Cilta-cel is Safe, Feasible in Outpatient Settings for R/R Multiple Myeloma

Taiga Nishihori, MD

Delivering ciltacabtagene autoleucel (cilta-cel; Carvykti) in the outpatient setting to patients with relapsed/refractory (R/R) multiple myeloma appears to be safe and feasible when followed by close monitoring of patients who are undergoing the chimeric antigen receptor (CAR) T-cell therapy, according to a single-center, retrospective study.¹

“We wanted to look at our experience on treating patients with multiple myeloma who received cilta-cel, which is a CAR T-cell [therapy]. We started looking at this in 2022,” explained Taiga Nishihori, MD, senior member in the Blood & Marrow Transplant and Cellular Immunotherapy Department at Moffitt Cancer Center, in an interview with Targeted Oncology^TM.

Patients with R/R multiple myeloma who were hospitalized and treated commercial cilta-cel at Moffitt Cancer Center between May 2022 and May 2023 were the focus of the study. Investigators specifically looked at the first 30 days postinfusion.

In the initial group evaluated, patients were given lymphodepleting chemotherapy as outpatient, then CAR T-cell infusion as inpatient along with monitoring. The patient was then discharged to an outpatient immune cell therapy service.

A close-up of a red cell with a red blood cell in the background Generative AI: © Bipul Kumar - stock.adobe.com

“Initially, we started doing an outpatient model, which was the beginning of it, and then we changed it to inpatient. The chemotherapy was given, lymphodepletion in particular, and chemotherapy was given as an outpatient; they readmitted patients,” Nishihori said. “But then we quickly realized that patients who are in the hospital were basically spending a lot of time waiting for toxicity to occur. We changed our approach [to] entirely outpatient.”

The process was modified to deliver patients lymphodepleting chemotherapy and cilta-cel as entirely outpatient, and patients were also followed in this setting. Patients were only admitted to inpatient if and when clinical needs came up. Additionally, patients were monitored closely through day +30 postinfusion, and they were evaluated to see if cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) arose.

“We looked at over 20 patients who received those. We also demonstrated that the amount of time they spend in a hospital has been cut down from 11 days to a median of 4 days,” said Nishihori.

There were 43 patients with R/R multiple myeloma treated, including 10 patients (23.3%) for scheduled inpatient, 6 patients (14.0%) for inpatient, and 27 patients (62.8%) as outpatient. The median duration of days for those entirely inpatient was 19. Four of these patients were hospitalized due to multiple myeloma-related conditions, 1 for a chemotherapy-related gastrointestinal toxicity, and 1 for patient preference.

“We wanted to look at the hospital duration. We also wanted to look at the outcomes of this approach. We have established our system to take care of patients, mostly on the outpatient side. The patients are seen daily in what's called 3 central outpatient areas, and we have managed to conduct this safely as an outpatient,” Nishihori explained.

Among the 10 patients in the scheduled inpatient group, the median duration was 11 days, and all patients were admitted on day –1. Of those in the outpatient group, 25 patients (92.6%) were admitted post-CAR T, and the median hospital stay duration was 4 (range, 1-33) days.

Patients were primarily admitted due to CRS (n = 22). An additional 5 patients had various clinical indications, including arrhythmia, infection, and social reasons. Of the patients who underwent outpatient immune cell therapy, 3 (11.1%) were in need of second admission within 30 days of receiving the CAR T-cell therapy. Two of these resulted from ICANS and 1 from infection.

Looking at overall survival (OS) and progression-free survival (PFS), rates were similar across the administration types. At 1-year, the OS for outpatient was 96.3% (95% CI, 76.5%-99.5%; P =.068) for outpatient, and the PFS rate was 85.8% (95% CI, 60.6%-95.5%; P =.10). For outpatient, the median follow-up for surviving patients was 7.7 months (range, 2.9-14.4).

“We have shown that the duration of hospitalization is reduced. The survival rates and progression-free survival are similar between those patients who had mostly inpatient or outpatient inpatient vs entirely outpatient,” Nishihori stated.

For the community oncologist, Nishihori shares that cilta-cel can be delivered to patients with R/R multiple myeloma using an outpatient model.

“This will expand the patient's ability to stay out of the hospital and have more time to relax while undergoing CAR T-cell therapy. We are attempting to expand this further to different products and maybe in the future indications. We will have more patients going through outpatient CAR T.”

REFERENCE:

Waqar S, Hansen DK, Freeman CL, et al. Evaluation of outpatient administration of ciltacabtagene autoleucel in relapsed/refractory multiple myeloma: single center experience. Presented at: 2024 Transplantation & Cellular Therapy Meetings: February 21-24, 2024; San Antonio, TX. Abstract 532.