Clinical trial · Interventional
Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia
Phase II Study of Velcade in Waldenstrom's Macroglobulinemia
NCT00142129CI-TRIAL-00005091completedPhase 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)
The purpose of this study is to evaluate how tumors in patients with Waldenstrom's macroglobulinemia respond to treatment with bortezomib (Velcade) and to see what effects (good and bad) it has on the cancer.
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's Macroglobulinemia | Waldenstrom Macroglobulinemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib (Velcade) | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine response rate along with attainment of stable disease following treatment with bortezomib in patients with Waldenstrom's macroglobulinemia.
Secondary outcomes (1)
- measure
- To assess the safety and tolerability of bortezomib in this patient population.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Clinicopathological diagnosis of Waldenstrom's macroglobulinemia who have failed one first line therapy * Measurable disease, defined as presence of immunoglobulin M (Ig M) paraprotein with a minimum IgM level of \>2 times ULN * Karnofsky performance status of \>60 * Life expectancy of \> 3 months * Baseline platelet count \>50,000,000,000/L and ANC of 750,000,000/L * AST and ALT \< 3 x ULN * Total bilirubin \< 2 x ULN * Calculated or measured creatinine clearance \> 30mL/minute * Serum sodium \> 130 mmol/L Exclusion Criteria: * Greater than or equal to Grade 2 peripheral neuropathy * Hypersensitivity to bortezomib, boron or mannitol * Prior therapy with Velcade * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.