A multi-centre, randomised studyof Zoledronic Acid versus Observationin Patients with Asymptomatic Myeloma - ND

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 个研究点开始时间: 2007年6月27日最近更新: 2012年3月19日

试验速览

暂无简介。

•Understanding and voluntary signing of informed consent form (ICF)
•Age 18 years at the time of signing ICF
•Newly diagnosed asymptomatic MM
•Asymptomatic MM, previously followed-up, with stable serum or urine M component (no
•50% increase in serum or urine M component during the last 24 months)
•Measurable M component in serum (
•1.0 g/L for IgG, 0.5g/L for IgA or IgM) or urine (
•0.2g/ 24h)
•Bone marrow plasmacytosis > 10%
•Absence of signs or symptoms of end organ damage attributable to neoplastic plasma cell
•proliferation
•No evidence of bone involvement at standard X-ray survey (osteolytic lesions, pathological
•fractures) or MRI (structural damage or tumor masses; focal or diffuse signal alterations allow
•Performance status ECOG 0-3
•Bilirubin serum level < 2.5mg/dl
•SGOT/SGPT < 2N
•Ability to comply with trial requirements
•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

•Symptomatic MM
•Non secretory MM
•Extramedullary plasmacytoma
•Previous bisphosphonate therapy ( a three-month wash-out required in caso of treatment with
•oral bisphosphonates for benign osteoporosis)
•Hypersensitivity to bisphosphonates
•Previous therapy for MM (either cytotoxic or Thalidomide/Thalidomide analogues/Bortezomib) Corrected serum calcium < 8mg/dl Hypercalcemia (1mg/dl > normal)
•Calculated creatinine clearance < 30 ml/min or creatinine 1mg/dl > normal
•Pregnancy or childbearing potential without any contraception method adopted
•Prevoius history of malignancy other than MM, unless the subject has been free of the disease
•for 5 years, except in situ carcinoma of the cervix or skin
•Previous cancer metastatic to the bone
•Bone-related disorder (e.g. Paget disease)
•Amyloidosis
•Any psychiatric illness impairing the ability to comply with trial requirements
•Current active dental problems including infection of the teeth or jawbone (maxilla or
•mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw
•(ONJ), of exposed bone in the mouth, or of slow healing after dental procedures (see appendix
•for details).
•Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants) (see
•appendix for details)

发起方

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI