Evaluation of febrile event during emopoietic progenitor cells aferesi post chemotherapy treatment in patients affected by multiple myeloma. - ND

• Conditions: Multiple myeloma; MedDRA version: 6.1Level: PTClassification code 10028228

• Registration Number: EUCTR2005-004885-18-IT
• Lead Sponsor: AZIENDA OSPEDALIERA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

-Multiple myeloma diagnosis -Time from prymary chemotherapy to HD chemotherapy between 30/60 days. -HCV HBSAG negative.
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

-Document or probabily infections. -Cardiological disease -Other medical conditions uncontrolled.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of febrile event incidence in both treatment arms.;Secondary Objective: Evaluation of quality and quantity of progenitor stem cells products.;Primary end point(s): Evaluation of febrile event incidence in both treatment arms.