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
Condition(s) studied
Investigational drug(s) / intervention(s)
Sonrotoclax: Administered orally daily
Dexamethasone: Once weekly either orally or intravenously
Carfilzomib: Administered intravenously weekly
Daratumumab: Administered subcutaneously weekly
Pomalidomide: Administered orally daily
Study 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.
Eligibility
Primary outcome measure(s)
- Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs) — Up to 28 days
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. - 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). — Up to 30 days after last dose of study drug
- Part 2: Overall response rate (ORR) as Assessed by Investigator — Approximately 4 years
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 - Part 2: Very Good Partial Response (VGPR) or Better Response Rate as Assessed by Investigator — Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 4 years]
Defined as the percentage of participants with a documented VGPR or better (including sCR, CR, and VGPR) - Part 2: Complete Response (CR) or Stringent Complete Response (sCR) as Assessed by Investigator — Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 4 years])
defined as the percentage of participants with a documented CR or sCR
Trial sites (77)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama At Birmingham Hospital | Birmingham | Alabama | Recruiting |
| City of Hope National Medical Center | Duarte | California | Recruiting |
| City of Hope Irvine Lennar | Irvine | California | Recruiting |
| University of Miami | Miami | Florida | Recruiting |
| Emory University Winship Cancer Center | Atlanta | Georgia | Recruiting |
| University of Chicago Medical Center | Chicago | Illinois | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Completed |
| Washington University School of Medicine | St Louis | Missouri | Recruiting |
| Hackensack University Medical Center | Hackensack | New Jersey | Recruiting |
| Memorial Sloan Kettering Cancer Center Mskcc | New York | New York | Recruiting |
| The James Cancer Hospital and Solove Research Institute At Ohio State University | Columbus | Ohio | Recruiting |
| Huntsman Cancer Institute | Salt Lake City | Utah | Recruiting |
| University of Washington | Seattle | Washington | Recruiting |
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | Recruiting |
| Canberra Hospital | Garran | Australian Capital Territory | Recruiting |
| Nepean Hospital | Kingswood | New South Wales | Recruiting |
| Monash Health | Clayton | Victoria | Recruiting |
| St Vincents Hospital Melbourne | Fitzroy | Victoria | Recruiting |
| The Alfred Hospital | Melbourne | Victoria | Recruiting |
| Royal Perth Hospital | Perth | Western Australia | Recruiting |
| Hospital Sirio Libanes Brasilia | Brasília | Brazil | Recruiting |
| Instituto Dor de Pesquisa E Ensino Distrito Federal | Brasília | Brazil | Recruiting |
| Centro Gaucho Integrado de Oncologia Hospital Mae de Deus | Porto Alegre | Brazil | Recruiting |
| Hospital Sao Rafael (Rede Dor) | Salvador | Brazil | Recruiting |
| Hospital Sirio Libanes | São Paulo | Brazil | Recruiting |
| Instituto Dor de Pesquisa E Ensino Sao Paulo | São Paulo | Brazil | Recruiting |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein | São Paulo | Brazil | Recruiting |
| Cross Cancer Institute | Edmonton | Alberta | Recruiting |
| British Columbia Cancer Agency the Vancouver Centre | Vancouver | British Columbia | Recruiting |
| Princess Margaret Cancer Centre | Toronto | Ontario | Recruiting |
| Peking University Third Hospital | Beijing | Beijing Municipality | Recruiting |
| Beijing Chao Yang Hospital | Beijing | Beijing Municipality | Recruiting |
| Peking University Peoples Hospital | Beijing | Beijing Municipality | Recruiting |
| Chongqing Cancer Hospital | Chongqing | Chongqing Municipality | Recruiting |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | Completed |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | Completed |
| Sun Yat Sen University Cancer Center | Guangzhou | Guangdong | Recruiting |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | Completed |
| Henan Cancer Hospital | Zhengzhou | Henan | Recruiting |
+ 37 more sites — see the full list on the official registry below.
On this site
📄 Darzalex (daratumumab) drug profile →More BeOne Medicines trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04973605 on ClinicalTrials.gov ↗ ← All trials in Italy