caregivers’ familiarity with remote access to healthcare, and thus increase quality of care regardless of geographical location. This one-of-a-kind resource center is intended to educate the myeloma community on the practical usage of telemedicine tools, to humanize patient and provider experiences.
Here’s a summary view of the knowledge gained about telemedicine to help provide optimal care to myeloma patients and to aid in receiving optimal care no matter virus limitations, where patients live, and other factors.
Benefits and Limitations of Telemedicine Visits
There are both benefits and limitations of telemedicine visits. Some benefits of telehealth include:
- Telemedicine allows care providers the opportunity to determine when myeloma patients really need to be seen in-person.
- Standard of care and maintenance treatment are usually a good fit for using some telemedicine visits in clinical trials.
- The option to get laboratory work done closer to home is a benefit for saving travel time and from taking time off of work and also lessens patient exposure to viruses.
- Telehealth allows care providers the opportunity to meet family members of some patients who can’t make it to in-person visits and to get to know their patients on a more personal level.
- Care providers are now able to provide second opinions to patients in other parts of their state and even to some patients across the country.
Unfortunately, some limitations of telehealth include:
- Gauging toxicity and other things with new treatments are usually best done along with performing a physical exam.
- Some patients only have technology access to talk over the phone and don’t have access to use video due to their device or due to lack of Wi-Fi bandwidth.
- Physical examinations cannot be performed via telehealth visits.
- Some providers feel it’s more difficult to establish a bond with some patients and to have considerable discussions with then over telemedicine.
- Open and honest communication between patients and care providers is sometimes better served in-person.
How to Optimize a Telemedicine Visit
Just like in-person care visits, telemedicine visits are scheduled with a time limit in mind. Some things to remember about telemedicine visits are:
- Try to write down your questions for your doctor or care provider before your appointment to keep on track. Keep it next to you for easy access during your visit.
- If patients normally have a friend or loved one join or doctors have a nurse or pharmacist join for in-person visits, have them join your telemedicine visits to help take notes, to ask questions, and/or to provide answers or additional information.
- If a video conferencing tool is needed for your visit, install the tool on your laptop, tablet, or smartphone ahead of time to prevent rushing before your appointment. If possible, try to test the video conferencing tool with a friend or loved one a day or so ahead of your appointment.
- If there’s anything you don’t understand during the appointment, ask your doctor to explain it again – whether it’s medication instructions, test results, a new medical term, or anything else.
- If you feel like a treatment isn’t working well for you, ask your doctor about possible medication or dosage changes.
- Just like in-person doctor visits, your doctor or care provider may run a few minutes late. Try your best to remain flexible and to be patient.
Telemedicine and Multiple Myeloma Clinical Trials
To the surprise of some, telemedicine has taken a role in multiple myeloma clinical trials. Currently, and looking to the future, patients can expect:
- Telemedicine to continue as an option for follow-up visits along with in-person visits in clinical trials.
- Paperwork for clinical trials to be available to complete online for an easier process for joining clinical trials.
- Multiple myeloma clinical trials to provide optimal care through the use of both telemedicine and in-person visits.
- Telemedicine to provide more options for clinical trial access for those who live in remote areas.
- Multiple myeloma clinical trials for quality-of-life studies, engagement studies, educational studies, and possibly others to be available via telemedicine.
Financial Benefits of Telemedicine
Telemedicine has brought some financial benefits for multiple myeloma patients, including:
- Telemedicine saves the time and costs of traveling to appointments and can reduce or sometimes eliminate the need to take time off from work for an appointment.
- The option of connecting with your doctor via telemedicine can sometimes eliminate the need for costly urgent care visits.
- The use of telemedicine eliminates the need to find child care for patients and care partners with young children who couldn’t take them along to in-person doctor appointments.
Here are some helpful telemedicine terms to know:
- HIPAA – HIPAA, or the Health Information Portability and Accountability Act, is a healthcare compliance law providing data security and privacy for the safeguarding of patient medical information. In telemedicine, provider-patient communication must take place through HIPAA-compliant secure platforms.
- Patient portal – a secure Internet sign-on that allows patients to contact their provider, review medical tests and records, access health education materials, and seek appointments. Most provider networks develop a patient portal before they move to full video appointments.
- Remote monitoring – type of ambulatory healthcare where patients use mobile medical devices to perform a routine test and send the test data to a healthcare professional in real-time.
