Study of VTD in Waldenstrom's Macroglobulinemia (BOMB-THROW)

Seoul National University

Status and phase: Unknown; Phase 2

Conditions: Waldenstrom Macroglobulinemia; Lymphoplasmacytic Lymphoma

Treatments: Drug: Bortezomib

Study type: Interventional

Funder types: Other

Identifiers

NCT03335098

1605-137-765

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Study arm

Experimental group

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)

Treatment:

Drug: Bortezomib