Myelofibrosis Clinical Trial
Official title:
A Prospective Multicentre Phase II Trial of Zoledronic Acid in Patients With Myelofibrosis With Myeloid Metaplasia (MMM)
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).
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
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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