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

Last updated: February 18, 2025
Sponsor: BeiGene
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoproliferative Disorders

Platelet Disorders

Bone Neoplasm

Treatment

Carfilzomib

Pomalidomide

Dexamethasone

Clinical Study ID

NCT04973605
BGB-11417-105
2023-507751-30-00
U1111-1277-5444
2021-003614-39
  • Ages > 18
  • All Genders

Study Summary

Study consists of two parts, a part 1 dose escalation and a part 2 cohort expansion in combination with dexamethasone and carfilzomib intravenously across two cohorts with a monotherapy component as well.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

  2. A confirmed diagnosis of multiple myeloma (must have an M-component in serum and/orurine)

  3. Measurable disease defined as: i. M-spike ≥ 500mg/dL, or ii. Urine protein M-spike of ≥ 200 mg/day, or iii. Serumfree light chains ≥ 10 mg/dL, and an abnormal κ:λ ratio

  4. Participant has documented relapsed or progressive MM on or after any regimen or whoare refractory to the most recent line of therapy. i. Relapsed MM is defined as previously treated MM that progresses and requiresinitiation of salvage therapy but does not meet the criteria for refractory MM. ii. Refractory MM is defined as disease that is nonresponsive (failure to achieveminimal response or development of progressive disease) while on primary or salvagetherapy or progresses within 60 days of last therapy.

  5. In Part 1 should have relapsed or progressive disease and have had ≥ 3 priorlines of therapy including a proteasome inhibitor, an IMiD, and an anti-CD38monoclonal antibody, and no more available approved therapies.

  6. Participants in Part 2 should have relapsed or progressive disease and have had ≥ 1 prior line of therapy

  7. Prior treatment with carfilzomib is allowed but the patient must not beconsidered carfilzomib refractory by the investigator.

  8. Positivity for t(11;14) translocation must be confirmed by validated fluorescence insitu hybridization (FISH) testing assay in a pre-defined laboratory a. fresh bone marrow aspirate sample must be collected at screening and sent tocentral laboratory for t(11;14) FISH testing.

  9. Adequate organ function defined as:

  10. Hemoglobin ≥ 8.0 g/dL within 7 days before first dose of study treatment, (transfusions, in accordance with institutional guidelines, are permitted)

  11. Platelet count ≥ 75,000/μL, within 7 days before first dose of study treatment,independent of growth factor support and transfusions

  12. Absolute neutrophil count (ANC) ≥ 1000/mm^3 within 7 days before first dose ofstudy treatment

  13. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upperlimit of normal (ULN) and total bilirubin ≤ 2.0 x ULN N (total bilirubin mustbe < 3 x ULN for patients with Gilbert's syndrome)

Exclusion

Exclusion Criteria:

  1. Participant has any of the following conditions:

  2. Non secretory MM (Serum free light chains < 10 mg/dL)

  3. Solitary plasmacytoma

  4. Active plasma cell leukemia (ie, either 20% of peripheral white blood cells or > 2.0 x 109/L circulating plasma cells by standard differential)

  5. Waldenström macroglobulinemia

  6. Amyloidosis.

  7. Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome

  8. Chronic respiratory disease that requires continuous oxygen

  9. Significant cardiovascular disease, including but not limited to:

  10. Myocardial infarction ≤ 6 months before screening

  11. Ejection fraction ≤ 50%

  12. Unstable angina≤ 3 months before screening

  13. New York Heart Association Class III or IV congestive heart failure

  14. History of clinically significant arrhythmias (eg, sustained ventriculartachycardia, ventricular fibrillation, or torsades de pointes)

  15. Heart rate-corrected QT interval > 480 milliseconds based on Fridericia'sformula

  16. History of Mobitz II second-degree or third-degree heart block without apermanent pacemaker in place

  17. Uncontrolled hypertension at screening, defined as systolic blood pressure > 170 mmHg and diastolic blood pressure > 105 mmHg by ≥ 2 consecutivemeasurements. Prior therapy with sonrotoclax or other agents inhibiting BCL2activity (eg, venetoclax)

  18. Known infection with human immunodeficiency virus (HIV)

  19. Serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows:

  20. Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Participants with presence of HBcAb, but absence of HBsAg, areeligible if HBV DNA is undetectable (limitation of sensitivity < 20 IU/mL) ,),and if they are willing to undergo monthly monitoring for HBV reactivation.

