CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
bortezomib +6 moredrug
Likely dose
bortezomib 1.3 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/NCT00520767
NCT00520767Phase 2Completed

A Multicenter Phase II Trial of Bortezomib (Velcade), Melphalan, and Dexamethasone (V-MD) in Patients With Symptomatic AL-Amyloidosis or Light Chain Deposition Disease

Barbara Ann Karmanos Cancer Institute·interventional·Posted Aug 27, 2007·Updated Dec 22, 2023

In Brief

A Phase 2 clinical trial evaluating bortezomib, dexamethasone, and 5 other interventions for Primary Systemic Amyloidosis and Light Chain Deposition Disease. Completed, enrolled 35 participants across 7 sites.

Detailed Summary

RATIONALE: Giving bortezomib together with melphalan and dexamethasone may be an effective treatment for primary amyloidosis and light chain deposition disease. PURPOSE: This phase II trial is studying how well giving bortezomib together with melphalan and dexamethasone works in treating patients with primary amyloidosis or light chain deposition disease.

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 27, 2007
Enrollment StartSep 1, 2007
Primary CompletionOct 1, 2010
Study CompletionJun 6, 2019
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 18.8 years ago

Interventions

bortezomibdrug

Bortezomib 1.3 mg/m2 days 1, 8, 15, 22

dexamethasonedrug

Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23

melphalandrug

Melphalan 9 mg/m2/day days 1-4

microarray analysisgenetic

≤28 days prior to enrollment

flow cytometryother

Day 1 of cycles 6, 12, 18 and at end of study.

laboratory biomarker analysisother

≤28 days prior to enrollment

quality-of-life assessmentprocedure

Start of each cycle