Clinical Trial: Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Pilot Study of Lenalidomide and Dexamethasone in Patients With Primary Plasma Cell Leukemia

Brief Summary: This is an open label, multicenter, exploratory, single arm, two-stage study aiming to explore efficacy and safety of lenalidomide and dexamethasone combination (LD) as first line therapy in previously untreated patients with primary Plasma Cell leukemia (PPCL).

Detailed Summary: The primary endpoint was response rate according to International Uniform Criteria; secondary endpoints were: i) time to progression (TTP), progression free survival (PFS, and overall survival (OS); ii) percentage of eligible PPCL patients able to mobilize and collect peripheral blood stem cells after LD treatment; iii) percentage of eligible PPCL patients able to undergo autologous or allogeneic stem cells transplantation after LD treatment; iv) serious/severe adverse event (SAEs) rate.
Sponsor: IRCCS Centro di Riferimento Oncologico della Basilicata

Current Primary Outcome:

  • Overall response rate [ Time Frame: 4 months ]
    IMWG criteria
  • Complete remission rate [ Time Frame: 4 months ]
    IMWG
  • At least Very good partial remission rate [ Time Frame: 4 months ]
    IMWG


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression free survival [ Time Frame: 24 months ]
    Median follow-up
  • Overall survival [ Time Frame: 24 months ]
    Median follow-up
  • Percentage of patients able to perform stem cell transplantation [ Time Frame: 12 months ]
    Number of eligible patients reaching stem cell transplantation procedure
  • Safety [ Time Frame: 4-8 months, according to protocol ]
    Number of severe/serious adverse events


Original Secondary Outcome: Same as current

Information By: IRCCS Centro di Riferimento Oncologico della Basilicata

Dates:
Date Received: March 3, 2012
Date Started: March 2009
Date Completion:
Last Updated: March 13, 2012
Last Verified: March 2012