NCT01160107

Revlimid And Prednisone Followed By Revlimid, Melphalan And Prednisone In Multiple Myeloma Patients

A Multicenter, Open Label Study Of Oral Revlimid And Prednisone (Rp) Followed By Oral Revlimid Melphalan And Prednisone (Mpr) In Newly Diagnosed Elderly Multiple Myeloma Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Fondazione EMN Italy Onlus · Academic / Other
• Sex: All
• Age: 65 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study will determine whether the association of Revlimid and Prednisone (RP) as induction treatment followed by Revlimid, Melphalan and Prednisone (MPR) as consolidation treatment is safe and induce a significant rate of PR (and CR) in newly diagnosed elderly MM patients.

Detailed description

This phase II study is a multicenter, open label trial designed to determine whether the association of Revlimid and Prednisone (RP) as induction treatment followed by Revlimid, Melphalan and Prednisone (MPR) as consolidation treatment is safe and induce a significant rate of PR (and CR) in newly diagnosed elderly MM patients. This study consists of 3 phases for each study subject: Pre-treatment, Treatment, long-term follow-up (LTFU). Pre-treatment period: after providing written informed consent, patients will undergo screening for protocol eligibility as outlined in the Schedule of Study Assessments. Treatment period: includes induction, consolidation and maintenance. Induction regimen:Patients will start induction treatment with association of Lenalidomide and Prednisone (RP). Consolidation regimen After the completion of the 4 RP cycles therapy will continue with the MPR association:· According to the results after the first stage the decisions are as follows: 1. The study may continue to a second stage, at the same dose of lenalidomide of MPR cycles, if grade 3-4 adverse events are 25-50% and PR \> 50%; 2\. The study may be stopped (if PR \< 40% and grade 3-4 adverse events \> 25-30%) 3\. A new first stage may be started: * At an increase dose of Lenalidomide administered in advanced MPR cycles if grade 3-4 adverse events are \< 25-30%, independently from efficacy; * At a reduced dose of Lenalidomide administered in advanced MPR cycles if grade 3-4 adverse events are \> 50% and PR rate \> 50% Maintenance: Within 3 months from the last MPR cycle, therapy will continue with RP as maintenance. Each cycle will be repeated every 28 days, until PD.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	RP followed by MPR	Induction (4 cycles):Lenalidomide 25 mg/die for 21 days followed by a 7 days rest period and Prednisone at 50 mg three times a week continuously . Consolidation (6 cycles): Melphalan 2 mg three times a week, Prednisone 50 mg three times a week, and Lenalidomide 15 mg/die for 21 days followed by a 7 days rest period. According to the results of the first stage the decisions are as follows: 1. Starting a second stage, at the same dose of lenalidomide for MPR cycles, if grade 3-4 adverse events are 25-50% and PR \> 50%; 2. The study stop (if PR \<40% and grade 3-4 adverse events \>25-30%) 3. A new first stage may be started: - Lenalidomide 20 mg/die if grade 3-4 adverse events are \< 25-30%, independently from efficacy; - Lenalidomide 10 mg/die if grade 3-4 adverse events are \> 50% and PR rate \> 50%. Maintenance: Lenalidomide 10 mg/day from day 1 to 21, followed by a 7-day rest period and Prednisone 25 mg three times a week.Each cycle will be repeated every 28 days, until PD.

Timeline

• Start date: 2008-07-01
• Primary completion: 2012-08-01
• Completion: 2022-12-22
• First posted: 2010-07-12
• Last updated: 2023-06-29