- VPN – a VPN, or virtual private network, is a secure and private way to connect to the Internet over public wireless connections. VPNs are particularly important for those living the digital nomad lifestyle and connecting in foreign countries where networks may be more vulnerable to communication transmission interference.
Now that telemedicine tools continue to increase in use and to be refined, multiple myeloma patients can feel hopeful about improved care and treatment ahead for patients. As a step in that direction, take advantage of the resources below and continue to visit the Myeloma TelemEDucation Empowerment Resource Center for informative content about multiple myeloma and telemedicine.
Resources for Telemedicine and Multiple Myeloma
Even before the coronavirus pandemic arrived, health and patient support organizations made resolute efforts to examine and address health inequities for multiple myeloma patients in Black, Indigenous, and People of Color (BIPOC) communities. Diverse Health Hub and the Patient Empowerment Network partnered to help improve health outcomes for underserved myeloma patients through the Diverse Partners in Your Myeloma Care program. With a tumultuous year filled with the killing of George Floyd, social unrest, and coronavirus health disparities for BIPOC groups, these issues prompted us to focus on where things stand with multiple myeloma health disparities. We’ll take a look at what we know, what we’ve learned, and what help and resources are needed to continue advancing care for BIPOC myeloma patients.
Disparity Facts About BIPOC Myeloma Patients
Both Black Americans and Latina and Latino Americans show a myeloma precursor called MGUS, or monoclonal gammopathy of undetermined significance, more frequently than others—.88 percent in Black Americans, .44 percent in Latina and Latino Americans, and .22 percent in white Americans.
Although multiple myeloma is diagnosed at a younger age in both Black Americans and Latina and Latino Americans, both groups are less likely to receive a transplant and start treatment later than patients of other races.
Black Americans are actually known to have less aggressive myeloma, which should show better health outcomes—yet that is not the case.
Learnings About BIPOC Myeloma Patients
Black and other BIPOC patients often have mistrust of doctors and researchers due to past experiments like the Tuskegee Study and Henrietta Lacks – whose now infamous immortal HeLa cells were taken without her consent. “If I were to walk into any community, African American community, or underserved community, that is one of the first things. They’re going to be mistrustful of me. And it’s a very difficult barrier to overcome. And that also leads over into African Americans contributing, being donors, African Americans participating in trials. It all feeds over into everything that’s done in the African American community or underserved community in regards to healthcare,” says patient navigator Diahanna Vallentine.
Barriers to care must be overcome according to Dr. Sikander Ailawadhi from the Mayo Clinic, “Myeloma patients who are African-American and Hispanic typically get to the right treatment much later. In a lot of cases they may not get to the right treatment at all. We also know that the burden of cost of care is much higher for minority patients.”
Improvements are happening in care as explained by Dr. Ajay Nooka from Emory University School of Medicine, “What’s really interesting in this meeting is that there has been a lot of large database integrations, including one database called the National Cancer Database (NCBD) where people have looked at 20-year history of how these treatments have panned out. Which of the minority populations or which subset of patients gained the most benefit over the last 20 years? And we see minorities have gotten a lot of improvement and a lot of access to care over the last 20 years, but that’s not the end of the story, we have to catch up a lot more.”
The Path to Health Equity
Although the additional focus on health inequities has started to improve access to care, there is still a critical need to raise awareness about the treatment gaps for myeloma patients in BIPOC populations. How can myeloma patients get the best care no matter where they live when factors like age, geography, socioeconomic status, ethnicity, gender, and insurance type heavily influence the path to better health outcomes?
Some valuable steps that patients, community leaders, and healthcare providers can take to improve care include:
Support organizations providing educational materials to patients that are target specific BIPOC groups
Patients and advocates making the BIPOC voice heard by asking for funds from community and political leaders to improve care
Healthcare providers developing relationships and partnerships with political leaders and support organizations to continue building momentum in improving patient care
Patients taking advantage of social workers and patient navigators at their clinics and support organizations
Patients, advocates, and healthcare providers working to increase clinical trial participation
Healthcare providers integrating cultural competency as a universal approach in the healthcare model
Resources like myeloma patient resource guides, informational graphics, and the Myeloma Coach section on the Myeloma Crowd website provide valuable information for patients. And though trust of clinical trials by BIPOC populations remains an issue, there are initiatives like Diversity in Clinical Trials Benefits Everyone. BIPOC patients can take action working together with medical researchers to increase clinical trial participation to improve and refine myeloma treatment developments for specific patient populations. If you want to explore options in your treatment, seek out resources that embrace diversity in clinical trials. The “All of Us” program is a public health initiative designed to remove the barriers that prevent inclusive access.
