Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I
Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I
Multiple myeloma is a disease of B-lymphocytes producing malignant plasma cells. Malignant
 plasma cells induce osteolytic lesions, which is characteristic for progression of multiple
 myeloma. It is the aim of this study to investigate whether zoledronic acid has an influence
 on the progression of multiple myeloma.
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.