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

Sponsor
Kosin University Gospel Hospital
Study ID
NCT03697356
Phase
PHASE2
Status
Recruiting
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Conditions

  • Waldenström's Macroglobulinemia

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenalidomide, Bortezomib, Rituximab, Dexamethasone — DRUG
    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.

Study Details

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)

Key Dates

Start date
Mar 6, 2019
Status verified
Oct 2023
Primary completion
May 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
54 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab&Bortezomib&Lenalidomide&Dexamethasone
    Rituximab\&Bortezomib\&Lenalidomide\&Dexamethasone

Primary Outcome Measure

survival [ Time Frame: 2 years ]

Central Contacts