Multiple MyelomaPhase 4MagnoliaNCT02286830
Prolonged Protection From Bone Disease in Multiple Myeloma
A Phase 4 study testing Zoledronic acid in people with Multiple Myeloma, run by Thomas Lund at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Zoledronic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to 16 Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Magnolia Study Prolonged Protection From Bone Disease in Multiple Myeloma. An Open Label Phase 3 Multicenter International Randomised Trial
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
Read the 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
- Conditions
- Multiple Myeloma
- Being tested
- Zoledronic acid
- Keywords
- osteolysis, zoledronic acid, osteonecrosis, bone markers, low-dose CT
- Medical subject headings
- Multiple Myeloma, Osteolysis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acidDrug
Also called Zometa
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.
| Study group | Role | What they receive |
|---|---|---|
| zoledronic acid | Active comparator | treatment with zoledronic acid for 4 years Receives: Drug: Zoledronic acid |
| no treatment | Placebo comparator | treatment with zoledronic acid withheld after two years Receives: Drug: Zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From year two to year four
Secondary outcomes (1)
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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startJan 2015
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Lund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Lund, Odense University Hospital
- Investigators
- Thomas LunD, MD Ph.D., Principal investigator, Department of hematology, Odense University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286830
- Sponsor's protocol ID
- NMSG 22/14
- Other IDs
- 2014-001121-32, 2014
- Acronym
- Magnolia
- Status last verified
- Feb 2023
- First submitted
- 12 Mar 2014
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnolia Study Prolonged Protection From Bone Disease in Multiple Myeloma. An Open Label Phase 3 Multicenter International Randomised Trial
- ClinicalTrials.gov ID
- NCT02286830
- Acronym / sponsor ID
- Magnolia / NMSG 22/14
- Conditions
- Multiple Myeloma
- Keywords
- osteolysis, zoledronic acid, osteonecrosis, bone markers, low-dose CT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Thomas LundUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zoledronic acid | Active comparator | Drug: Zoledronic acidtreatment with zoledronic acid for 4 years |
| no treatment | Placebo comparator | Drug: Zoledronic acidtreatment with zoledronic acid withheld after two years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic acidAlso: ZometaZoledronic 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. | Drug | no treatment, zoledronic acid |
Primary outcome
time to first skeletal related event after randomisations at year two
Time frame: From year two to year four
After two years of zoledronic acid treatment patients will be randomized to A continue treatment B stop treatment.
1 secondary outcome
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.
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas LunD, MD Ph.D. principal investigator
Department of hematology, Odense University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zoledronic acid in people with Multiple Myeloma, run by Thomas Lund at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to first skeletal related event after randomisations at year two (time frame: From year two to year four). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.