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)
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
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
Absolute neutrophil count (ANC) <1,000 / μL
Single group
Lenalidomide, Bortezomib, Rituximab, Dexamethasone
Drugstep 1; R-VRD induction : rituximab, bortezomib, lenalidomide, and dexamethasone induction * Rituximab 375 mg/m2 intravenous on day 1 * Bortezomib 1.3mg/m2 subcutaneous on day 1, 8, 15 * Lenalidomide 15mg p.o on day 1-21 * Dexamethasone 20 mg/m2 intravenous or p.o on day 1-4 Step 2 ; Maintenance Beginning 8 weeks after completion of induction therapy, patients receive lenalidomide 10mg once day 1-21 for 4 weeks. Treatment repeats every 1 months for 24 months.
survival
Response assessment in Waldenström macroglobulinaemia
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