Sara A Scott, Danielle L Roberts, Vikas A Gupta, Nisha S Joseph, Craig C Hofmeister, Madhav V Dhodapkar, Sagar Lonial, Ajay K Nooka, Jonathan L Kaufman
{"title":"双特异性抗体门诊用药模式的可行性和安全性:国际骨髓瘤学会第21届年会论文集。","authors":"Sara A Scott, Danielle L Roberts, Vikas A Gupta, Nisha S Joseph, Craig C Hofmeister, Madhav V Dhodapkar, Sagar Lonial, Ajay K Nooka, Jonathan L Kaufman","doi":"10.1016/j.clml.2025.04.002","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":10348,"journal":{"name":"Clinical Lymphoma, Myeloma & Leukemia","volume":" ","pages":""},"PeriodicalIF":2.7000,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Feasibility and Safety of Outpatient Model for Administration of Bispecific Antibodies: Proceedings from an International Myeloma Society 21st Annual Meeting Oral Abstract.\",\"authors\":\"Sara A Scott, Danielle L Roberts, Vikas A Gupta, Nisha S Joseph, Craig C Hofmeister, Madhav V Dhodapkar, Sagar Lonial, Ajay K Nooka, Jonathan L Kaufman\",\"doi\":\"10.1016/j.clml.2025.04.002\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":10348,\"journal\":{\"name\":\"Clinical Lymphoma, Myeloma & Leukemia\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.7000,\"publicationDate\":\"2025-04-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Lymphoma, Myeloma & Leukemia\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.clml.2025.04.002\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"HEMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Lymphoma, Myeloma & Leukemia","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.clml.2025.04.002","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEMATOLOGY","Score":null,"Total":0}
Feasibility and Safety of Outpatient Model for Administration of Bispecific Antibodies: Proceedings from an International Myeloma Society 21st Annual Meeting Oral 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.
期刊介绍:
Clinical Lymphoma, Myeloma & Leukemia is a peer-reviewed monthly journal that publishes original articles describing various aspects of clinical and translational research of lymphoma, myeloma and leukemia. Clinical Lymphoma, Myeloma & Leukemia is devoted to articles on detection, diagnosis, prevention, and treatment of lymphoma, myeloma, leukemia and related disorders including macroglobulinemia, amyloidosis, and plasma-cell dyscrasias. The main emphasis is on recent scientific developments in all areas related to lymphoma, myeloma and leukemia. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.