Clinical Trial: Prolonged Protection From Bone Disease in Multiple Myeloma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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: 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 Summary:

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


Sponsor: Thomas Lund

Current Primary Outcome: time to first skeletal related event after randomisations at year two [ Time Frame: From year two to year four ]

After two years of zoledronic acid treatment patients will be randomized to A continue treatment B stop treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome: Value of serum bone marker ratio (bone resorption / bone formation markers) as predictor of skeletal related related events analysed by time-dependent multiparameter Cox regression analysis. [ Time Frame: 4 years ]

Development in bone markers prior to progression in osteolytic lesions will be investigated


Original Secondary Outcome: Same as current

Information By: Odense University Hospital

Dates:
Date Received: March 12, 2014
Date Started: January 2015
Date Completion: March 2021
Last Updated: April 14, 2016
Last Verified: April 2016