Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- zoledronic acid
- description
- treatment with zoledronic acid for 4 years
- interventionNames
- Drug: Zoledronic acid
- type
- PLACEBO_COMPARATOR
- label
- no treatment
- description
- treatment with zoledronic acid withheld after two years
- interventionNames
- Drug: Zoledronic acid
Primary outcomes (1)
- measure
- time to first skeletal related event after randomisations at year two
- timeFrame
- From year two to year four
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available