Participating in clinical trials not only will improve myeloma treatments down the line but also provides a minimum of standard of care treatment at no cost to the patient. It’s a win-win for both the patient who participates in the study and also helps the progression of treatment for BIPOC patients diagnosed with myeloma in the future. Though progress has been made, patients, advocates, community leaders, and healthcare providers must take action to continue an upward movement to achieve equitable care that BIPOC myeloma patients deserve. Take advantage of the resources below and continue to visit our Multiple Myeloma Hub as we publish more on health equity developments for multiple myeloma.
Resources to Learn About Improving Myeloma Health Disparities
How Can a Myeloma Patient Advocate/Financial Advisor Help? Patient Empowerment Network website. https://powerfulpatients.org/2020/08/17/how-can-a-myeloma-patient-advocate-financial-advisor-help/ Accessed October 19, 2020.
Multiple myeloma patient Judith shares her personal journey of empowerment in this Patient Empowerment Network program.
Watch as she explains how seeking a second opinion after her diagnosis changed the path of her treatment and life with multiple myeloma.
Judith’s advice: “Don’t be afraid to get a second opinion or even a third opinion. Getting a second opinion saved my life.”
How can health equity be achieved for underserved communities in multiple myeloma patient care? Watch as a panel of myeloma experts explains.
I want to ask each of you to answer a question. So how can we achieve health equity in the care of multiple myeloma patients sooner rather than later?
I think we all appreciate the fact that the African American or underserved communities do not have enough people that are either willing or know that we need to go into those communities the way they are, meet the people the way they are, so that we can provide them with education, with resources, that are available. I think that is one of the first steps. And fortunately, or unfortunately, with the racial problems we’re having in our country right now, a lot of governors and mayors are opening up opportunities that we got to get into the communities. And I think this might be a great opportunity for the myeloma community to perhaps step up and say we would like to be presented or represented in the community when there are funds and when the interest is really high. I think that if we could establish a foothold that way, then we can just go on and work toward lessening that gap and disparities in the undeserved communities.
Dr. Sikander Ailawadhi:
Diahanna, that was really nicely put. I think what I can add to that is that we basically are already seeing a lot more discussion, a lot more focus coming up to this topic of racial disparity in multiple myeloma at different levels. So, what we need to do is continue to build upon that momentum, continue to build the relationships so that there is actually a combined force from various aspects. I would love to do telehealth going forward, but like Dr. Usmani brought up, if there is not enough reimbursement or leadership or legislation to support all of that, then our wants and needs may not be served fully. So I think developing those relationships, developing those partnerships and moving forward as we’re gaining momentum to address this particular question, this particular issue is extremely important. And I feel it is more hopeful and exciting in the future as compared to where we’ve come from.
I would just reiterate what Diahanna said. I think it’s in building the programs that are simple enough for everybody to understand and utilize that makes just the usability of them as available as possible, and then building that relationship in those communities where the needs are. I totally agree with what Diahanna’s saying, you need to take the programs to the people where they are and not to expect them to come to your programs.
Dr. Saad Usmani:
I agree with everything that has been said on this topic. And I have to say that this is going to be a two-way dialogue, a two-way partnership. That’s the only way that this can succeed moving forward. Racial disparities are an inherent part of our everyday life, whether it’s in healthcare, whether it’s in other interactions we have with each other, and there’s a lot of historic perspective and context to that. This is not going to be a quick fix, this is going to be a long-term process. But it will have to be a partnership. And I’m talking on a broader level with myeloma care and better survival outcomes for all myeloma patients as the goal. But then looking at the overall societal goals as well, and trying to see how we can remove the inherent biases that everyone has and develop more fruitful productive relationships going forward in our respective geographic regions, but overall in our country as well. I think that’s the overarching theme and tone of the conversations we’re having in the country right now, and it certainly makes sense to do that for myeloma care as well.
I want to take the time to thank each and every one of you for joining me today. On behalf of the Patient Empowerment Network and Diverse Health Hub, I am Rebecca Law. Thank you.
