Waldenstrom Macroglobulinemia
Conditions
Brief summary
This is a hybrid (retrospective and prospective) non-interventional registry study to further describe the clinical profile of zanubrutinib in Waldenström macroglobulinemia (WM) participants with and without specific mutations and from racial and ethnic minority groups. Data collected from this registry study will be used to better understand the clinical benefit and safety of zanubrutinib for the treatment of participants in these populations.
Interventions
DRUGZanubrutinib
Dosing and treatment duration are at the discretion of the prescribing physician and in accordance with local labeling
Sponsors
BeiGene
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. 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 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Response Rate (MRR) | Up to approximately 4 years | MRR is defined as the proportion of participants achieving either complete response (CR), very good partial response (VGPR), or partial response (PR) as determined by the investigator using an adaptation of the response criteria updated at the Sixth International Workshop on WM (IWWM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VGPR+ Rate | Up to approximately 5 years | VGPR+ rate is defined as the proportion of participants achieving either CR or VGPR |
| Overall Response Rate (ORR) | Up to approximately 5 years | ORR is defined as the proportion of participants achieving either CR, VGPR, PR, or minor response (MR) |
| Duration of Response (DOR) | Up to approximately 5 years | DOR is defined as the time from the first determination of response (CR, VGPR, or PR) until first documentation of or death, whichever comes first |
| Number of Participants with Treatment-emergent Adverse Events | Up to approximately 5 years | — |
Countries
Puerto Rico, United States
Contacts
CONTACTStudy Director
STUDY_DIRECTORStudy Director
BeiGene
Outcome results
None listed