CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 enrolled
Drug / intervention
bortezomibdrug
Likely dose
Bortezomib (dose not specified in published record)AI-extracted
Key inclusion· 5
  • Confirmed diagnosis of multiple myeloma
  • Measurable disease: serum monoclonal spike >1 g/dL or urine spike >200 mg/24 hours
  • Karnofsky performance status >60
  • Hemoglobin >8.0 g/dL
Key exclusion· 10
  • Prior systemic chemotherapy (treatment-naïve required)
  • POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes)
  • Plasma cell leukemia
  • Creatinine clearance <30 mL/min within 14 days of enrollment

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

Search/NCT00153920
NCT00153920Phase 2Completed

Phase II Trial of Velcade (Bortezomib) in Patients With Previously Untreated Multiple Myeloma

Dana-Farber Cancer Institute·interventional·Posted Sep 12, 2005·Updated Jun 11, 2019

In Brief

A Phase 2 clinical trial evaluating bortezomib for Multiple Myeloma. Completed, enrolled 66 participants across 6 sites.

Detailed Summary

Bortezomib (Velcade) has just recently been approved by the FDA for the treatment of multiple myeloma in patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. This study will determine if Velcade is effective in treating patients with multiple myeloma that have had no prior treatment for the disease. We will also use whole-genome scanning to identify drug response biomarkers in bone marrow samples as well as nerve fiber studies to compare nerves prior to the use of Velcade and after treatment with Velcade.

Study Details

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartDec 1, 2003
Primary CompletionJul 1, 2007
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 20.8 years ago

Interventions

bortezomibdrug