Multiple MyelomaPhase 1/2NCT00281476
The Effect of High Dose Simvastatine on Multiple Myeloma
A Phase 1/2 study testing Simvastatine in people with Multiple Myeloma, run by Vejle Hospital.
Trial summary
The purpose of the study is to evaluate the effect of high doses of Simvastatine on bone metabolisme and biochemical markers of disease in Multiple Myeloma 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?
- Simvastatine
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Nov 2007
- Phase
- Phase 1/2
- 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
- multiple myeloma-patients in need of treatment
- stable og progressive disease
- age = or > 18 years
- performance status < 3
- life expectancy > 3 months
Who cannot join
- pregnancy
- patients incapable of giving personally concent
- renal insufficiens with creatinine clearance below 25 ml/min
- alanin aminotransferasis > 2,5 x upper reference limit
- thyroxine below lower reference limit
- known familiar muscle-disease ar previous myopati
- creatinine kinase > 10 x upper reference limit
- medication with drugs with known interactions wiht simvastatine
About this study
The purpose of the study is to evaluate the effect of high doses of Simvastatine on bone metabolisme and biochemical markers of disease in Multiple Myeloma
- Conditions
- Multiple Myeloma
- Being tested
- Simvastatine
- Keywords
- multiple myeloma, statins, bone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response estimated by internationally approved criteria after 8 weeks of intermittend treatment with simvastatine
Measured: 8 weeks after treatment start
Secondary outcomes (2)
Changes in markers of bone metabolisme after 8 weeks of intermittend treatment with simvastatine
Measured: 8 weeks after start of treatment
Toxicity according to CTC after 8 weeks of intermittend treatment with simvastatine
Measured: 8 weeks after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2006 (estimated)
- Study startFeb 2006
- Study completionNov 2007
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Torben Plesner, DMSc., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281476
- Sponsor's protocol ID
- 2005-004933-16
- Other IDs
- 2005
- Status last verified
- Oct 2011
- First submitted
- 23 Jan 2006
- Last updated
- 1 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Dose Simvastatine on Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00281476
- Acronym / sponsor ID
- 2005-004933-16
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, statins, bone
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Nov 2007 (actual)
- First posted
- 24 Jan 2006 (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.
The purpose of the study is to evaluate the effect of high doses of Simvastatine on bone metabolisme and biochemical markers of disease in Multiple Myeloma
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- multiple myeloma-patients in need of treatment
- stable og progressive disease
- age = or > 18 years
- performance status < 3
- life expectancy > 3 months
Key exclusion criteria (8 listed)
- pregnancy
- patients incapable of giving personally concent
- renal insufficiens with creatinine clearance below 25 ml/min
- alanin aminotransferasis > 2,5 x upper reference limit
- thyroxine below lower reference limit
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 |
|---|---|---|
| Simvastatine | Drug | – |
Primary outcome
Response estimated by internationally approved criteria after 8 weeks of intermittend treatment with simvastatine
Time frame: 8 weeks after treatment start
2 secondary outcomes
Changes in markers of bone metabolisme after 8 weeks of intermittend treatment with simvastatine
Time frame: 8 weeks after start of treatment
Toxicity according to CTC after 8 weeks of intermittend treatment with simvastatine
Time frame: 8 weeks after start of treatment
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 1 Nov 2011.
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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.
Torben Plesner, DMSc. principal investigator
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Simvastatine in people with Multiple Myeloma, run by Vejle Hospital.
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 8 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 1 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Response estimated by internationally approved criteria after 8 weeks of intermittend treatment with simvastatine (time frame: 8 weeks after treatment start). 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 1 Nov 2011.