CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 330 enrolled
Drug / intervention
CC-5013 +1 moredrug
Likely dose
CC-5013 25mgfrom 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/NCT00622336
NCT00622336Phase 3Completed
CompareCT.gov

Open-Label, Single-Arm Study of the Safety and Efficacy of CC-5013 Monotherapy for Subjects With Multiple Myeloma: A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010

Celgene·interventional·Posted Feb 25, 2008·Updated Nov 20, 2019

In Brief

A Phase 3 clinical trial evaluating CC-5013 and Lenalidomide for Multiple Myeloma. Completed, enrolled 330 participants across 7 sites in 2 countries.

Detailed Summary

The study evaluated the safety of Lenalidomide monotherapy in participants with advanced multiple myeloma who had discontinued treatment with combination thalidomide plus high-dose dexamethasone or high-dose dexamethasone alone in studies Thal-MM-003, CC-5013-MM-009 and CC-5013-MM-010 due to the development of documented disease progression or the inability to tolerate the lowest dosing regimen per previous protocol of thalidomide and/or high-dose dexamethasone without grade 3 or 4 toxicity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesRussia, Ukraine
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 25, 2008
Enrollment StartApr 1, 2003
Primary CompletionNov 25, 2013
TodayJul 2, 2026
Enrollment to primary: 10.7 yearsPosted 18.4 years ago

Interventions

CC-5013drug

Oral 25mg daily on Days 1-21 every 28 days.

Lenalidomidedrug

Oral Lenalidomide 25mg daily on Days 1-21 every 28 days.