Study of VTD in Waldenstrom's Macroglobulinemia

Waldenstrom Macroglobulinemia Clinical Trial

— BOMB-THROW  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03335098
• Other study ID #: 1605-137-765
• Status: Recruiting
• Phase: Phase 2
• First received: November 4, 2017
• Last updated: November 6, 2017
• Start date: November 21, 2016
• Est. completion date: December 2020

Study information

• Verified date: November 2017
• Source: Seoul National University Hospital
• Contact: Eun-Hee Park, CRN
• Phone: +82-10-3349-1453
• Email: eh.park[@]daum.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoplasmacytic Lymphoma
• Waldenstrom Macroglobulinemia

Intervention

Drug:
• Bortezomib
Six 4-week cycles

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate	Overall response rate as per Lugano criteria	at 3 years
Secondary	Progression-free survival	Time from enrollment to disease progression or death from any cause	at 3 years
Secondary	Overall survival	Time from enrollment to death from any cause	at 3 years