- Completed
NCT00480363: Phase 3: Revlimid / Dex ( ReDex) VS Observation in Smoldering MM (QUIREDEX)
Updated: Sep 19, 2022
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: 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
Collaborator
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
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
Spanish Myeloma Group (GEM-PETHEMA) Posts
NCT00461747: Phase 3 - GEM05 for Patients With Multiple Myeloma Under 65 Years (GEM05MENOS65)
NCT01916252: Phase 3 - Bortezomib, Lenalidomide & IV Busulfan Under 65 - (GEM2012MENOS65) PETHEMA
NCT02406144: Phase 3 - Maint. Lenalidomide, Dex VS Lenalidomide, Dex. & MLN9708 After ASCT NDMM
NCT02415413: Phase 2 - Carfilzomib in Patients Under 65 With High Risk Smoldering MM (GEM-CESAR trial)
NCT03336073: Phase 2: GEM-KyCyDex - Carfilzomib, Cyclophosphamide, Dexamethasone in Multiple Myeloma
NCT04802356: Phase 2: Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma
NCT05060627: Phase 1/2: Belantamab Mafodotin + Kd RRMM Multiple Myeloma, Refractory to Lenalidomide