MM-146: IONA-MM: A Prospective, Non-Interventional, Multinational, Observational Study with Isatuximab in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

Abstract

Context: Isatuximab (Isa) is a monoclonal antibody that binds to a specific epitope on the human CD38 receptor and triggers a cascade of events, leading to CD38-expressing tumor cell death. The phase 3 ICARIA-MM study compared Isa plus pomalidomide-dexamethasone (Pd) versus Pd in patients with relapsed/refractory multiple myeloma (RRMM). ICARIA-MM demonstrated improved median progression free survival (PFS) with Isa-Pd versus Pd (11.53 vs. 6.47 months, HR 0.596),1 and led to FDA approval of isatuximab-irfc (Sarclisa®) in March 2020 for use in combination with Pd to treat adults with RRMM who received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor. Currently, Isa is being assessed in combination with carfilzomib-dexamethasone (Isa-Kd) versus Kd in the phase 3, IKEMA study in RRMM.2 It is also being assessed in combination with bortezomib-lenalidomide-dexamethasone (Isa-VRd) versus VRd in the phase 3 IMROZ study in newly diagnosed MM.3 At present, no data are available on the patient characteristics, efficacy, safety, or quality of life (QoL) of patients treated with Isa-based regimens in a real-world setting. Aim: Investigate the effectiveness, safety, and QoL in RRMM patients, treated with isatuximab-based regimens, in routine clinical practice. Design and Patients: IONA-MM is a prospective, non-interventional, observational study of RRMM patients treated with Isa in routine clinical practice. This study will enroll approximately 1,100 RRMM patients across 100-125 sites in Asia, Europe, Latin and North America. Eligible patients include those ≥18 years, with RRMM (having received ≥1 prior line) per International Myeloma Working Group criteria. The treating physician will determine Isa treatment. Follow-up will occur for ≤6 months after Isa discontinuation. Outcome Measures: The study objectives are to assess: (1) the overall response rate of patients receiving Isa; (2) other efficacy parameters including PFS, PFS rate, duration of response, time to response, rate of very good partial response or better, and rate of complete response; (3) demographics, disease characteristics, comorbidities, and treatment history; (4) safety of Isa in clinical practice; (5) QoL via two patient-reported questionnaires. Data collection will be exploratory and will be summarized descriptively. This study is open for enrollment.