Multiple myeloma, Hodgkin lymphoma, Non-Hodgkin lymphoma. MedDRA version: 9.1 Level: HLGT Classification code 10025319 MedDRA version: 9.1 Level: HLGT Classification code 10025322
Conditions
Interventions
Trade Name: EMEND*1CPS 125MG+2CPS 80MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Aprepitant
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharm
Sponsors
AZIENDA OSPEDALIERA DI PERUGIA
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed