Initial Monitoring for CRS and AEs in Patients With MM on Bispecifics


Expert perspectives on ensuring the early detection and treatment of CRS and other adverse events when initiating bispecific therapy in patients with multiple myeloma.


Cesar Rodriguez, MD: When patients are being treated, some have had to transition to the inpatient setting due to adverse effects. Do they go through the emergency department [ED], or do you have a fast-track system and approval process? I’d like to get an idea of how that works.

Scott A. Soefje, PharmD, MBA, BCOP, FCCP, FHOPA: Both. We try to send patients through the fast track. If the problem comes through the remote monitoring, there’s a way to get the patient directly admitted to the hospital if they need it. We’ve had times when they told the patients to go to the ED because the hospital didn’t have a bed. We had to get the patient in the ED, get them stabilized, and find the bed to put them in.

Cesar Rodriguez, MD: Do you require any financial authorization for the patient’s admission? Or can you bypass that because it’s an adverse event or an emergency?

Scott A. Soefje, PharmD, MBA, BCOP, FCCP, FHOPA: I don’t think we’re able to get the hospital admission precertified up front. We try, but I don’t think it’s ever done because they’re not sure we’re going to admit somebody. We tell the payers that we may have to admit these patients. If we do, it would be due to adverse effect management, and it’s going to be urgent. We’re not doing it up front.

I also want to mention the caregiver burden. We require the caregiver to be with the patient, so if someone has to take off work for a couple of weeks to monitor the patient, there’s a burden.

Cesar Rodriguez, MD: Thecaregiver is trained for monitoring or identifying CRS [cytokine release syndrome] or ICANS [immune effector cell-associated neurotoxicity syndrome]. Do you feel like the caretakers get more than just a financial burden? Is it also emotionally stressful to be on the lookout for these significant adverse effects? Or do you think the system you’ve implemented is very patient friendly, and they can quickly call? Or they will be in the clinic most of the day?

Scott A. Soefje, PharmD, MBA, BCOP, FCCP, FHOPA: It’s mostly patient friendly. I’m not going to tell you there’s no stress. With outpatient BMTs [bone marrow transplants] and CAR [chimeric antigen receptor] T cell therapy, we require a caregiver because there’s stress there. The remote monitoring adds a sense that somebody else is also paying attention. The ability to call somebody 24/7 and ask questions is helpful. The amount of training and teaching we do is significant. We’ve talked to these patients, and nobody has complained about this. All patients liked the experience and all felt they recognized this, even the ones who got admitted. In fact, 1 of our patients’ caregivers called and said, “They’re not acting right.” It turned out that they were developing ICANS, so we brought them in. It was a great system; it worked. We’ve had our first admission of a patient who doesn’t have a caregiver, and there’s no wait. We’re going to do their nurse step-up on the inpatient site. This will be our first comparison.

Cesar Rodriguez, MD: That will be interesting to see how that turns out. Another difference during the first dose is during the step-up period. That’s where we see the bulk of CRS and ICANS. For inpatient, it’s easy for us to monitor them on a daily basis because we have nurses who do vitals and a neuro check. They use the ICE [Immune Effector Cell-Associated Encephalopathy] scoring system to assess for ICANS. We hook them up to a telemetry monitor, so it’s easy to identify CRS. At the first sign of fever, we’ve started to give tocilizumab and not wait for grade 2 CRS. This has helped reduce the amount of patients who evolve into grade 2 CRS in the amount of hypertension or oxygen requirement if we treat it early on.

Scott, in the outpatient setting, you mentioned wearables and monitors to check vitals while they’re at home or at the hospitality house. Is it a research project? Is this something that’s billed to insurance? What else do you have for mitigating and managing CRS in the outpatient setting during the step-up?

Scott A. Soefje, PharmD, MBA, BCOP, FCCP, FHOPA: I don’t know exactly how it’s billed to insurance, but there’s a process to bill remote monitoring. All these things are hooked up by Bluetooth to the internet, so they’re live 24/7. If a patient takes their temperature, we see the temperature change as if they were in the institution. I’ve wondered if we’re missing mild CRS. If the patient was an inpatient, do we sometimes overreact and treat too soon? What’s that balance? As you said, if we aggressively treat CRS early, it doesn’t progress. There are some cases where the temperature goes up a little, and we don’t need to do anything and then it will go away. But if they’re inpatient and we see that, do we treat them? There’s a balance: where we go and what do we do? We’ve got a real-world ongoing clinical trial monitoring these patients prospectively and looking at their outcomes, response rates, and outcomes with the adverse effects. Our intent is to present this at ASH [American Society of Hematology Annual Meeting]. Hopefully we’ll have 30 to 50 patients by that time so we can report and see what we have.

Cesar Rodriguez, MD: It would be great to get that information and have a nice comparison of how individuals do outpatient and the financial burden for outpatients. [Then we can look at] an institution that’s inpatient and see the financial burden, outcomes, and whether we overdid the dose and other ways of mitigating it.

Transcript edited for clarity.

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