Relapsed/Refractory Multiple MyelomaPhase 1/2NCT04973605
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
A Phase 1/2 study testing Sonrotoclax, Dexamethasone and Carfilzomib in people with Relapsed/Refractory Multiple Myeloma, run by BeOne Medicines at 74 sites in 13 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- Sonrotoclax, Dexamethasone and Carfilzomib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 74 sitesin 13 countries
- Study dates
- 16 Sep 2021to Nov 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- M-spike ≥ 500mg/dL, or ii. Urine protein M-spike of ≥ 200 mg/day, or iii. Serum free light chains ≥ 10 mg/dL, and an abnormal κ:λ ratio
- Participant has documented relapsed or progressive MM on or after any regimen or who are refractory to the most recent line of therapy.
- Relapsed MM is defined as previously treated MM that progresses and requires initiation of salvage therapy but does not meet the criteria for refractory MM.
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- Refractory MM is defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy 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 ≥ 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
- fresh bone marrow aspirate sample must be collected at screening and sent to central laboratory for t(11;14) FISH testing.
- Adequate organ function defined as:
- Hemoglobin ≥ 8.0 g/dL within 7 days before first dose of study treatment, (transfusions, in accordance with institutional guidelines, are permitted)
- Platelet count ≥ 75,000/μL, within 7 days before first dose of study treatment, independent of growth factor support and transfusions
- Absolute neutrophil count (ANC) ≥ 1000/mm^3 within 7 days before first dose of study treatment
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN) and total bilirubin ≤ 2.0 x ULN N (total bilirubin must be < 3 x ULN for patients with Gilbert's syndrome)
Who cannot join
- Participant has any of the following conditions:
- Non secretory MM (Serum free light chains < 10 mg/dL)
- Solitary plasmacytoma
- Active plasma cell leukemia (ie, either 20% of peripheral white blood cells or > 2.0 x 109/L circulating plasma cells by standard differential)
- Waldenström macroglobulinemia (WM)
- Amyloidosis.
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- Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome
- Chronic respiratory disease that requires continuous oxygen
- Significant cardiovascular disease, including but not limited to:
- Myocardial infarction ≤ 6 months before screening
- Ejection fraction ≤ 50%
- Unstable angina≤ 3 months before screening
- New York Heart Association Class III or IV congestive heart failure
- History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
- Heart rate-corrected QT interval > 480 milliseconds based on Fridericia's formula
- History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
- Uncontrolled hypertension at screening, defined as systolic blood pressure > 170 mmHg and diastolic blood pressure > 105 mmHg by ≥ 2 consecutive measurements. Prior therapy with sonrotoclax or other agents inhibiting BCL2 activity (eg, venetoclax)
- Known infection with human immunodeficiency virus (HIV)
- Serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows:
- Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Participants with presence of HBcAb, but absence of HBsAg, are eligible if HBV DNA is undetectable (limitation of sensitivity < 20 IU/mL) ,), and if they are willing to undergo monthly monitoring for HBV reactivation.
- Presence of HCV antibody. Participants with presence of HCV antibody are eligible if HCV RNA is undetectable (limitation of sensitivity < 15 IU/mL).
