You're listening to ReachMD. I'm your host, Rebecca Elias, and I'm excited to present you with this medical industry feature titled "Behind the Scenes of Care, Supporting Patients with Relapsed Refractory Multiple Myeloma."
This program is sponsored by Amgen and is intended for U.S. healthcare professionals. The speaker has been compensated for participating in this presentation.
Today's guest is a medical oncologist and hematologist at Tennessee Oncology who did his fellowship at Vanderbilt University. We'll hear him talk about his experience treating relapsed refractory multiple myeloma and how important it is to understand the appropriate treatment for your patient's lifestyle. Please welcome Dr. Jeremy McDuffie.
Thanks for having me.
Oh, I am excited to be talking to you today Dr. McDuffie. I've heard you have a unique approach to the conversations you have with your patients.
Well, I wouldn't say that I have an approach to conversations with patients, but rather an ethos. I try to make each individual conversation organic and tailored to the patient.
An ethos? I love that. So, I'm curious, with something that can feel as overwhelming as relapsed refractory multiple myeloma, how do you approach that first relapse conversation with your patients?
That conversation starts on day one with cycle one of the original regimen. So when you bring up relapse it's not the first time they've heard it will happen. And then I try to be active in listening because patients will often suspect something is off before you know it clinically. There will be a new symptom or an old one will exacerbate. And so in that case the bone marrow biopsy or pet scan or skeletal survey simply confirms what they already know.
Something I do is tailor each conversation as I get to know the patient. While part of my job is to convey the science, it's also to get to know the patient so I can offer information in a way that they'll best receive it, which becomes the art of medicine.
The art of medicine, I like that. Now, depth of remission is something you consider when recommending a treatment for your patients, or picking a paint for your canvas if you wanna keep that art theme going. But what else do you consider?
Well, we know that the depth of remission generally correlates with time in remission, and depth and time provide tangible, meaningful experiences to the patient. Another factor is the side effect profile. My practice is in a suburb of Nashville, Tennessee, and we have a lot of musicians. So if a drug works but gives them markedly increased neuropathy and a patient loves playing the guitar or the piano, I might be taking something away from them that enhances their lives or even takes away their livelihood. So it's important not to just lengthen their life, but to honor the things that they attach value to in their life.
Oh, wow. Do you ever think about what if this was me?
All the time. I think if it were me, what treatment decisions would really mean…am I going to be able to spend time with loved ones? Or am I going to have debilitating side effects that prevent that. I've got a two and a half year old who is the absolute joy of our lives and so I would measure it in what things I would get to see him do on this earth and that would certainly guide my decision-making and treatments for myself.
I had a guy who came in seven years ago for a benign diagnosis thinking it was anemia or something. We did a little digging and found that his proteins were elevated, so we ordered imaging, eventually a bone marrow biopsy.
His whole family was there the day I delivered the unfortunate news of his diagnosis. I was a younger doctor then, so cancer was a diagnosis of my parents or grandparents, but yet here's this multiple myeloma patient who's within a couple years of my age.
It's never left me. For the first time, I could be that person sitting across from me. I learned so much from him and I told him, "I'm going to make the most out of my life because of you.” And so when this interview is over, I'm going to play with my kid because we don't know how much time we're given.
Wow, that is so powerful. Is there any other patient story that jumps to your mind, maybe one where you had to change treatment options?
Actually, I had a myeloma patient and his initial regimen was velcade, revlimid, and dexamethasone. Unfortunately, he was in the minority of patients who did not respond. In speaking with his transplanter, we used KYPROLIS®, along with lenalidomide and dexamethasone, and he was able to get in a deep enough remission to have a stem cell transplant. My patient currently remains in remission to this day.
KYPROLIS® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone to treat adult patients with relapsed or refractory multiple myeloma who have received one to three previous treatments for multiple myeloma.
It is important to keep in mind safety information about KYPROLIS®, including cardiac toxicities, new onset or worsening of preexisting cardiac failure, such as congestive heart failure, pulmonary edema, decreased ejection fraction, cardiomyopathy, myocardial ischemia, and myocardial infarction, including fatalities have occurred following administration of KYPROLIS®.
