Open-Label, Single-Arm Phase 2a Study of Bortezomib, Lenalidomide, Dexamethasone, and Elotuzumab in Newly Diagnosed MM
Elotuzumab is a SLAMF7-directed immunostimulatory antibody indicated for use in combination with lenalidomide and dexamethasone for relapsed or refractory multiple myeloma (MM). This phase 2a study evaluated the efficacy and safety of elotuzumab in combination with lenalidomide, bortezomib, and dexamethasone in newly diagnosed, transplant-eligible patients with MM.
In this study, elotuzumab was administered on days 1, 8, and 15 of the first two 28-day cycles and on days 1 and 11 in cycles 3 and 4. Following cycle 4, patients underwent stem-cell mobilization and could then proceed either to receive autologous stem-cell transplant (ASCT) or defer transplantation and receive 4 more cycles of induction therapy. Dependent on whether they received ASCT or 8 cycles of induction chemotherapy, patients were transitioned to risk-adapted maintenance therapy, which was determined according to whether the patient had high-risk cytogenetics or International Staging System stage II or III disease. Patients received either elotuzumab, lenalidomide, and dexamethasone plus every other week of bortezomib (high-risk) or elotuzumab, lenalidomide, and dexamethasone.
A total of 40 patients with a median age of 60 years were enrolled in this study. The overall response rate after 4 cycles was 97%. Over the duration of the study, 33 of 40 patients (83%) achieved partial response or better, including 22 (55%) with very good partial response and 6 (15%) with complete response. Infection occurred in 505 patients overall. One patient died of sepsis-related complications; another experienced grade 4 sepsis. A total of 4 patients had grade 3 or higher lung infection.
This study shows that the combination of elotuzumab plus lenalidomide, bortezomib, and dexamethasone was effective and tolerable in newly diagnosed, ASCT-eligible patients with MM.
Laubach J, et al. ASCO Abstract 8002.