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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
246
Administered orally daily
Once weekly either orally or intravenously
Administered intravenously weekly
Administered subcutaneously weekly
Administered orally daily
University of Alabama At Birmingham Hospital
Birmingham, Alabama, United States
RECRUITINGCity of Hope National Medical Center
Duarte, California, United States
RECRUITINGCity of Hope At Irvine Lennar
Irvine, California, United States
RECRUITINGUniversity of California At San Francisco
San Francisco, California, United States
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])
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
TTR is defined as the time from start of treatment (for nonrandomized cohorts) or date of randomization (for randomized cohorts to first documentation of response of Partial Response (PR) or better
Time frame: Approximately 4 years
Part 2: Duration of response (DOR) as Assessed by Investigator
DOR is defined as the time from the date of the first documented response (PR or better) after treatment initiation until the date of first documented disease progression or death due to any cause, whichever occurs first. DOR will be analyzed only for patients who have achieved an overall response of at least PR. The distribution of DOR will be summarized by the Kaplan-Meier method.
Time frame: Approximately 4 years
Part 2: Progression-free survival (PFS) as Assessed by Investigator
PFS is defined as time from start of treatment (for nonrandomized cohorts) or date of randomization (for randomized cohorts) to the first documentation of disease progression or death, whichever occurs first
Time frame: Approximately 4 years
Part 2: Overall survival (OS) as Assessed by Investigator
OS defined as the time from start of treatment (for nonrandomized cohorts) or date of randomization (for randomized cohorts to the date of death due to any cause
Time frame: Approximately 4 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Miami
Miami, Florida, United States
RECRUITINGEmory University Winship Cancer Center
Atlanta, Georgia, United States
RECRUITINGUniversity of Chicago Medical Center
Chicago, Illinois, United States
RECRUITINGSouthern Illinois University School of Medicine
Springfield, Illinois, United States
COMPLETEDMassachusetts General Hospital
Boston, Massachusetts, United States
COMPLETEDWashington University School of Medicine
St Louis, Missouri, United States
RECRUITING...and 74 more locations