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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03335098
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Youngil Koh, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Waldenstrom Macroglobulinemia Lymphoplasmacytic Lymphoma Drug: Bortezomib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Evaluate the Efficacy of Bortezomib in Patients With De-novo Waldenstrom's Macroglobulinemia and Lymphoplasmacytic Lymphoma
Actual Study Start Date : November 21, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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:
  • Thalidomide
  • Dexamethasone

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: at 3 years ]
    Overall response rate as per Lugano criteria

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: at 3 years ]
    Time from enrollment to disease progression or death from any cause

  2. Overall survival [ Time Frame: at 3 years ]
    Time from enrollment to death from any cause

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03335098

Contact: Eun-Hee Park, CRN +82-10-3349-1453
Contact: Junghoon Shin, MD +82-10-2015-4932

Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of, 13620
Contact: Yun-Jin Kim, CRC    +82-31-787-8226   
Contact: Jeong-Ok Lee, MD    +82-31-787-7055   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Eun-Hee Park, CRN    +82-10-3349-1453   
Contact: Junghoon Shin, MD    +82-10-2015-4932   
Sub-Investigator: Junghoon Shin, MD         
Principal Investigator: Youngil Koh, MD         
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital

Responsible Party: Youngil Koh, Assistant professor, Seoul National University Hospital Identifier: NCT03335098     History of Changes
Other Study ID Numbers: 1605-137-765
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD regarding participant demographics, study treatment, response, survival, and adverse events will be shared after publishment of the study results.
Time Frame: IPD will be shared after the publication of the study results without time limit.
Access Criteria: IPD will be shared only for the research purpose.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Youngil Koh, Seoul National University Hospital:
Waldenstrom's macroglobulinemia
Lymphoplasmacytic lymphoma

Additional relevant MeSH terms:
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents