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

November 6, 2017 updated by: Youngil Koh, Seoul National University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Eun-Hee Park, CRN
  • Phone Number: +82-10-3349-1453
  • Email: eh.park@daum.net

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seongnam, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Contact:
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Sub-Investigator:
          • Junghoon Shin, MD
        • Principal Investigator:
          • Youngil Koh, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study arm
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
Six 4-week cycles
Other Names:
  • Dexamethasone
  • Thalidomide

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 4, 2017

First Submitted That Met QC Criteria

November 6, 2017

First Posted (Actual)

November 7, 2017

Study Record Updates

Last Update Posted (Actual)

November 7, 2017

Last Update Submitted That Met QC Criteria

November 6, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1605-137-765

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD regarding participant demographics, study treatment, response, survival, and adverse events will be shared after publishment of the study results.

IPD Sharing Time Frame

IPD will be shared after the publication of the study results without time limit.

IPD Sharing Access Criteria

IPD will be shared only for the research purpose.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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