Supportive Care Strategies for Patients with MM on Bispecifics Treatment
Key opinion leaders consider when it is appropriate to utilize bispecific dose holds or reductions when treating patients with multiple myeloma.
Transcript:
Cesar Rodriguez, MD: So, Franny, you have some experience with holding therapy, and we’ve had a couple of patients that have required delay in therapy because of either cytopenias or because of infections. Tell us a little bit about the process at [Mount] Sinai. How we’re doing and patients who are being held for a long period of time for treatment.
Frances A. Bell, NP: I’ve had a couple of patients who’ve been held either because of prolonged cytopenias or infection. One patient had CMV [cytomegalovirus] reactivation who needed to be held for an extended time. They both had been just at/or around the 28 days. That requires the readmission, and it’s per guideline or per the FDA insert if it’s more than 28 days.
Cesar Rodriguez, MD: Twenty-eight days.
Frances A. Bell, NP: If it’s exactly 28 days and we can try to give it in the outpatient setting, one of them was a special circumstance. The patient’s cytopenias were so pronounced, we ended up dose reducing her in the outpatient setting. In some patients we’re making clinical judgments whether to continue those patients on weekly dosing versus trialing them every other week to see how that affects their cytopenias. In many cases, it’s actually been working really well to keep it in the outpatient setting and keep them on therapy without being prolonged longer.
Cesar Rodriguez, MD: We have had to delay patients because of infections or prolonged cytopenias, CMV reactivation, which is something that we’ve seen in some of our patients. The FDA advises that if the treatment is held for more than 28 days to re-step up. If it is within 28 days, you can give outpatient and administer regimens as well if you want to reduce the risk of CRS [cytokine release syndrome], which is recommended. Unless there’s a contraindication to it or the decision believes that it's not needed. We have had patients that went past the 6-week mark of delay and we had to readmit and do the whole step-up process at the end. The patient didn’t have any CRS, but in these transitions, when the patient’s being in the community, that means that we need to coordinate with the institution that’s going to be admitting the patient for these re-step-ups and get authorization for it again. In the case of Mayo Clinic, if it’s going to be outpatient, they’re still going to require authorization to be able to give treatment. Every time we’re shifting the patient from one place to another, it’s another authorization. Hopefully not too frequently. It is important to point out these pauses because once a patient is in the community setting and they’re getting treatment, the things that are going to lead us to problems are infections and holds in therapy. If a patient has an infection, it’s advised to hold off on the treatment until the infection is completely cleared so that the patient doesn’t have an increased risk of CRS. You do not want to have CRS in the community. You want to try to keep it as nice and clean in your practice so you don’t have to be dealing with those issues. If there’s any concern of “OK, I’ve delivered for this much and I’m not as comfortable,” it’s always good to touch base with the initial team to see if they would like to give the next doses and transition the care back to the institution that started the step-ups. Even if they’re not going to do step-ups, just to give the first doses in case there’s any concern for CRS or if they’re not comfortable, familiar, or have the staff for it, and then transition back to the community. Scott, do you guys have any guidelines or any recommendations at the Mayo Clinic that might be different or similar to what we’re doing?
Scott A. Soefje, PharmD, MBA, BCOP, FCCP, FHOPA: Very similar at the Mayo Clinic. We have seen 1 patient develop CRS. It was the day 28 dose and they ended up being admitted for it. That’s the only thing we’ve seen so far. We’ve come close with the delays a couple of times, but nothing that we’ve had to restart so far. The other burden we haven’t talked about is to make sure the patients know where they’re going. Again, because our step-up clinic and our regular clinic are on the same campus, the patient got confused and went to the step-up clinic thinking they were getting their dose there that day, so we had to redirect them to the other clinic. Again, making sure patients know where they’re going is also an important thing. We don’t have anything different from what you guys have already talked about. In other words, once it reaches that part, we’re following the same standards that everybody else has.
Cesar Rodriguez, MD: A navigator is a very important thing to have in treating these patients that can help guide the patient through the whole inpatient, outpatient, or transition to the community or back into our facilities and institutions for re-step-ups or for management of their CRS.
Transcript edited for clarity.
