Lombardi Comprehensive Cancer Center Clinical Trials Protocol
Cancer Type: Multiple Myeloma
TItle: A Randomized, Double-Blind, Multicenter Study of Denosumab Compared with Zoledronic Acid (Zometa) in the Treatment of Bone Disease in Subjects with Newly Diagnosed Multiple Myeloma
Description: This study is for men and women who have been newly diagnosed with multiple myeloma and have bone disease. Both denosumab and zoledronic acid are FDA-approved and marketed to reduce fractures, bone pain and spinal compression in patients with cancer. Denosumab is not approved for multiple myeloma. In this study, patients with multiple myeloma will be treated with standard chemotherapy and either zoledronic acid or denosumab. Since zoledronic acid is given in the vein and denosumab is injected under the skin, patients receive both a drug given in the vein and one injected under the skin. Patients are randomly assigned to receive either drug. In the case they are assigned to zoledronic acid, they also receive a placebo injection under the skin. If they are assigned to denosumab they also receive a placebo infusion into the vein.
Hospitals Offering This Trial: Georgetown University Hospital, Franklin Square Hospital Center, Washington Hospital Center
Contact: Jeanette Crawford