The intravenous administration of the anti-CD38 antibody isatuximab, in conjunction with pomalidomide and dexamethasone, has received approval for the treatment of patients with relapsed or refractory multiple myeloma (RRMM), as established by the findings of the ICARIA-MM study (NCT02990338) and presented at the International Myeloma Society 21st Annual Meeting & Exposition.
The administration of isatuximab via the on-body delivery system (OBDS) approach is being assessed in phase 3 trials for patients with RRMM as part of the IRAKLIA trial (NCT05405166), and for patients with newly diagnosed multiple myeloma in the GMMG-HD8 trial (NCT05804032).
This article presents a summary of findings from a targeted survey aimed at assessing nurses’ experiences with the administration of isatuximab through the OBDS. OBDS is a novel approach to help minimize the time patients spend in clinics and decrease patient burden.1
A survey featuring 32 questions was designed by a team of professionals from various disciplines, including nurses with expertise in subcutaneous administration in oncology, clinical researchers, and experts in patient-reported outcomes for the subcutaneous device. The survey aimed to examine the various delivery modalities and the predefined lists of advantages and potential limitations of isatuximab treatment via the OBDS, as assessed by nurses based on their clinical trial experiences.
Between December 8, 2023, and January 3, 2024, registered nurses who took part in the phase 1b and phase 3 GMMG-HD8 trials at clinical sites located in Australia, France, Germany, and Spain were invited to complete the online survey questionnaire in their respective native languages.
All 12 nurses who were invited to participate in this survey submitted their responses to the questionnaire. Ten of the 12 nurses participated in the phase 1b GMMG-HD8 trial and 2 nurses participated in the phase 3 GMMG-HD8 trial. Of the nurses surveyed, 75% (n=9) had direct experience with the administration of isatuximab using the OBDS, and all nurses were engaged in monitoring patients and providing education. All nurses felt confident using the OBDS to administer treatment. The primary benefits recognized by healthcare professionals in utilizing the OBDS included the ability to administer treatment hands-free, enabling minor tasks to be performed during the process (100% of respondents; N=12). Additionally, there was a notable reduction in physical strain compared with subcutaneous administration via manual syringe push for large-volume (15 mL) antibody formulations (100%). Other advantages included improved patient management (100%), minimal needle exposure (92%), regulated treatment delivery with a constant flow rate (92%), and a reduction in labor requirements (92%). A total of 83% of the nurses concurred that the statement “if an injection is interrupted, it is not clear how much drug has been administered” represents a possible limitation for healthcare professionals. The nurses agreed that use of the OBDS facilitated a good treatment experience for their patients (100% of respondents; N=12). In comparison with the subcutaneous administration of large-volume (15 mL) antibody formulations using a syringe (n=10), the nursing staff concurred that the implementation of the OBDS could significantly decrease the time patients spend in the clinic by 60%, enhance patient comfort by 50%, and reduce patient anxiety by 50%.
The nurses who participated in the survey demonstrated a strong sense of confidence in utilizing the hands-free OBDS for the administration of isatuximab treatment. They found the system to be straightforward to learn and implement, resulting in enhanced efficiency while minimizing physical strain. According to the nurses’ observations, the implementation of the OBDS resulted in a positive treatment experience for patients, characterized by enhanced comfort, time efficiency, and reduced anxiety in comparison with intravenous dosing. These results imply that the OBDS is suitable for the efficient administration of subcutaneous isatuximab in everyday clinical settings.
Reference
- Avello NS, Pajares PC, Cordero P, et al. Subcutaneous administration of isatuximab by an on-body delivery system (OBDS) in multiple myeloma patients: results of a nurse survey. Presented at: 21st International Myeloma Society Annual Meeting. September 25-28, 2024; Rio de Janeiro, Brazil. Poster P-418.