Impact of post-autologous stem cell transplant (ASCT) maintenance therapy on outcomes in patients (Pts) with newly diagnosed multiple myeloma (NDMM) using the large prospective community-based Connect MM registry.

Abstract

8040 Background: Maintenance therapy (MT) improved progression-free survival (PFS) and overall survival (OS) in MM clinical trials. The observational Connect MM registry, which is largely community based, was used to assess impact of MT on outcomes in ASCT-eligible NDMM pts. Methods: Adult NDMM pts ≤60 days from diagnosis were eligible for enrollment. Pts receiving induction and ASCT were included and analyzed by 4 MT regimens: No MT, lenalidomide-based (LEN), bortezomib-based (BORT), and LEN+BORT MT. Duration was from 100 days post-ASCT (no MT group) or start of MT until progressive disease, death, discontinuation, or data cutoff. End points were PFS, 2nd PFS, OS, and safety. An exploratory analysis of the impact of baseline characteristics was performed. Results: Of 1493 enrolled pts (Cohort 1; Sep 2009 – Dec 2011), 1450 were treated; 81% (n=1173) were in a community setting. A total of 432 (29%) met analysis criteria. Data cutoff was Jan 7, 2016 (median follow-up of 39.3 mo). Median age was 60 y (range, 24-78 y); 60%, men; and 86%, white. 165 pts did not receive MT. Of 267 pts receiving MT, 213 (80%) received LEN; 30 (11%), BORT; and 16 (6%), LEN+BORT. Only LEN MT is presented, as interpretation of other MT data was limited by small sample sizes. Median treatment duration for LEN MT vs No MT was 35.2 vs 26.1 mo, respectively. PFS and OS significantly increased with LEN MT vs No MT (Table); 2nd PFS was similar for both. Exploratory analyses showed generally similar PFS and OS improvements across subgroups (age, ECOG status, ISS stage, risk group, and induction regimen). No new safety signals were observed. Conclusions: In ASCT-eligible NDMM pts, PFS and OS improved with LEN MT vs No MT and appeared to be independent of induction regimen. Preliminary analysis of 2nd PFS suggests no impact on the efficacy of 2nd line therapy. These data from a largely community-based setting confirm results from randomized phase III trials. Clinical trial information: NCT01081028. [Table: see text]