  21. Presence of HCV antibody. Participants with presence of HCV antibody areeligible if HCV RNA is undetectable (limitation of sensitivity < 15 IU/mL).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 167
Treatment Group(s): 6
Primary Treatment: Carfilzomib
Phase: 1/2
Study Start date:
September 16, 2021
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Canberra Hospital

    Garra, Australian Capital Territory 2605
    Australia

    Site Not Available

  • Canberra Hospital

    Garran, Australian Capital Territory 2605
    Australia

    Site Not Available

  • Nepean Hospital

    Kingswood, New South Wales 2747
    Australia

    Active - Recruiting

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • Monash Health

    Melbourne, Victoria
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Royal Perth Hospital

    Perth, Western Australia 6000
    Australia

    Active - Recruiting

  • St. Vincent's Hospital Melbourne

    Fitzroy, 3065
    Australia

    Active - Recruiting

  • Hospital Sirio Libanes Brasilia

    Brasilia, 70200-730
    Brazil

    Active - Recruiting

  • Instituto Dor de Pesquisa E Ensino Distrito Federal

    Brasilia, 70390140
    Brazil

    Active - Recruiting

  • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

    Porto Alegre, 90850-170
    Brazil

    Active - Recruiting

  • Hospital Sao Rafael (Rede Dor)

    Salvador, 41253-190
    Brazil

    Site Not Available

  • Accamargo Cancer Center

    Sao Paulo, 01508-010
    Brazil

    Active - Recruiting

  • Clinica Sao Germano

    Sao Paulo, 04537-080
    Brazil

    Active - Recruiting

  • Hospital Nove de Julho Dasa

    Sao Paulo, 01409-902
    Brazil

    Active - Recruiting

  • Hospital Sirio Libanes

    Sao Paulo, 01308-050
    Brazil

    Active - Recruiting

  • Hospital Sirio Libanes Sao Paulo

    Sao Paulo, 01308-050
    Brazil

    Active - Recruiting

  • Instituto Dor de Pesquisa E Ensino Sao Paulo

    Sao Paulo, 01401-002
    Brazil

    Active - Recruiting

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    Sao Paulo, 05653-120
    Brazil

    Active - Recruiting

  • Cross Cancer Institute

    Edmonton, Alberta T6G1Z2
    Canada

    Active - Recruiting

  • British Columbia Cancer Agency the Vancouver Centre

    Vancouver, British Columbia V5Z 4E6
    Canada

    Active - Recruiting

  • British Columbia Cancer Center

    Vancouver, British Columbia V5Z4E6
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2C9
    Canada

    Active - Recruiting

  • University Health Network - Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2C9
    Canada

    Site Not Available

  • Jewish General Hospital

    Montreal, Quebec QC H3t 1E2
    Canada

    Active - Recruiting

  • CIUSSS de l'Est de-L'Île-de-Montréal installation Hôpital Maisonneuve-Rosemont

    Montréal, Quebec H1T2M4
    Canada

    Site Not Available

  • Jewish General Hospital

    Montréal, Quebec H3T1E2
    Canada

    Site Not Available

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui 241001
    China

    Site Not Available

  • Beijing Chao Yang Hospital

    Beijing, Beijing 100020
    China

    Active - Recruiting

  • Peking University Peoples Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

  • Chongqing Cancer Hospital

    Chongqing, Chongqing 400030
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361003
    China

    Active - Recruiting

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

  • The First Affiliated Hospital, Sun Yat Sen University

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Jieyang Peoples Hospital (Jieyang Affiliated Hospital, Sun Yat Sen University )

    Jieyang, Guangdong 522000
    China

    Site Not Available

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050000
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Active - Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 221000
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University Branch Xianghu

    Nanchang, Jiangxi 332000
    China

    Active - Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning 110001
    China

    Active - Recruiting

  • Qingdao Municipal Hospital

    Qingdao, Shandong 266000
    China

    Active - Recruiting

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Shanghai Fourth Peoples Hospital Affiliated to Tongji University

    Shanghai, Shanghai 200434
    China

    Active - Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300052
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

