CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 163 enrolled
Drug / intervention
Cyclophosphamide +3 moredrug
Likely dose
Cyclophosphamide 500 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/NCT00908232
NCT00908232Phase 2Completed

Efficacy and Safety of Velcade Plus Dexamethasone (VD), VD+Cyclophosphamide or VD Plus Lenalidomide in MMY Patients Who Are Refractory or Have Relapsed After Their Primary Therapy for MMY and Have Achieved Stable Disease After 4 Cycles of VD

Janssen-Cilag International NV·interventional·Posted May 25, 2009·Updated Jan 15, 2015

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide, Bortezomib, and 2 other interventions for Multiple Myeloma. Completed, enrolled 163 participants across 42 sites in 10 countries.

Detailed Summary

The purpose of this study is to test the effectiveness and safety of adding cyclophosphamide or lenalidomide to the VD combination in the treatment of patients with multiple myeloma that have achieved a stable response after 4 initial cycles of treatment with VD. Multiple myeloma is the second most common cancer of the blood. Bortezomib disrupts the life cycle of the cell, affecting numerous biologic pathways, including those related to growth and survival of cancer cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Germany, Greece, Hungary, Lithuania, Poland, Serbia, Spain, Turkey (Türkiye), United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 25, 2009
Enrollment StartMay 1, 2008
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.1 years ago

Interventions

Cyclophosphamidedrug

500 mg, p.o daily, days 1, 8 and 15 for cycles 5 to 8 cycles

Bortezomibdrug

1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 for cycles 1 to 8

Dexamethasonedrug

20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycles 1 to 8

Lenalidomidedrug

10 mg orally daily, days 1-14 for cycles 5 to 8