A roadmap shares guidelines for the safe administration of bispecific antibodies to patients with multiple myeloma in outpatient and community settings.
Bispecific antibodies for patients with multiple myeloma can be safely administered in the outpatient and community oncology settings with proper planning and adherence to protocols thus expanding access to these therapies, according to a guidance roadmap published in Frontiers in Oncology.1
“Outpatient administration of bispecific antibodies can be both effective and safe when supported by appropriate infrastructure, a well-prepared multidisciplinary team of health care professionals, and clear, accessible plans and protocols guiding the entire treatment process—from clinical setup to treatment initiation and ongoing management,” lead study author Alfred L. Garfall, MD, and coauthors, wrote in the article.
Garfall is the director of Autologous Hematopoietic Stem Cell Transplantation, section chief of myeloma in the Division of Hematology/Oncology, and an associate professor of medicine (hematology-oncology) at Perelman School of Medicine, University of Pennsylvania, in Philadelphia.
Three bispecific antibodies are currently FDA approved as monotherapies for use in relapsed/refractory multiple myeloma.
Steps for Initiating Outpatient Bispecific Antibody Administration:
The roadmap authors noted that as single agents, these bispecific antibodies yield response rates that are comparable with those achieved with CAR T-cell therapies. Moreover, the authors highlighted that bispecific antibodies offer unique benefits over that modality, most notably their feasibility to be administered as off-the-shelf, subcutaneous agents. They also explained that bispecific antibodies are suitable for use in a variety of patient populations, regardless of age or frailty.
However, they emphasized that this class of agents is associated with adverse effects (AEs) such as cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome, and infections that need to be monitored for and managed appropriately. Therefore, most bispecific antibodies are currently administered in academic and hospital settings. Additionally, the US prescribing information for each of these approved agents requires that patients be hospitalized for 24 to 48 hours after step-up dosing with these therapies.
“Adoption in other practice settings, such as outpatient clinics and community centers, can be challenging due to a lack of physician experience with bispecific antibodies and necessary infrastructure and resources,” the authors stated. “Developing strategies to implement bispecific antibody use in outpatient and community settings is a critical step toward lowering disparities in relapsed/refractory multiple myeloma treatment, as well as decreasing inpatient hospitalization time, lowering overall health care costs, and enhancing the patient experience.”
The guidance in this roadmap was collected based on consensus decisions reached during 3 international clinician advisory workshops that occurred in the US, Latin America, and Europe between June 2024 and September 2024. In these workshops, clinicians discussed key components of leveraging bispecific antibodies in the community and outpatient settings, including practice setup, treatment initiation, and ongoing disease management.
The roadmap states that health care centers should make plans for outpatient bispecific antibody administration based on type of center (existing outpatient clinic vs new clinic) and existence of an onsite emergency department (ED; yes vs no) to assist patients in the event of serious complications. Outpatient clinic teams should either train their existing ED teams to treat patients with bispecific antibody–related inpatient needs, or form partnerships with hospitals. Beyond the ED and medical wards, clinics should secure intensive care unit (ICU) capacity. Outpatient clinics should also do the following:
Outpatient clinics should create clear protocols for every step of the bispecific antibody treatment pathway. These protocols should do the following:
The roadmap notes that, in certain cases, clinics may be able to integrate bispecific antibody administration protocols into existing protocols for the management of other malignancies.
Importantly, streamlined hospital admission pathways should be outlined to help patients bypass the ED if they experience serious AEs. This involves proactive communication between the outpatient facility and the hospital, the availability of team members within the hospital workflow who are trained in the management of bispecific antibody–related AEs, the availability of on-call staff within the outpatient facility, and the availability of medications like tocilizumab (Actemra) and dexamethasone for CRS management.
The roadmap stresses the importance of having a well-trained multidisciplinary team that includes hematologists, physicians, nurses, ED specialists, ICU specialists, infectious disease specialists, pharmacists, and authorization teams. Protocols should outline the roles of each member of the team to ensure proper care at each step in the treatment process.
Moreover, the authors note that clinics should receive authorization to administer bispecific antibodies in the outpatient setting, as well as to stock and prescribe supportive medicines such as tocilizumab and dexamethasone.
The authors note that most patients with relapsed/refractory multiple myeloma are eligible to receive bispecific antibodies in the outpatient setting, particularly those who meet the following criteria (although those with higher-risk features may still be considered):
Outpatient clinics should also educate patients and caregivers about the following:
The roadmap notes that patient advisory groups and digital tools may provide additional patient-focused resources. Patients should also receive the following:
Prior to treatment, clinics should obtain the following from each patient:
Infusion staff then administer the bispecific antibodies to patients via a step-up dosing schedule, then monitor the patient using routine protocols until the patient is cleared for checkout.
Following treatment initiation, patients should be monitored for typical or opportunistic infections, which are at a heightened risk of developing in patients with the following:
Infection prophylaxis may be mediated by factors such as the following:
Outpatient clinic teams should be familiar with recognizing and managing the oral- and skin-related AEs that are associated with bispecific antibodies.
The roadmap emphasizes that patient referrals from community oncology practices should be conducted with the guidance of academic centers that have experience administering bispecific antibodies. After step-up dosing in the outpatient setting, these patients may transition back to treatment follow-up in community centers.
“Centers can start slowly, gaining experience with patients in the hospital setting and then moving patients to an established outpatient setting,” the authors concluded. “While these recommendations provide a practical roadmap for implementing bispecific antibody administration in outpatient and community settings, some limitations persist, as not all centers will have adequate staffing, equipment, or infrastructure. However, enabling more centers to adopt these practices is critical to increase the accessibility of care and improve outcomes for patients with relapsed/refractory multiple myeloma.”
