Aprepitant for prevention of acute and delayed nausea and vomiting: a phase III, double-blind, randomized, palcebo-controlled trial in patients receiving a high-emetogenic dose of cyclophosphamide for peripheral blood stem cells harvesting - ND

• Conditions: Multiple myeloma, Hodgkin lymphoma, Non-Hodgkin lymphoma.; MedDRA version: 9.1Level: HLGTClassification code 10025319; MedDRA version: 9.1Level: HLGTClassification code 10025322

• Registration Number: EUCTR2009-017603-28-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI PERUGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-21
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Male or female patients ≥ 18 years of age -Patient is able to understand study procedure and agrees to participate in the study by giving written informed consent. -Patient is scheduled to receive a highly emetogenic cyclophosphamide IV chemotherapy (3 g/m2) for autologous PBSC harvesting -Karnofsky score ≥60 -Normal epatic function (bilirubin < 1.5 mg/dl) ed renal function (creatinin < 2 mg/dl). -Normal ECG -HBV-, HCV- and HIV- negative -Negative urine pregnancy test for women of childbearing age
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Serious accompanying disorders or impaired organ function (in particular impaired left ventricular function or severe cardiac arrhythmias) - Platelets < 100 000/mm3 , leukocytes < 2 500/mm3 - Known hypersensitivity to the medications to be used - Known HIV-positivity - Active hepatitis infection - Pregnancy and lactation period - Not application of inclusion criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To confirm and extend our preliminary data on the efficacy and safety of combined aprepitant, palonosetron and dexamethasone in preventing CINV after high emetic therapy with cyclophosphamide 3 g/m2 compared with the palonosetron and dexamethasone regimen.;Secondary Objective: To monitor peripheral blood stem cell harvest.;Primary end point(s): The complete response (CR) rate defined as the number of patients with no emetic episodes and no rescue medication in the first 120 hours post-chemotherapy.