Some events occurred in patients with normal baseline ventricular function. Death due to cardiac arrest has occurred within one day of administration. Monitor patients for signs or symptoms of cardiac failure or ischemia. Evaluate promptly if cardiac toxicity is suspected. Withhold KYPROLIS® for grade three or four cardiac adverse reactions until recovery, and consider whether to restart at one dose level reduction based on a benefit/risk assessment.
It's rewarding to see that now patients are not just getting better, but they can turn their lives around. I must admit I have a bit of imposter syndrome because while I feel good about picking the treatments when patients do well, you really have to take your hat off to science.
To science indeed. So why is it critical to not reserve powerful treatments for later lines?
I just don't see the benefit of reserving therapies that have the power to help patients. I focus on getting the depth of remission that I know is possible. I like KYPROLIS® at first relapse because it has demonstrated remissions with manageable side effects and it can be paired nicely with other drugs. Specifically, in a phase three study, patients on KYPROLIS® and dexamethasone experienced five times less peripheral neuropathy versus bortezomib and dexamethasone where it can be present for many years time after discontinuation, with some studies saying it can take well over five years to resolve.
So is there anything else you consider in your conversations and treatment decisions with patients at first relapse?
To keep an open mind, as each multiple myeloma patient will have a unique story and that we now have incredible drugs with meaningful clinical benefit in time and durability of response, allowing patients to get back to what matters in their lives.
What a beautiful way to end our interview. Dr. McDuffie, thank you so much for taking the time to chat with me today.
My pleasure, thanks for having me.
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KYPROLIS®, carfilzomib, is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab plus dexamethasone or with isatuximab plus dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
Important Safety Information for KYPROLIS®, carfilzomib
New onset or worsening of pre-existing cardiac failure, for example, congestive heart failure, pulmonary edema, decreased ejection fraction, cardiomyopathy, myocardial ischemia, and myocardial infarction, including fatalities, have occurred following administration of KYPROLIS®. Some events occurred in patients with normal baseline ventricular function. Death due to cardiac arrest has occurred within one day of administration.
Monitor patients for signs or symptoms of cardiac failure or ischemia. Evaluate promptly if cardiac toxicity is suspected. Withhold KYPROLIS® for grade 3 or 4 cardiac adverse reactions until recovery and consider whether to restart at one dose-level reduction based on a benefit-risk assessment.
While adequate hydration is required prior to each dose in cycle 1, monitor all patients for evidence of volume overload, especially patients at risk for cardiac failure. Adjust total fluid intake as clinically appropriate. For patients greater than or equal to 75 years, the risk of cardiac failure is increased. Patients with New York Heart Association Class III and IV heart failure, recent myocardial infarction, conduction abnormalities, angina, or arrhythmias may be at greater risk for cardiac complications and should have a comprehensive medical assessment prior to starting treatment with KYPROLIS® and remain under close follow-up with fluid management.
Acute renal failure
Cases of acute renal failure including some fatal renal failure events and renal insufficiency, including renal failure, have occurred. Acute renal failure was reported more frequently in patients with advanced, relapsed, and refractory multiple myeloma who received KYPROLIS® monotherapy. Monitor renal function with regular measurement of the serum creatinine and/or estimated creatinine clearance. Reduce or withhold dose as appropriate.
Tumor Lysis Syndrome
Cases of tumor lysis syndrome, TLS, including fatal outcomes, have occurred.
Patients with a high tumor burden should be considered at greater risk for TLS.Adequate hydration is required prior to each dose in cycle 1 and in subsequent cycles as needed. Consider uric acid lowering drugs in patients at risk for TLS. Monitor for evidence of TLS during treatment and manage promptly and withhold until resolved.
Acute respiratory distress syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred. Some events have been fatal. In the event of drug-induced pulmonary toxicity, discontinue KYPROLIS®.
Pulmonary arterial hypertension (PAH) was reported. Evaluate with cardiac imaging and/or other tests as indicated. Withhold KYPROLIS® for PAH until resolved or returned to baseline and consider whether to restart based on a benefit-risk assessment.
