A Phase I/II, Multi-center, Open Label Study of Pomalidomide, Cyclophosphamide and Prednisone (PCP) in Patients With Multiple Myeloma Relapsed and/or Refractory to Lenalidomide
This is a prospective multicenter phase I followed by a phase II trial designed to evaluate
the safety and efficacy of the combination of Pomalidomide with Cyclophosphamide and
Prednisone in patients with multiple myeloma relapsed and/or refractory to lenalidomide.
Patients will be evaluated at scheduled visits in up to 3 study periods: pre-treatment,
treatment and long-term follow-up (LTFU).
The pre-treatment period includes: screening visits, performed at study entry. After
providing written informed consent to participate in the study, patients will be evaluated
for study eligibility. The screening period includes the evaluation of inclusion criteria
described above. Subjects who meet all the inclusion criteria will be enrolled.
The treatment period includes: administration of the salvage treatment PCP for 6 cycles and
maintenance treatment. In order to assess the toxicity of treatment, patients will attend
study centre visits at least every 2 weeks, unless clinically indicated. The response will
be assessed after each cycle.
During the LTFU period, after development of confirmed PD, all patients are to be followed
for survival every 1-3 months via telephone or office visit.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PCP safety and efficacy
We aim to identify the maximum tolerated dose (MTD) of Pomalidomide delivered in combination with Cyclophosphamide and Prednisone, defined as the dose that achieves a dose-limiting toxicity (DLT) in 25% of patients. The efficacy will be assessed by evaluating the very good partial response (VGPR) rate following the proposed regimen.
Antonio Palumbo, MD
Division of Hematology - University of Torino - A.O.U. San Giovanni Battista - Torino - Italy
Italy: Ministry of Health