Use Via Early Access to Ixazomib (UVEA-IXA) Study: Effectiveness and Safety of Ixazomib-based Therapy in Relapsed/Refractory Multiple Myeloma Outside of the Clinical Trial Setting.
Ludwig, Heinz Ramasamy, Karthik Mateos, María-Victoria Kishore, Bhuvan Gergely, Varga Ladicka, Miriam Ori, Alessandra Simoni, Lucia Bent-Ennakhil, Nawal Stull, Dawn Marie
Ludwig, Heinz
Ramasamy, Karthik
Mateos, María-Victoria
Kishore, Bhuvan
Gergely, Varga
Ladicka, Miriam
Ori, Alessandra
Simoni, Lucia
Bent-Ennakhil, Nawal
Stull, Dawn Marie
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2024-02-01
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Abstract
Background: In multiple myeloma (MM), improving our understanding of routine clinical practice and the effectiveness of agents outside of clinical trials is important. TOURMALINE-MM1 data resulted in approval of ixazomib for MM patients who have received ≥ 1 prior therapy.
Patients and methods: UVEA-IXA comprised a retrospective chart review in the early access program, and a prospective 1-year follow-up period. Eligible patients had had a biochemical and/or symptomatic relapse after 1-3 prior lines of therapy; no anti-MM therapy for > 3 cycles at the start of ixazomib therapy; and an Eastern Cooperative Oncology Group performance score of 0-2. Lenalidomide- or proteasome inhibitor (PI)-refractory patients were ineligible. Primary endpoints were response and progression-free survival (PFS).
Results: Of 357 enrolled patients, 309 were evaluable; most patients received ixazomib alongside lenalidomide (98%) and dexamethasone (97%); 61% had received 2-3 prior lines of therapy. Median PFS was 15.6 months (95% confidence interval [CI]: 12.0-20.6) in all evaluable patients, and 19.6 (95% CI: 12.1-27.0) and 13.9 (95% CI: 10.1-18.1) months in patients who received 1 and ≥ 2 prior lines of therapy, respectively. The overall response rate was 67% in all evaluable patients, and 72% and 63%, respectively, in patients who received 1 and ≥ 2 prior lines of therapy. Median overall survival was 35.5 months. The ixazomib safety profile was consistent with previous reports.
Conclusion: This study supports ixazomib-based therapy as an effective and tolerable treatment in the real-world. Outcomes were favorable in patients with 1 or ≥ 2 prior lines of therapy who were not lenalidomide- or PI-refractory.
Keywords: Cohort study; Early access program; Europe; Overall response rate; Progression-free survival.
Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.
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Ludwig H, Ramasamy K, Mateos MV, Kishore B, Gergely V, Ladicka M, Ori A, Simoni L, Bent-Ennakhil N, Stull DM, Gavini F, Terpos E, Hájek R. Use Via Early Access to Ixazomib (UVEA-IXA) Study: Effectiveness and Safety of Ixazomib-based Therapy in Relapsed/Refractory Multiple Myeloma Outside of the Clinical Trial Setting. Clin Lymphoma Myeloma Leuk. 2024 Feb;24(2):e40-e49.e3. doi: 10.1016/j.clml.2023.10.003. Epub 2023 Oct 14.
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