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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00287261




Registration number
NCT00287261
Ethics application status
Date submitted
2/02/2006
Date registered
6/02/2006
Date last updated
9/12/2014

Titles & IDs
Public title
A Trial of Zoledronic Acid in Patients With Myelofibrosis With Myeloid Metaplasia (MMM)
Scientific title
A Prospective Multicentre Phase II Trial of Zoledronic Acid in Patients With Myelofibrosis With Myeloid Metaplasia (MMM)
Secondary ID [1] 0 0
CZOL446G2422
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myelofibrosis 0 0
Myeloid Metaplasia 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - zoledronic acid

Experimental: zometa - 3-weekly infusion of zometa (zoledronic acid) 4 mg


Treatment: Drugs: zoledronic acid
4 mg IV every 3 weeks for 36 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
effect of monthly zoledronic acid infusion on hemoglobin level and spleen size
Timepoint [1] 0 0
36 weeks
Secondary outcome [1] 0 0
red blood cell transfusion need
Timepoint [1] 0 0
36 weeks
Secondary outcome [2] 0 0
performance status
Timepoint [2] 0 0
36 weeks
Secondary outcome [3] 0 0
constitutional symptoms
Timepoint [3] 0 0
36 weeks
Secondary outcome [4] 0 0
leukocyte count
Timepoint [4] 0 0
36 weeks
Secondary outcome [5] 0 0
thrombocyte count
Timepoint [5] 0 0
36 weeks
Secondary outcome [6] 0 0
serum LDH
Timepoint [6] 0 0
36 weeks
Secondary outcome [7] 0 0
bone marrow histology
Timepoint [7] 0 0
36 weeks
Secondary outcome [8] 0 0
safety of zometa infusions
Timepoint [8] 0 0
until progression or death

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2008
Sample size
Target
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Cancer Care Services - Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
France
State/province [2] 0 0
Bobigny
Country [3] 0 0
Germany
State/province [3] 0 0
Kiel
Country [4] 0 0
Israel
State/province [4] 0 0
Haifa
Country [5] 0 0
Spain
State/province [5] 0 0
Lorca

Funding & Sponsors
Primary sponsor type
Other
Name
Universitaire Ziekenhuizen KU Leuven
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00287261
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michel Delforge, MD, PhD
Address 0 0
University Hospital Leuven, Belgium
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00287261