CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Bortezomib (Velcade) +3 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/NCT00369226
NCT00369226Phase 2Completed
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Phase I/II Trial of Bortezomib (Velcade) in Addition to Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease (GVHD) After Mismatched Allogeneic Non-Myeloablative Peripheral Blood Stem Cell Transplantation

Dana-Farber Cancer Institute·interventional·Posted Aug 29, 2006·Updated Jul 25, 2013

In Brief

A Phase 2 clinical trial evaluating Bortezomib (Velcade), Tacrolimus, and 2 other interventions for Hematologic Malignancies. Completed, enrolled 45 participants across 2 sites.

Detailed Summary

The purpose of this study is to determine if Velcade (also known as bortezomib) can help prevent graft versus host disease (GVHD) developing after transplantation. This is done by using a combination of three immune suppressive medications: Velcade, tacrolimus and methotrexate. Stem cell transplantation is one of the options for patients with cancer of the blood or blood forming organs. Recently, allogeneic stem cell transplants have been performed using lower doses of chemotherapy and radiotherapy: non-myeloablative or "mini" transplants. GVHD is a significant problem that may occur even after "mini" transplantations. Information from other research studies, suggests that Velcade may help to reduce the risk of developing GVHD when given early after transplantation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematologic Malignancies
CountriesUnited States
CollaboratorsBrigham and Women's Hospital, Millennium Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 29, 2006
Enrollment StartAug 1, 2006
Primary CompletionJul 1, 2010
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 19.8 years ago

Interventions

Bortezomib (Velcade)drug

Infusion for a total of 3 doses

Tacrolimusdrug

Taken until Doctor determines it is not necessary any more

Methotrexatedrug

Infusion for a total of 4 doses

blood stem cell transplantationprocedure

Allogeneic Non-myeloablative peripheral blood stem cell transplantation