NCT00891384

Comparison of 25mg Versus 5 mg Lenalidomide as Maintenance Therapy in Patients With Multiple Myeloma

A Randomised Comparison of Daily 25 mg Versus 5 mg Lenalidomide as Maintenance Therapy After High-dose Therapy and Autologous Stem Cell Transplantation in Patients With Multiple Myeloma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is a randomised, parallel-group, multicenter phase III study for maintenance therapy with lenalidomide in patients with multiple myeloma who were treated with high-dose therapy and autologous stem cell transplantation as first line therapy.

Detailed description

High-dose therapy will be performed as first line treatment. After high-dose therapy and autologous stem cell transplantation the patients will be included and randomised. Three month after high-dose therapy all patients will receive consolidation therapy with 6 cycles of lenalidomide 25 mg daily for 21 days every 28 days. Afterwards patients will receive maintenance therapy according to their assigned treatment arm. Randomisation will be performed in a 1:1 ratio to continuous maintenance therapy with either 25mg or 5mg lenalidomide daily for 21 days every 28 days.Randomisation will be stratified by ISS-stage (1+2 vs 3, age (younger than 66 years versus 66 years or older), response after high-dose therapy (CR+vgPR vs PR vs MR/SD. Patients will be treated until disease progression.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Lenalidomide	Patients will receive maintenance therapy according to their assigned treatment arm: 25 mg daily for 21 days every 28 days. During the treatment period patients will be seen every 4 weeks until disease progression is documented. All patients who have to discontinue the study drug will be followed until disease progression.
DRUG	Lenalidomide	Patients will receive maintenance therapy according to their assigned treatment arm:5 mg daily for 21 days every 28 days. During the treatment period patients will be seen every 4 weeks until disease progression is documented. All patients who have to discontinue the study drug will be followed until disease progression

Timeline

• Start date: 2009-04-01
• Primary completion: 2017-06-22
• Completion: 2017-06-22
• First posted: 2009-05-01
• Last updated: 2018-01-19

Locations

5 sites across 1 country: Germany