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

Primary Purpose

Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bortezomib
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Waldenstrom Macroglobulinemia focused on measuring Waldenstrom's macroglobulinemia, Lymphoplasmacytic lymphoma, Bortezomib, Thalidomide

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting
  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study arm

Arm 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)

Outcomes

Primary Outcome Measures

Overall response rate
Overall response rate as per Lugano criteria

Secondary Outcome Measures

Progression-free survival
Time from enrollment to disease progression or death from any cause
Overall survival
Time from enrollment to death from any cause

Full Information

First Posted
November 4, 2017
Last Updated
November 6, 2017
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03335098
Brief Title
Study of VTD in Waldenstrom's Macroglobulinemia
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 21, 2016 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
Keywords
Waldenstrom's macroglobulinemia, Lymphoplasmacytic lymphoma, Bortezomib, Thalidomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study arm
Arm Type
Experimental
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Thalidomide, Dexamethasone
Intervention Description
Six 4-week cycles
Primary Outcome Measure Information:
Title
Overall response rate
Description
Overall response rate as per Lugano criteria
Time Frame
at 3 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Time from enrollment to disease progression or death from any cause
Time Frame
at 3 years
Title
Overall survival
Description
Time from enrollment to death from any cause
Time Frame
at 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eun-Hee Park, CRN
Phone
+82-10-3349-1453
Email
eh.park@daum.net
First Name & Middle Initial & Last Name or Official Title & Degree
Junghoon Shin, MD
Phone
+82-10-2015-4932
Email
freeustand@gmail.com
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun-Jin Kim, CRC
Phone
+82-31-787-8226
Email
r0638@snubh.org
First Name & Middle Initial & Last Name & Degree
Jeong-Ok Lee, MD
Phone
+82-31-787-7055
Email
jeongok77@gmail.com
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun-Hee Park, CRN
Phone
+82-10-3349-1453
Email
eh.park@daum.net
First Name & Middle Initial & Last Name & Degree
Junghoon Shin, MD
Phone
+82-10-2015-4932
Email
freeustand@gmail.com
First Name & Middle Initial & Last Name & Degree
Junghoon Shin, MD
First Name & Middle Initial & Last Name & Degree
Youngil Koh, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Study of VTD in Waldenstrom's Macroglobulinemia

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