Administering Step-up and Treatment Doses of Bispecifics in Patients With MM
Frances A. Bell, NP, leads a conversation on key steps taken leading up to the initial administering of bispecific therapy in patients with multiple myeloma.
Transcript:
Cesar Rodriguez, MD: The FDA approved this agent using2 step-up doses. The first dose is 0.6 mg/kg, followed by a second dose at 0.3 mg/kg and then the full dose of 1.5 mg/kg. The time between these step-up doses can range between 2 and 7 days, depending on the institution where you’re giving it. If the patient has developed any adverse events or CRS [cytokine release syndrome], then you’ll want to wait for that to pass. After that, the risk of CRS tends to drop significantly. Maybe start at an institution and then transition. I want to hold that thought. I will bring this up later in the discussion.
One thing I want to talk about is the starting phase. When we see a patient in the clinic, and we [think] the patient will benefit from teclistamab, there are 2 main paths we can take. We have a nice representation of how we can do it. The way the FDA approved this is that patients need to be enrolled in the REMS [Risk Evaluation and Mitigation Strategy] program to mitigate any risks from this agent. It’s also requesting or requiring that patients be monitored for 48 hours after each step-up dose and the first full dose…. I’d like Franny to give us her thoughts on when you have a patient in the clinic. If you say this patient is going to benefit from teclistamab, and we’ve agreed to offer teclistamab, what steps do you take to start the process of teclistamab for that patient?
Frances A. Bell, NP: The prior discussion about where it fits in is interesting. We’re seeing the patients and trying to see if they can get on a clinical trial and if they’re eligible…. We’re often pivoting toward commercial teclistamab. At that point, there are a lot of steps to take to make sure they get set up for the inpatient and outpatient part and that everything is in order. Our institution [Mount Sinai Health System] created a teclistamab checklist. We have a checklist we’re going to go through on that first visit with the patient to see if they have baseline labs done, which includes basic labs, CBC [complete blood count] and CMP [comprehensive metabolic panel]. We’re also doing ferritin, CRP, CMV [cytomegalovirus], and now G6PD, which we’ll talk about later for the PCP [pneumocystis jiroveci pneumonia] prophylaxis.
In addition to the baseline labs, at that point we’ll also go through the consent for teclistamab and also for tocilizumab, because they often need it at some point during the inpatient stay. After the consent, we go through the chart and make sure they have a health care proxy, that it’s updated and current. If they don’t have 1, then we create a new 1 with the patient during that time. This is because if they have CRS or neurotoxicity during the hospital stay, then it’s important to know what their wishes are and whom they want to be contacted. In addition, we also need to put in everything for the authorization. We enter a plan into the system for the treatment plan, which prompts the outpatient authorization. We have to enter another order for the inpatient authorization and then request a bed for the patient for the inpatient stay. Once we do everything, we send an email to a 1000 individuals to make sure everyone is on track and working on the authorizations because often we’re trying to get them into the hospital within a 1- to 2-week time span. Everything has to happen in a timely manner.
Cesar Rodriguez, MD: You describe it very nicely. Once we have somebody identify for teclistamab and we see that they’re eligible for it, the process to get things going financially requires a lot of steps. At Mount Sinai, we do the step-up dosing in the hospital. We admit the patient, give the first dose outpatient, then admit the patient and give the second dose on day 3. Then we give the full dose on day 5 and keep them on observation for 48 hours—7 days total in the hospital. If they’re doing fine at that point, they get discharged. The following doses are given in the clinic. From what you’re describing, Franny, we require an insurance authorization for the admission and also for the treatment in the outpatient setting. At the same time, we need to get the ball rolling to request the bed admission so the patient can be there for a whole week. [We need to] make sure that the patient doesn’t have any active viral infections, like uncontrolled CMV, HIV, or any other potential infections that could potentially flare. So you bring up a good point. We’d like to see patients at least a week from when they’re going to start therapy to make sure there are no red flags. Then on the day of starting the treatment, we could potentially increase the risk of CRS neurotoxicity or other adverse effects.
Transcript edited for clarity.
