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, Hematology-Oncology, and an associate professor of medicine (hematology-oncology) at the Hospital of the University of Pennsylvania in Philadelphia.
What Bispecific Antibodies Are Currently Available for Patients With Relapsed/Refractory Multiple Myeloma?
Steps for Initiating Outpatient Bispecific Antibody Administration:
- Compile and train a multidisciplinary team
- Facilitate relationships between community and academic oncology centers
- Coordinate multicenter patient care and referrals
What Is the Rationale for Administering Bispecific Antibodies in Outpatient Settings?
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) like 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 United States (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.”
How Was the Bispecific Antibody Implementation Roadmap Compiled?
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.
What Clinical and Operational Elements Are Needed for the Safe and Effective Administration of Bispecific Antibodies in Outpatient and Community Settings?
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:
- Account for baseline bed capacity
- Allocate resources accordingly
- Outline the availability of on-call care teams to determine how many patients can be treated at a given time
Outpatient clinics should create clear protocols for every step of the bispecific antibody treatment pathway. These protocols should:
- Guide patients about the necessity of having a reliable and knowledgeable caregiver who can recognize the signs of AEs, communicate with medical professionals, and coordinate patient transportation
- Provide accommodation plans for patients and caregivers who live far from treatment centers
- Define pretreatment requirements, prophylactic options, and admission practices
- Outline AE monitoring, reporting, and management strategies
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 like tocilizumab and dexamethasone.
How Should Clinics Identify and Prepare Patients for Bispecific Antibody Therapy?
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):
- Low tumor burden
- An ECOG performance status of 0 to 2
- Good mental status
- Minimal or stable complications from myeloma progression
- Well-controlled comorbidities
- Close proximity to a hospital
- A reliable caregiver
Outpatient clinics should also educate patients and caregivers about:
- AE symptoms to watch for
- Actions to take if AEs arise
- Using at-home monitoring equipment
The roadmap notes that patient advisory groups and digital tools may provide additional patient-focused resources. Patients should also receive:
- Medical team contact information
- AE management medications
- A logbook
- A symptom reminder sheet
- Monitoring equipment
What Are the Steps for Initiating Outpatient Bispecific Antibody Treatment Practices?
Prior to treatment, clinics should obtain the following from each patient:
- Baseline laboratory data
- Vital signs
- Results of tests for endemic infections (when relevant)
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:
- A history of multiple prior lines of therapy for multiple myeloma
- A history of receiving immunosuppressive therapies for AE management
- Neutropenia
- Hypogammaglobulinemia
Infection prophylaxis may be mediated by factors such as:
- Comorbidities
- Cytopenias
- Prior therapy
- Prior infections
Outpatient clinic teams should be familiar with recognizing and managing the oral- and skin-related AEs that are associated with bispecific antibodies.
How Can Community Oncology Practices Refer Patients for Outpatient Bispecific Antibody Treatment?
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.”
References
- Garfall AL, Banerjee R, Frenzel L, et al. A roadmap to implementing outpatient administration of bispecific antibodies in multiple myeloma. Front Oncol. Published online July 30, 2025. doi:10.3389/fonc.2025.1630146
- FDA approves teclistimab-cqyv for relapsed or refractory multiple myeloma. FDA. October 25, 2022. Accessed September 11, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-teclistamab-cqyv-relapsed-or-refractory-multiple-myeloma
- US FDA approves Talvey (talquetamab-tgvs), a first-in-class bispecific therapy for the treatment of patients with heavily pretreated multiple myeloma. News release. Janssen. August 10, 2023. Accessed September 11, 2025. https://www.janssen.com/us-fda-approves-talveytm-talquetamab-tgvs-first-class-bispecific-therapy-treatment-patients-heavily
- Pfizer’s Elrexfio receives US FDA accelerated approval for relapsed or refractory multiple myeloma. News release. Pfizer. August 14, 2023. Accessed September 11, 2025. https://investors.pfizer.com/Investors/News/news-details/2023/Pfizers-ELREXFIO-Receives-U.S.-FDA-Accelerated-Approval-for-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx