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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

StatusRecruiting
PhasePhase 1/2
Started2021-09-16
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 56 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-10
Study Status, Contacts/Locations v55
Trial sites reduced: 82 → 78 locations
2026-08-21
Study Status, Contacts/Locations v54
Study sites83→82
2026-08-06
Study Status, Contacts/Locations v53
Study sites84→83
2026-07-22
Study Status, Contacts/Locations v52
Study sitesdetails revised at 1 of 84 sites
2026-07-08
Study Status, Contacts/Locations v51
Study sitesdetails revised at 2 of 84 sites
2026-05-08
Study Status, Contacts/Locations v50
Study sites83→84
2026-04-21
Study Status, Contacts/Locations v49
Trial sites expanded: 80 → 83 locations
2026-04-15
Study Status, Contacts/Locations v48
Trial sites reduced: 83 → 80 locations
2026-03-18
Study Status, Contacts/Locations v47
Study sites83 entries, revised
City of Hope At Irvine Lennar
2026-02-19
Study Status, Contacts/Locations v46
Study sites84→83
2026-02-09
Study Status, Contacts/Locations v45
Study sitesdetails revised at 3 of 84 sites
2026-01-21
Study Status, Contacts/Locations v44
Study sitesdetails revised at 1 of 84 sites
2026-01-15
Study Status, Study Description, Contacts/Locations v43
Study sites85→84
Study description+209 characters
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.
2025-12-15
Study Status, Contacts/Locations v42
Study sites86→85
2025-11-20
Study Status, Contacts/Locations v41
Study sites88→86
2025-11-11
Study Status, Sponsor/Collaborators, Contacts/Locations, IPDSharing v40
Study sites93→88
Lead sponsorBeiGene→BeOne Medicines
2025-10-23
Study Identification, Study Status, Contacts/Locations v39
Study sites94→93
2025-09-12
Study Status, Contacts/Locations v38
Study sitesdetails revised at 2 of 94 sites
2025-08-19
Study Status, Contacts/Locations v37
Study sites89→94
2025-08-05
Study Status, Contacts/Locations v36
Study sites88→89
2025-06-20
Study Status, Oversight, Contacts/Locations v35
Study sitesdetails revised at 2 of 88 sites
2025-06-16
Study Identification, Study Status, Oversight, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v34
Enrollment target167→246
Eligibility criteria+255 characters
[...] rapy 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 ≥ [...] 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 [...] t 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 [...] [...]
Secondary endpoints11 entries, revised
Part 2: Time to response (TTR) as assessedAssessed by investigatorInvestigator Part 2: Duration of response (DOR) as assessedAssessed by investigatorInvestigator Part 2: Progression-free survival (PFS) as assessedAssessed by investigatorInvestigator Part 2: Overall survival (OS) as assessedAssessed by investigatorInvestigator
Primary endpoints5 entries, revised
Part 2: Complete Response (CR) or betterStringent Complete Response (sCR) as Assessed by Investigator Part 2: Overall response rate (ORR) as Assessed by Investigator Part 2: Very goodGood partialPartial responseResponse (VGPR) or betterBetter responseResponse rateRate as Assessed by Investigator
Study sitesdetails revised at 5 of 88 sites
2025-05-19
Study Status, Study Description, Study Design, Arms and Interventions, Contacts/Locations v33
Study sites89→88
2025-02-18
Study Status, Contacts/Locations, IPDSharing v32
Study sites88→89
2025-02-07
Study Identification, Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility v31
InterventionsBGB-11417 (Drug), Carfilzomib (Drug), Dexamethasone (Drug)→Carfilzomib (Drug), Daratumumab (Drug), Dexamethasone (Drug), Pomalidomide (Drug), Sonrotoclax (Drug)
Eligibility criteria-391 characters
[...] lvage therapy or progresses within 60 days of last therapy. Participants inIn Part 1 should have failedrelapsed allor otherprogressive availabledisease optionsand including havinghave had ≥ 3 prior lines of therapy including a proteasome inhibitor, an IMiD agent, and an anti-CD38 monoclonal antibody, and no more available approved therapies. Participants in Part 2 should have hadrelapsed or progressive disease and failedhave had ≥ 1 but ≤ 7 prior lines of therapy and will have had prior treatment with both a proteasome inhibitor and an IMiD agent. Note: A line of therapy consists of greater ≥ [...] [...]
