MyelomaPhase 1NCT00164086
Atorvastatin in Myeloma
A Phase 1 study testing atorvastatin in people with Myeloma, run by Bayside Health at 1 site in Australia.
Trial summary
The purpose of this trial is to study the effects of a medication already widely used to treat cardiovascular disease and diabetes, in reducing the progression of myeloma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myeloma
- What is being tested?
- atorvastatin
- How many people
- Not given
- Where
- 1 siteAustralia
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Myeloma in remission
Who cannot join
- Adverse events (AEs) to statin, already on a statin, or contraindication to statin
Trial locations and contacts
1 site in 1 country.
Australia1 site
Alfred Hospital
Melbourne, Victoria, 3181
Jennifer Martin, MBChB, FRACP, 0405 341 676, jennifer.martin@med.monash.edu.au
About this study
The purpose of this trial is to study the effects of a medication already widely used to treat cardiovascular disease and diabetes, in reducing the progression of myeloma.
- Conditions
- Myeloma
- Being tested
- atorvastatin
- Medical subject headings
- Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Investigators
- Andrew Spencer, MBChB, FRACP, PhD, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164086
- Sponsor's protocol ID
- 7/04
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 11 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atorvastatin in Myeloma
- ClinicalTrials.gov ID
- NCT00164086
- Acronym / sponsor ID
- 7/04
- Conditions
- Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Bayside HealthOther government
- First posted
- 14 Sep 2005 (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 this trial is to study the effects of a medication already widely used to treat cardiovascular disease and diabetes, in reducing the progression of myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Myeloma in remission
Key exclusion criteria (1 listed)
- Adverse events (AEs) to statin, already on a statin, or contraindication to statin
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 |
|---|---|---|
| atorvastatin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2006.
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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.
Andrew Spencer, MBChB, FRACP, PhD principal investigator
The Alfred
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing atorvastatin in people with Myeloma, run by Bayside Health at 1 site in Australia.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Oct 2006. 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 Australia. 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. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Jennifer Martin, MBChB, FRACP (0405 341 676, jennifer.martin@med.monash.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 11 Oct 2006.