CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,718 enrolled
Drug / intervention
Denosumab +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01345019
NCT01345019Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid in the Treatment of Bone Disease in Subjects With Newly Diagnosed Multiple Myeloma

Amgen·interventional·Posted Apr 29, 2011·Updated Nov 8, 2022

In Brief

A Phase 3 clinical trial evaluating Denosumab, Zoledronic acid, and 3 other interventions for Cancer and 5 related conditions. Completed, enrolled 1,718 participants across 309 sites in 29 countries.

Detailed Summary

The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer, Hematologic Malignancies, Multiple Myeloma, Oncology, Bone Metastases, Multiple Myeloma Bone Lesions
CountriesAustralia, Austria, Bulgaria, Canada, Czechia, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Japan, Lithuania, Malaysia, New Zealand, Poland, Portugal, Russia, Singapore, Slovakia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsDaiichi Sankyo

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 29, 2011
Enrollment StartMay 17, 2012
Primary CompletionJul 19, 2016
Study CompletionMar 29, 2019
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 15.2 years ago

Interventions

Denosumabdrug

Administered by subcutaneous injection once every 4 weeks.

Zoledronic aciddrug

Administered by intravenous infusion over 15 minutes once every 4 weeks

Placebo to Denosumabdrug

Administered by subcutaneous injection once every 4 weeks.

Placebo to zoledronic aciddrug

Administered by intravenous infusion over 15 minutes once every 4 weeks

Denosumab (for the open-label treatment phase)drug

Administered by subcutaneous injection once every 4 weeks.