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

Phase 2
18 Years
Not Enrolling
Myelofibrosis, Myeloid Metaplasia

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Trial Information

A Prospective Multicentre Phase II Trial of Zoledronic Acid in Patients With Myelofibrosis With 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

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 (following the Dupriez score) may be included 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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

effect of monthly zoledronic acid infusion on hemoglobin level and spleen size

Outcome Time Frame:

36 weeks

Safety Issue:


Principal Investigator

Michel Delforge, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Leuven, Belgium


Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:




Start Date:

February 2006

Completion Date:

March 2008

Related Keywords:

  • Myelofibrosis
  • Myeloid Metaplasia
  • myelofibrosis
  • D009191
  • Primary Myelofibrosis
  • Metaplasia