drugset / Trial / NCT02215980

STUDY TO DETERMINE THE EFFICACY AND SAFETY OF STANDARD SCHEDULE VERSUS A NEW ALGORITHM OF DOSE REDUCTIONS IN ELDERLY AND UNFIT NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS RECEIVING LENALIDOMIDE PLUS STEROIDS

NCT02215980

Phase 3 Completed 210 enrolled Fondazione EMN Italy Onlus
RandomizedParallel-groupOpen-labelTreatment

Summary

This protocol is a phase III multicenter, randomized, controlled study designed to assess the safety and the efficacy of standard schedule versus a new algoritm of dose reductions in elderly and unfit newly diagnosed Multiple Myeloma (MM) patients receiving lenalidomide plus steroids.

Timeline

Start
2014-07
Primary completion
2022-07
Completion
2024-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 20 mg Oral
Subject Lenalidomide Other / unclassified 10 mg Oral
Subject Lenalidomide Other / unclassified 25 mg Oral

Indications