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Pomalidomide, Cyclophosphamide and Prednisone (PCP) in Patients With Multiple Myeloma (MM) Relapsed and/or Refractory to Lenalidomide

NCT01166113 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2023-06-29

No results posted yet for this study

Summary

This study will evaluate if the combination of Pomalidomide, Cyclophosphamide and Prednisone is safe and provides benefits in patients with multiple myeloma relapsed and/or refractory to lenalidomide.

Conditions

Interventions

DRUG

Pomalidomide, Cyclophosphamide, Prednisone

Induction 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

Sponsors & Collaborators

  • Fondazione EMN Italy Onlus

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-06-30
Completion
2023-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01166113 on ClinicalTrials.gov