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Adding elotuzumab to an induction and consolidation regimen of lenalidomide, bortezomib, and dexamethasone (RVd), and to a lenalidomide maintenance regimen, does not improve outcomes among patients with transplant-eligible, newly diagnosed multiple myeloma (NDMM), according to research presented at 2021 American Society of Hematology (ASH) Annual Meeting.
Treatment regimens in the NDMM setting are increasingly making use of combinations of proteasome inhibitors, immunomodulation agents, and monoclonal antibodies. The role of elotuzumab has, however, not previously been defined in this patient population. For this randomized phase 3 trial, researchers evaluated the conditions under which adding elotuzumab to an RVd induction/consolidation regimen and to a lenalidomide maintenance regimen may improve outcomes in transplant-eligible NDMM.
Patients were stratified according to the International Staging System (ISS) and randomly assigned to 1 of 4 treatment arms:
- A1, RVd induction followed by high-dose melphalan (HDM), autologous blood stem cell transplantation (ASCT), RVd consolidation, and lenalidomide maintenance;
- A2, RVd induction followed by HDM, ASCT, elotuzumab plus RVd consolidation, and elotuzumab plus lenalidomide maintenance;
- B1, elotuzumab plus RVd induction followed by HDM, ASCT, RVd consolidation, and lenalidomide maintenance;
- B2, elotuzumab plus RVd induction followed by HDM, ASCT, elotuzumab plus RVd consolidation, and elotuzumab plus lenalidomide maintenance.
Between 2015 and 2017, 564 patients were enrolled; the intention-to-treat (ITT) population included 559 patients, while the safety analysis population included 555 patients. Overall, in the ITT population, 139 patients were randomly assigned to A1, 141 patients were assigned to A2, 137 patients were assigned to B1, and 142 patients were assigned to B2. The median age at baseline was 59 years overall, with patient characteristics balanced in the 4 arms.
While 4 induction cycles were completed by 92.5% of the ITT population, 81.2% of patients initiated maintenance therapy. In the A1, A2, B1, and B2 groups, 78.9%, 78.2%, 81.5%, and 80.7% of patients had a very good partial response or better before initiating consolidation therapy (P = .95).
At a median follow-up of 49.8 months, analysis suggested no difference in progression-free survival (P =.86) or in overall survival (P =.43) among the 4 arms.
Predictors of worse progression-free survival included ISS stage II, ISS stage III, and adverse cytogenetics.
At least 1 serious adverse event occurred in 95.6%, 91.3%, 92.8%, and 89.4% of patients in the A1, A2, B1, and B2 groups, respectively, though there was no significant difference in these rates (P =.25).
The presenter added, however, that subgroup analyses are ongoing.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Goldschmidt H, Mai EK, Bertsch U, et al. Elotuzumab in combination with lenalidomide, bortezomib, dexamethasone and autologous transplantation for newly-diagnosed multiple myeloma: results from the randomized phase III GMMG-HD6 Trial. Presented at ASH 2021; December 11 to 14, 2021. Abstract 486.
This article originally appeared on Hematology Advisor