Inclusion Criteria

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.