Clinician and Administrator Perspectives on Chimeric Antigen Receptor (CAR) T-Cell Therapy Outpatient Administration in Relapsed or Refractory Multiple Myeloma (RRMM) in the United States

Background Ciltacabtagene autoleucel (cilta-cel) was approved for use in RRMM after four or more prior lines of therapy in 2022. While the pivotal studies exclusively treated patients in an inpatient setting, robust infrastructure planning at some centers across US has fostered outpatient administration of the commercially available product. We thus conducted a qualitative study to evaluate clinical and administrative perspectives and trends in outpatient administration of commercialized cilta-cel with an aim to understand best practices from certified CAR-T centers in the US. Methods A targeted literature review was conducted to understand current practices around CAR-T outpatient administration and inform the development of primary research materials for interviews. Two 60-minute exploratory interviews were conducted with participants (n=5) from two certified cilta-cel centers with significant volume of outpatient administration of cilta-cel. Two 90-minute panels were subsequently conducted with multi-stakeholder participants (n=14) from six certified cilta-cel centers, including centers from exploratory interviews, focusing on clinical and administrative topics across the patient journey. Results Using Likert scales, participants from all centers ranked space/capacity as the most important factor in decision-making process for outpatient cilta-cel administration, and reimbursement incentives as a highly (67% of participants) or a moderately (33%) important factor. Having a dedicated outpatient infrastructure, 24/7 support, outpatient bone marrow transplant or cell therapy experience, and robust multidisciplinary teams were considered key factors to setting-up successful outpatient centers for cilta-cel therapy.The participants agreed that cilta-cel can be administered safely in an outpatient setting due to generally predictable, delayed onset of potential adverse events (AEs). Participants also considered caregiver support and lodging availability as important factors for outpatient administration. Institutionally established AE monitoring protocols are critical for safe use of cilta-cel in an outpatient setting. While patients may be admitted for toxicity events, all of centers interviewed had 24-hour coverage and bed availability for patients if needed. Conclusions This study supports that centers can safely administer cilta-cel in an outpatient setting if appropriate infrastructure is in place. Additional best practices for new outpatient sites include adequate infrastructure, SOPs, a well-trained and multidisciplinary team, and education of patients and caregivers. Outpatient management and earlier intervention for low-grade AEs is currently evolving, with more real-world research required. Continued expert sharing of best practices can aid centers in implementing outpatient administration of CAR-T therapies.