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Continuous Elotuzumab, Pomalidomide and Dexamethasone Maintenance Following Second Autologous Transplant for Multiple Myeloma: Results of a Prospective, Phase 2 Multicenter Trial
Slade, M., Fiala, M. A., Kirchmeyer, M., King, J., Gao, F., Schroeder, M. A., Stewart, A. K., Stockerl-Goldstein, K., Chen, C., Vij, R.
Transplantation and cellular therapy. 2023
Abstract
BACKGROUND Second autologous hematopoietic cell transplant (AHCT2) is a useful therapeutic modality for fit patients with multiple myeloma who have a durable remission after upfront autologous hematopoietic cell transplant. Retrospective studies have suggested a significant benefit of incorporating maintenance therapy post-AHCT2, but prospective data regarding specific regimens is lacking. OBJECTIVE(S): The purpose of this study was to investigate the use of elotuzumab, pomalidomide and dexamethasone (EPd) as salvage therapy prior to and maintenance after AHCT2 for relapsed multiple myeloma. STUDY DESIGN This prospective, single-arm phase II trial investigated the use of elotuzumab, pomalidomide and dexamethasone in combination with second autologous stem cell transplant in patients with relapsed multiple myeloma. It was conducted at two academic centers in North America. The primary outcome was 1-year progression free survival (PFS). RESULTS 25 patients were enrolled on the study. 16 patients underwent EPd induction. 6 (38%) progressed during salvage therapy and were removed from trial prior to AHCT2. Following a planned safety analysis, the protocol was amended and EPd induction was removed from the study schema. An additional 9 patients underwent induction off-study and were enrolled on trial for AHCT2 and EPd maintenance. In total, 18 patients underwent AHCT2 and received EPd maintenance. Two patients discontinued treatment due to toxicity, one attributed to elotuzumab and one to pomalidomide. The 1-year PFS was 72% and the median PFS was 19 months. The study was closed early due to poor accrual and 6 patients remained on therapy at time of analysis. CONCLUSION(S): EPd maintenance after AHCT2 was safe and tolerable. The 1-year and median PFS were similar to previous retrospective reports of outcomes following AHCT2. Further studies are needed to define the optimal use of and protocol for AHCT2 in fit patients with relapsed multiple myeloma.