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

A PHASE III, MULTICENTRE, RANDOMIZED, CONTROLLED 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Fondazione EMN Italy Onlus · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

TREATMENT PERIOD: Arm A: Rd * Lenalidomide: at the dose of 25 mg/daily as oral administration (PO) on days 1-21. * Dexamethasone: at the dose of 20 mg as oral administration (PO) once weekly. Each cycle will be repeated every 28 days until progression or intolerance. Arm B: Rd-R (reduced) * Lenalidomide: at the dose of 25 mg/daily as oral administration (PO) on days 1-21 * Dexamethasone: at the dose of 20 mg as oral administration (PO) once weekly. Each cycle will be repeated every 28 days, for a total of 9 cycles. Maintenance until progression or intolerance: \- Lenalidomide: 10 mg/daily on days 1-21 of each 28-day cycle

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Lenalidomide
DRUG	Dexamethasone

Timeline

• Start date: 2014-07-01
• Primary completion: 2022-07-01
• Completion: 2024-07-01
• First posted: 2014-08-13
• Last updated: 2024-07-22

Locations

1 site across 1 country: Italy