Efficacy and safety of induction therapy with IAd versus IRd regimen in fragile elderly patients with newly diagnosed multiple myeloma: results of a prospective multicenter clinical trail

Background Fragile elderly patients with multiple myeloma (MM) have low survival rate due to complications, poor tolerance and complianceand lack of effective treatment. This prospective multicenter non-randomized controlled study designed to assessment the efficacy and safety of IAd versus IRd in fragile elderly NDMM. Methods This ongoing trial is conducted at 14 hospitals. Inclusion criteria was aged ≥ 65 years, IMWG GA score ≥ 2 or Mayo geriatric vulnerability scoring system defined as vulnerable. Patients with acute cardiovascular and cerebrovascular events were excluded. Schemes included IAd (ixazomib 4mg d1,8,15, liposome doxorubicin 40mg d1,dex 20mg d1,8,15,22), IRd (ixazomib 4mg d1,8,15, lenalidomide 25mg d1-14, dex 20mg d1,8,15,22), in 4-week cycles. For patients with effective response (≥ PR) after 6 to 8 cycles, Id maintenance initiated until progression. The study was powered for a primary endpoint of ORR,with PFS,OS,toxicity,health-related Qol as secondary endpoints. This study planned to enroll 120 patients, 60 in each group (chiCTR1900024917). Results From Oct 2019 to May 2021, 95 patients were enrolled, median age 71(65-88) yrs, 29.5% of patients ≥75 yrs,18.9% of patients with renal insufficiency(eGFR Conclusion Overall efficacy and safety results support the use of IAD or IRD as frontline therapy for fragile elderly MM patients. Both regimenswere effective, with an overall response rate of 80.9% and 12-month OS of 81.0%. AE were tolerable. Mortality rate are comparably high in fragile elderly MM patients,it is still a challenge for treatment.