A prospective multicentre phase II trial of zoledronic acid in patients with myelofibrosis with myeloid metaplasia (MMM)
- Conditions
- myelofibrosis with myeloid metaplasia (MMM)MedDRA version: 9.1Level: LLTClassification code 10028538Term: Myelofibrosis with myelometaplasia
- Registration Number
- EUCTR2005-003985-40-FR
- Lead Sponsor
- niversity Hospital Leuven - Department of Haematology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 16
- written informed consent
- at least 18 years-of-age
- histologically confirmed diagnosis of MMM (include idiopathic myelofibrosis, polycythemia vera and essential thrombocytemia)
- presence of measurable, clinically relevant disease manifestations
- ECOG performance status of 0, 1 or 2
- life expectancy of at least 3 months
- women of childbearing potential must use a medically acceptable form of contraception during the study and must have a negative urine or serum pregnancy test within 7 days of randomization
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
- diseases associated with secondary myelofibrosis, such as metastatic carcinoma, lymphoma, myelodisplasia, hairy cell leukemia, mast cell disease, acute leukemia
- presence of the chromosomal translocation t(9:22) or molecular BCR/ABL rearrangement
- any anti-myelofibrosis drug therapy during the last 4 weeks. This includes chemotherapy, androgens, steroids, thalidomide, hematopoietic growth factors or any other investigational drug
- patients that have received biphosphonates in the previous 3 months
- known allergy or intolerance to bisphosphonates
- abnomal renal function (calculated creatinine clearance < 30mL/min )
- corrected serum calcium < 8.0 mg/dL.
- current active dental problems, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed in the mouth, or of slow healing after dental procedures
- patients with nonmalignant conditions wich would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol including (uncontrolled infections, uncontrolled type 2 Diabetes Mellitus, disease with influence on bone metabolism such as Paget's disease or uncontrolled thyroid or parathyroid dysfunction, cardiovascular, renal, hepatic, pulmonary, and neurologic/psychiatric disease wich would prevend prolonged follow-up)
- pregnant or breast feeding females
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method