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RECRUITING
NCT03697356
PHASE2

R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom's Macroglobulinemia

Sponsor: Kosin University Gospel Hospital

View on ClinicalTrials.gov

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)

Official title: A Multicenter Prospective Phase II Study of Rituximab Combined, Lenalidomide, Dexamethasone Followed by Lenalidomide Maintenance in Patients With Newly Diagnosed Waldenström's Macroglobulinemia

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2019-03-06

Completion Date

2026-06-30

Last Updated

2023-10-06

Healthy Volunteers

No

Interventions

DRUG

Lenalidomide, Bortezomib, Rituximab, Dexamethasone

step 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.

Locations (1)

Kosin University Gospel Hospital

Busan, Sue-gu, South Korea