Ixazomib, Daratumumab and Low Dose Dexamethasone in Intermediate-Fit Patients with Newly Diagnosed Multiple Myeloma (NDMM); Results of Induction Treatment of the Phase II HOVON 143 Study

Introduction Non-transplant eligible newly diagnosed multiple myeloma (NTE-NDMM) patients have a heterogeneous clinical outcome, which can be partly explained by differences in frailty level. Accordingly, intermediate-fit patients, according to the IMWG frailty index, have an inferior survival and h...

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Published in:Blood 2021-11, Vol.138 (Supplement 1), p.80-80
Main Authors: Groen, Kaz, Stege, Claudia A.M., Nasserinejad, Kazem, de Heer, Koen, Van Kampen, Roel J.W., Leijs, Maria B.L., Thielen, Noortje, Westerman, Matthijs, Wu, Ka Lung, Ludwig, Inge, Issa, Djamila, Velders, Gerjo A., Vekemans, Marie-Christiane, van de Donk, Niels W.C.J., Timmers, Gert-Jan, Sonneveld, Pieter, Seefat, Maarten R., Croon-de Boer, Fransien, Tick, Lidwine W., van der Spek, Ellen, De Waal, Esther G.M., Sohne, Maaike, Ypma, Paula F, Nijhof, Inger S., Klein, Saskia K., Levin, Mark-David, Zweegman, Sonja
Format: Article
Language:English
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Summary:Introduction Non-transplant eligible newly diagnosed multiple myeloma (NTE-NDMM) patients have a heterogeneous clinical outcome, which can be partly explained by differences in frailty level. Accordingly, intermediate-fit patients, according to the IMWG frailty index, have an inferior survival and higher rates of treatment discontinuation as compared to fit NTE-NDMM patients. The aim of this study was to prospectively investigate the efficacy and tolerability of the novel regimen ixazomib-daratumumab-low dose dexamethasone in intermediate-fit NTE-NDMM patients. This trail is registered at www.trialregister.nl as NTR6297. Methods In the phase II HOVON 143 study, intermediate-fit NTE-NDMM patients were treated with nine 28-day induction cycles, consisting of ixazomib 4mg (day 1, 8, 15), daratumumab 16mg/kg (cycle 1-2 on day 1, 8, 15, 22; cycle 3-6 on day 1, 15; cycle 7-9 on day 1) and dexamethasone (on days of daratumumab; cycle 1-2 20mg, subsequent cycles 10mg), followed by maintenance therapy of 8-week cycles with ixazomib (days 1, 8, 15, 29, 36, 43), and daratumumab (day 1), of maximum 2 years or until earlier progression. Inclusion criteria were NTE-NDMM patients who were intermediate-fit according to the IMWG frailty index. Main exclusion criteria were severe cardiac dysfunction, chronic obstructive pulmonary disease with an FEV1
ISSN:0006-4971
1528-0020
DOI:10.1182/blood-2021-152112