A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dex… (NCT04973605) | Clinical Trial Compass
RecruitingPhase 1/2
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
United States246 participantsStarted 2021-09-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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.
✓. 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
Exclusion criteria
✕. Participant has any of the following conditions:
✕. Non secretory MM (Serum free light chains \< 10 mg/dL)
What they're measuring
1
Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)
Timeframe: Up to 28 days
2
Part 1 And 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events Leading to Discontinuation and Adverse Events of Special Interest (AESIs).
Timeframe: Up to 30 days after last dose of study drug
3
Part 2: Overall response rate (ORR) as Assessed by Investigator
Timeframe: Approximately 4 years
4
Part 2: Very Good Partial Response (VGPR) or Better Response Rate as Assessed by Investigator
Timeframe: Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 4 years]
5
Part 2: Complete Response (CR) or Stringent Complete Response (sCR) as Assessed by Investigator
Timeframe: Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 4 years])