Dyspnea was reported in patients treated with KYPROLIS®.
Evaluate dyspnea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes. Stop KYPROLIS® for grade 3 or 4 dyspnea until resolved or returned to baseline. Consider whether to restart based on a benefit-risk assessment.
Hypertension, including hypertensive crisis and hypertensive emergency, has been observed, some fatal. Control hypertension prior to starting KYPROLIS®.
Monitor blood pressure regularly in all patients. If hypertension cannot be adequately controlled, withhold KYPROLIS® and evaluate. Consider whether to restart based on a benefit-risk assessment.
Venous thromboembolic events, including deep venous thrombosis and pulmonary embolism, have been observed. Thromboproflaxis for patients being treated with the combination of KYPROLIS® with dexamethasone or with lenolinamide plus dexamethasone or with daratumumab and dexamethasone. The Thromboproflaxis regimen should be based on an assessment of the patient's underlying risks.
For patients using hormonal contraception associated with a risk of thrombosis, consider an alternative method of effective contraception during treatment. Infusion-related reactions Infusion-related reactions, including life-threatening reactions, have occurred. Signs and symptoms include fever, chills, arthralgia, myalgia, facial flushing, facial edema, laryngeal edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. These reactions can occur immediately following or up to 24 hours after administration. Premedicate with dexamethasone to reduce the incidence and severity of infusion-related reactions.
Fatal or serious cases of hemorrhage have been reported. Hemorrhagic events have included gastrointestinal, pulmonary, and intracranial hemorrhage and epistaxis. Promptly evaluate signs and symptoms of blood loss. Reduce or withhold dose as appropriate.
KYPROLIS® causes thrombocytopenia with recovery to baseline platelet count usually by the start of the next cycle. Monitor platelet counts frequently during treatment. Reduce or withhold dose as appropriate.
Hepatic Toxicity and Hepatic Failure
Cases of hepatic failure, including fatal cases, have occurred. KYPROLIS® can cause increased serum transaminases, monitor liver enzymes regularly regardless of baseline values, reduce or withhold dose as appropriate.
Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic, purpurahemolytic uremic syndrome (TTPHUS), including fatal outcomes have occurred. Monitor for signs and symptoms of TTP-HUS. Discontinue if diagnosis is suspected. If the diagnosis of TTP-HUS is excluded, KYPROLIS® may be restarted. The safety of reinitiating KYPROLIS® is not known.
Posterior Reversible Encephalopathy Syndrome (PRES)
Cases of PRES have occurred in patients receiving KYPROLIS®. If PRES is suspected, discontinue and evaluate with appropriate imaging. The safety of reinitiating KYPROLIS® is not known.
Progressive Multifocal Leukoencephalopathy (PML)
Cases of PML, including fatal cases, have occurred. In addition to KYPROLIS®, other contributory factors may include prior or concurrent use of immunosuppressive therapy. Consider PML in any patient with new onset of or changes in pre-existing neurological signs or symptoms.
If PML is suspected, discontinue and initiate evaluation for PML, including neurology consultation. increased fatal and serious toxicities in combination with melphalan and prednisone in newly diagnosed transplant ineligible patients. In a clinical trial of transplant ineligible patients with newly diagnosed multiple myeloma comparing KYPROLIS®, melphalan and prednisone (KMP) versus bortezomib, melphalan and prednisone (VMP), a higher incidence of serious and fatal adverse reactions was observed in patients in the KMP arm. KMP is not indicated for transplant-ineligible patients with newly diagnosed multiple myeloma.
KYPROLIS® can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Females of reproductive potential should use effective contraception during treatment with KYPROLIS® and for 6 months following the final dose. Males of reproductive potential should use effective contraception during treatment with KYPROLIS® and for 3 months following the final dose.
The most common adverse reactions occurring in at least 20% of patients taking KYPROLIS® in the combination therapy trials: anemia, diarrhea, hypertension, fatigue, upper respiratory tract infection, thrombocytopenia, pyrexia, cough, dyspnea, and insomnia.
Please see full Prescribing Information available at kyprolis-hcp.com.