myelofibrosis with myeloid metaplasia
Conditions
Interventions
Trade Name: Zometa
Product Name: Zometa
Product Code: EU/1/01/176/001-003
Pharmaceutical Form: Intravenous infusion
Sponsors
Department of Internal Medicine, University Hospital Gasthuisberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? male or female and at least 18 years-of-age ? histologically confirmed diagnosis of myelofibrosis with myeloid metaplasia (MMM). This includes patients with agnogenic myeloid metaplasia (also known as idiopathic myelofibrosis) and patients with a preceding history of polycythemia vera or essential thrombocytemia (also known as post-polycytemic myelofibrosis). (see Appendix A) ? patients with low, intermediate and high risk disease categories may be included. (see Appendix C) - low risk meaning: Hb > 10 g/dl, and WBC between 4 and 30 x 109/l - intermediate risk meaning: Hb 30 x 109/l - high risk meaning: Hb 30 x 109/l ? presence of measurable, clinically relevant disease manifestations (especially for low risk patients) ? 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. ? written informed consent 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
Exclusion criteria: ? diseases associated with secondary myelofibrosis, such as metastatic carcinoma, lymphoma, myelodysplasia, hairy cell leukemia, mast cell disease, acute leukemia (including M7 disease or acute panmyelosis with myelofibrosis) ? presence of the chromosomal translocation t(9:22) or molecular BCR/ABL rearrangement as detected by RT-PCR in bone marrow or peripheral blood ? 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 bisphosphonates in the previous 3 months ? known allergy or intolerance to bisphosphonates ? abnormal renal function as evidenced by: a calculated creatinine clearance < 30 ml/min (creatinine clearance (CrCl) is calculated using the Cockcroft and Gault formula) (see Appendix F) ? corrected serum calcium < 8.0 mg/dL . Corrected serum calcium (mg/dl) = measured calcium (mg/dl) + 0.8*[4 – patient serum albumin (g/dl)] ? patients with nonmalignant conditions which 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 ? diseases with influence on bone metabolism such as Paget’s disease or uncontrolled thyroid or parathyroid dysfunction ? cardiovascular, renal, hepatic, pulmonary and neurologic/psychiatric diseases which would prevent prolonged follow-up ? current active dental problems including infection of the teeth or jawbone (maxilla or mandibula); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures ? recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants) ? patients with a history of non-compliance to medical regimens and patients who are considered potentially unreliable and/or not cooperative ? patients treated with any systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days ? pregnant or breast feeding females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess the efficacy and safety of zoledronic acid in patients with myelofibrosis;Secondary Objective: The secondary objectives of this study are to evaluate in patients with myelofibrosis the effect of Zometa® on: ? red blood cell transfusion need ? performance status and constitutional symptoms ? leukocyte/thrombocyte count ? bone marrow histology, i.e. reticulin fibrosis, collagen fibrosis, osteosclerosis and angiogenesis ? serum LDH ? cytogenetics i.e. clonal evolution or regression ? bone remodelling ;Primary end point(s): The primary objectives of this study are to evaluate in patients with myelofibrosis: ? the effect of Zometa® on hemoglobin level ? the effect of Zometa® acid on spleen size ? the safety of Zometa® | — |
Countries
Belgium, France, Germany, Spain
Outcome results
None listed