  • Hopital Claude Huriez Chu Lille

    Lille, 59000
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire Nantes Hotel Dieu

    Nantes Cedex, 44093
    France

    Active - Recruiting

  • Chu de Poitiers Site de La Mileterie

    Poitiers, 86000
    France

    Active - Recruiting

  • Universitaetsklinikum Aachen

    Aachen, 52074
    Germany

    Site Not Available

  • Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden

    Dresden, 01307
    Germany

    Active - Recruiting

  • Universitatsklinikum Hamburg Eppendorf

    Hamburg, 20251
    Germany

    Active - Recruiting

  • Universitatsklinikum Wurzburg

    Wurzburg, 97080
    Germany

    Site Not Available

  • University Hospital of Alexandroupolis

    Alexandroupolis, 68100
    Greece

    Active - Recruiting

  • General Hospital of Athens Alexandra

    Athens, 11528
    Greece

    Active - Recruiting

  • Rabin Medical Center

    Petach Tikva, 49100
    Israel

    Active - Recruiting

  • Rabin Medical Center

    Petah Tikva, 49100
    Israel

    Site Not Available

  • Sourasky Medical Center

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Azienda Ospedaliera Policlinico Di Bari

    Bari, 70124
    Italy

    Active - Recruiting

  • Policlinico Sorsola Malpighi, Aou Di Bologna

    Bologna, 40138
    Italy

    Active - Recruiting

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

    Meldola, 47014
    Italy

    Active - Recruiting

  • Istituto Europeo Di Oncologia

    Milano, 20141
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168
    Italy

    Active - Recruiting

  • Istituto Di Candiolo Irccs

    Torino, 10060
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Delle Marche

    Torrette, 60020
    Italy

    Active - Recruiting

  • Asan Medical Center

    Seoul, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea, Seoul St Marys Hospital

    Seoul, Seoul Teugbyeolsi 06591
    Korea, Republic of

    Active - Recruiting

  • Aotearoa Clinical Trials

    Auckland, 2025
    New Zealand

    Active - Recruiting

  • Middlemore Hospital

    Auckland, 1640
    New Zealand

    Active - Recruiting

  • National University Hospital Singapore

    Singapore, 119074
    Singapore

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 8036
    Spain

    Active - Recruiting

  • Hospital San Pedro de Alcantara

    Caceres, 10003
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de La Victoria

    Malaga, 29010
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Inselspital Bern (Inselspital, Universitatsspital Bern)

    Bern, 3010
    Switzerland

    Site Not Available

  • Churchill Hospital Oxford University Hospital Nhs Trust

    Headington, OX3 7LE
    United Kingdom

    Active - Recruiting

  • University College Hospital

    London, NW1 2PG
    United Kingdom

    Active - Recruiting

  • Royal Marsden Nhs Foundation Royal Marsden Hospital

    Sutton, SM2 5PT
    United Kingdom

    Active - Recruiting

  • Royal Cornwall Hospitalsnhs Trust

    Truro, TR1 3LJ
    United Kingdom

    Active - Recruiting

  • University of Alabama At Birmingham Hospital

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • City of Hope National Medical Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • City of Hope At Irvine Lennar

    Irvine, California 92618
    United States

    Active - Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California 90067
    United States

    Site Not Available

  • University of California At San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Sylvester Cancer Centre, University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Site Not Available

  • Emory University Winship Cancer Center

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Winship Cancer Institute of Emory

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • University of Illinois Cancer Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Southern Illinois University School of Medicine

    Springfield, Illinois 62629
    United States

    Active - Recruiting

  • Luminis Health Anne Arundel Medical Center

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Maryland Oncology

    Columbia, Maryland 21044
    United States

    Site Not Available

  • Maryland Oncology Hematology, Pa

    Columbia, Maryland 21044
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Emory University Winship Cancer Center

    Detroit, Michigan 30322
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York 10065
    United States

    Active - Recruiting

  • Weill Cornell Medical College Newyork Presbyterian Hospital

    New York, New York 10021
    United States

    Active - Recruiting

  • Ohio State University Comprehensive Cancer Center- James Cancer Hospital

    Columbus, Ohio 43210
    United States

    Site Not Available

  • The James Cancer Hospital and Solove Research Institute At Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • University of Utah Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98195
    United States

    Active - Recruiting

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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