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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03335098

Acronym

BOMB-THROW

Enrollment

Registered

2017-11-07

Start date

2016-11-21

Completion date

2020-12-31

Last updated

2017-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoplasmacytic Lymphoma, Waldenstrom Macroglobulinemia

Keywords

Waldenstrom's macroglobulinemia, Lymphoplasmacytic lymphoma, Bortezomib, Thalidomide

Brief 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.

Interventions

DRUGBortezomib

Six 4-week cycles

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Overall response rate	at 3 years	Overall response rate as per Lugano criteria

Secondary

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

Countries

South Korea

Contacts

Primary ContactEun-Hee Park, CRN

eh.park@daum.net+82-10-3349-1453

Backup ContactJunghoon Shin, MD

freeustand@gmail.com+82-10-2015-4932

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026