CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 54 target
Drug / intervention
Lenalidomide, Bortezomib, Rituximab, Dexamethasonedrug
Likely dose
Lenalidomide, Bortezomib, Rituximab, Dexamethasone 375 mg/m2from record
Key inclusion· 7
  • ✓Clinicopathological diagnosis of Waldenström's Macroglobulinemia
  • ✓Meets criteria for treatment per Second International Workshop consensus
  • ✓Age ≥19 years
  • ✓Measurable disease with IgM >0.5g/dL
Key exclusion· 14
  • ✕CNS involvement by Waldenström's macroglobulinemia
  • ✕Prior rituximab, lenalidomide, or bortezomib therapy
  • ✕Allergy or hypersensitivity to mouse, chimeric, human, humanized proteins, lenalidomide, or bortezomib
  • ✕Renal failure requiring hemodialysis or peritoneal dialysis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03697356
NCT03697356Phase 2RecruitingMonitorUpdated 32mo ago · Completion was 1mo ago
Slow Enrollment
Long Recruiting
Monitor
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A Multicenter Prospective Phase II Study of Rituximab Combined, Lenalidomide, Dexamethasone Followed by Lenalidomide Maintenance in Patients With Newly Diagnosed Waldenström's Macroglobulinemia

Kosin University Gospel Hospital·interventional·Posted Oct 5, 2018·Updated Oct 6, 2023

In Brief

A Phase 2 clinical trial evaluating Lenalidomide, Bortezomib, Rituximab, Dexamethasone for Waldenström's Macroglobulinemia. Currently recruiting, targeting 54 participants across 1 site.

Signals

Enrolling slower than its timeline implies

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWaldenström's Macroglobulinemia
CountriesSouth Korea
Collaborators--

Timeline

Phase 2RecruitingOverdue
20192020202120222023202420252026
First PostedOct 5, 2018
Enrollment StartMar 6, 2019
Primary CompletionMay 31, 2026
Study CompletionJun 30, 2026
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 7.7 years ago

Interventions

Lenalidomide, Bortezomib, Rituximab, Dexamethasonedrug

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.