Are multiple myeloma clinical trials becoming more critical for African, Hispanic, Asian, and other racial and ethnic groups as U.S. demographics change? Watch as Dr. Sikander Ailawadhi from the Mayo Clinic explains the impact of low trial participation rates by African Americans and his experience with some of his myeloma patients.
Dr. Ailawadhi, the demographic in America is changing quite rapidly. Does this mean clinical trial participation is more critical than ever?
Dr. Sikander Ailawadhi:
It absolutely is, Rebecca. There is no way to kind of shine enough of a bright light on this topic. And I’m glad that we’re talking about it. There is more interest and also more thought process being put behind it. So you’re right in saying that the demographics are changing quite a bit. So we don’t know how and when we’ll get all the 2020 Census data; but over the past few years, the Census Bureau has been releasing updates where we know that Hispanics are the fastest growing racial ethnic group in the country and followed by Asians and African Americans are already a huge part of our demographic. So whatever we’ve discussed before when we said that patients can present at different ages, they can present with different symptoms, we also know from our experience of other diseases like hypertension, high blood pressure, diabetes, that the way certain drugs are metabolized could be inherently genetically different between, let’s say, African Americans and whites.
Unfortunately, in myeloma, we don’t know any of that, because clinical trial participation overall in cancer and also especially in myeloma, in a disease where African Americans may be affected by this diagnosis way more, the clinical trial participation is extremely low, in single digits. Which means that all the drugs that we utilize are FDA-approved, have become FDA-approved with not enough safety or benefit data in racial ethnic minorities. Now, I’m not saying that there is any problem in using those drugs; we use them, they benefit patients outrightly. But I think that underscores the importance that clinical trial data and generating robust safety and benefit data in all racial ethnic groups, considering that our demographic 10 years from today is not going to be what it is now or what it was 10 years ago. So understanding the dynamics of drugs, their impact, their benefit, their safety, in all racial ethnic groups becomes extremely important. And that can only be done when either clinical trials are specifically done in those populations, which, as Diahanna mentioned very well, appropriately before, it’s a very challenging thing, because there has been a traditional lack of trust there. So it becomes very important.
I can tell you that I had mentioned earlier that we’re doing a questionnaire just to understand why patients don’t want to go on clinical trials, or do they not want to go on. It’s just maybe, it’s an access issue. And I distinctly remember—I cannot take an anecdotal look at it, because I’m a clinician, I’m a researcher, I’m not supposed to look at the end of one. But I’ve had at least two specific cases where newly diagnosed multiple myeloma African American patients who’ve come, and I’ve very clearly explained to them that I’m just wanting them to consider going on this study with a one-time questionnaire. No samples, no bone marrows, no treatment, no nothing. All I want to understand is what they think about clinical trials. It’s a five-page questionnaire, 50 questions, multiple choices. We’re not taking any other data. Both these patients took the—they signed the consent, so they took the questionnaire. They took it home, we could do it electronically, but they said they wanted to think about it.
“Know what? I don’t feel comfortable with going on a clinical trial, even though it’s a one-time questionnaire. I’m going to kind of respectfully decline.” And I initially could not understand the whole thought process because it seemed, “Well, it’s just a questionnaire. We do so many surveys online.” But I’ve talked to them several times since then, and the thought process, which Diahanna brought, up about that lack of trust, that came out loud and clear. These patients are still receiving their treatment with us, because initially there were concerns, they said, “Well, if I don’t do the questionnaire, maybe this doctor won’t treat me.” They’re receiving their treatment with us, they are continuing, we’re good, we have a very good relationship, but they decided not to go on those. So I think clinical trial participation is extremely important, especially because of the changing demographics, like you said.
Diahanna Vallentine has not only experienced life as a multiple myeloma caregiver and patient advocate but also as a financial advisor to patients. Watch as she shares things she’s learned talking with African American patients—and how she helps those in underserved communities with affordable access to myeloma treatment.
Diahanna, we know many of the roadblocks to treatment boil down to access and the web of financial toxicity. In the work you do, how are you helping patients make informed decisions, and can you please provide some examples?
I think one of the main variables that causes the disparity overall before even treatment is needed is a mistrust in the African American community as a result of past historical treatments, experiments that were done on the African Americans. And I find that talking to anyone. If I were to walk into any community, African American community, or underserved community, that is one of the first things. They’re going to be mistrustful of me. And it’s a very difficult barrier to overcome. And that also leads over into African Americans contributing, being donors, African Americans participating in trials. It all feeds over into everything that’s done in the African American community or underserved community in regards to healthcare.
