“This has improved to 91% based on best response estimates on study, including 51% who have achieved CR or sCR,” Thomas said. Investigators observed no difference in PFS according to cytogenetic risk. Six patients progressed, 3 with high-risk features and 3 with standard-risk features. One patient with high-risk features died while in VGPR.
Three patients have died, 2 from progressive disease while on salvage therapy and a third from acute encephalopathy with refractory status epilepticus while in VGPR.
Seventy-one percent of patients had any-grade anemia, 69% had neutropenia, and 68% had thrombocytopenia. Grade ≥3 anemia, neutropenia, and thrombocytopenia occurred in 6%, 31%, and 7% of patients, respectively. The rate of grade ≥3 febrile neutropenia was 4%. Fatigue (76%) was the most common non-hematologic adverse event (AE), followed by myalgias (71%), diarrhea (69%), respiratory infections (57%), nausea/vomiting (57%), and dizziness (56%).
Forty-four percent of patients required dose reductions of lenalidomide. Thomas said most patients are currently dosed at 10 mg on days 1 through 21 of the 28-day cycle due to intolerability.
Four patients developed secondary primary malignancies—intraepidermal adenocarcinoma of the neck, mucinous appendiceal neoplasm, renal cell carcinoma, and therapy-related myelodysplastic syndrome. The first 3 were managed with curative resection and the patinets remain free of disease related to their second primary malignancy. Two patients remain on study.
- Thomas SK, Shah JJ, Weber DM, et al. Preliminary results of a phase II study of lenalidomide-elotuzumab as maintenance therapy post-autologous stem cell transplant in patients with multiple myeloma. Presented at: Presented at: American Society of Hematology 59th Annual meeting; December 9-12, 2017; Atlanta, GA. Abstract 840.
- McCarthy PL, Ozwar K, Hofmeister CC, et al. Lenalidomide after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012;366:1770-81.
- Attal M, Lauwers-Cances V, MaritG, et al. Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012;366:1782-91.
- Dimopoulos MA, Lonial S, White D, et al. Elotuzumab plus lenalidomide/dexamethasone for relapsed or refractory multiple myeloma: ELOQUENT-2 follow-up and post-hoc analyses on progression-free survival and tumour growth. Br J Haematol. 2017;178:896-905.