Multiple Myeloma Clinical Trial

Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies

Summary

The purpose of this study is to evaluate the long-term safety of zanubrutinib regimens in participants with B-cell malignancies who participated in a BeiGene parent study for zanubrutinib.

View Eligibility Criteria

Eligibility Criteria

Currently participating or participated recently in a BeiGene parent study

Intent to continue or start zanubrutinib treatment after any of the following:

At time of final analysis or study closure of the eligible BeiGene parent study
At time of progressive disease (PD); and investigator, patient and medical monitor agree it is in the patient's best interest
At an alternative timepoint for an alternative reason

Patient who is currently on zanubrutinib treatment:

Does not meet any protocol-specified criteria for zanubrutinib hold or permanent discontinuation, and, in the opinion of the investigator, will continue to benefit from zanubrutinib treatment

Zanubrutinib-naive patient:

Must meet the following criteria ≤ 15 days before first dose of study drug:

Platelets ≥ 50,000/mm3
Absolute neutrophil count ≥ 750/mm3
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal
Serum total bilirubin ≤ 3 x upper limit of normal (not required for Gilbert Syndrome)
QT interval corrected for heart rate using Fridericia's formula (QTcF) ≤ 480 msec
No known New York Heart Association (NYHA) Class III or IV congestive heart failure
Creatinine clearance ≥ 30 mL/min
Female participants of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control.

Key Exclusion Criteria:

Permanently discontinued from zanubrutinib treatment in the BeiGene parent study due to unacceptable toxicity, non-compliance with study procedures, or withdrawal of consent
Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy
Life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of zanubrutinib, or put the study outcomes at undue risk
Concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based therapies, or any prohibited concomitant therapy outlined in the protocol
Pregnant or lactating woman
Inability to comply with study procedures
Concurrent participation in another therapeutic clinical study
History of progressive disease (PD) while receiving a BTK inhibitor (excluding zanubrutinib)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

500

Study ID:

NCT04170283

Recruitment Status:

Enrolling by invitation

Sponsor:

BeiGene

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There are 79 Locations for this study

