NCT00287261

A Trial of Zoledronic Acid in Patients With Myelofibrosis With Myeloid Metaplasia (MMM)

A Prospective Multicentre Phase II Trial of Zoledronic Acid in Patients With Myelofibrosis With Myeloid Metaplasia (MMM)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this trial, the question is addressed if zoledronic acid (Zometa, Novartis Pharma)could be of clinical benefit for patients with myelofibrosis and myeloid metaplasia (MMM).

Detailed description

This is a prospective, multicentre phase II study in adult patients with documented MMM and requiring therapy for their disease. Patients will be treated every 3 weeks with 4 mg zoledronic acid (Zometa), administered by a 15 min. intravenous infusion. Study duration is 36 weeks (12 infusions). After the study it is recommended to continue treatment until disease progression, or the occurrence of unacceptable treatment-related toxicity. Objectives of the trial are: Primary objectives: the effect of monthly infusion of zoledronic acid 4 mg on: hemoglobin level, spleen size Secondary objectives the effect of monthly infusion of zoledronic acid 4 mg on: red blood cell transfusion need performance status constitutional symptoms leukocyte count thrombocyte count bone marrow fibrosis serum LDH

Conditions

• Myelofibrosis
• Myeloid Metaplasia

Interventions

Type	Name	Description
DRUG	zoledronic acid	4 mg IV every 3 weeks for 36 weeks

Timeline

• Start date: 2006-02-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2006-02-06
• Last updated: 2014-12-09

Locations

6 sites across 6 countries: Australia, Belgium, France, Germany, Israel, Spain