Multiple Myeloma Clinical Trial

BGB 3111 in Combination With Obinutuzumab in Participants With B-Cell Lymphoid Malignancies

Summary

This study evaluated the safety and preliminary efficacy of BGB-3111 (zanubrutinib) in combination with obinutuzumab in participants with B-cell lymphoid malignancies.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Aged ≥18 years, able and willing to provide written informed consent and to comply with the study protocol.

Laboratory parameters as specified below:

Hematologic: Platelet count >40x10^9/liter (L) (may be post-transfusion); absolute neutrophil count >1.0x10^9/L (growth factor use is allowed to bring pre-treatment neutrophils to >1.0x10^9 cells/L if marrow infiltration is involved).
Hepatic: Total bilirubin <3 x upper limit normal (ULN); and aspartate aminotransferase and alanine transaminase ≤3 x ULN.
Renal: Creatinine clearance ≥50 milliliters/minute (as estimated by the Cockcroft Gault equation or as measured by nuclear medicine scan or 24-hour urine collection); participants requiring hemodialysis will be excluded.
Anticipated survival of at least 6 months.
Eastern Cooperative Oncology Group performance status of 0 to 2.
Female participants of childbearing potential and non-sterile males must have agreed to practice at least one of the following methods of birth control with partner(s) throughout the study and for ≥3 months after discontinuing zanubrutinib or ≥18 months following obinutuzumab treatment, whichever was longer: total abstinence from sexual intercourse, double barrier contraception, intra uterine device or hormonal contraceptive initiated at least 3 months prior to first administration of study drug.
Male participants must have not donated sperm from first study drug administration, until 3 months after zanubrutinib discontinuation or 18 months following obinutuzumab treatment, whichever is longer.

Exclusion Criteria:

Known central nervous system lymphoma or leukemia.
Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome.
Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.
History of significant cardiovascular disease.
Severe or debilitating pulmonary disease.
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy.
Prior Bruton tyrosine kinase inhibitor treatment.
Used medications which were strong cytochrome P450 (CYP) 3A inhibitors and strong CYP3A inducers.
Vaccination with a live vaccine within 28 days of the initiation of treatment.
Allogeneic stem cell transplantation within 6 months, or had active graft versus host disease requiring ongoing immunosuppression.
Receipt of the following treatment prior to first administration of zanubrutinib, corticosteroids given with anti-neoplastic intent within 7 days, chemotherapy or radiotherapy within 3 weeks, monoclonal antibody within 4 weeks.
Participated in any investigational drug study within 28 days of study entry, or not recovered from non-hematologic toxicity of any prior chemotherapy up to ≤ Grade 1 (except for alopecia).
History of other active malignancies within 2 years of study entry.
Major surgery in the past 4 weeks.
Active symptomatic fungal, bacterial and/or viral infection including evidence of infection with human immunodeficiency virus, human T cell lymphotropic virus seropositive status.
Inability to comply with the study procedures.
Pregnant or nursing women.
Any illness or condition that in the opinion of the investigator may have affected the safety of treatment or evaluation of any study's endpoints.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

119

Study ID:

NCT02569476

Recruitment Status:

Completed

Sponsor:

BeiGene

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There are 15 Locations for this study

See Locations Near You

Florida Cancer Specialists
Fort Myers Florida, 33916, United States
Florida Cancer Specialists
Saint Petersburg Florida, 33705, United States
Tennessee Oncology, PLLC - Nashville
Nashville Tennessee, 37203, United States
Border Medical Oncology
Albury New South Wales, 2640, Australia
St George Hospital
Kogarah New South Wales, 2217, Australia
Brisbane Clinic for Lymphoma, Myeloma and Leukaemia
Greenslopes Queensland, 4120, Australia
Ashford Cancer Centre Research
Kurralta Park South Australia, 5037, Australia
St Vincent's Hospital Melbourne
East Melbourne Victoria, 3002, Australia
University Hospital Geelong
Geelong Victoria, 3220, Australia
St Frances Xavier Cabrini Hospital
Malvern Victoria, 3144, Australia
The Alfred Hospital
Melbourne Victoria, 3181, Australia
Royal Perth Hospital
Perth Western Australia, 6000, Australia
Severance Hospital, Yonsei University
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

119

Study ID:

NCT02569476

Recruitment Status:

Completed

Sponsor:


BeiGene

How clear is this clinincal trial information?

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