NCT03335098

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2016

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

4 years

First QC Date

November 4, 2017

Last Update Submit

November 6, 2017

Conditions

Waldenstrom MacroglobulinemiaLymphoplasmacytic Lymphoma

Keywords

Waldenstrom's macroglobulinemiaLymphoplasmacytic lymphomaBortezomibThalidomide

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

    Overall response rate as per Lugano criteria

    at 3 years

Secondary Outcomes (2)

  • Progression-free survival

    at 3 years

  • Overall survival

    at 3 years

Study Arms (1)

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)

Drug: Bortezomib

Interventions

BortezomibDRUG

Six 4-week cycles

Also known as: Thalidomide, Dexamethasone
Study arm

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Waldenstrom MacroglobulinemiaLymphoma, B-Cell, Marginal Zone

Interventions

BortezomibThalidomideDexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, Non-HodgkinLymphoma

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsPiperidonesPiperidinesIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Central Study Contacts

Eun-Hee Park, CRN

CONTACT

+82-10-3349-1453eh.park@daum.net

Junghoon Shin, MD

CONTACT

+82-10-2015-4932freeustand@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 4, 2017

First Posted

November 7, 2017

Study Start

November 21, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

November 7, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will share

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.

Locations

KR(2)