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

NCT00480363 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-07-31

No results posted yet for this study

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

Conditions

Interventions

PROCEDURE

Maintenance with lower doses of lenalidomide and dexamethasone

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

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • PETHEMA Foundation

    lead OTHER

Principal Investigators

  • Mª Victoria Mateos, Dr · Hospital Clinico Universitario de Salamanca

  • Jesús San Miguel, Dr · Hospital Clínico Universitario de Salamanca

  • Joan Bladé, Dr · Hospital Clinic of Barcelona

  • Juan José Lahuerta, Dr · HOSPITAL DOCE DE OCTUBRE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-12-31
Completion
2013-07-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00480363 on ClinicalTrials.gov