IMS 2025 | The BOSS program: improving the safety of bispecific outpatient step-up dosing for multiple myeloma

So first of all I’d like to thank VJHemOnc for this opportunity to share our experience of BOSS program and BOSS stands for Bispecific Outpatient Safe Step Up. And this is a quality improvement initiative that we established at Massachusetts General Hospital to make the bispecific antibody therapy safer, more scalable, and basically more patient-friendly and be able to adopt it in the real-world practice. So as we know, bispecific antibodies have been transformative in the relapsed/refractory setting. And in fact, we are trying to move this therapy to the frontline setting so that they are available for newly diagnosed and also in early relapse multiple myeloma patients. However, the standard approach has inpatient step-up dosing to monitor for early toxicities such as cytokine release syndrome and ICANS. That’s a limiting factor and that creates barriers which I’d say prevents easy adoption of these therapies in the community and rural settings. And these admissions are costly, are logistically demanding, and we have to come up with a system, right? With a model that we could use, which is more friendly in the rural setting, in the communities, to be able to use this groundbreaking therapy, right, for multiple myeloma. So what we did to address this, we created BOSS, And BOSS is an outpatient protocol for delivery of the step-up dosing of the bispecifics in the ambulatory setting. And we did that by using prophylactic dexamethasone, no preemptive tocilizumab, that was combined with remote telehealth monitoring of symptoms. And for the beginning, at the start, we used some patient selection criteria. So we included patients with a lesser disease burden, with no severe cytopenias, with preserved organ function. And for the pilot, we included 15 patients. And what we did, right, we just gave them the step-up doses in the clinic. But on the days in between, patients were just going on with their own life, right, at home, taking prophylactic dexamethasone together with the infectious prophylaxis and answering our calls just to make sure that they’re doing okay. And when we compared our safety data, right, the incidence of CRS, of ICANS, infections, the duration of hospitalization of our BOSS patients to the historical patients that received their step-up dosing inpatient, that underwent step-up dosing inpatient, we noticed a dramatic decrease in the CRS incidence. ICANS, the infections were comparable, so that wasn’t an issue. But most importantly, 87% of the BOSS patients completed their step-up dosing completely outpatient. So, they didn’t have to be admitted. And I think that’s a win, because what our program showed is that you can use prophylactic dexamethasone combined with telehealth monitoring and patient selection criteria to provide this platform which is safe, it’s scalable, it’s patient-friendly and could be probably used as a blueprint to adopt bispecific therapy in the rural settings and in the community I think.

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