Waldenstrom MacroglobulinemiaPhase 2BOMB-THROWNCT03335098
Study of VTD in Waldenstrom's Macroglobulinemia
A Phase 2 study testing Bortezomib in people with Waldenstrom Macroglobulinemia and Lymphoplasmacytic Lymphoma, run by Seoul National University Hospital at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
- What is being tested?
- Bortezomib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 21 Nov 2016to Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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)
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- Pregnancy
- Uncontrolled epilepsy
- Uncontrolled psychological disease
- Peripheral neuropathy of grade 3 or higher
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
Yun-Jin Kim, CRC, +82-31-787-8226, r0638@snubh.org
Jeong-Ok Lee, MD, +82-31-787-7055, jeongok77@gmail.com
- Recruiting
Seoul National University Hospital
Seoul, 03080
Eun-Hee Park, CRN, +82-10-3349-1453, eh.park@daum.net
Junghoon Shin, MD, +82-10-2015-4932, freeustand@gmail.com
About this study
Official title: 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.
- Being tested
- Bortezomib
- Keywords
- Waldenstrom's macroglobulinemia, Lymphoplasmacytic lymphoma, Bortezomib, Thalidomide
- Medical subject headings
- Waldenstrom Macroglobulinemia, Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called Thalidomide, Dexamethasone
Six 4-week cycles
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | 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) Receives: Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Overall response rate as per Lugano criteria
Measured: at 3 years
Secondary outcomes (2)
Progression-free survival
Time from enrollment to disease progression or death from any cause
Measured: at 3 years
Overall survival
Time from enrollment to death from any cause
Measured: at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start21 Nov 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waldenstrom MacroglobulinemiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Responsible party
- Principal investigator, Youngil Koh, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335098
- Sponsor's protocol ID
- 1605-137-765
- Acronym
- BOMB-THROW
- Status last verified
- Nov 2017
- First submitted
- 4 Nov 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD regarding participant demographics, study treatment, response, survival, and adverse events will be shared after publishment of the study results.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate the Efficacy of Bortezomib in Patients With De-novo Waldenstrom's Macroglobulinemia and Lymphoplasmacytic Lymphoma
- ClinicalTrials.gov ID
- NCT03335098
- Acronym / sponsor ID
- BOMB-THROW / 1605-137-765
- Keywords
- Waldenstrom's macroglobulinemia, Lymphoplasmacytic lymphoma, Bortezomib, Thalidomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Drug: BortezomibSubcutaneous 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) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- Diagnosed with other malignancy within 5 years before enrollment
- Prior hematopoietic stem cell transplantation
- Prior organ transplantation
- Uncontrolled central nervous system involvement
- Congenital immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BortezomibAlso: Thalidomide, DexamethasoneSix 4-week cycles | Drug | Study arm |
Primary outcome
Overall response rate
Time frame: at 3 years
Overall response rate as per Lugano criteria
2 secondary outcomes
Progression-free survival
Time frame: at 3 years
Overall survival
Time frame: at 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Individual participant dataSharing planned: Yes. IPD regarding participant demographics, study treatment, response, survival, and adverse events will be shared after publishment of the study results.
Related trials for Waldenstrom Macroglobulinemia
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
Not yet recruitingPhase 2
Epcoritamab as Consolidative Therapy for Waldenstr(SqrRoot)(Delta)m Macroglobulinemia (WM) Treated With a Bruton Tyrosine Kinase Inhibitor (BTKi)
Waldenstrom Macroglobulinemia
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
RecruitingPhase 2
A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
RecruitingPhase 1
A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )
Lymphoma, Non-Hodgkin, B-cell Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bortezomib in people with Waldenstrom Macroglobulinemia and Lymphoplasmacytic Lymphoma, run by Seoul National University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eun-Hee Park, CRN (+82-10-3349-1453, eh.park@daum.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: at 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.