FDAnews
www.fdanews.com/articles/67472-clinical-trial-initiated-to-evaluate-quadramet-in-combination-with-bisphosphonates-for-the-treatment-of-multiple-myeloma

CLINICAL TRIAL INITIATED TO EVALUATE QUADRAMET IN COMBINATION WITH BISPHOSPHONATES FOR THE TREATMENT OF MULTIPLE MYELOMA

January 12, 2005

Cytogen has announced that researchers at a leading medical institution have initiated a new clinical trial to evaluate the use of Quadramet in combination with bisphosphonates for the treatment of pain associated with metastatic bone disease in patients with recurrent or refractory multiple myeloma.

The escalating-dose clinical study will evaluate both the safety profile and effects on painful symptoms and analgesic use. In addition, preliminary information regarding the effect of Quadramet (samarium Sm-153 lexidronam) on the underlying disease will be determined by monitoring levels of M-protein, a marker for multiple myeloma activity.