The purpose of this study is to assess the safety, tolerability, and efficacy of sonrotoclax as monotherapy and in various combinations in patients with relapsed/refractory (R/R) multiple myeloma (MM) and chromosomal translocation t(11;14).
The study investigates sonrotoclax alone and in combination with dexamethasone and other agents, including carfilzomib, daratumumab, and pomalidomide.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
A confirmed diagnosis of multiple myeloma (must have an M-component in serum and/or urine)
Participant has documented relapsed or progressive MM on or after any regimen or who are refractory to the most recent line of therapy.
In Part 1 and Part 2 Cohorts 1 and 2 participants should have relapsed or progressive disease and have had ≥ 3 prior lines of therapy including a proteasome inhibitor, an IMiD, and an anti-CD38 monoclonal antibody, and no more available approved therapies.
Non secretory MM (Serum free light chains < 10 mg/dL)
Solitary plasmacytoma
Active plasma cell leukemia (ie, either 20% of peripheral white blood cells or > 2.0 x 109/L circulating plasma cells by standard differential)
Waldenström macroglobulinemia (WM)
BeOne Medicines
Lead sponsor