Outpatient BiTE Therapy Model Expands Access for Patients With Multiple Myeloma
Pharmacy Times interviews Nicole McMullin, regional clinical pharmacist at American Oncology Network, on how BiTE therapy is changing care for relapsed/refractory multiple myeloma and how AON developed an all-outpatient step-up dosing model.
In an interview with Pharmacy Times, Nicole McMullin, regional clinical pharmacist at American Oncology Network, discussed the clinical significance of bispecific T-cell engager therapy in relapsed or refractory multiple myeloma and how AON developed an all-outpatient step-up dosing model to support safe administration in the community oncology setting.
McMullin explained that BiTE therapy has changed the treatment landscape for heavily pretreated patients with multiple myeloma. In clinical trials, these therapies produced overall response rates of approximately 60% to 70% in patients who were refractory to multiple prior lines of therapy, making them an important option for individuals with limited remaining treatment choices. She also noted that bispecific therapy offers an “off-the-shelf” approach compared with CAR T-cell therapy. Unlike CAR T-cell therapy, which requires referral to a specialized treatment center, manufacturing of patient-specific cells, lymphodepleting chemotherapy, and a lead time that may extend up to a month, BiTE therapy can be initiated more quickly and closer to home.
McMullin also described AON’s process for building an outpatient step-up dosing model. The organization developed standard operating procedures for cellular therapy initiation, beginning with bispecific therapies for multiple myeloma and later expanding to CAR T-cell therapy. A major early step was establishing patient selection criteria for all-outpatient step-up dosing. These criteria included living within 1 hour of the clinic, having a reliable caregiver available around the clock during the step-up period, avoiding disease-specific factors associated with increased risk for cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome, and having reasonable access to a hospital if urgent evaluation is needed.
To support implementation, AON created multidisciplinary clinic-based teams that include a physician champion, oncology pharmacist, clinic nurse manager, infusion nurses, and financial team members. McMullin emphasized that safety planning also requires immediate access to tocilizumab and emergency medications, home monitoring for CRS and ICANS, staff and patient education, and coordination with local hospitals to ensure rapid triage and treatment when needed.
