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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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.
Show all 17Show fewer
  • 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.
Show all 22Show fewer
  • 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.

BeOne Medicines contact

1.877.828.5568

clinicaltrials@beonemed.com

74 sites in 13 countries

China21 sites, 14 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

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Completed

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    Completed

  • 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

    Recruiting

  • Shanghai Fourth Peoples Hospital Affiliated to Tongji University

    Shanghai, Shanghai Municipality, 200434

    Completed

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Completed

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

    Completed

  • 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

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

    Completed

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Active, not recruiting

Other trials in China

United States15 sites, 14 recruiting

  • Emory University Winship Cancer Center

    Atlanta, Georgia, 30322-1013

    Recruiting

  • University of Alabama At Birmingham Hospital

    Birmingham, Alabama, 35294-0004

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Completed

  • 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

    Recruiting

Other trials in United States

Brazil7 sites, 7 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

    Recruiting

Other trials in Brazil

Australia6 sites, 6 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

    Recruiting

Other trials in Australia

Italy5 sites, 5 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

    Recruiting

Other trials in Italy

South Korea5 sites, 5 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

    Recruiting

Other trials in South Korea

Germany4 sites, 4 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

    Recruiting

Other trials in Germany

Canada3 sites, 3 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

    Recruiting

Other trials in Canada

United Kingdom3 sites, 3 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

    Recruiting

Other trials in United Kingdom

Greece2 sites, 2 recruiting

  • University Hospital of Alexandroupolis

    Alexandroupoli, 68100

    Recruiting

  • General Hospital of Athens Alexandra

    Athens, 115 28

    Recruiting

Other trials in Greece

France1 site

  • Chu de Poitiers Site de La Mileterie

    Poitiers, 86000

    Completed

Other trials in France

Singapore1 site, 1 recruiting

  • National University Hospital Singapore

    Singapore, 119074

    Recruiting

Other trials in Singapore

Spain1 site

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Active, not recruiting

Other trials in Spain

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.

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 groups in NCT04973605
Study groupRoleWhat they receive
Part 1 Dose EscalationExperimentalDose-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 ExpansionExperimentalThere 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.

  1. 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

  2. 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

  3. 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

  4. 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]

  5. 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)

  1. 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)

  2. Part 1: Maximum observed plasma concentration (Cmax) After a Single Dose of Sonrotoclax

    Measured: Cycle 1 (each cycle is up to 28 days)

  3. Part 1: Time to reach Cmax (tmax) After a Single Dose of Sonrotoclax

    Measured: Cycle 1 (each cycle is up to 28 days)

  4. Part 1: At Steady-state: AUC last, ss

    Measured: Cycle 2 (each cycle is up to 28 days)

  5. Part 1: At Steady-state: Cmax, ss

    Measured: Cycle 2 (each cycle is up to 28 days)

  6. Part 1: At Steady-state: trough plasma concentration (Ctrough) ss

    Measured: Cycle 2 (each cycle is up to 28 days)

  7. Part 1: At Steady-state: time to reach Cmax (tmax,ss)

    Measured: Cycle 2 (each cycle is up to 28 days)

  8. 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

  9. 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

  10. 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

  11. 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.

  1. First posted22 Jul 2021
  2. Study start16 Sep 2021
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

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)
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.

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?

On the ClinicalTrials.gov record for NCT04973605.

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.

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