Clinical trials

RV-MM-PI-302
07/04/2008

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

Patients receive 4 cycles of RP, followed by consolidation with 6 cycles of MPR. Finally, maintenance therapy follows, with RP administered until any sign of disease progression.

STUDY OBJECTIVES:

Primary objectives:
  • Determine whether the association of RP followed by MPR as induction treatment is safe and induce a significant rate of PR (and CR) in elderly patients with newly diagnosed symptomatic multiple myeloma patients who are 65 years of age or older

Secondary objectives:
  • Determine progression free survival (PFS), time to progression (TTP) and overall survival (OS)
  • Determine whether responses obtained with RP - MPR treatment, are associated with a prolongation of PFS, in comparison with non-responding patients
 

STUDY POPULATION:

Newly diagnosed MM patients who are older than 65 years of age


STUDY DRUGS:

Lenalidomide
Prednisone
Melphalan


TOTAL SAMPLE SIZE: 46

STUDY DURATION: 36 months
  • Study type: New Diagnosis
  • Enrollment: Closed
  • Study phase:
    Phase 2
  • Sponsor: FONESA Onlus
    Italian coordinator:
  • Sara Bringhen
    Torino
    Patients description:
  • Patients with 65 years of age or older
    Geographic area:

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