Abstract
Background Teclistamab (Tec) and talquetamab (Tal) are the two first approved T-cell engaging bispecific antibodies (BsAbs) for the treatment of relapsed/refractory multiple myeloma (RRMM), which are initiated using step-up dosing (SUD), usually in an inpatient (IP) setting to mitigate the risk of adverse events (AEs) such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). However, institutions are transitioning to outpatient (OP) SUD models to reduce healthcare resource utilization (HCRU). Remote patient monitoring (RPM) during OP-SUD may enable timely detection of CRS to help improve patient (pt) safety, reduce IP HCRU and improve pt experience. This real-world study evaluated the safety outcomes and HCRU of patients with RRMM initiating Tec or Tal SUD in an OP-RPM setting at a large academic cancer center in the USA.
Methods This retrospective, observational study included adult pts with RRMM who initiated Tec or Tal between May 2024 – Jun 2025 in an OP-RPM setting. Pts selected for OP-RPM SUD were required to have a caregiver, stay <1.5 hrs of main campus, have ECOG 0-1, and be without high disease burden, cognitive or neurological impairments, or complex co-morbidities. The institutional protocol was amended in Dec 2024 to administer prophylactic tocilizumab before the first SUD for all OP-RPM pts initiating Tec or Tal. Pts were provided with RPM devices for the entirety of OP-SUD. They captured continuous pulse rate, oxygen saturation, respiratory rate from the upper arm, continuous temperature from the axilla and intermittent blood pressure 4x daily. Results were summarized descriptively.
Results This study included 13 pts with RRMM who received a total of 14 treatments with Tec or Tal in an OP-RPM setting (Tec=10, Tal=4). The median age was 67 years, 61.5% male, 53.8% White, 23.1% Asian, 15.4% Hispanic; 46.2% had high-risk cytogenetics per IMWG criteria. Pts lived a median of 19 miles away from main campus (range 1-55 miles) and treatments were given at both main campus and regional sites. OP-RPM pts had received a median of 5 prior lines of therapy (range 3-11), including prior CAR-T (50%), prior antibody drug conjugate (7.1%), and prior BsAbs (35.7%).
About 43% of OP-RPM pts received prophylactic tocilizumab, none of whom experienced CRS or ICANS events. Most OP-RPM pts (n=12, 86%) completed SUD, of whom 8 completed in OP setting entirely while 4 completed in OP+IP setting (3 Tec related AEs and 1 non-Tec/Tal related). Two pts did not complete SUD (1 pt was hospitalized for non-Tec related reasons while 1 pt refused IP care despite having grade 1 CRS).
During the SUD phase, the CRS rates observed were 57% (all grade 1), and all CRS events were identified via RPM. Recurrent grade 1 CRS was observed in the 2 pts who did not receive prophylactic tocilizumab and did not complete SUD. Only 2 pts experienced ICANS during SUD, with 1 pt having grade 2 as the highest severity and required hospitalization. No recurrence of ICANS or discontinuation due to CRS or ICANS was observed.
Pts wore the RPM device for a median of 8.6 (IQR: 6.3 – 10.6) days during the SUD period, and median adherence to the wearable device was 85.2% (IQR: 79.0% – 92.1%). The RPM devices triggered alarms for 8 pts who required care for CRSs, which led to appropriate same day intervention at urgent care clinics (n=4) and hospitalizations (n=3), while 1 pt declined IP care. Conversely, pts who did not require care did not have any clinical alarms requiring contact from the clinical monitoring team.
Overall, 4 all-cause hospitalizations (29% incidence of hospitalizations; 1 not Tec/Tal related) were observed among the OP-RPM pts, which was a 71% reduction in incidence of hospitalizations compared to the conventional IP SUD model. Among pts who completed SUD, 3 cases of hospitalization during SUD period resulted in a median length of hospital stay of 5 days (range 2-6).
Conclusions Prophylactic use of tocilizumab resulted in no CRS events for patients treated in OP-RPM. OP-RPM enabled a safe OP-SUD initiation of Tec/Tal by identifying CRS and escalating to appropriate care in a timely manner, thus reducing HCRU. This study shows the feasibility of initiating Tec/Tal SUD in OP setting, utilizing RPM and prophylactic tocilizumab to reduce CRS rates and severity and HCRU.
