The addition of consolidation chemotherapy or a second autologous hematopoietic cell transplantation (HCT) to upfront treatment was not superior to a single autologous HCT followed by lenalidomide maintenance in patients with multiple myeloma, a study presented at the American Society of Hematology (ASH) 58th Annual Meeting and Exposition has shown.1
Although lenalidomide maintenance after autologous HCT has improved progression-free and overall survival in patients with multiple myeloma, the benefit of additional therapies after autologous HCT, such as tandem autologous HCT or triple therapy consolidation, remains unclear.
To assess the impact of additional interventions, researchers enrolled 758 transplant-eligible patients younger than 71 years with symptomatic myeloma and without prior progression. Participants in the phase 3 trial (ClinicalTrials.gov Identifier: NCT01109004) were randomly assigned 1:1:1 to receive melphalan plus autolous HCT with 4 cycles of RVD (lenalidomide, bortezomib, dexamethasone) consolidation (ACM), tandem melphalan and autolous HCT (TAM) or a single autolous HCT (AM).
The results showed no significant difference in the 38-month progression-free survival rate, the study’s primary end point, between the 3 treatment arms. Researchers estimated progression-free survival at 38 months in 57% (95% CI, 50-63) of patients given ACM, 56% (95% CI, 49-63) of those who received TAM, and 52% (95% CI, 45-59) of those in AM.
Researchers also found that the 38-month estimated probabilities for overall survival were 86% (95% CI, 80-90), 82% (95% CI, 76-87), and 83% (95% CI, 78-88) with ACM, TAM, and AM, respectively. Median overall survival has not been reached.
“These results are very important because they answer a question that has been ongoing and has not been compared head-to-head: ‘Does the addition of these interventions result in a true advantage for these patients?'” said lead investigator Edward A. Stadtmauer, MD, of the Abramson Cancer Center, University of Pennsylvania in Philadelphia.
“The conclusion of this study, so far, is that the other interventions are not superior to initial melphalan therapy followed by a single autologous HCT followed by lenalidomide maintenance,” Dr Stadtmauer said.
A long-term follow-up trial to continue tracking outcomes of these patients is ongoing.
1. Stadtmauer EA, Pasquini MC, Blackwell B, et al. Comparison of autologous hematopoietic cell transplant (autoHCT), bortezomib, lenalidomide (len) and dexamethasone (RVD) consolidation with len maintenance (ACM), tandem autoHCT with len maintenance (TAM) and autoHCT with len Maintenance (AM) for up-front treatment of patients with multiple myeloma (MM): Primary results from the randomized phase III trial of the Blood and Marrow Transplant Clinical Trials Network (BMT CTN 0702 – StaMINA Trial). Paper presented at: American Society of Hematology (ASH) 58th Annual Meeting and Exposition; December 3-6, 2016; San Diego, CA.