Denosumab for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will assess the safety and tolerability of denosumab in smoldering multiple myeloma subjects as well to see if denosumab can reduce subjects' risk of getting multiple myeloma.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used certain medications like IV bisphosphonates or high-dose corticosteroids recently. It's best to discuss your current medications with the study team.
Is denosumab generally safe for humans?
Denosumab has been used safely in patients with bone metastases from solid tumors and in those with multiple myeloma, but there is a risk of a condition called MRONJ (medication-related osteonecrosis of the jaw), which can occur after dental procedures. This condition resolved after stopping the drug.12345
How is the drug denosumab unique in treating multiple myeloma?
Denosumab is unique because it is a fully human monoclonal antibody that targets RANKL, a protein involved in bone breakdown, which helps prevent bone complications. Unlike some other treatments, it is administered as a subcutaneous injection every four weeks, offering a different approach to managing bone-related issues in multiple myeloma.12367
What data supports the effectiveness of the drug Denosumab for treating multiple myeloma?
Who Is on the Research Team?
Brea Lipe, MD
Principal Investigator
University of Rochester Wilmot Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with smoldering multiple myeloma (SMM) who meet specific health criteria, including normal organ function and a life expectancy of more than a year. They must be able to take daily calcium and vitamin D, have no history of certain bone treatments, and agree to use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive denosumab 120mg subcutaneously every 4 weeks for 12 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Denosumab
Denosumab is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Rochester
Lead Sponsor
Amgen
Industry Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London