Secondary endpoints11 entries, revised
Part 1: Area under the plasma concentration-time curve time 0 to the last measurable concentration (AUCAUClast) After a Single Dose of Sonrotoclax Part 1: Maximum observed plasma concentration (Cmax) After a Single Dose of Sonrotoclax Part 1: Time to reach Cmax (tmax) After a Single Dose of Sonrotoclax Part 1: AfterAt steadySteady-state: AUC last, ss Part 1: AfterAt steadySteady-state: Cmax, ss Part 1: AfterAt steadySteady-state: trough plasma concentration (Ctrough) ss Part 1: AfterAt steadySteady-state: time to reach Cmax (tmax,ss)
Primary endpoints5 entries, revised
Part 1 And 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and, Serious Adverse Events (SAEs), withAdverse adverseEvents events leadingLeading to discontinuation,Discontinuation and AEsAdverse gradedEvents accordingof NCI-CTCAESpecial VersionInterest 5(AESIs).
Study title+85 characters
A Phase 1b/2 Study of Sonrotoclax (BGB-11417in11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and CarfilzomibDexamethasone Plus Pomalidomide in Multiple Myeloma
2025-01-10
Study Status, Contacts/Locations v30
Study sitesdetails revised at 1 of 88 sites
2024-12-12
Study Status, Contacts/Locations v29
Study sites32→88
2024-10-23
Study Status, Contacts/Locations v28
Study sites77→32
2024-10-16
Study Status, Contacts/Locations v27
Study sites70→77
2024-08-16
Study Status, Contacts/Locations v26
Study sites71→70
2024-07-30
Study Status, Contacts/Locations v25
Study sites69→71
2024-07-22
Study Status, Contacts/Locations v24
Study sites64→69
2024-06-05
Study Status, Contacts/Locations v23
Study sites64 entries, revised
ValkyrieHospital ClinicalSirio TrialsLibanes Sao Paulo TampaThe GeneralFirst Affiliated Hospital of Xiamen University MarylandJiangsu OncologyProvince Hematology, PaHospital
2024-05-29
Study Status, Contacts/Locations v22
Study sites61→64
2024-04-24
Study Status, Contacts/Locations v21
Study sites56→61
2024-02-05
Study Status, Contacts/Locations v20
Study sites49→56
2024-01-17
Study Status, Contacts/Locations v19
Study sites42→49
2024-01-03
Study Status, Contacts/Locations v18
Study sites27→42
2023-11-02
Study Status, Contacts/Locations v17
Study sites27 entries, revised
MiddlemoreAotearoa HospitalClinical Trials
2023-09-26
Study Status, Contacts/Locations v16
Study sites24→27
2023-08-24
Study Status, Contacts/Locations v15
Study sites23→24
2023-07-21
Study Status, Contacts/Locations v14
Study sites74→23
2023-06-30
Study Status, Arms and Interventions v13
Re-verified, no change to tracked fields
2023-05-31
Study Status, Contacts/Locations v12
Study sites24→74
2022-11-01
Study Status, Contacts/Locations v11
Primary completion date2023-09→2026-11
Completion date2025-09→2026-11
Study sites24 entries, revised
FroedtertMedical College of Wisconsin Nepean Hospital CIUSSS de l'Est de-L'Île-de-Montréal installation Hôpital Maisonneuve-Rosemont
2022-09-29
Study Status, Contacts/Locations v10
Study sites22→24
2022-08-08
Study Status, Contacts/Locations v9
Study sites21→22
2022-07-15
Study Status, Contacts/Locations v8
Study sites6→21
2022-05-11
Study Status, Contacts/Locations v7
Study sites4→6
2022-04-22
Study Identification, Study Status v6
Re-verified, no change to tracked fields
BeOne Medicines
59 trials monitored
See 7 trials at risk
Multiple Myeloma
1,228 trials monitored
See 75 trials at risk
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.
Trial Details
NCT Number NCT04973605
Lead Sponsor BeOne Medicines
Conditions Relapsed/Refractory Multiple Myeloma
Enrollment 246 participants
Start Date 2021-09-16
Primary Completion 2026-11 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2026-09-28