The addition of consolidation therapy or a second autologous transplant is not superior to a single autologous transplant followed by lenalidomide maintenance in the upfront treatment of multiple myeloma, according to research presented at the Late-Breaking Abstracts session at ASH.
Lead author, Dr. Edward Stadtmauer of the Abramson Cancer Center, Philadelphia, reported results of the randomized phase 3 trial conducted by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) of 758 patients with multiple myeloma transplanted between 2010 and 2013.
All patients were transplant-eligible, had symptomatic multiple myeloma, were less than 71 years of age within 12 months of initiating therapy and without prior disease progression.
Patients were randomly assigned 1:1:1 to receive autologous hematopoietic cell transplant (HCT) and 4 cycles of RVD consolidation (lenalidomide, dexamethasone, bortezomib) (ACM), a tandem autologous HCT (TAM), or a single autologous HCT (AM). All 3 arms included lenalidomide maintenance with dose modifications based on tolerance.
At a median follow up of 38 months, progression-free survival (PFS) was 57% (95% CI: 50-63%), 56% (95% CI: 49-63%), and 52% (95% CI: 45-59%) for ACM, TAM, and AM, respectively (all pairwise p-values n.s.). Corresponding probabilities of OS were 86% (95% CI: 80-90%), 82% (95%CI: 76-87%), and 83% (95% CI: 78-88%).
Cumulative incidences of disease progression at 38 months were 42% (95% CI: 36-48%), 42% (95% CI: 35-48%), and 47% (95% CI: 40-54%) for the ACM, TAM, and AM arms, respectively (all pairwise p-values n.s.).
Dr. Stadtmauer concluded that all 3 treatments have comparable PFS and OS, and that adding RVD consolidation or a second autologous HCT was not superior to a single autologous HCT followed by lenalidomide maintenance in the upfront treatment of multiple myeloma. A long-term follow-up trial to track outcomes in these patients is ongoing.