A Study to Assess BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients

Inclusion Criteria:

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)

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 FreeLiteâ„¢)

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
Current or planned treatment with zoledronic acid
Ambulatory patients aged 18 years or older
Adequate organ function

Exclusion Criteria:

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

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)
Patients who are allergic to/ intolerant of bisphosphonate therapy
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
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