NCT00142129

CompletedPhase 2

Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia

Dana-Farber Cancer Institute Source

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Other study identifiers

Sponsor study identifier

03-248

Study Type

interventional

Reported enrollment (type unavailable)

27

Locations

1 country

Sites

2

Timeline

Study Start

December 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2007

Actual (reported)

Study Completion

June 2007

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 27 participants
Study completion date: June 2007
Actual (reported)
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 2003
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 1, 2005
Actual (reported)
First Posted
September 2, 2005
Actual (reported)
Primary Completion
June 2007
Actual (reported)
Study Completion
June 2007
Actual (reported)

Last Updated: June 27, 2011
Status Verified: June 2011
Last Update Submitted: June 23, 2011

Conditions

Waldenstrom's Macroglobulinemia Lymphoplasmacytic 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

Sponsors & Collaborators

Beth Israel Deaconess Medical Center
Othercollaborator
Brigham and Women's Hospital
Othercollaborator
Millennium Pharmaceuticals, Inc.

Study Sites (2)

Dana-Farber Cancer Center

Boston, Massachusetts, 02115, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

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 Disorders

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 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2007

Actual (reported)

NCT00153920

Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma

Phase 2Completed

NCT00250926

Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia

Phase 2Completed

NCT00142116

Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia

Phase 2Completed

NCT00045695

Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia

Phase 2Completed

NCT00193557

Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma

Phase 2Completed

NCT00504634

Bortezomib (Velcade) Post Allogenic Peripheral Blood Stem Cell Transplantation for Myeloma

Phase 2Completed

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.

Industrycollaborator

Dana-Farber Cancer Institute

Otherlead

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Immune System Diseases

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Lymphoma

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Completion

June 2007

Actual (reported)

Last Updated

June 27, 2011

Record last verified: 2011-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00142129
Data provider: ClinicalTrials.gov
Source updated: 2011-06-27
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:52 UTC

Locations

US(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations