Status:
COMPLETED
Prolonged Protection From Bone Disease in Multiple Myeloma
Lead Sponsor:
Thomas Lund
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Main hypothesis: Patients who continue zoledronic acid after year 2 have longer time until progression in bone disease compared to patients who stop treatment after two years? Secondary hypothesis: S...
Detailed Description
Newly diagnosed myeloma patients will be followed for 4 years. The first two years they will be treated with zoledronic acid monthly. At year 2 they will be randomized to A continue treatment for 2 mo...
Eligibility Criteria
Inclusion
- Symptomatic Multiple Myeloma regardless of bone disease status
- Signed Informed Consent
- Age ≥ 18 years
- Remaining life expectancy ≥ 2 years
- Any concurrently anti-myeloma treatment are allowed
Exclusion
- Previous treatment with bisphosphonate within the last 6 months
- Severely reduced renal function (creatinine clearance \<30 mL/min despite fluid replacement)
- Known concurrent malignancy, excluding skin cancer
- Known hypersensitivity to zoledronic acid
- Pregnant or lactating women
- Women of childbearing potential or men engaging in sexual activity with a woman of childbearing potential who refuse to use contraception
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 16 2023
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT02286830
Start Date
January 1 2015
End Date
February 16 2023
Last Update
February 17 2023
Active Locations (1)
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1
Odense University Hospital
Odense C, Denmark, 5000