Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse

Zometa is administrated every 4 weeks at dose of 4 mg. The limit of administrations is 12. The first infusion is in the visit 2 and the last is in visit 13

Inclusion criteria

• Male or female patients aged ≥18 years.
• Signed informed consent before performing any study procedure that is not the part of the regular medical care of the patients.
• Diagnosis of MM, with biochemical relapse after initial response with no symptoms resulting from the disease (CRAB), defined as a re-positivation of a previous immunofixation (two samples) or increase above 25% of serum or urine protein M.
• In the investigator's opinion, ability to meet all clinical trial requirements

Exclusion criteria

• Treatment with bisphosphonates (oral route and/or endovenous route) within 3 months prior to inclusion.
• Treatment with denosumab within three months prior to inclusion.
• Criteria of symptomatic disease or organic damage related to disease, defined as:

• Impaired renal function: serum creatinine >2 mg/dl or 173 mmol/l. Calcium increase: serum calcium ≥12 mg/dl within 28 days prior to inclusion.
• Anaemia: haemoglobin < 10 g/dl or 2 g/dl below normal ranges.
• Bone injury: new osteolytic lesions (from diagnosis) seen within 3 months prior to inclusion, current pathological fractures or increase of osteopenia (from diagnosis) in bone radiology series.
• Others: amyloidosis with current organic damage, recurrent bacterial infections (more than 2 events in 12 months), symptomatic hyperviscosity, presence of plasmacytomas.
• Patients with current and active dental disorders (dental, jaw infection, bone exposed in the mouth, jaw osteonecrosis).
• Patients developing jaw osteonecrosis or other serious adverse events due to treatment with any bisphosphonate .
• Significant liver disease:
• Bilirubin > 3 g/dl.
• ALT > 2.5 x the upper limit of normal
• AST > 2.5 x the upper limit of normal
• Patients who are currently in another clinical trial or receiving any investigational agent.
• Pregnancy or nursing.
• Parathyroid gland diseases.
• Previous malignancy with a high risk of death or bone disease: breast cancer, prostate cancer or lung cancer, even if on complete response.
• Active presence of neoplasms other than Multiple Myeloma