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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.
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
RP followed by MPR
Active, not recruiting
Fondazione Neoplasie Sangue Onlus
Published on BioPortfolio: 2014-07-23T21:08:29-0400
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