Prolonged Protection From Bone Disease in Multiple Myeloma

Multiple Myeloma Clinical Trial

— Magnolia  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02286830
• Other study ID #: NMSG 22/14
• Secondary ID: 2014-001121-32
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: February 16, 2023

Study information

• Verified date: February 2023
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: February 16, 2023
• Est. primary completion date: February 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Bone Diseases
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense C

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Lund

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of lesions identified with conventional radiography and low-dose CT	Patients will have low-dose CT and conventional x-ray made at predefined time points to compare the sensitivity between the two modalities	4 years
Other	register incidence of osteonecrosis of the jaw		4 years
Other	register creatinine levels in serum	nephrotoxicity	4 years
Other	register ionized calcium in serum	hypocalcemia	4 years
Primary	time to first skeletal related event after randomisations at year two	After two years of zoledronic acid treatment patients will be randomized to A continue treatment B stop treatment.	From year two to year four
Secondary	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.	Development in bone markers prior to progression in osteolytic lesions will be investigated	4 years