At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 351 enrolled

Drug / intervention

CC-5013 plus dexamethasone +1 moredrug

Likely dose

CC-5013 plus dexamethasone 25 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/NCT00424047

NCT00424047Phase 3Completed

Compare CT.gov

The Official Title is A Multi-center, Randomized, Parallel-group, Double-blind, Placebo Controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma.

Celgene·interventional·Posted Jan 18, 2007·Updated Oct 19, 2017

In Brief

A Phase 3 clinical trial evaluating CC-5013 plus dexamethasone and Dexamethasone plus Placebo for Multiple Myeloma. Completed, enrolled 351 participants across 69 sites in 15 countries.

Detailed Summary

To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for subjects with relapsed or refractory multiple myeloma."

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMultiple Myeloma

CountriesAustralia, Austria, Belgium, France, Germany, Greece, Ireland, Israel, Italy, Poland, Spain, Sweden, Switzerland, Ukraine, United Kingdom

Collaborators--

Timeline

Phase 3CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJan 2003

Primary CompletionNov 2005

First PostedJan 2007

Study CompletionNov 2013

TodayJul 2026

First PostedJan 18, 2007

Enrollment StartJan 1, 2003

Primary CompletionNov 1, 2005

Study CompletionNov 12, 2013

TodayJul 2, 2026

Enrollment to primary: 2.8 yearsPosted 19.5 years ago

Interventions

CC-5013 plus dexamethasonedrug

25 mg daily for 21 days every 28 days.

Dexamethasone plus Placebodrug

Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle.