The inclusion of active maintenance therapy improved progression-free survival (PFS) and overall survival (OS) in multiple myeloma (MM) in a number of clinical trials. The observational Connect MM registry, which is largely community based, was used to assess the impact of maintenance therapy on outcomes in autologous stem-cell transplant (ASCT)-eligible patients with newly diagnosed MM (NDMM).
To be eligible for enrollment, adult patients who were newly diagnosed with MM had to be enrolled ≤60 days from diagnosis. Patients receiving induction and ASCT were included and randomized to 4 maintenance regimens: no maintenance therapy, lenalidomide-based maintenance therapy, bortezomib-based maintenance therapy, and lenalidomide plus bortezomib maintenance therapy. Patients were to remain on their respective maintenance regimens from either 100 days post-ASCT (in the group that did not receive maintenance therapy) or until progressive disease, death, discontinuation, or data cutoff. The primary end points tested were PFS, second PFS, OS, and safety. Of the 1493 patients enrolled, 1450 were treated, and a total of 432 patients met analysis criteria and were randomized into the 4 maintenance-regimen groups. Patients included in this study had a median age of 60 years (range, 24-78); 60% of patients were men; and 86% of patients included were white. Of the 267 patients receiving maintenance therapy, 213 (80%) received lenalidomide, 30 (11%) received bortezomib, and 16 (6%) received lenalidomide plus bortezomib. A total of 165 patients did not receive maintenance therapy. The median study follow-up was 39.3 months. Due to small sample sizes, only data from the lenalidomide maintenance group were presented.
In the lenalidomide maintenance group, median treatment duration was 35.2 months, compared with 26.1 months in the group not receiving maintenance therapy. PFS was significantly improved with lenalidomide at 50.3 months versus 30.8 months in the group that did not receive maintenance therapy (P = 0.0009). The 3-year PFS rate was 56% for lenalidomide maintenance versus 42% for no maintenance. OS also increased significantly with lenalidomide maintenance versus no maintenance (P <0.005); 3-year OS was 85% versus 70%. Exploratory analyses of the participants’ baseline characteristics, such as age, Eastern Cooperative Oncology Group performance status, International Staging System stage, risk group, and induction regimen, showed generally similar PFS and OS improvements across subgroups.
In ASCT-eligible patients with NDMM, PFS and OS significantly improved with lenalidomide maintenance versus no maintenance, and no new safety signals were observed.
Jagannath S, et al. ASCO Abstract 8040.
