• Completed

NCT00480363: Phase 3: Revlimid / Dex ( ReDex) VS Observation in Smoldering MM (QUIREDEX)

Updated: Sep 19

QUIREDEX


PETHEMA/GEM

Spanish Myeloma Group

GEM (Grupo Español de Mieloma)/PETHEMA (Programa para el Estudio de la Terapéutica en Hemopatías Malignas) Cooperative Study Group

QUIREDEX - rev dex smoldering myeloma

QUIREDEX: Revlimid (Lenalidomide) and Dexamethasone (ReDex) Treatment Versus Observation in Patients With Smoldering Multiple Myeloma With High Risk of Progression (QUIREDEX)


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


Sponsor

PETHEMA Foundation


Collaborator

Celgene Corporation

 

ClinicalTrials.gov Identifier: NCT00480363


Official Title: 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

First Posted : May 30, 2007


Click here for details on ClinicalTrials.gov

 

Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information

 

International Myeloma Working Group. Criteria for the classification of monoclonal gammopathies, multiple myeloma and related disorders: a report of the International Myeloma Working Group.

Br J Haematol. 2003 Jun

Click here for details

 

A randomized phase 2 study of lenalidomide therapy for patients with relapsed or relapsed and refractory multiple myeloma.

Blood. 2006 Nov 15

Click here for details

 

Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma.

N Engl J Med. 2013 Aug

Click here for details

 

Lenalidomide plus dexamethasone versus observation in patients with high-risk smouldering multiple myeloma (QuiRedex): long-term follow-up of a randomised, controlled, phase 3 trial.

Lancet Oncol. 2016 Aug

Click here for details

 

Spanish Myeloma Group / Program Study and Treatment of Hematological Malignancies cooperative study groups. Immune status of high-risk smoldering multiple myeloma patients and its therapeutic modulation under LenDex: a longitudinal analysis.

Blood. 2016 Mar

Click here for details

 

Lenalidomide-dexamethasone versus observation in high-risk smoldering myeloma after 12 years of median follow-up time: A randomized, open-label study ScienceDirect - Available online 5 September 2022

Click here for details

 

Location

Spain

 

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