Clinical trial · Interventional
Study of VTD in Waldenstrom's Macroglobulinemia
A Phase 2 Study to Evaluate the Efficacy of Bortezomib in Patients With De-novo Waldenstrom's Macroglobulinemia and Lymphoplasmacytic Lymphoma
NCT03335098CI-TRIAL-00030244BOMB-THROWunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a phase 2, single-arm, open-label, multi-institutional trial to evaluate the efficacy of combination therapy of bortezomib, thalidomide, and dexamethasone in patients with newly diagnosed Waldenstrom's macroglobulinemia and lymphoplasmacytic lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoplasmacytic Lymphoma | Lymphoplasmacytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Waldenstrom Macroglobulinemia | Waldenstrom Macroglobulinemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study arm
- description
- Subcutaneous bortezomib 1.3mg/m2 on days 1, 4, 8, and 11 (every 4 weeks, up to 6 cycles) Oral thalidomide 50mg daily on days 1-28 (every 4 weeks, up to 6 cycles) Intravenous or oral dexamethasone 40mg on days 1-4 (every 4 weeks, up to 6 cycles)
- interventionNames
- Drug: Bortezomib
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- at 3 years
- description
- Overall response rate as per Lugano criteria
Secondary outcomes (2)
- measure
- Progression-free survival
- timeFrame
- at 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Age of 19 or older * Newly diagnosed Waldenstrom's macroglobulinemia or lymphoplasmacytic lymphoma * Previously untreated with chemotherapy * ECOG performance status of 2 or lesser * Peripheral blood white blood cell count ≥ 3,500/uL * Peripheral blood neutrophil count ≥ 1,000/uL * Peripheral blood platelet count ≥ 20,000/uL * Peripheral blood hemoglobin ≥ 6.0g/dL * Serum total bilirubin ≤ 2.0 mg/dL * Serum aspartate aminotransferase ≤ 2.5 x (upper normal limit) * Serum alanine aminotransferase ≤ 2.5 x (upper normal limit) Exclusion Criteria: * Diagnosed with other malignancy within 5 years before enrollment * Prior hematopoietic stem cell transplantation * Prior organ transplantation * Uncontrolled central nervous system involvement * Congenital immunodeficiency * Acquired immune deficiency syndrome (AIDS) * Pregnancy * Uncontrolled epilepsy * Uncontrolled psychological disease * Peripheral neuropathy of grade 3 or higher
References
Publications (0)
Data not yet available
No reference posted for this study.