CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
bortezomib +2 moredrug
Likely dose
bortezomib 1.3 mgfrom 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/NCT00609167
NCT00609167Phase 2Completed

A Phase II Trial of Cyclophosphamide, Bortezomib and Dexamethasone (CYBOR-D) in Patients With Newly Diagnosed Active Multiple Myeloma

Mayo Clinic·interventional·Posted Feb 6, 2008·Updated May 17, 2011

In Brief

A Phase 2 clinical trial evaluating bortezomib, cyclophosphamide, and 1 other intervention for Multiple Myeloma and Plasma Cell Neoplasm. Completed, enrolled 63 participants across 2 sites in 2 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy such as cyclophosphamide and dexamethasone work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide and dexamethasone together with bortezomib may kill more cancer cells. PURPOSE: This phase II trial is studying giving cyclophosphamide and dexamethasone together with bortezomib to see how well it works in treating patients with newly diagnosed multiple myeloma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2008
Enrollment StartDec 1, 2006
Primary CompletionJan 1, 2009
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.4 years ago

Interventions

bortezomibdrug

First 33 patients: 1.3 mg/m\^2 IV Days 1, 4, 8 \& 11 Remaining 30 patients: 1.5 mg/m\^2 IV Days 1, 8, 15 \& 22

cyclophosphamidedrug

300mg/m\^2 PO days 1, 8, 15 \& 22

dexamethasonedrug

First 33 patients: 40 mg PO Days 1-4, 9-12, 17-20 Remaining 30 patients: 40 mg PO Days 1-4, 9-12, 17-20 for cycles 1-2; Days 1, 8, 15, 22 for cycle 3+2 for cycle 3 and beyond