Newly diagnosed asymptomatic MM MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 inclusion) Performance status ECOG 0-3 Bilirubin serum level =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 normal) Calculated creatinine clearance 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To define the time to the first skeletal event in patients with asymptomatic myeloma treated or not with Zoledronic Acid 4 mg administered as 15-minute infusion every 4 weeks for at maximum 24 months.;Secondary Objective: To define time to progression, time to the need of chemo-radiotherapy and safety/tolerability of Zoledronic Acid in this setting of patients.;Primary end point(s): To demonstrate that time to the first skeletal event is reduced in patients with asymptomatic myeloma receiving Zoledronic Acid at the dose of 4 mg every months for two years. | — |
Countries
Italy
Outcome results
None listed