Trial intelligence / Profile preview

Lenalidomide Maintenance in Mantle Cell Lymphoma (RENEW)

NCT01021423Phase 3

Key facts

Status: Terminated
Start: Apr 2010
Primary completion: Mar 2011
Countries: 12
Sponsor: Celgene Corporation
Modality: Small Molecules

Drugs: lenalidomide
Conditions: mantle cell lymphoma (MCL)

Overview

Phase 3, randomised, double-blind trial in mantle cell lymphoma (MCL) comparing Lenalidomide with Placebo (2 arms). Primary endpoint: Progression-Free Survival up to 7 years. Started Apr 2010; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

Lenalidomide
Lenalidomide 15 mg orally once daily on Days 1-21 of every 28-day cycle
Placebo
Matched placebo orally once daily on Days 1-21 of every 28-day cycle

Who it enrols

Patients with histologically-proven mantle cell lymphoma who achieved PR or CR after first-line induction chemotherapy containing rituximab.

Endpoints

Primary

Progression-Free Survivalup to 7 years

Secondary

Overall Survivalup to 7 years
Participants With Treatment Emergent Adverse Eventsup to 9 months
Time to Progressionup to 7 years
Time to Treatment Failureup to 2 years
Participants With a Tumor Responseup to 7 years

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