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

This study is currently recruiting participants.
Verified November 2017 by Youngil Koh, Seoul National University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03335098
First Posted: November 7, 2017
Last Update Posted: November 7, 2017
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.
Collaborator:
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Youngil Koh, Seoul National University Hospital
  Purpose
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 Intervention Phase
Waldenstrom Macroglobulinemia Lymphoplasmacytic Lymphoma Drug: Bortezomib Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Youngil Koh, Seoul National University Hospital:

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


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

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


Estimated Enrollment: 15
Actual Study Start Date: November 21, 2016
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT03335098


Contacts
Contact: Eun-Hee Park, CRN +82-10-3349-1453 eh.park@daum.net
Contact: Junghoon Shin, MD +82-10-2015-4932 freeustand@gmail.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of, 13620
Contact: Yun-Jin Kim, CRC    +82-31-787-8226    r0638@snubh.org   
Contact: Jeong-Ok Lee, MD    +82-31-787-7055    jeongok77@gmail.com   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Eun-Hee Park, CRN    +82-10-3349-1453    eh.park@daum.net   
Contact: Junghoon Shin, MD    +82-10-2015-4932    freeustand@gmail.com   
Sub-Investigator: Junghoon Shin, MD         
Principal Investigator: Youngil Koh, MD         
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
  More Information

Responsible Party: Youngil Koh, Assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03335098     History of Changes
Other Study ID Numbers: 1605-137-765
First Submitted: November 4, 2017
First Posted: November 7, 2017
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.
URL: http://

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
Bortezomib
Thalidomide

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