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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00287261
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : December 9, 2014
Information provided by (Responsible Party):
prof. dr. Hans Wildiers, Universitaire Ziekenhuizen Leuven

Brief 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).

Condition or disease Intervention/treatment Phase
Myelofibrosis Myeloid Metaplasia Drug: zoledronic acid Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multicentre Phase II Trial of Zoledronic Acid in Patients With Myelofibrosis With Myeloid Metaplasia (MMM)
Study Start Date : February 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Arm Intervention/treatment
Experimental: zometa
3-weekly infusion of zometa (zoledronic acid) 4 mg
Drug: zoledronic acid
4 mg IV every 3 weeks for 36 weeks

Primary Outcome Measures :
  1. effect of monthly zoledronic acid infusion on hemoglobin level and spleen size [ Time Frame: 36 weeks ]

Secondary Outcome Measures :
  1. red blood cell transfusion need [ Time Frame: 36 weeks ]
  2. performance status [ Time Frame: 36 weeks ]
  3. constitutional symptoms [ Time Frame: 36 weeks ]
  4. leukocyte count [ Time Frame: 36 weeks ]
  5. thrombocyte count [ Time Frame: 36 weeks ]
  6. serum LDH [ Time Frame: 36 weeks ]
  7. bone marrow histology [ Time Frame: 36 weeks ]
  8. safety of zometa infusions [ Time Frame: until progression or death ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00287261

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Australia, Queensland
Cancer Care Services
Brisbane, Queensland, Australia, 4029
University Hospital Leuven
Leuven, Belgium, 3000
Hopital Avicenne and Paris 13 University
Bobigny, France, 93000
Medizinische Klinik Kiel
Kiel, Germany, 24105
RAMBAM Medical Center and Technion
Haifa, Israel, 31096
Hospital Rafael éndez
Murcia, Lorca, Spain, 30800
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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Principal Investigator: Michel Delforge, MD, PhD University Hospital Leuven, Belgium
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Responsible Party: prof. dr. Hans Wildiers, adjuvnt head of clinic, Universitaire Ziekenhuizen Leuven Identifier: NCT00287261    
Other Study ID Numbers: CZOL446G2422
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014
Keywords provided by prof. dr. Hans Wildiers, Universitaire Ziekenhuizen Leuven:
Additional relevant MeSH terms:
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Primary Myelofibrosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Pathologic Processes
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs