Prolonged Protection From Bone Disease in Multiple Myeloma

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Lund
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

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