NCT02286830

Prolonged Protection From Bone Disease in Multiple Myeloma

Magnolia Study Prolonged Protection From Bone Disease in Multiple Myeloma. An Open Label Phase 3 Multicenter International Randomised Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Thomas Lund · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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: Serum will bone markers increase prior to progression in bone disease in the individual patient? Secondary hypothesis: Low-dose CT will detect more cases of osteolytic bone disease in Multiple Myeloma compared to conventional radiography

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 more years or B stop treatment. The primary outcome of the study will be time to progressive bone disease from year 2 and onward. Serum bone markers will be measured throughout the study. In patients who experience progressive bone disease, development of bone markers prior to the radiological progression will be investigated to see the if it could have been predicted with the use of serum markers During the four year period patients will have low-dose CT superior and conventional radiography made at predefined time points. The secondary outcome of the study is to compare the sensitivity of the two modalities

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Zoledronic acid	Zoledronic acid will be given to all participants for two years. Then patients will be randomized to A receive 2 more years of treatment or B stop treatment.

Timeline

• Start date: 2015-01-01
• Primary completion: 2023-02-16
• Completion: 2023-02-16
• First posted: 2014-11-10
• Last updated: 2023-02-17

Locations

1 site across 1 country: Denmark