Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma

Inclusion Criteria:

1. Confirmed diagnosis of SMM with high-risk for progression to multiple myeloma

1. BMPC ≥ 10% and serum M-protein level ≥ 3 g/dL, OR

2. BMPC ≥ 10%, serum M-protein level < 3 g/dL, and an abnormal free light chain
ratio of < 0.125 or > 8.0

2. No previous or current anti-myeloma therapies

3. Patients ≥ 18 years of age

4. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 1

Exclusion Criteria:

1. Previous treatment with IV bisphosphonates (i.e., pamidronate or zoledronic acid

2. Another primary malignant disease that requires systemic treatment

3. Concomitant Paget's disease of bone, uncorrected hyperparathyroidism, or uncontrolled
thyroid disease

4. Clinically significant uncontrolled heart disease (e.g., unstable angina, congestive
heart failure, uncontrolled hypertension, ventricular or atrial arrhythmias)

5. Treatment with an investigational product within 28 days before the first dose of
study treatment

6. Pregnant or nursing (lactating) women

7. Women of child-bearing potential, UNLESS they are using two birth control methods.
The two methods can be a double barrier method or a barrier method plus a hormonal
method.

Other protocol-defined inclusion/exclusion criteria may apply