CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
Bortezomib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00422799
NCT00422799Phase 2Completed
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Phase II Study of Combination Bortezomib (Velcade PS-341) and Rituximab in Patients With Previously Untreated and Relapsed/Refractory Waldenstrom's Macroglobulinemia

Dana-Farber Cancer Institute·interventional·Posted Jan 17, 2007·Updated Oct 27, 2020

In Brief

A Phase 2 clinical trial evaluating Bortezomib and Rituximab for Waldenstrom's Macroglobulinemia. Completed, enrolled 63 participants across 1 site.

Detailed Summary

In this study, we are trying to find out if the combination of these two drugs is effective in treating Waldenstrom's macroglobulinemia (WM). The combination of these two drugs has not been studied for patients with relapsed or refractory macroglobulinemia. The U.S. Food and Drug Administration (FDA) has approved bortezomib for the treatment of multiple myeloma, a cancer that is closely related to Waldenstrom's macroglobulinemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWaldenstrom's Macroglobulinemia
CountriesUnited States
CollaboratorsMillennium Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 17, 2007
Enrollment StartAug 30, 2006
Primary CompletionOct 9, 2015
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 19.5 years ago

Interventions

Bortezomibdrug

Once weekly for 3 weeks

Rituximabdrug

Intravenously once a week for the first and fourth weeks of a cycle