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Ixazomib, daratumumab and low-dose dexamethasone in intermediate-fit patients with newly diagnosed multiple myeloma:an open-label phase 2 trial
- Source :
- Groen , K , Stege , C A M , Nasserinejad , K , de Heer , K , van Kampen , R J W , Leys , R B L , Thielen , N , Westerman , M , Wu , K L , Ludwig , I , Issa , D E , Velders , G A , Vekemans , M C , Timmers , G J , de Boer , F , Tick , L W , Verbrugge , A , Buitenhuis , D , Cunha , S M , van der Spek , E , de Waal , E G M , Sohne , M , Sonneveld , P , Nijhof , I S , Klein , S K , van de Donk , N W C J , Levin , M D , Ypma , P F & Zweegman , S 2023 , ' Ixazomib, daratumumab and low-dose dexamethasone in intermediate-fit patients with newly diagnosed multiple myeloma : an open-label phase 2 trial ' , EClinicalMedicine , vol. 63 , 102167 .
- Publication Year :
- 2023
-
Abstract
- Background: The outcome of non-transplant eligible newly diagnosed multiple myeloma (NDMM) patients is heterogeneous, partly depending on frailty level. The aim of this study was to prospectively investigate the efficacy and safety of Ixazomib-Daratumumab-low-dose dexamethasone (Ixa-Dara-dex) in NDMM intermediate-fit patients. Methods:In this phase II multicenter HOVON-143 study, IMWG Frailty index based intermediate-fit patients, were treated with 9 induction cycles of Ixa-Dara-dex, followed by maintenance with ID for a maximum of 2 years. The primary endpoint was overall response rate on induction treatment. Patients were included from October 2017 until May 2019. Trial Registration Number: NTR6297.Findings: Sixty-five patients were included. Induction therapy resulted in an overall response rate of 71%. Early mortality was 1.5%. At a median follow-up of 41.0 months, median progression-free survival (PFS) was 18.2 months and 3-year overall survival 83%. Discontinuation of therapy occurred in 77% of patients, 49% due to progression, 9% due to toxicity, 8% due to incompliance, 3% due to sudden death and 8% due to other reasons. Dose modifications of ixazomib were required frequently (37% and 53% of patients during induction and maintenance, respectively), mainly due to, often low grade, polyneuropathy. During maintenance 23% of patients received daratumumab alone. Global quality of life (QoL) improved significantly and was clinically relevant, which persisted during maintenance treatment. Interpretation: Ixazomib-Daratumumab-low-dose dexamethasone as first line treatment in intermediate-fit NDMM patients is safe and improves global QoL. However, efficacy was limited, partly explained by ixazomib-induced toxicity, hampering long term tolerability of this 3-drug regimen. This highlights the need for more efficacious and tolerable regimens improving the outcome in vulnerable intermediate-fi
Details
- Database :
- OAIster
- Journal :
- Groen , K , Stege , C A M , Nasserinejad , K , de Heer , K , van Kampen , R J W , Leys , R B L , Thielen , N , Westerman , M , Wu , K L , Ludwig , I , Issa , D E , Velders , G A , Vekemans , M C , Timmers , G J , de Boer , F , Tick , L W , Verbrugge , A , Buitenhuis , D , Cunha , S M , van der Spek , E , de Waal , E G M , Sohne , M , Sonneveld , P , Nijhof , I S , Klein , S K , van de Donk , N W C J , Levin , M D , Ypma , P F & Zweegman , S 2023 , ' Ixazomib, daratumumab and low-dose dexamethasone in intermediate-fit patients with newly diagnosed multiple myeloma : an open-label phase 2 trial ' , EClinicalMedicine , vol. 63 , 102167 .
- Notes :
- application/pdf, English
- Publication Type :
- Electronic Resource
- Accession number :
- edsoai.on1398451820
- Document Type :
- Electronic Resource