A Phase Ib/II Multicenter Dose-determination Study, With an Adaptive, Randomized, Placebo-controlled, Double-blind Phase II, Using Various Repeated IV Doses of BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients With Prior Skeletal-related Event

Inclusion Criteria:

1. Relapsed or refractory multiple myeloma patients requiring treatment with a
non-bortezomib-containing regimen (prior treatment with bortezomib is acceptable)

• The diagnosis of symptomatic multiple myeloma (International Myeloma Working Group)

2. Patients with multiple myeloma who do not have measurable serum M-protein or
measurable urine M-protein must have measurable increased concentrations of free
light chains (using FreeLite™)

3. At least one prior SRE defined as one of the following:

- Pathologic fracture

- Spinal cord compression

- Requirement for either radiation or surgery to bone due to:

- Pain

- Prevention of imminent fracture

- Stabilization of a fracture

4. Current or planned treatment with zoledronic acid

5. Ambulatory patients aged 18 years or older

6. Adequate organ function

Exclusion Criteria:

1. Known concomitant disease(s) known to influence calcium metabolism including
hyperparathyroidism, hyperthyroidism and/or Paget's disease of bone.

2. Current active dental problems including

- Ongoing infection of the teeth or jawbone (maxilla or mandibula)

- Current exposed bone in the mouth

- Dental or fixture trauma

- Current or previous osteonecrosis of the jaw

- Slow healing after dental procedures

- Recent (within 6 weeks) or planned dental or jaw surgery during the study
(extraction, implants)

3. Patients who are allergic to/ intolerant of bisphosphonate therapy

4. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g.
uncontrolled diabetes, active or uncontrolled infection, uncontrolled diarrhea) that
could cause unacceptable safety risks or compromise compliance with the protocol

5. Other clinically significant heart disease (e.g. symptomatic congestive heart
failure, uncontrolled arrhythmia, uncontrolled hypertension, history of labile
hypertension, or history of poor compliance with an antihypertensive regimen)

Other protocol-defined inclusion/exclusion criteria may apply