A phase II Study of Bortezomib (Velcade), a proteasome Inhibitor, in treating patients with idiopathic Myelofibrosis (IM) randomized to receive new investigational drugs. - ND

Conditions: idiopathic myelofibrosis
MedDRA version: 6.1Level: PTClassification code 10028537

Registration Number: EUCTR2006-001462-16-IT

Lead Sponsor: OSPEDALE POLICLINICO S. MATTEO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 35

Inclusion Criteria

-voluntary written informed consent, definite diagnosis of IM, age > 18 and < 80 years,...
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

platelet count < 100 x 10exp9/l within 14 days before enrollment, absolute neutrophil count of < 1.0 x 10 exp 9/l within 14 days before enrollment, ...

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: evaluate the antileukemic activity of bortezomib in patients with IM who are either resistant or not candidate to conventional therapy as measured by analysis of individual hematological parameters and by a summary severity score of the disease; determine the safety and tolerability of bortezomib in patients with IM.;Secondary Objective: - evaluate quality of life (QoL) and treatment-related toxicities in IM patients treated with bortezomib.;Primary end point(s): Response assessment will be evaluated by using a severity score calculated from one clinical variable (spleen volume or liver volume) and three biological variables (hemoglobin concentration, white blood cell count and platelet blood count).

Secondary Outcome Measures