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.
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
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There are 79 Locations for this study
Gilbert Arizona, 85234, United States
Gilbert Arizona, 85234, United States
Denver Colorado, 80218, United States
Fort Myers Florida, 33961, United States
Saint Petersburg Florida, 33705, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Ann Arbor Michigan, 48109, United States
Rochester Minnesota, 55905, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Seattle Washington, 98195, United States
Phillip Australian Capital Territory, 2606, Australia
Concord New South Wales, , Australia
Kogarah New South Wales, , Australia
St Leonards New South Wales, 2065, Australia
Sydney New South Wales, , Australia
Westmead New South Wales, , Australia
Greenslopes Queensland, 4120, Australia
Tugun Queensland, 4224, Australia
Woolloongabba Queensland, , Australia
Adelaide South Australia, 5000, Australia
Bedford Park South Australia, 5042, Australia
Kurralta Park South Australia, 5125, Australia
Hobart Tasmania, , Australia
Box Hill Victoria, , Australia
Clayton Victoria, , Australia
Frankston Victoria, , Australia
Geelong Victoria, 3220, Australia
Heidelberg Victoria, , Australia
Malvern Victoria, 3144, Australia
Melbourne Victoria, 3004, Australia
Melbourne Victoria, , Australia
Nedlands Western Australia, 6009, Australia
Perth Western Australia, , Australia
Fitzroy , 3065, Australia
Geelong , , Australia
Malvern , , Australia
Melbourne , , Australia
Wodonga , , Australia
Beijing Beijing, 10000, China
Beijing Beijing, 10004, China
Beijing Beijing, 10014, China
Beijing Beijing, 10073, China
Fuzhou Fujian, 35000, China
Guangzhou Guandong, 51006, China
Guangzhou Guandong, 51051, China
Harbin Heilongjiang, 15000, China
Zhengzhou Henan, 45000, China
Wuhan Hubei, 43003, China
Nanjing Jiangsu, 21500, China
Xuzhou Jiangsu, 22100, China
Changchun Jilin, 13002, China
Shanghai Shanghai, 20009, China
Chengdu Sichuan, 61004, China
Tianjin Tianjin, 31000, China
Tianjin Tianjin, , China
Hangzhou Zhejiang, 31002, China
Hangzhou Zhejiang, 31003, China
Shanghai , 20002, China
Hradec Králové , , Czechia
Ostrava , 70852, Czechia
Prague , 10034, Czechia
Praha , 12808, Czechia
Bordeaux , 33076, France
Paris , 75010, France
Sigmaringen , 72488, Germany
Athens , 11528, Greece
Bologna , 40138, Italy
Milan , 20160, Italy
Milan , 20162, Italy
Novara , 28100, Italy
Pavia , 27100, Italy
Roma , , Italy
Terni , 05100, Italy
Torino , 10126, Italy
Udine , 33100, Italy
Busan , 47392, Korea, Republic of
Busan , 49201, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Amsterdam , 1105A, Netherlands
Utrecht , 3584 , Netherlands
Auckland , 0620, New Zealand
Auckland , 1023, New Zealand
Chorzów Slaskie, , Poland
Bydgoszcz , 85-16, Poland
Kraków , , Poland
Barcelona , 08025, Spain
Barcelona , 08036, Spain
Barcelona , 08916, Spain
Barcelona , 8035, Spain
Salamanca , , Spain
Valencia , 46026, Spain
London Greater London, WC1N , United Kingdom
Glasgow Scotland, G12 0, United Kingdom
Bournemouth , BH7 7, United Kingdom
Leeds , LS97T, United Kingdom
London , EC1A , United Kingdom
Manchester , M20 4, United Kingdom
Nottingham , , United Kingdom
Oxford , OX3 7, United Kingdom
Plymouth , PL68D, United Kingdom
Plymouth , , United Kingdom
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