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
Study Status
Open to Enrollment
Study Description
This clinical trial is for men and women who have multiple myeloma with bone lesions and who are planning on receiving frontline therapy for myeloma.
The purpose of the study is to determine if the drug denosumab is safe and effective in the treatment of bone metastases (cancer that has spread to the bones). In the study, denosumab will be compared to the drug zoledronic acid.
Denosumab is FDA-approved for the prevention of skeletal complications in people with bone metastases from solid tumors, but it is not approved for use in people multiple myeloma. Zoledronic acid is FDA-approved for treatment of multiple myeloma bone metastases.
Study participants will be randomly assigned to receive either denosumab or zoledronic acid. Participants will not know which drug they are receiving (blinded therapy). Participants will receive first-line treatment for myeloma as standard of care with their physicians.
Participants will receive the study drug via infusion or injection every 4 weeks for up to approximately 48 weeks (4 years). After that, if denosumab is determined to have a positive effect compared to zoledronic acid, participants still receiving blinded therapy will be offered denosumab for another 24 months (2 years), or participants may be involved in long-term follow-up without study drug for approximately 2 years.
Follow the Myeloma Center online:
Website: http://myelomacenter.org
Blog: http://myelomacenterblog.com
Facebook: Click here to visit the Myloma Facebook Page
Disease Status and/or Stage
Newly Diagnosed Multiple Myeloma
Sponsor
Amgen
Key Eligibility
- Men and women age 18 and older
- Newly diagnosed multiple myeloma
- At least 1 bone lesion
- Planning on receiving frontline anti-myeloma therapies
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- The Myeloma Center
- (212) 746-3964
- [email protected]
Healthy Volunteers
As a healthy volunteer in a clinical trial you may make a significant contribution to the discovery of medical knowledge and new treatments that could impact people around the world.
Click here for studies seeking healthy volunteers.
Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
