Outpatient administration of idecabtagene vicleucel in relapsed refractory multiple myeloma without planned prophylaxis or remote monitoring.
Abstract
e19577 Background: Idecabtagene vicleucel is a chimeric antigen receptor T-cell therapy (CAR-T) targeting the B-cell maturation antigen (BCMA) that has shown efficacy in the treatment of relapsed/refractory multiple myeloma (R/R MM. Due to potentially early and significant toxicities like Cytokine release syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS), many institutions have elected to administer this therapy on the inpatient setting. Little is known regarding the safety and feasibility of this therapy in the outpatient setting. Methods: After obtaining Institutional IRB approval, we performed a retrospective analysis of all adult patients with Multiple Myeloma who received idecabtagene vicleucel at the University of Oklahoma Medical Center from 2019 through 2024. Descriptive statistics were created for all variables. Kaplan-Meier analysis and Cox Proportional Hazards Regression were used to explore OS. SAS 9.4 was used to perform all analysis. An alpha of 0.05 was used to determine significance. Results: A total of 16 patients were identified with a median age 65.5 years. White represented 75.0% of the cohort and 43.8% were female. The majority (93.7%) had ECOG 2 or less. The median prior lines of treatment were four and 71.4% had history of prior Bone Marrow Transplantation. Two patients (12.5%) had impaired renal function at the time of infusion. Fludarabine plus cyclophosphamide was the lymphodepletion regimen used for all patients. CRS was reported in 12 patients (85.7%), mostly (83.3%) Grade 1 CRS. Of note, no Grade 3 or Grade 4 CRS was reported. Most CRS events occurred within 1 day of infusion (83%) and Tocilizumab was used to manage all CRS events. Grade 1 ICANS was reported in one patient for whom steroids and Anakinra was used for management. Infections within 100 days was reported in 9.1% of patients . Thirteen patients were alive at the time of this analysis and the median follow up time was 10.4 months. Conclusions: Our findings indicate that outpatient administration of Idecabtagene Vicleucel is feasible with adequate institutional experience and proper toxicity monitoring and management. The majority of patients were still living, so longer follow up time is required to explore the full outpatient experience for patients on this treatment and to understand all pertinent patient outcomes.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (18)
Ayesha Aijaz
Noha Soror
1University of Oklahoma Health Sciences Center, Oklahoma City, United States
Niveditha Popuri
1University of Oklahoma Health Sciences Center, Oklahoma City, United States
Satya Sai Venkata Lakshmi Arepalli
1University of Oklahoma Health Sciences Center, Oklahoma City, United States
Aminah Tayyab
1University of Oklahoma Health Sciences Center, Oklahoma City, United States
Joseph Spear
The University of Oklahoma College of Medicine, Oklahoma City, OK
Adolfo Diaz Barba
1University of Oklahoma Health Sciences Center, Oklahoma City, United States
Bibi Maryam
1University of Oklahoma Health Sciences Center, Oklahoma City, United States
Michael Machiorlatti
2Hudson College of Public Health, Oklahoma City, United States
Silas Day
1University of Oklahoma Health Sciences Center, Oklahoma City, United States
Muhammad Salman Faisal
1University of Oklahoma Health Sciences Center, Oklahoma City, United States
Zimu Gong
9Oklahoma University Stephenson Cancer Center, Oklahoma City, United States
Manu Pandey
6University of Oklahoma Stephenson Cancer Center, Oklahoma City, United States
Sami Ibrahimi
16Department of Hematology Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, OK
Mohamad Osama Khawandanah
The University of Oklahoma Health Sciences Center, Oklahoma City, OK
Jennifer Holter Chakrabarty
Stephenson Cancer Center at The University of Oklahoma Health Sciences Center, Oklahoma City, OK
Adam Steven Asch
Stephenson Cancer Center, Oklahoma City, OK
Taha Al-Juhaishi
1University of Oklahoma Health Sciences Center, Oklahoma City, United States