See Locations Near You

Banner MD Anderson Cancer Center - Critical Care
Gilbert Arizona, 85234, United States
Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Florida Cancer Specialists and Research Institute - South
Fort Myers Florida, 33961, United States
Florida Cancer Specialists and Research Institute - North
Saint Petersburg Florida, 33705, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
University of Michigan Health System - Oncology
Ann Arbor Michigan, 48109, United States
University of Michigan Health System
Ann Arbor Michigan, 48109, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
The University of Texas, MD Anderson Cancer Center
Houston Texas, 77030, United States
Fred Hutchinson Cancer Center
Seattle Washington, 98195, United States
Woden Dermatology
Phillip Australian Capital Territory, 2606, Australia
Concord Repatriation General Hospital
Concord New South Wales, , Australia
St George Hospital
Kogarah New South Wales, , Australia
Royal North Shore Hospital
St Leonards New South Wales, 2065, Australia
St George Hospital
Sydney New South Wales, , Australia
Westmead Hospital
Westmead New South Wales, , Australia
Brisbane Clinic for Lymphoma, Myeloma and Leukaemia
Greenslopes Queensland, 4120, Australia
John Flynn Private Hospital
Tugun Queensland, 4224, Australia
Princess Alexandra Hospital
Woolloongabba Queensland, , Australia
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia
Flinders Medical Centre
Bedford Park South Australia, 5042, Australia
Ashford Cancer Centre Research
Kurralta Park South Australia, 5125, Australia
Royal Hobart Hospital
Hobart Tasmania, , Australia
Box Hill Hospital (AUS)
Box Hill Victoria, , Australia
Monash Health
Clayton Victoria, , Australia
Peninsula Private Hospital
Frankston Victoria, , Australia
Barwon Health, University Hospital Geelong
Geelong Victoria, 3220, Australia
Austin Health
Heidelberg Victoria, , Australia
Cabrini Hospital
Malvern Victoria, 3144, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
Peter MacCallum Cancer Center
Melbourne Victoria, , Australia
Sir Charles Gairdner Hospital
Nedlands Western Australia, 6009, Australia
Royal Perth Hospital
Perth Western Australia, , Australia
St. Vincent's Hospital Melbourne
Fitzroy , 3065, Australia
Geelong University Hospital
Geelong , , Australia
Cabrini Hospital
Malvern , , Australia
St Vincent's Hospital
Melbourne , , Australia
Border Medical Oncology
Wodonga , , Australia
Peking University Third Hospital
Beijing Beijing, 10000, China
Peking University People's Hospital
Beijing Beijing, 10004, China
Beijing Cancer Center
Beijing Beijing, 10014, China
Peking Union Medical College Hospital
Beijing Beijing, 10073, China
Fujian Medical University Union Hospital
Fuzhou Fujian, 35000, China
Guangdong Province People's Hospital
Guangzhou Guandong, 51006, China
Nanfang hospital of Southern Medical University
Guangzhou Guandong, 51051, China
Affiliated Tumor Hospital of Harbin Medical University
Harbin Heilongjiang, 15000, China
Henan Cancer Hospital
Zhengzhou Henan, 45000, China
Tongji Hospital of Tongji Medical College
Wuhan Hubei, 43003, China
Jiangsu Province Hospital
Nanjing Jiangsu, 21500, China
The affiliated Hospital of Xuzhou Medical University
Xuzhou Jiangsu, 22100, China
The first Bethune Hospital of Jilin University
Changchun Jilin, 13002, China
Xia Hua Hospital Affiliated to Shanghai Jiao Tong University School of medicine
Shanghai Shanghai, 20009, China
West China Hospital, Sichuan University
Chengdu Sichuan, 61004, China
Institute of Hematology and Hospital of Blood Disease
Tianjin Tianjin, 31000, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin Tianjin, , China
Zhejiang Cancer Hospital
Hangzhou Zhejiang, 31002, China
The First Affiliated Hospital of Zhejiang University
Hangzhou Zhejiang, 31003, China
Fudan University Shanghai Cancer Center
Shanghai , 20002, China
Fakultni nemocnice Hradec Kralove
Hradec Králové , , Czechia
Fakultni nemocnice Ostrava
Ostrava , 70852, Czechia
University Hospital Vinohrady
Prague , 10034, Czechia
Všeobecná fakultní nemocnice v Praze
Praha , 12808, Czechia
Institut Bergonie
Bordeaux , 33076, France
Hôpital Saint-Louis
Paris , 75010, France
SRH Kliniken Landkreis Sigmaringen
Sigmaringen , 72488, Germany
General Hospital of Athens Alexandra
Athens , 11528, Greece
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna , 40138, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan , 20160, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan , 20162, Italy
AOU Maggiore della Carità
Novara , 28100, Italy
IRCCS Policlinico San Matteo
Pavia , 27100, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma , , Italy
Azienda Ospedaliera S. Maria Di Terni
Terni , 05100, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Torino , 10126, Italy
AOU Santa Maria della Misericordia
Udine , 33100, Italy
Inje University Busan Paik Hospital
Busan , 47392, Korea, Republic of
Dong-A University Hospital
Busan , 49201, Korea, Republic of
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Severance Hospital, Yonsei University
Seoul , 03722, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
AMC Universiteit van Amsterdam
Amsterdam , 1105A, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht , 3584 , Netherlands
North Shore Hospital (NZ)
Auckland , 0620, New Zealand
Auckland City Hospital
Auckland , 1023, New Zealand
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzów Slaskie, , Poland
Szpital Uniwersytecki Nr. 2 im Dr. Jana Biziela w Bydgoszczy
Bydgoszcz , 85-16, Poland
Malopolskie Centrum Medyczne
Kraków , , Poland
Hospital de La Santa Creu i Sant Pau
Barcelona , 08025, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Institut Catala d'Oncologia-Hospital Universitari Germans Trias i Pujol
Barcelona , 08916, Spain
Hospital Universitario Vall D'Hebron
Barcelona , 8035, Spain
Hospital Universitario de Salamanca
Salamanca , , Spain
Hospital Universitari i Politècnic La Fe
Valencia , 46026, Spain
University College London Hospitals
London Greater London, WC1N , United Kingdom
Beatson West of Scotland Cancer Centre - Oncology
Glasgow Scotland, G12 0, United Kingdom
The Royal Bournemouth and Christchurch Hospitals NHS Foundation
Bournemouth , BH7 7, United Kingdom
St James Hospital
Leeds , LS97T, United Kingdom
St Barts Hospital
London , EC1A , United Kingdom
The Christie Hospital
Manchester , M20 4, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham , , United Kingdom
Churchill Hospital - Oxford University Hospital NHS Trust
Oxford , OX3 7, United Kingdom
Derriford Hospital
Plymouth , PL68D, United Kingdom
Derriford Hospital
Plymouth , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

500

Study ID:

NCT04170283

Recruitment Status:

Enrolling by invitation

Sponsor:


BeiGene

How clear is this clinincal trial information?

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