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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001462-16-IT

Enrollment

Registered

2007-05-09

Start date

2006-03-14

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

idiopathic myelofibrosis MedDRA version: 6.1 Level: PT Classification code 10028537

Interventions

Trade Name: VELCADE*INIET 1FL 3,5MG 1MG/ML Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Bortezomib Concentration unit: mg milligram(s) Concentration type: equal Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -voluntary written informed consent, definite diagnosis of IM, age > 18 and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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, ...

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026