A Phase 1b/2 Dose-Escalation and Cohort-Expansion Study to Determine the Safety and Efficacy of BGB-11417as Monotherapy, in Combination With Dexamethasone, Dexamethasone/Carfilzomib, Dexamethasone/Daratumumab, and Dexamethasone/Pomalidomide in Patients With Relapsed/Refractory Multiple Myeloma and t(11;14)
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.
Detailed description
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.
Arms & interventions
- DrugSonrotoclax
Administered orally daily
- DrugDexamethasone
Once weekly either orally or intravenously
- DrugCarfilzomib
Administered intravenously weekly
- DrugDaratumumab
Administered subcutaneously weekly
- DrugPomalidomide
Administered orally daily
Outcome measures
Primary
Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)
DLTs will be based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and will include most grade 3 or higher events, as defined in the protocol.
Time frame: Up to 28 days
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).
Time frame: Up to 30 days after last dose of study drug
Part 2: Overall response rate (ORR) as Assessed by Investigator
Defined as the percentage of participants who achieved a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per International Myeloma Working Group (IMWG) criteria
Time frame: Approximately 4 years
Part 2: Very Good Partial Response (VGPR) or Better Response Rate as Assessed by Investigator
Defined as the percentage of participants with a documented VGPR or better (including sCR, CR, and VGPR)
Time frame: Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 4 years]
Part 2: Complete Response (CR) or Stringent Complete Response (sCR) as Assessed by Investigator
defined as the percentage of participants with a documented CR or sCR
Time frame: Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 4 years])
Secondary
Part 1: Area under the plasma concentration-time curve time 0 to the last measurable concentration (AUClast) After a Single Dose of Sonrotoclax
Time frame: Cycle 1 (each cycle is up to 28 days)
Part 1: Maximum observed plasma concentration (Cmax) After a Single Dose of Sonrotoclax
Time frame: Cycle 1 (each cycle is up to 28 days)
Part 1: Time to reach Cmax (tmax) After a Single Dose of Sonrotoclax
Time frame: Cycle 1 (each cycle is up to 28 days)
Part 1: At Steady-state: AUC last, ss
Time frame: Cycle 2 (each cycle is up to 28 days)
Part 1: At Steady-state: Cmax, ss
Time frame: Cycle 2 (each cycle is up to 28 days)
Part 1: At Steady-state: trough plasma concentration (Ctrough) ss
Time frame: Cycle 2 (each cycle is up to 28 days)
Part 1: At Steady-state: time to reach Cmax (tmax,ss)
Time frame: Cycle 2 (each cycle is up to 28 days)
Part 2: Time to response (TTR) as Assessed by Investigator
Time frame: Approximately 4 years
Part 2: Duration of response (DOR) as Assessed by Investigator
Time frame: Approximately 4 years
Part 2: Progression-free survival (PFS) as Assessed by Investigator
Time frame: Approximately 4 years
Part 2: Overall survival (OS) as Assessed by Investigator
Time frame: Approximately 4 years
Eligibility criteria
Study locations (16)
University of Alabama At Birmingham Hospital
Birmingham, Alabama, 35294-0004
City of Hope National Medical Center
Duarte, California, 91010-3012
City of Hope Irvine Lennar
Irvine, California, 92618-2377
University of Miami
Miami, Florida, 33136-2107
Emory University Winship Cancer Center
Atlanta, Georgia, 30322-1013
University of Chicago Medical Center
Chicago, Illinois, 60637-1443
Massachusetts General Hospital
Boston, Massachusetts, 02114
Washington University School of Medicine
St Louis, Missouri, 63110-1010
Hackensack University Medical Center
Hackensack, New Jersey, 07601-1915
Weill Cornell Medical College Newyork Presbyterian Hospital
New York, New York, 10065-4870
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, 10065-6800
The James Cancer Hospital and Solove Research Institute At Ohio State University
Columbus, Ohio, 43210-1240
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
University of Washington
Seattle, Washington, 98195
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792-0001
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-1222