Multiple Myeloma
Conditions
Keywords
osteolysis, zoledronic acid, osteonecrosis, bone markers, low-dose CT
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 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
Interventions
DRUGZoledronic 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.
Sponsors
Thomas Lund
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to first skeletal related event after randomisations at year two | From year two to year four | After two years of zoledronic acid treatment patients will be randomized to A continue treatment B stop treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 4 years | Development in bone markers prior to progression in osteolytic lesions will be investigated |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of lesions identified with conventional radiography and low-dose CT | 4 years | Patients will have low-dose CT and conventional x-ray made at predefined time points to compare the sensitivity between the two modalities |
| register incidence of osteonecrosis of the jaw | 4 years | — |
| register creatinine levels in serum | 4 years | nephrotoxicity |
| register ionized calcium in serum | 4 years | hypocalcemia |
Countries
Denmark
Outcome results
None listed