CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 120 enrolled
Drug / intervention
Maintenance with lower doses of lenalidomide and dexamethasoneprocedure
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/NCT00480363
NCT00480363Phase 3Completed

QUIREDEX: A National, Open-Label, Multicenter, Randomized, Phase III Study of Revlimid (Lenalidomide) and Dexamethasone (ReDex) Treatment Versus Observation in Patients With Smoldering Multiple Myeloma With High Risk of Progression

PETHEMA Foundation·interventional·Posted May 30, 2007·Updated Jul 31, 2013

In Brief

A Phase 3 clinical trial evaluating Maintenance with lower doses of lenalidomide and dexamethasone for Multiple Myeloma. Completed, enrolled 120 participants across 13 sites.

Detailed Summary

The primary objective is to evaluate when Revlimid and Dexamethasone treatment extend the time to progression to symptomatic MM in patients with smoldering MM. The second one is to evaluate the efficacy of the treatment in response rate terms. Otherwise this study wants to evaluate the safety and tolerability of the treatment

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
CollaboratorsCelgene Corporation

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 30, 2007
Enrollment StartMay 1, 2007
Primary CompletionDec 1, 2008
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.1 years ago

Interventions

Maintenance with lower doses of lenalidomide and dexamethasoneprocedure

After 9 cycles of lenalidomide and dexamethasone, it follows with lower doses for maintenance