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)

Who is this study for? Patients with relapsed/refractory multiple myeloma
What treatments are being studied? BGB-11417
Status: Recruiting
Location: See all (84) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

• i. 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.

• i. 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.

• ii. 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

• a. 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)

Locations
United States
Alabama
University of Alabama At Birmingham Hospital
RECRUITING
Birmingham
California
City of Hope National Medical Center
RECRUITING
Duarte
City of Hope At Irvine Lennar
RECRUITING
Irvine
University of California At San Francisco
COMPLETED
San Francisco
Florida
University of Miami
RECRUITING
Miami
Georgia
Emory University Winship Cancer Center
RECRUITING
Atlanta
Illinois
University of Chicago Medical Center
RECRUITING
Chicago
Southern Illinois University School of Medicine
COMPLETED
Springfield
Massachusetts
Massachusetts General Hospital
COMPLETED
Boston
Missouri
Washington University School of Medicine
RECRUITING
St Louis
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
New York
Memorial Sloan Kettering Cancer Center Mskcc
RECRUITING
New York
Weill Cornell Medical College Newyork Presbyterian Hospital
RECRUITING
New York
Ohio
The James Cancer Hospital and Solove Research Institute At Ohio State University
RECRUITING
Columbus
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Washington
University of Washington
RECRUITING
Seattle
Wisconsin
University of Wisconsin Carbone Cancer Center
RECRUITING
Madison
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Australia
Monash Health
RECRUITING
Clayton
St Vincents Hospital Melbourne
RECRUITING
Fitzroy
Canberra Hospital
RECRUITING
Garran
Nepean Hospital
RECRUITING
Kingswood
The Alfred Hospital
RECRUITING
Melbourne
Royal Perth Hospital
RECRUITING
Perth
Brazil
Hospital Sirio Libanes Brasilia
RECRUITING
Brasília
Instituto Dor de Pesquisa E Ensino Distrito Federal
RECRUITING
Brasília
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
RECRUITING
Porto Alegre
Hospital Sao Rafael (Rede Dor)
RECRUITING
Salvador
Hospital Sirio Libanes
RECRUITING
São Paulo
Instituto Dor de Pesquisa E Ensino Sao Paulo
RECRUITING
São Paulo
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
RECRUITING
São Paulo
Canada
Cross Cancer Institute
RECRUITING
Edmonton
Princess Margaret Cancer Centre
RECRUITING
Toronto
British Columbia Cancer Agency the Vancouver Centre
RECRUITING
Vancouver
China
Beijing Chao Yang Hospital
RECRUITING
Beijing
Peking University Peoples Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Hunan Cancer Hospital
COMPLETED
Changsha
Chongqing Cancer Hospital
RECRUITING
Chongqing
Fujian Medical University Union Hospital
COMPLETED
Fuzhou
Sun Yat Sen University Cancer Center
RECRUITING
Guangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First Affiliated Hospital of Nanchang University Branch Xianghu
RECRUITING
Nanchang
Jiangsu Province Hospital
RECRUITING
Nanjing
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
RECRUITING
Nanjing
Qingdao Municipal Hospital
RECRUITING
Qingdao
Affiliated Zhongshan Hospital of Fudan University
RECRUITING
Shanghai
Shanghai Fourth Peoples Hospital Affiliated to Tongji University
COMPLETED
Shanghai
The First Hospital of China Medical University
RECRUITING
Shenyang
The Second Hospital of Hebei Medical University
COMPLETED
Shijiazhuang
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
RECRUITING
Tianjin
Tianjin Medical University General Hospital
COMPLETED
Tianjin
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
The First Affiliated Hospital of Xiamen University
COMPLETED
Xiamen
Henan Cancer Hospital
RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Germany
Universitaetsklinikum Aachen
RECRUITING
Aachen
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
RECRUITING
Dresden
Universitatsklinikum Hamburg Eppendorf
RECRUITING
Hamburg
Universitatsklinikum Wurzburg
RECRUITING
Würzburg
Greece
University Hospital of Alexandroupolis
RECRUITING
Alexandroupoli
General Hospital of Athens Alexandra
RECRUITING
Athens
Israel
Sourasky Medical Center
COMPLETED
Tel Aviv
Italy
Azienda Ospedaliera Policlinico Di Bari
RECRUITING
Bari
Policlinico Sorsola Malpighi, Aou Di Bologna
RECRUITING
Bologna
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
RECRUITING
Meldola
Istituto Europeo Di Oncologia
RECRUITING
Milan
Istituto Di Candiolo Irccs
RECRUITING
Torino
Azienda Ospedaliera Universitaria Delle Marche
RECRUITING
Torrette
Republic of Korea
Samsung Medical Center
RECRUITING
Gangnamgu
The Catholic University of Korea, Seoul St Marys Hospital
RECRUITING
Seochogu
Severance Hospital Yonsei University Health System
RECRUITING
Seodaemungu
Seoul National University Hospital
RECRUITING
Seoul
Asan Medical Center
RECRUITING
Songpagu
Singapore
National University Hospital Singapore
RECRUITING
Singapore
Spain
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital San Pedro de Alcantara
RECRUITING
Cáceres
Hospital Universitario Virgen de La Victoria
RECRUITING
Málaga
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
United Kingdom
Churchill Hospital Oxford University Hospital Nhs Trust
RECRUITING
Headington
University College Hospital
RECRUITING
London
Royal Marsden Nhs Foundation Royal Marsden Hospital
RECRUITING
Sutton
Royal Cornwall Hospitalsnhs Trust
RECRUITING
Truro
Contact Information
Primary
BeOne Medicines
clinicaltrials@beonemed.com
1.877.828.5568
Time Frame
Start Date: 2021-09-16
Estimated Completion Date: 2026-11
Participants
Target number of participants: 246
Treatments
Experimental: Part 1 Dose Escalation
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.
Experimental: Part 2 Cohort Expansion
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
Related Therapeutic Areas
Sponsors
Leads: BeOne Medicines

This content was sourced from clinicaltrials.gov