Prolonged Protection From Bone Disease in Multiple Myeloma (Magnolia)

Thomas Lund

Status and phase: Completed; Phase 4

Conditions: Multiple Myeloma

Treatments: Drug: Zoledronic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02286830

NMSG 22/14

2014-001121-32 (EudraCT Number)

Details and patient eligibility

About

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

Full 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

Enrollment: 158 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups, including a placebo group

zoledronic acid

Active Comparator group

Description:

treatment with zoledronic acid for 4 years

Treatment:

Drug: Zoledronic acid

no treatment

Placebo Comparator group

Description:

treatment with zoledronic acid withheld after two years

Treatment:

Drug: Zoledronic acid