Feasibility and Safety of Outpatient Model for Administration of Bispecific Antibodies: Proceedings from an International Myeloma Society 21st Annual Meeting Oral Abstract
- PMID: 40345961
- DOI: 10.1016/j.clml.2025.04.002
Feasibility and Safety of Outpatient Model for Administration of Bispecific Antibodies: Proceedings from an International Myeloma Society 21st Annual Meeting Oral Abstract
Abstract
Background: Teclistamab, elranatamab, and taqluetamab are T-cell redirecting bispecific antibodies (BsAbs) that gained accelerated approval for the treatment of patients with relapsed/refractory multiple myeloma (RRMM). All 3 FDA labels suggest hospitalization for the step-up doses (SUDs) to monitor for CRS and ICANS.
Methods: We implemented an institutional protocol to deliver SUD and target doses in the outpatient (OP) setting to minimize hospitalization and reimbursement burdens. Patient disease and social factors were evaluated for OP protocol eligibility. SUDs were administered on days 1, 4 and 8 preceded by acetaminophen, diphenhydramine, and dexamethasone. All patients received prophylactic tocilizumab per institutional protocol. From initiation of SUD #1 until 48-hours after the target dose, patients self-monitored temperature every 8 hours or in the setting of new signs or symptoms suggestive of CRS/ICANS. If fever or neurologic change should occur, patients were educated to take medications (acetaminophen 650 mg, diphenhydramine 50 mg and dexamethasone 20 mg) and present to the Immediate Care Center for assessment and management.
Results: From 9/1/2023 to 8/31/2024, 52 patients received OP BsAb SUD. CRS occurred in 10 patients (19.2%, 9/10 events grade 1/2) and ICANS occurred in 3 patients (5.8%, grade 1). Four patients (7.7%) required hospitalization for toxicity management. All patients recovered from CRS and ICANS without additional toxicity.
Conclusion: Implementation of this OP BsAb SUD protocol is feasible with acceptable risk of CRS/ICANS and hospitalization without compromising on safety. The low incidence of CRS/ ICANS with prophylactic tocilizumab and premedication and low hospitalization rates make this appealing for selected RRMM patients.
Keywords: Multiple myeloma; Prophylactic tocilizumab; Step-up dose administration; T-cell engager; T-cell redirecting therapy.
Copyright © 2025 The Author(s). Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Disclosure The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Sara A Scott reports a relationship with Pfizer Inc that includes: consulting or advisory. Sara A Scott reports a relationship with Janssen Pharmaceuticals Inc that includes: consulting or advisory. Sara A Scott reports a relationship with Sanofi that includes: consulting or advisory. Nisha S Joseph reports a relationship with Janssen Pharmaceuticals Inc that includes: consulting or advisory and funding grants. Nisha S Joseph reports a relationship with Bristol-Myers Squibb Co that includes: consulting or advisory and funding grants. Nisha S Joseph reports a relationship with Takeda Oncology that includes: funding grants. Nisha S Joseph reports a relationship with AstraZeneca Pharmaceuticals LP that includes: funding grants. Nisha S Joseph reports a relationship with GlaxoSmithKline Inc that includes: funding grants. Jonathan L Kaufman reports a relationship with Janssen Pharmaceuticals Inc that includes: consulting or advisory and funding grants. Jonathan L Kaufman reports a relationship with Takeda Oncology that includes: consulting or advisory and funding grants. Jonathan L Kaufman reports a relationship with Bristol-Myers Squibb Co that includes: consulting or advisory and funding grants. Jonathan L Kaufman reports a relationship with AbbVie Inc that includes: consulting or advisory and funding grants. Jonathan L Kaufman reports a relationship with Roche Diagnostics Corporation that includes: consulting or advisory and funding grants. Jonathan L Kaufman reports a relationship with Seattle Genetics that includes: consulting or advisory and funding grants. Jonathan L Kaufman reports a relationship with Celgene that includes: consulting or advisory and funding grants. Jonathan L Kaufman reports a relationship with Amgen Inc that includes: consulting or advisory and funding grants. Jonathan L Kaufman reports a relationship with Sutro Biopharma Inc that includes: consulting or advisory and funding grants. Jonathan L Kaufman reports a relationship with Karyopharm Therapeutics Inc that includes: consulting or advisory and funding grants. Jonathan L Kaufman reports a relationship with Pharmacyclics LLP that includes: consulting or advisory and funding grants. Craig C Hofmeister reports a relationship with Celgene that includes: consulting or advisory and funding grants. Craig C Hofmeister reports a relationship with Janssen Pharmaceuticals Inc that includes: funding grants. Craig C Hofmeister reports a relationship with Bristol-Myers Squibb Co that includes: funding grants. Craig C Hofmeister reports a relationship with Takeda Oncology that includes: funding grants. Ajay K Nooka reports a relationship with Amgen Inc that includes: consulting or advisory and funding grants. Ajay K Nooka reports a relationship with Spectrum Pharmaceuticals Inc that includes: consulting or advisory. Ajay K Nooka reports a relationship with Takeda Oncology that includes: consulting or advisory and funding grants. Ajay K Nooka reports a relationship with Celgene that includes: consulting or advisory and funding grants. Ajay K Nooka reports a relationship with Bristol-Myers Squibb Co that includes: consulting or advisory and funding grants. Ajay K Nooka reports a relationship with GlaxoSmithKline Inc that includes: consulting or advisory and funding grants. Ajay K Nooka reports a relationship with Adaptive Technologies that includes: consulting or advisory. Ajay K Nooka reports a relationship with Janssen Pharmaceuticals Inc that includes: consulting or advisory and funding grants. Ajay K Nooka reports a relationship with Novartis Pharmaceuticals Corporation that includes: funding grants. Ajay K Nooka reports a relationship with Roche that includes: funding grants. Ajay K Nooka reports a relationship with Kite Pharma Inc that declaration statement includes: funding grants. Madhav V Dhodapkar reports a relationship with Amgen Inc that includes: consulting or advisory. Madhav V Dhodapkar reports a relationship with Janssen Pharmaceuticals Inc that includes: consulting or advisory. Sagar Lonial reports a relationship with Takeda Oncology that includes: consulting or advisory and funding grants. Sagar Lonial reports a relationship with Novartis Pharmaceuticals Corporation that includes: consulting or advisory and funding grants. Sagar Lonial reports a relationship with Bristol-Myers Squibb Co that includes: consulting or advisory and funding grants. Sagar Lonial reports a relationship with GlaxoSmithKline Inc that includes: consulting or advisory and funding grants. Sagar Lonial reports a relationship with Amgen Inc that includes: consulting or advisory and funding grants. Sagar Lonial reports a relationship with Merck & Co Inc that includes: consulting or advisory and funding grants. Sagar Lonial reports a relationship with Celgene that includes: consulting or advisory and funding grants. Sagar Lonial reports a relationship with Janssen Pharmaceuticals Inc that includes: consulting or advisory and funding grants. Dr. Sagar Lonial is an Editor-In-Chief for Clinical Leukemia, Myeloma and Lymphoma. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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