Study of VTD in Waldenstrom's Macroglobulinemia

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2 Study to Evaluate the Efficacy of Bortezomib in Patients With De-novo Waldenstrom's Macroglobulinemia and Lymphoplasmacytic Lymphoma

Conditions
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Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma

Intervention / Treatment
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* Drug: Bortezomib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm<br>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) | Drug: Bortezomib<br>* Six 4-week cycles<br>* Other names: Dexamethasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate | Overall response rate as per Lugano criteria | at 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Time from enrollment to disease progression or death from any cause | at 3 years | 
| Overall survival | Time from enrollment to death from any cause | at 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Waldenstrom's macroglobulinemia, Lymphoplasmacytic lymphoma, Bortezomib, Thalidomide