NCT00142129

Brief Summary

The purpose of this study is to evaluate how tumors in patients with Waldenstrom's macroglobulinemia respond to treatment with bortezomib (Velcade) and to see what effects (good and bad) it has on the cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2003

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

3.5 years

First QC Date

September 1, 2005

Last Update Submit

June 23, 2011

Conditions

Waldenstrom's MacroglobulinemiaLymphoplasmacytic Lymphoma

Keywords

bortezomibVelcadeWaldenstrom's macroglobulinemia

Outcome Measures

Primary Outcomes (1)

  • To determine response rate along with attainment of stable disease following treatment with bortezomib in patients with Waldenstrom's macroglobulinemia.

Secondary Outcomes (1)

  • To assess the safety and tolerability of bortezomib in this patient population.

Interventions

Bortezomib (Velcade)DRUG

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinicopathological diagnosis of Waldenstrom's macroglobulinemia who have failed one first line therapy
  • Measurable disease, defined as presence of immunoglobulin M (Ig M) paraprotein with a minimum IgM level of \>2 times ULN
  • Karnofsky performance status of \>60
  • Life expectancy of \> 3 months
  • Baseline platelet count \>50,000,000,000/L and ANC of 750,000,000/L
  • AST and ALT \< 3 x ULN
  • Total bilirubin \< 2 x ULN
  • Calculated or measured creatinine clearance \> 30mL/minute
  • Serum sodium \> 130 mmol/L

You may not qualify if:

  • Greater than or equal to Grade 2 peripheral neuropathy
  • Hypersensitivity to bortezomib, boron or mannitol
  • Prior therapy with Velcade
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dana-Farber Cancer Center

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Waldenstrom MacroglobulinemiaLymphoma, B-Cell, Marginal Zone

Interventions

Bortezomib

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 Compounds

Study Officials

  • Steven Treon, MD, MA, PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

December 1, 2003

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

June 27, 2011

Record last verified: 2011-06

Locations

US(2)