Revlimid And Prednisone Followed By Revlimid, Melphalan And Prednisone In Multiple Myeloma Patients (RP_MPR)
Recruitment status was Active, not recruiting
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- RP as induction followed by MPR as consolidation treatment is safe and induce a significant rate of PR (and CR) [ Time Frame: Approximately 24 months ] [ Designated as safety issue: Yes ]Determine whether the association of RP as induction followed by MPR as consolidation treatment is safe and induce a significant rate of PR (and CR) in elderly patients with newly diagnosed multiple myeloma.
- Determine the progression free survival (PFS), overall survival (OS) and whether responses obtained with RP - MPR treatment, are associated with a prolongation of PFS, in comparison with non-responding patients. [ Time Frame: Approximately 24 months ] [ Designated as safety issue: Yes ]
The secondary objectives of this study are:
- To determine progression free survival (PFS)
- To determine overall survival (OS)
- To determine whether responses obtained with RP - MPR treatment, are associated with a prolongation of PFS, in comparison with non-responding patients.
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||August 2013|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Drug: RP followed by MPR
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01160107
|Principal Investigator:||Antonio Palumbo, MD||Divisione di Ematologia dell'Università di Torino, A.O.U. San Giovanni Battista, Torino; Italy|