Pomalidomide, Cyclophosphamide and Prednisone (PCP) in Patients With Multiple Myeloma (MM) Relapsed and/or Refractory to Lenalidomide (PCP)
|Multiple Myeloma||Drug: Pomalidomide, Cyclophosphamide, Prednisone||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- PCP safety and efficacy [ Time Frame: 3 years ]
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.
- Overall survival [ Time Frame: 3 years ]
- Progression-free survival [ Time Frame: 3 years ]
- Time-to-progression [ Time Frame: 3 years ]
- Time to next therapy [ Time Frame: 3 years ]
- Tumor response and survival in particular subgroups of patients [ Time Frame: 3 years ]
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||July 2018|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Drug: Pomalidomide, Cyclophosphamide, Prednisone
This multicenter phase I followed by a phase II trial will evaluate the safety and efficacy of the combination Pomalidomide-Cyclophosphamide-Prednisone (PCP) in patients (pts) with MM relapsed/refractory to lenalidomide.
In the phase I we assess the maximum tolerated dose (MTD) of PCP in 25% of pts. The first 4 pts are given the second dose level, accrual continues with 4 pts per dose level for a maximum of 24 pts.
The dose level associated with an updated DLT is recommended for the next patient cohort.
Each patient is assigned to a salvage therapy including Cyclophosphamide and Prednisone (both 50 mg every other d), and Pomalidomide at one of the following doses:1 mg/d;1.5 mg/d;2 mg/d;2.5 mg/d
In the phase II a total of 43 pts will be treated with the MTD of PCP. Pts enrolled at the MTD during the phase I will be included in the Phase II trial.
Maintenance (each cycle repeated every 28 d, until PD) Pomalidomide: 2.5 mg/d; Prednisone: 25 mg every other d
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166113
|A.O.U. San Giovanni Battista|
|Torino, Italy, 10126|
|Principal Investigator:||Antonio Palumbo, MD||Division of Hematology - University of Torino - A.O.U. San Giovanni Battista - Torino - Italy|