Revlimid And Prednisone Followed By Revlimid, Melphalan And Prednisone In Multiple Myeloma Patients
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): RP followed by MPR
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Revlimid; Prednisone; Melphalan
Intervention MeSH terms: Prednisone; Melphalan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diagnosis; Elderly Patients; Imids; Chemotherapy