CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 58 enrolled
Drug / intervention
Cyclophosphamide +1 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/NCT00750815
NCT00750815Phase 2Completed

An Open Label Phase I/II Study of the Safety and Efficacy of Cyclophosphamide, Bortezomib (VELCADE), Pegylated Liposomal Doxorubicin (DOXIL), and Dexamethasone, (CVDD) in Newly Diagnosed Patients With Multiple Myeloma

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Sep 11, 2008·Updated Jan 20, 2014

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide and Bortezomib; Pegylated Liposomal Doxorubicin; Dexamethasone (VDD) for Multiple Myeloma. Completed, enrolled 58 participants across 1 site.

Detailed Summary

Cyclophosphamide is a chemotherapy agent with known activity in myeloma. The new regimen that we will test in this study is called CVDD and contains Cyclophosphamide with Bortezomib (VELCADE), Pegylated Liposomal Doxorubicin (DOXIL®, PLD), and Dexamethasone (VDD). The purpose of this study is to determine if the addition of another type of chemotherapy agent, Cyclophosphamide, to the regimen VDD (CVDD) is well tolerated and improves response rates in myeloma. We will also find the highest safe dose of the study drugs taken together that a patient can tolerate, and how long it takes for multiple myeloma patients to respond after they have taken the study drugs and how long the response lasts.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 11, 2008
Enrollment StartSep 1, 2008
Primary CompletionDec 1, 2012
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 17.8 years ago

Interventions

Cyclophosphamidedrug

Enroll patients into 4 different dose levels. The dose of Cyclophosphamide they receive will depend on how many patients have been treated.

Bortezomib; Pegylated Liposomal Doxorubicin; Dexamethasone (VDD)drug

Patients will receive Bortezomib, Pegylated Liposomal Doxorubicin and Dexamethasone at standard doses.