QUIREDEX: Revlimid (Lenalidomide) and Dexamethasone (ReDex) Treatment Versus Observation in Patients With Smoldering Multiple Myeloma With High Risk of Progression (QUIREDEX)
|Multiple Myeloma||Procedure: Maintenance with lower doses of lenalidomide and dexamethasone||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- The primary objective is to evaluate when Revlimid and Dexamethasone treatment extend the time to progression to symptomatic MM in patients with smoldering MM [ Time Frame: one year ]
- Evaluate the efficacy of the treatment in response rate terms [ Time Frame: one year ]
- Evaluate the safety and tolerability of the treatment [ Time Frame: one year ]
|Study Start Date:||May 2007|
|Study Completion Date:||July 2013|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Lenalidomide + Dexamethasone for 9 cycles and maintenance
Procedure: Maintenance with lower doses of lenalidomide and dexamethasone
After 9 cycles of lenalidomide and dexamethasone, it follows with lower doses for maintenance
No Intervention: 2
A total of up to 120 patients diagnosed of smoldering Multiple Myeloma with high risk of progression to symptomatic MM will be included.
Patients will be stratified according its diagnosis date and randomized 1 to 1 to receive Revlimid and Dexamethasone (Group A) in 9 treatment cycles and maintenance with lower doses until progression or No treatment and observation until progression (Group B).
The patients will be evaluated at scheduled visits in up to three study periods: Pre-treatment, Treatment and Follow up.
The Pre-treatment includes Screening and baseline visits. After providing informed consent, patients will be evaluated for study eligibility and then Patients will be stratified and randomized (1:1) to Group A or Group B.
During Treatment Period patients will be evaluated once a month. Once the treatment period has finished a maintenance treatment with low doses of Revlimid and Dexamethasone will be carry out in Group A. During this period we will evaluate response, progression-free survival and global survival every two months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480363
|Hospital germans Trias i Pujol|
|Hospital Clínic i Provincial de Barcelona|
|Hospital de la Santa Creu i Sant Pau|
|Hospital del SAS de Jerez de la Frontera|
|Jerez de la Frontera, Spain|
|Hospital de la Princesa|
|Hospital Dode de Octubre|
|Hospital Ramón y Cajal|
|Hospital General Univeristario Morales Messeguer|
|Hospital Clínico de Salamanca|
|Hospital Universitario de Canarias|
|Hospital Clínico de Valencia|
|Hospital Universitario la Fe|
|Hospital Clínico Universitario Lozano Blesa|
|Principal Investigator:||Mª Victoria Mateos, Dr||Hospital Clinico Universitario de Salamanca|
|Principal Investigator:||Jesús San Miguel, Dr||Hospital Clínico Universitario de Salamanca|
|Principal Investigator:||Joan Bladé, Dr||Hospital Clinic of Barcelona|
|Principal Investigator:||Juan José Lahuerta, Dr||HOSPITAL DOCE DE OCTUBRE|