P-064: Trial in Progress: A Retrospective Multi-Country Study of Clinical Outcomes in Patients with R/R Multiple Myeloma Treated with Teclistamab Outside of Clinical Trials

Introduction: Teclistamab is a T cell redirecting bispecific monoclonal antibody that has shown promising results in triple-class exposed patients with relapsed/refractory multiple myeloma (RRMM) in the MajesTEC-1 clinical trial¹. In a recent analysis of the CONNECT MM registry, it was reported that up to 40% of patients treated in routine care would be ineligible for enrollment in randomized trials due to stringent eligibility criteria². Therefore, there is a growing demand from healthcare providers for data outside of clinical trials that provide a better understanding of the safety and effectiveness of emerging antimyeloma treatments in these patient populations. This data can be partly obtained from pre-approval access programs and/or early phases of commercialization but for interpretation, it needs to be considered that the majority of patients treated in this setting are heavily pre-treated and in an advanced stage of disease. Nevertheless, studies conducted in this setting are useful to address areas of unmet medical need, evidence gaps, results in populations underrepresented in clinical trials, management of adverse events and sequencing of therapies.

Methods: REALiTEC is a retrospective, non-interventional, international study to describe the use of teclistamab in patients with RRMM outside of clinical trials. Data from patient´s medical records will be collected to assess their characteristics and demography, history of prior antimyeloma treatments, teclistamab treatment patterns (healthcare setting, dosing frequency), effectiveness parameters (progression free survival, overall survival, response rates, duration of response, time to response, time to next treatment), safety, medical resource utilization and subsequent therapies. To be eligible, patients included in this study will need to have received at least one dose of teclistamab on/before 31^st of December 2022, either in pre-approval access programs and/or the health care system, to ensure sufficient data availability at the time of enrollment in the study. Since there is no formal statistical hypothesis and study objectives are of descriptive nature, based on feasibilities, a sample size of 180 patients has been established. 27 sites from 10 countries have been approached to participate in this study and enrollment began in December 2023 and is currently ongoing.

Results: N/A

Conclusions: Non-trial patient populations represent a considerable proportion of patients seen in clinics and may have substantially different patient/disease characteristics compared with clinical trial cohorts. Information on the management and outcomes of these patients is limited. Hence, this study will provide valuable data in RRMM patients treated in early access programs and early commercial phases to complement data from clinical trials and potentially inform future management of teclistamab by the medical community.
1. Moreau P et al, NEJM 2022;387:495-505. 2. Shah JJ et al, Clin Lymphoma Myeloma Leuk 2017;17:575-83.e2.