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

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.

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