A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma
18 Years and older, Male and Female
BGB-11417-105 (primary)
NCI-2022-07236
2021-003614-39
U1111-1277-5444
Summary
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.
Objectives
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some
of our older studies were sponsored under the name BeiGene, you may see both names used
for this study on this website.
Eligibility
- 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)
- Measurable disease defined as: i. M-spike = 500mg/dL, or ii. Urine protein M-spike of = 200 mg/day, or iii. Serum free light chains = 10 mg/dL, and an abnormal ?:? ratio
- Participant has documented relapsed or progressive MM on or after any regimen or who are refractory to the most recent line of therapy. i. Relapsed MM is defined as previously treated MM that progresses and requires initiation of salvage therapy but does not meet the criteria for refractory MM. ii. Refractory MM is defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy or progresses within 60 days of last 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.
- Participants in Part 2 Cohorts 3, 4, and 5 should have relapsed or progressive disease and have had = 1 prior line of therapy. Prior treatment with carfilzomib is allowed but the patient must not be considered carfilzomib refractory by the investigator.
- Participants in Part 2 Cohorts 6 and 7 should have relapsed or progressive disease and have had 1 to 3 prior lines of therapy and previously treated with a proteasome inhibitor and an IMiD
- Positivity for t(11;14) translocation must be confirmed by validated fluorescence in situ hybridization (FISH) testing assay in a pre-defined laboratory a. fresh bone marrow aspirate sample must be collected at screening and sent to central laboratory for t(11;14) FISH testing.
- Adequate organ function defined as:
- Hemoglobin = 8.0 g/dL within 7 days before first dose of study treatment, (transfusions, in accordance with institutional guidelines, are permitted)
- Platelet count = 75,000/µL, within 7 days before first dose of study treatment, independent of growth factor support and transfusions
- Absolute neutrophil count (ANC) = 1000/mm^3 within 7 days before first dose of study treatment
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 x upper limit of normal (ULN) and total bilirubin = 2.0 x ULN N (total bilirubin must be < 3 x ULN for patients with Gilbert's syndrome)
Treatment Sites in Georgia
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