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
74 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
74 sites in 13 countries
China21 sites, 14 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
- Recruiting
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, 100020
- Recruiting
Peking University Peoples Hospital
Beijing, Beijing Municipality, 100044
- Completed
Hunan Cancer Hospital
Changsha, Hunan, 410013
- Recruiting
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030
- Completed
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
- Recruiting
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
- Recruiting
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi, 332000
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
- Recruiting
Qingdao Municipal Hospital
Qingdao, Shandong, 266000
- Recruiting
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
- Completed
Shanghai Fourth Peoples Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, 200434
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
- Completed
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
- Completed
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
- Recruiting
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
Tianjin, Tianjin Municipality, 301617
- Recruiting
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
- Completed
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
- Active, not recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
United States15 sites, 14 recruiting
- Recruiting
Emory University Winship Cancer Center
Atlanta, Georgia, 30322-1013
- Recruiting
University of Alabama At Birmingham Hospital
Birmingham, Alabama, 35294-0004
- Completed
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637-1443
- Recruiting
The James Cancer Hospital and Solove Research Institute At Ohio State University
Columbus, Ohio, 43210-1240
- Recruiting
City of Hope National Medical Center
Duarte, California, 91010-3012
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601-1915
- Recruiting
City of Hope Irvine Lennar
Irvine, California, 92618-2377
- Recruiting
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792-0001
- Recruiting
University of Miami
Miami, Florida, 33136-2107
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3522
- Recruiting
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, 10065-6800
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
- Recruiting
University of Washington
Seattle, Washington, 98195
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110-1010
Brazil7 sites, 7 recruiting
- Recruiting
Hospital Sirio Libanes Brasilia
Brasília, 70200-730
- Recruiting
Instituto Dor de Pesquisa E Ensino Distrito Federal
Brasília, 70390140
- Recruiting
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, 90110-270
- Recruiting
Hospital Sao Rafael (Rede Dor)
Salvador, 41253-190
- Recruiting
Hospital Sirio Libanes
São Paulo, 01308-050
- Recruiting
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, 01401-004
- Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652-900
Australia6 sites, 6 recruiting
- Recruiting
Monash Health
Clayton, Victoria, VIC 3168
- Recruiting
St Vincents Hospital Melbourne
Fitzroy, Victoria, VIC 3065
- Recruiting
Canberra Hospital
Garran, Australian Capital Territory, ACT 2605
- Recruiting
Nepean Hospital
Kingswood, New South Wales, NSW 2747
- Recruiting
The Alfred Hospital
Melbourne, Victoria, VIC 3004
- Recruiting
Royal Perth Hospital
Perth, Western Australia, WA 6000
Italy5 sites, 5 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Delle Marche
Ancona, 60020
- Recruiting
Azienda Ospedaliera Policlinico Di Bari
Bari, 70124
- Recruiting
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, 40138
- Recruiting
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
Meldola, 47014
- Recruiting
Istituto Europeo Di Oncologia
Milan, 20141
South Korea5 sites, 5 recruiting
- Recruiting
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, 06351
- Recruiting
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, 06591
- Recruiting
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722
- Recruiting
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080
- Recruiting
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, 05505
Germany4 sites, 4 recruiting
- Recruiting
Universitaetsklinikum Aachen
Aachen, 52074
- Recruiting
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
Dresden, 01307
- Recruiting
Universitatsklinikum Hamburg Eppendorf
Hamburg, 20251
- Recruiting
Universitatsklinikum Wurzburg
Würzburg, 97080
Canada3 sites, 3 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
- Recruiting
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
United Kingdom3 sites, 3 recruiting
- Recruiting
Oxford University Hospitals Nhs Trust Churchill Hospital
Headington, OX3 7LE
- Recruiting
University College Hospital
London, NW1 2PG
- Recruiting
Royal Marsden Nhs Foundation Royal Marsden Hospital
Sutton, SM2 5PT
Greece2 sites, 2 recruiting
- Recruiting
University Hospital of Alexandroupolis
Alexandroupoli, 68100
- Recruiting
General Hospital of Athens Alexandra
Athens, 115 28
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital Singapore
Singapore, 119074
About this study
Official title: 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)
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.
