CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Bortezomibdrug
Likely dose
Bortezomib 1.6 mg/m2from 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/NCT01090921
NCT01090921Phase 2Completed

Phase II Study to Evaluate Efficacy and Safety of Single Weekly Administration of Bortezomib in Newly Diagnosed Multiple Myeloma

Boston VA Research Institute, Inc.·interventional·Posted Mar 23, 2010·Updated Sep 9, 2020

In Brief

A Phase 2 clinical trial evaluating Bortezomib for Multiple Myeloma. Completed, enrolled 50 participants across 11 sites.

Detailed Summary

This is a research study to see if a new drug called bortezomib is useful to treat multiple myeloma in people who are newly diagnosed, and have not yet received treatment for their disease. VELCADE® (bortezomib) for Injection is a drug under development by Millennium Pharmaceuticals, Inc.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 23, 2010
Enrollment StartMay 1, 2007
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 16.3 years ago

Interventions

Bortezomibdrug

Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone.