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
Language English Country United States Media print-electronic
Document type Journal Article, Research Support, Non-U.S. Gov't
PubMed
37996265
DOI
10.1016/j.clml.2023.10.003
PII: S2152-2650(23)02148-1
Knihovny.cz E-resources
- Keywords
- Cohort study, Early access program, Europe, Overall response rate, Progression-free survival,
- MeSH
- Dexamethasone therapeutic use MeSH
- Glycine analogs & derivatives MeSH
- Lenalidomide therapeutic use MeSH
- Humans MeSH
- Neoplasm Recurrence, Local drug therapy MeSH
- Multiple Myeloma * MeSH
- Prospective Studies MeSH
- Antineoplastic Combined Chemotherapy Protocols adverse effects MeSH
- Retrospective Studies MeSH
- Boron Compounds * MeSH
- Uvea MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Names of Substances
- Dexamethasone MeSH
- Glycine MeSH
- ixazomib MeSH Browser
- Lenalidomide MeSH
- Boron Compounds * MeSH
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.
Department of Hematology University Hospital of Salamanca IBSAL CIC IBMCC Salamanca Spain
Heart of England University Hospitals Birmingham NHS Foundation Trust Birmingham United Kingdom
MediNeos Observational Research Modena Italy
National Cancer Institute Bratislava Slovakia
Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom
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