Some of the things that I am doing is I try to be available to talk to anybody, no matter what time of day it is, talk to them where they’re wanting—where their needs are, listening to them and not making preconceived notions about who they are, where they come from, what their experiences are. And it’s an ongoing educational program for me, because we all come in—as difficult as we are, come in with preconceived notions of what our knowledge is, what our experience is, and how we’ve treated other people. And that has been one of the things that I have been practicing every day when I talk to patients, whether it’s in-person or on the phone. I have a unique perspective having been a financial advisor for more than 20 years, being a caregiver to a myeloma patient, being a patient advocate and not having the fear. I guess that’s something I grew up with. Not having the fear to talk to people or ask people questions, and let them know from the on-go that we all have something in common.
And once you establish that area of trust, then everything else comes easy. When you realize that that could be me in that bed, that could be my mother, my father in that bed, then we all become as one, per se. And so some of the things that I do is I talk to a person at the level they want to be spoken to. I ask them how they want me to communicate with them, how often they want me to communicate with them, is there anyone else they want to be involved in it. And then I take that information that they’re trying to gather and find resources for them so that financial toxicity will not become an issue, so that we can discuss with their caregivers what the treatment plan is, what the anticipated cost is, so that we can work around some of those financial barriers that they may come up against. And whether that’s looking at their current insurance plans, insurance plans they may have access to in the future, whether it’s through a spouse or their employers, or Medicare, Medicaid. We try to anticipate what those things are so that the financial toxicity does not become a burden, which again, affects their care, because stress affects your care and your outcomes.
How do health disparities in minority populations with multiple myeloma play out? Expert Dr. Sikander Ailawadhi from the Mayo Clinic joined to discuss data about African Americans and Hispanic Americans with myeloma. Watch as he shares the average age of disease onset, how their symptoms vary, transplant rates, new treatment rates and more.
Dr. Ailawadhi, for our audience who might not understand what health disparities in myeloma look like, can you give a high-level definition and overview, please?
Dr. Sikander Ailawadhi:
So, there are disparities at a lot of different levels, just taking the case of multiple myeloma, specifically. So, for example, patients from different racial and ethnic backgrounds tend to present in a different way. So, African Americans present with the diagnosis at a much younger age. The presence of the myeloma precursor called MGUS, or monoclonal gammopathy of undetermined significance, is seen much more frequently in African Americans. Even I would say include Hispanics into that, because Hispanics also get diagnosed at a much younger age. The disease presents very differently, for example, African Americans will present much more frequently with anemia or kidney dysfunction, but they will present with much lesser bone fractures in multiple myeloma.
So, those are disparities in how the disease presents or how it becomes kind of evident. Now, when we talk about disparities, one of the very stark shades of disparities in myeloma is how treatment is given or made available to patients, especially when we talk about racial minorities. So, there has been a lot of literature looking at this, and it has been seen that patients who belong to racial and ethnic minorities, they do not get access to the same kind of treatment in the same timely fashion. So, for example, African Americans and Hispanics are much lesser likely to get a transplant when it comes to myeloma treatment. Now again, I don’t want to say that improvements have not happened. The rates of transplant, rates of new drug use, have increased across the board for all races and ethnicities, but when we compare, the rate of that increase has been much slower in African Americans.
In fact, one of the studies that we looked at, some national data, it took Hispanics a little more than 100 days from the time of diagnosis to get to initial treatment with bortezomib (Velcade), which is a cornerstone drug and is used almost across the board for initial therapy. So, the treatment, there are disparities. And similar, there are some outcome disparities. While on the face of analysis, it’s been said several times that races or different racial sub-groups will have similar outcomes, I think the important thing to understand is that biologically, African Americans have a less aggressive disease, which means that if given the right kind of treatment, African Americans are supposed to in fact have a slightly better outcome than even whites. And there’s one large analysis that came out of the VA system from the Dana-Farber group last year, which was actually highlighting that, because they were able to show that in an equal access system like the VA, African Americans actually had better outcomes, or better survivable. So, there are disparities at the time of presentation, at the time of how treatment is received, how timely is the treatment, and in fact also, outcomes. Because I would say that having an equal outcome for a racial minority is not necessarily lack of disparity, that may actually be underscoring the disparity.