R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom's Macroglobulinemia (NCT03697356) | Clinical Trial Compass
RecruitingPhase 2
R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom's Macroglobulinemia
South Korea54 participantsStarted 2019-03-06
Plain-language summary
A multicenter prospective phase II study of rituximab combined, lenalidomide, dexamethasone followed by lenalidomide maintenance in patients with newly diagnosed Waldenström's macroglobulinemia (Ballondor trial)
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia
✓. Patients who meet criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom's macroglobulinemia
✓. Male or female patients aged ≥19 years
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
✓. Patients must have measurable disease, IgM \> 0.5g/dL
✓. Appropriate bone marrow, liver, and kidney function
✓. Patients who are able to understand oral and written instructions and who are able to comply with all requirements
✓. Patients who provided agreement of subject consent (ICF) prior to initiation of clinical trial.
Exclusion criteria
✕. Central nervous system involvement central nervous system (CNS) involvement by Waldenström's macroglobulinemia
✕. Patients who have received rituximab, lenalidomide, or bortezomib
✕. Patients who are allergic or hypersensitive to mouse (murine), chimeric, human or humanized proteins, lenalidomide, bortezomib
✕. One of the following labs or more:
✕. Renal failure requiring hemodialysis or peritoneal dialysis