Read the 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.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonrotoclaxDrug
Also called BGB-11417
Administered orally daily
DexamethasoneDrug
Once weekly either orally or intravenously
CarfilzomibDrug
Administered intravenously weekly
DaratumumabDrug
Administered subcutaneously weekly
PomalidomideDrug
Administered orally daily
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Dose Escalation | Experimental | Dose-escalation and de-escalation to determine maximum tolerated dose (MTD) of sonrotoclax plus dexamethasone, sonrotoclax plus dexamethasone plus carfilzomib, sonrotoclax plus dexamethasone plus daratumumab, and sonrotoclax plus dexamethasone plus pomalidomide. Receives: Drug: Sonrotoclax; Drug: Dexamethasone; Drug: Carfilzomib; Drug: Daratumumab; Drug: Pomalidomide |
| Part 2 Cohort Expansion | Experimental | There will be up to 7 expansion cohorts to further evaluate the safety and efficacy of sonrotoclax monotherapy, sonrotoclax plus dexamethasone in combination with dexamethasone plus carfilzomib, and in combination with dexamethasone plus daratumumab Receives: Drug: Sonrotoclax; Drug: Dexamethasone; Drug: Carfilzomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Measured: 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)
Measured: 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
Measured: Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 4 years])
Secondary outcomes (11)
Part 1: Area under the plasma concentration-time curve time 0 to the last measurable concentration (AUClast) After a Single Dose of Sonrotoclax
Measured: Cycle 1 (each cycle is up to 28 days)
Part 1: Maximum observed plasma concentration (Cmax) After a Single Dose of Sonrotoclax
Measured: Cycle 1 (each cycle is up to 28 days)
Part 1: Time to reach Cmax (tmax) After a Single Dose of Sonrotoclax
Measured: Cycle 1 (each cycle is up to 28 days)
Part 1: At Steady-state: AUC last, ss
Measured: Cycle 2 (each cycle is up to 28 days)
Part 1: At Steady-state: Cmax, ss
Measured: Cycle 2 (each cycle is up to 28 days)
Part 1: At Steady-state: trough plasma concentration (Ctrough) ss
Measured: Cycle 2 (each cycle is up to 28 days)
Part 1: At Steady-state: time to reach Cmax (tmax,ss)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start16 Sep 2021
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned sequentially in Part 1. In Part 2 participants will be assigned in parallel
- Masking
- None (open label)
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973605
- Sponsor's protocol ID
- BGB-11417-105
- Other IDs
- 2023-507751-30-00, 2021-003614-39, U1111-1277-5444, CTR20231932, 2023
- Status last verified
- Sep 2026
- First submitted
- 7 Jul 2021
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04973605
- Acronym / sponsor ID
- BGB-11417-105
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- BeOne MedicinesIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned sequentially in Part 1. In Part 2 participants will be assigned in parallel
| Arm | Type | Receives |
|---|---|---|
| Part 1 Dose Escalation | Experimental | Drug: Sonrotoclax, Drug: Dexamethasone, Drug: Carfilzomib, Drug: Daratumumab, Drug: PomalidomideDose-escalation and de-escalation to determine maximum tolerated dose (MTD) of sonrotoclax plus dexamethasone, sonrotoclax plus dexamethasone plus carfilzomib, sonrotoclax plus dexamethasone plus daratumumab, and sonrotoclax plus dexamethasone plus pomalidomide. |
| Part 2 Cohort Expansion | Experimental | Drug: Sonrotoclax, Drug: Dexamethasone, Drug: CarfilzomibThere will be up to 7 expansion cohorts to further evaluate the safety and efficacy of sonrotoclax monotherapy, sonrotoclax plus dexamethasone in combination with dexamethasone plus carfilzomib, and in combination with dexamethasone plus daratumumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
- Positivity for t(11;14) translocation must be confirmed by validated fluorescence in situ hybridization (FISH) testing assay in a pre-defined laboratory
Key exclusion criteria (22 listed)
- Participant has any of the following conditions:
- Significant cardiovascular disease, including but not limited to:
- Known infection with human immunodeficiency virus (HIV)
- Serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows:
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonrotoclaxAlso: BGB-11417Administered orally daily | Drug | Part 1 Dose Escalation, Part 2 Cohort Expansion |
| DexamethasoneOnce weekly either orally or intravenously | Drug | Part 1 Dose Escalation, Part 2 Cohort Expansion |
| CarfilzomibAdministered intravenously weekly | Drug | Part 1 Dose Escalation, Part 2 Cohort Expansion |
| DaratumumabAdministered subcutaneously weekly | Drug | Part 1 Dose Escalation |
| PomalidomideAdministered orally daily | Drug | Part 1 Dose Escalation |
Primary outcome
Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)
Time frame: 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).
Time frame: Up to 30 days after last dose of study drug
Part 2: Overall response rate (ORR) as Assessed by Investigator
Time frame: 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
Time frame: 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
Time frame: 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
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
74 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sonrotoclax, Dexamethasone and Carfilzomib in people with Relapsed/Refractory Multiple Myeloma, run by BeOne Medicines at 74 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in China, United States, Brazil, Australia, Italy and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BeOne Medicines (1.877.828.5568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs) (time frame: Up to 28 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.