A Randomized, Double-Blind, Multicenter Study of Denosumab ComparedWith Zoledronic Acid (Zometa) in the Treatment of Bone Disease inSubjects with Newly Diagnosed Multiple Myeloma

AMGEN INC.0 个研究点目标入组 1,718 人开始时间: 2012年6月15日最近更新: 2021年12月21日

适应症

试验速览

暂无简介。

•- Adults with newly diagnosed multiple myeloma; - Radiographic evidence of at least 1 bone lesion; - Plan to receive primary frontline anti-myeloma therapies; - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; - Adequate organ function; - Written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 560
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 960

•- Nonsecretory multiple myeloma (unless baseline serum free light chain level is elevated); - Plasma cell leukemia; - Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome; - Previous treatment with anti-myeloma therapy (does not include radiotherapy or a single short course of steroid [ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days]). Anti-myeloma therapy (excluding bisphosphonates) may be started before randomization if the subject has signed informed consent and screening blood samples have been collected for central analysis. - Planned radiation therapy or surgery to bone (does not include procedures; performed before randomization) - Prior administration of denosumab; - Prior or current IV bisphosphonate administration; - Use of oral bisphosphonates within the past 1 year; - Prior history or current evidence of osteonecrosis/ osteomyelitis of the jaw.

发起方

AMGEN INC.