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.
| Study Arm | Population | Intervention | Comparison | Outcome |
|---|---|---|---|---|
Part 1: Determination of RP2D |
R/R MM with (11;14) |
Sonrotoclax |
None |
Primary Endpoint: Safety, tolerability, and RP2D of sonrotoclax in combination with dexamethasone with or without carfilzomib; MTD for sonrotoclax in combination with dexamethasone Key Secondary Endpoints: PK of sonrotoclax in combination with dexamethasone with or without carfilzomib, ORR of sonrotoclax in combination with dexamethasone with or without carfilzomib; PK of dexamethasone in combination with sonrotoclax |
Part 2: Determination of combination doses |
R/R MM with (11;14) |
Sonrotoclax + Carfilzomib + Dexamethasone |
Primary Endpoint: Safety, tolerability, and RP2D of sonrotoclax in combination with dexamethasone with or without carfilzomib; MTD for sonrotoclax in combination with dexamethasone Key Secondary Endpoints: PK of sonrotoclax in combination with dexamethasone with or without carfilzomib, ORR of sonrotoclax in combination with dexamethasone with or without carfilzomib; PK of dexamethasone in combination with sonrotoclax |
