- Prostate cancer, breast cancer, renal cell carcinoma or multiple myeloma that has been
diagnosed as having metastasized to bone;
- Karnofsky Performance Score ≥40% at Baseline;
- patients randomized and treated with intravenous study drug in double-blind Study
A4091003.
- Patient was withdrawn from Study A4091003 for an adverse event or serious adverse
event;
- Occurrence of any adverse event or condition during Study A4091003 or since
termination from that study that, in the opinion of the Investigator, would put the
patient at increased safety risk or should exclude the subject from participating in
the open-label extension Study A4091029.