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

NCT03697356 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-10-06

No results posted yet for this study

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)

Conditions

  • Waldenström's Macroglobulinemia

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.

Sponsors & Collaborators

  • Kosin University Gospel Hospital

    lead OTHER

Principal Investigators

  • HoSup Lee · KUGH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-06
Primary Completion
2026-05-31
Completion
2026-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03697356 on ClinicalTrials.gov