Ajai Chari, MD: Let’s hear a little about the roles of the different health care team members. Kiah, tell us about the role you’ve had as a nurse practitioner [NP] in treating patients with bispecifics.

Kiah Purcell, NP: I’m a nurse practitioner with the research program at Mount Sinai. I see patients on clinical trials. We have a lot of patients enrolled on clinical trials with both bispecifics and CAR [chimeric antigen receptor] T cells, and we’ve been treating them on bispecifics for a lot longer than the approval. I’m very familiar with these symptoms and adverse effects. I see patients on clinical trials. I do a clinical visit with them and see if they have any new toxicities, and I treat them and manage their adverse effects and any other health concerns that they have. I’m a clinical person, but I also work with research.

Ajai Chari, MD: Tell us a little about your role before the patient even starts a bispecific. Historically, nurse practitioners have been very involved at our site in the consenting process. What are you consenting in that visit? What are you consenting for? We’ve had some lessons learned about not just consenting for the drug but also broader supportive care consent.

Kiah Purcell, NP: With bispecifics and CAR Ts, we have to make sure we do a lot of education. If you’re consenting on a research protocol, it’s a lengthy process, and you have to make sure the patient is aware of all possible adverse effects and management. Part of that is with bispecific antibodies. There’s the risk of CRS [cytokine release syndrome] and ICANS [immune effector cell-associated neurotoxicity syndrome], and there are specific treatments for it. In the consenting process, we make sure we educate on what to look for: fevers, fatigue, myalgias, and any neurological changes. We also consent for additional medication, such as tocilizumab in case it’s needed. If it’s needed, it might not be an opportune time to consent for those additional medications.

Ajai Chari, MD: We’re going to talk a lot about ICANS. When patients have cognitive impairment, it’s hard to give consent at that time. We’ve learned to do that rather than waiting for those to empirically consent for some basic supportive care, so we’re not scrambling. Thank you, Kiah. Let’s move to Annel next. Annel, tell us about your role as a nurse in the research program at Mount Sinai Health System.

Annel Urena, RN: I see a lot of patients in the outpatient setting. I make sure I do a clinical visit with the patients and review their toxicities, new adverse events, and medications. I facilitate any care they need with other providers. If patients are having toxicities, I review with infusion nurses when parameters are clear for treatment for these patients. We provide services and education to infusion nurses and inpatient nurses. Especially when these patients go into inpatient [care], we make sure all staff members are educated on the process: what the toxicities are, what the managements are, and whom to contact when there are issues with patients.

Ajai Chari, MD: Even among RNs [registered nurses], there are the nurses who are in myeloma in the clinic. On research side it’s you, and in clinical standard of care there are practice nurses. But there are also the very important infusion nurses, who administer the drug in the inpatient setting. Even among RNs, there are a lot of different stakeholders within 1 degree, which highlights the complexity of this therapeutic approach. Robert, tell us a little about your role as a pharmacist and how you fit in to all this.

Robert Mancini, PharmD, BCOP: When individuals think of the pharmacist, they think about drugs and how we’re going to be implementing those. Within the myeloma sphere, my biggest role is not just the drug access but also the ability to operationalize access to those drugs as well as any associated programs, such as the REMS [Risk Evaluation and Mitigation Strategy] program. That’s a big thing that I’ve been involved with. I was around when we started dispensing Revlimid. I got involved with the dispensing and the REMS program associated with that. As a lot of these new medications were coming out, specifically the bispecifics and their associated REMS program, I was called on to help operationalize that REMS program in the context of not only drug access but administration. Understanding the REMS program is all of our responsibilities, but we need to help educate on what that means for the medication, the access, who can get it, and how to order it. Those things are really important.

The other things are looking at workflow and how we’re going to transition these patients with the bispecifics. These patients are often bouncing back and forth between inpatient and outpatient settings, so we’re helping with transition of care. If we have the drug in the outpatient clinic vs the hospital, we’re making sure we have those doses available for our patients. The other thing you mentioned, which is really important, is medication review. With ICANS and the risk of what we’re evaluating with ICANS, we also have to look at what other medications they may be on that have CNS [central nervous system] effects, which could muddy the waters for us in diagnosing early onset ICANS. We need to be able to look at that stuff and integrate drug interactions, supportive care, medications. There’s a collaboration among myself, the APPs [advanced practice providers], the nurses, the physicians. That’s where we fit in as pharmacists in that collaboration.

Ajai Chari, MD: This is incredibly important. You brought up the important REMS program. Whom do you typically have do the program? We’re talking about the only commercially improved bispecific teclistamab. At your institution, who does the REMS for teclistamab?

Robert Mancini, PharmD, BCOP: That would be me. I was around when the IMiDs [immunomodulatory imide drugs] came out. I had to develop our REMS program for that. When the ADC [antibody-drug conjugate] came out and then bispecifics, everyone looked at me and said, “You’ve done this before. Get it set up, and help us get it done.” I coordinate the REMS programs for pretty much all myeloma REMS-related drugs.

Ajai Chari, MD: But specifically which providers? Physicians, NPs? Who does REMS? Whom do you ask to do REMS and keep track?

Robert Mancini, PharmD, BCOP: I help with providers. In the case of the commercially available bispecific we’re talking about, I start with our cellular therapy providers because they deal with it in CAR T. There are REMS programs associated with CAR T, so they’re familiar with them. We got them and then all our associated APPs who work with those providers are also REMS certified for this product. That’s the registration piece. Then I help with training at a health care setting, which also has to be REM certified. Luckily, we’re able to roll all our infusion centers and our inpatient unit into 1 overarching REMS certification.

Transcript edited for clarity.