Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I

Inclusion Criteria

• Evidence of myeloma according to the criteria of the British Columbia Cancer Agency (for the diagnosis, 2 of the 3 criteria must be met):

  • Evidence of paraprotein in the serum or urine
  • Bone marrow infiltration with plasma cells which represent more than 10% of the nucleated cells
  • Radiologically, at least one osteolytic lesion
• Asymptomatic patients with Stage I (Durie and Salmon) multiple myeloma

Exclusion criteria:

• Patients with more than one osteolytic lesion on conventional skeletal radiography
• Previous treatment with bisphosphonates
• bilirubin > 2.5 mg/dl

• Abnormal renal function as evidenced by: A calculated creatinine clearance < 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula:

  • CrCl= [140-age(years)] x weight(kg)/[72xserumcreatinine(mg/dL)] X {0.85 for female patients}
• Patients with other malignant diseases or severe concomitant diseases
• Potentially fertile patients who are not using a reliable and appropriate method of contraception
• Pregnancy or breast-feeding
• Participation in another clinical study with an investigational drug within 12 weeks of study entry
• 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.
• Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)

Other protocol-defined inclusion and exclusion criteria may apply.