STANDARDIZING CARE OF MULTIPLE MYELOMA PATIENTS RECEIVING INVESTIGATIONAL CAR-T

• Published in: Oncology nursing forum Vol. 51; no. 2; pp. 309C - 310C
• Main Authors: You, Ashlee, Catamero, Donna
• Format: Journal Article
• Language: English
• Published: Pittsburgh Oncology Nursing Society 01-03-2024
• Subjects: Clinical trials; Oncology; Patients; Standard of care
• ISSN: 0190-535X; 1538-0688

Clinical Trials offer patients novel therapies that may not have a commercially available equivalent. While investigational protocols dictate a schedule of assessments to be performed, there are other components of patient monitoring and management that are left to investigator discretion and standard of care practices. CAR-T cell therapy particularly has many potential adverse events, precautions, and monitoring to consider. The objective was to create universal clinical guidelines to manage the investigational CAR-T patient population that would supplement the requirements of their respective clinical trials. A particular challenge being to ensure that the guidelines would be comprehensive without having to be altered too drastically for individual clinical trials. A literature review was conducted to verify the current standard practices of monitoring CAR-T patients. Subsequently, a review of the institution's CAR-T clinical trials was performed to identify interventions that were typically cautioned, restricted, or prohibited. The sourced standard of care practices were then outlined in order of where in the process of the CAR-T journey they occur. During this process, interventions that were likely to be restricted by a clinical trial were notated as requiring verification prior to proceeding. When trial requirements differed from institutional practices the more stringent guidance was advised to be followed. The guideline was distributed to 3 research RNs and 6 Research NPs who care for the investigational CAR-T population. A period of thirty days was allotted for initial implementation and feedback from the team. During this time, there were 3 patients screened for investigational CAR-T protocols and 24 follow up visits. After the thirty day period a survey was distributed to evaluate utilization, effectiveness, and open comments for suggestions. Eight responses were received with an 87.5% utilization rate during the trial period and of those 100% reported benefit while utilizing. The feedback mechanism will remain open to allow for adjustments as updates in practice occur. Creating a management plan for the research CAR-T population that is mindful of clinical trial processes allows for patients to be treated while abiding by a common standard. This prevents omitting monitoring or interventions due to concern of conflicting with clinical trial restrictions. Clinical trials and CAR-T therapy are constantly evolving, therefore, it is imperative to ensure guidelines are re-visited regularly for any recommended updates in practice.