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

NCT00287261 | Completed Phase 2

• 1 other identifier: CZOL446G2422
• Study Type: interventional
• Target: 17
• Locations: 6 countries
• Sites: 6

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).

Conditions

Myelofibrosis; Myeloid Metaplasia

Keywords

myelofibrosis; D009191

Outcome Measures

Primary Outcomes (1)

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

  36 weeks

Secondary Outcomes (8)

• red blood cell transfusion need

  36 weeks

• performance status

  36 weeks

• constitutional symptoms

  36 weeks

• leukocyte count

  36 weeks

• thrombocyte count

  36 weeks

Study Arms (1)

zometa

EXPERIMENTAL

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

Drug: zoledronic acid

Interventions

zoledronic acid DRUG

4 mg IV every 3 weeks for 36 weeks

zometa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (6)

Cancer Care Services

Brisbane, Queensland, 4029, Australia

Location

University Hospital Leuven

Leuven, 3000, Belgium

Location

Hopital Avicenne and Paris 13 University

Bobigny, 93000, France

Location

Medizinische Klinik Kiel

Kiel, 24105, Germany

Location

RAMBAM Medical Center and Technion

Haifa, 31096, Israel

Location

Hospital Rafael éndez

Murcia, Lorca, 30800, Spain

Location

MeSH Terms

Conditions

Primary Myelofibrosis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Michel Delforge, MD, PhD

  University Hospital Leuven, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: adjuvnt head of clinic

Study Record Dates

• First Submitted: February 2, 2006
• First Posted: February 6, 2006
• Study Start: February 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

BE (1); FR (1); IL (1); ES (1); DE (1); AU (1)