This is a hybrid (retrospective and prospective), multicenter, non-interventional registry study. The primary objective of the study is to further describe the clinical profile of zanubrutinib in Treatment-naïve (TN) patients with MYD88 L265P mutation (MYD88L265P) Waldenström
macroglobulinemia (WM), TN and Relapsed/Refractory (R/R) patients with non-L265P MYD88 mutation(s) and
MYD88WT WM, and TN and R/R WM patients from racial and ethnic minority groups regardless of MYD88 status. Data collected from this registry study (newly registered patients and existing registries or databases)
will be used to characterize the clinical benefit and safety of zanubrutinib for the treatment of patients
in these populations.
Official Title
A Phase 4, Observational Study Evaluating the Efficacy and
Safety of the Bruton Tyrosine Kinase (BTK) Inhibitor
Zanubrutinib in Patients With Waldenström
Macroglobulinemia (BGB-3111-402)
Keywords
Waldenstrom Macroglobulinemia
Eligibility
for people 18 Years and up
Inclusion Criteria: Clinical and definitive histologic diagnosis of WM Measurable disease, as defined by a serum immunoglobulin M (IgM) level > 0.5 g/dL at the time of zanubrutinib initiation Started treatment with zanubrutinib, has been treated with zanubrutinib, or is planned to be prescribed zanubrutinib for the treatment of WM Bone marrow specimens with central MYD88 test results of: Cohort 1: MYD88 L265P mutation; enrollment of TN participants will be stopped in each racial and ethnic pa... more
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Inclusion Criteria: Clinical and definitive histologic diagnosis of WM Measurable disease, as defined by a serum immunoglobulin M (IgM) level > 0.5 g/dL at the time of zanubrutinib initiation Started treatment with zanubrutinib, has been treated with zanubrutinib, or is planned to be prescribed zanubrutinib for the treatment of WM Bone marrow specimens with central MYD88 test results of: Cohort 1: MYD88 L265P mutation; enrollment of TN participants will be stopped in each racial and ethnic participant group when the required numbers of participants in the group are met Cohort 2: non-L265P MYD88 mutation(s) and MYD88WT Exclusion Criteria: Evidence of disease transformation before the first dose of zanubrutinib Evidence of other non-Hodgkin Lymphoma (NHL) subtypes Prior or concurrent active malignancy = 2 years before the first dose of zanubrutinib, except for malignancies that, in the investigator’s opinion, will not obscure the interpretation of safety or efficacy results Concurrent participation in another therapeutic clinical study while receiving zanubrutinib, although the participant may be eligible depending on the status of the interventional study after discussion with the Medical Monitor or designee on an individual basis
Board Certified Medical Oncologist and Hematologist, Delshad Ahmad, MD, is dedicated to providing personalized cancer care for his patients and their families. He received his medical degree from Damascus University in Syria, where he also attended a residency program in internal medicine. Once in the United States, he completed a residency program in internal medicine at the Hurley Medical Center in Flint, Michigan. He then went on to complete a fellowship in Hematology/Oncology at Michigan Sta... more
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Board Certified Medical Oncologist and Hematologist, Delshad Ahmad, MD, is dedicated to providing personalized cancer care for his patients and their families. He received his medical degree from Damascus University in Syria, where he also attended a residency program in internal medicine. Once in the United States, he completed a residency program in internal medicine at the Hurley Medical Center in Flint, Michigan. He then went on to complete a fellowship in Hematology/Oncology at Michigan State University, East Lansing, Michigan. Currently, Dr. Ahmad is the Director of Thoracic Oncology at Eisenhower Lucy Curci Cancer Center (LCCC).
In his younger years, Dr. Ahmad excelled in sciences and coupled with his desire to help people and encouragement from his family he decided to pursue a medical degree while at university. During rotations in his residency program, he was drawn to the specialty of oncology (cancer) and hematology (blood diseases). “Oncology/Hematology offered me the greatest opportunity to positively affect patient’s lives,” states Dr. Ahmad. “It is a field that is in constant change, with new protocols and treatments always on the forefront of study. I am a constant learner and knew that this specialty of medicine would always challenge me.” The specialty of oncology/hematology was personal as well for Dr. Ahmad. While in medical school and residency, a close cousin was battling cancer and he became very involved with her treatment and care.
With regard to his approach to patient care, Dr. Ahmad strives to provide patients with all the options, possibilities and treatments with regard to treating their disease. “Every patient is unique and every treatment is unique,” states Dr. Ahmad. “I want to understand my patients' goals, provide them with the information they need to accomplish those and partner with them in developing their treatment plan. I am with them all along their journey toward health.”
Dr. Ahmad sees patients in Rancho Mirage, La Quinta and Yucca Valley.
