| Authors |
Partanen, Anu ; Waage, Anders ; Pečeliūnas, Valdas ; Schjesvold, Fredrik ; Anttila, Pekka ; Säily, Marjaana ; Uttervall, Katarina ; Putkonen, Mervi ; Carlson, Kristina ; Haukas, Einar ; Sankelo, Marja ; Szatkowski, Damian ; Hansson, Markus ; Marttila, Anu ; Svensson, Ronald ; Axelsson, Per ; Lauri, Birgitta ; Mikkola, Maija ; Karlsson, Conny ; Abelsson, Johanna ; Ahlstrand, Erik ; Sikiö, Anu ; Klimkowska, Monika ; Matuzevičienė, Rėda ; Fenstad, Mona Hoysaeter ; Ilveskero, Sorella ; Pelliniemi, Tarja-Terttu ; Nahi, Hareth ; Silvennoinen, Raija |
| Abstract [eng] |
Scarce data exist on double maintenance in transplant-eligible high-risk (HR) newly diagnosed multiple myeloma (NDMM) patients. This prospective phase 2 study enrolled 120 transplant-eligible NDMM patients. The treatment consisted of four cycles of ixazomib–lenalidomide–dexamethasone (IRD) induction plus autologous stem cell transplantation followed by IRD consolidation and cytogenetic risk-based maintenance therapy with lenalidomide + ixazomib (IR) for HR patients and lenalidomide (R) alone for NHR patients. The main endpoint of the study was undetectable minimal residual disease (MRD) with sensitivity of <10−5 by flow cytometry at any time, and other endpoints were progression-free survival (PFS) and overall survival (OS). We present the preplanned analysis after the last patient has been two years on maintenance. At any time during protocol treatment, 28% (34/120) had MRD < 10−5 at least once. At two years on maintenance, 66% of the patients in the HR group and 76% in the NHR group were progression-free (p = 0.395) and 36% (43/120) were CR or better, of which 42% (18/43) had undetectable flow MRD <10−5. Altogether 95% of the patients with sustained MRD <10−5, 82% of the patients who turned MRD-positive, and 61% of those with positive MRD had no disease progression at two years on maintenance (p < 0.001). To conclude, prolonged maintenance with all-oral ixazomib plus lenalidomide might improve PFS in HR patients. |
