Smoldering Multiple MyelomaPhase 2PSMMSSNCT00503763
Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma
A Phase 2 study testing Simvastatin in people with Smoldering Multiple Myeloma, run by Meir Medical Center.
Trial summary
The aim of the study is to evaluate the effect of statin administration on the course of progressive Smoldering Multiple Myeloma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Smoldering Multiple Myeloma
- What is being tested?
- Simvastatin
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Mar 2009
- Phase
- Phase 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients fulfilling the criteria of SMM. (see Appendix I)
- Patients with progressive smoldering Myeloma. (see Appendix II)
- Age 18-80 years.
- Signed informed consent prior to patient recruitment.
Who cannot join
- Patients fulfilling diagnostic criteria of active MM .(see Appendix I)
- Patients fulfilling diagnostic criteria of: solitary myeloma or non secreting myeloma or oligosecretory myeloma or light chain myeloma.
- Patients on statin treatment on the day of recruitment.
- Patients on chemotherapy or receiving steroids.
- Patients with any contraindication to statin treatment:
- Known intolerance or hypersensitivity to statin.
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- SGOT or SGPT above 1.5 times of upper normal level (UNL).
- CPK above UNL
- Concomitant treatment with macrolides and or antifungal agents (ketoconazole)
- Creatinine level above 1.5 mg%
- Any severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
- Patients with second primary malignancy (except for non melanoma skin malignancy) unless they have been disease free for at least five years.
- Patients who have a history of alcohol or drug abuse.
- Patients who are mentally or physically unable to comply with all aspects of the study.
- Participation to an investigational drug trial
About this study
Official title: Open -Label Phase IIa Trial of the Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma
The aim of the study is to evaluate the effect of statin administration on the course of progressive Smoldering Multiple Myeloma.
Read the detailed description
In vitro data indicate that statins affect myeloma cells, mainly by inducing cell death and growth suppression.
This is a national, multicenter, phase IIa, single arm (not controlled), open label clinical trial of Simvastatin 80mg p.o. /day in a population of patients with progressive SMM. Patients will be treated with Simvastatin 40 mg and if no side effect will be seen the dose will be escalated to 80 mg for up to 18 months. All further treatment decisions after completion of the study are at the discretion of the investigator.Approximately 15 patients will be enrolled.
- Conditions
- Smoldering Multiple Myeloma
- Being tested
- Simvastatin
- Keywords
- Smoldering multiple myeloma, Simvastatin, Paraprotein
- Medical subject headings
- Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Paraprotein level
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2009 (estimated)
- Study completionMar 2009 (estimated)
Why it stopped: We found out that there is another study on the same issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoldering 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Lishner, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503763
- Sponsor's protocol ID
- PSMMSS-01
- Acronym
- PSMMSS
- Status last verified
- Jul 2007
- First submitted
- 18 Jul 2007
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open -Label Phase IIa Trial of the Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00503763
- Acronym / sponsor ID
- PSMMSS / PSMMSS-01
- Conditions
- Smoldering Multiple Myeloma
- Keywords
- Smoldering multiple myeloma, Simvastatin, Paraprotein
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We found out that there is another study on the same issue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 19 Jul 2007 (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 aim of the study is to evaluate the effect of statin administration on the course of progressive Smoldering Multiple Myeloma.
Detailed description
In vitro data indicate that statins affect myeloma cells, mainly by inducing cell death and growth suppression.
This is a national, multicenter, phase IIa, single arm (not controlled), open label clinical trial of Simvastatin 80mg p.o. /day in a population of patients with progressive SMM. Patients will be treated with Simvastatin 40 mg and if no side effect will be seen the dose will be escalated to 80 mg for up to 18 months. All further treatment decisions after completion of the study are at the discretion of the investigator.Approximately 15 patients will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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 (4 listed)
- Patients fulfilling the criteria of SMM. (see Appendix I)
- Patients with progressive smoldering Myeloma. (see Appendix II)
- Age 18-80 years.
- Signed informed consent prior to patient recruitment.
Key exclusion criteria (15 listed)
- Patients fulfilling diagnostic criteria of active MM .(see Appendix I)
- Patients fulfilling diagnostic criteria of: solitary myeloma or non secreting myeloma or oligosecretory myeloma or light chain myeloma.
- Patients on statin treatment on the day of recruitment.
- Patients on chemotherapy or receiving steroids.
- Patients with any contraindication to statin treatment:
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 |
|---|---|---|
| Simvastatin | Drug | – |
Primary outcome
Paraprotein level
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
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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.
Michael Lishner, MD principal investigator
Meir Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simvastatin in people with Smoldering Multiple Myeloma, run by Meir Medical Center.
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 4 inclusion and 15 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: withdrawn, as of the sponsor's last update on 16 Apr 2015. 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 phase mean?
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 was withdrawn before enrolling participants, so there are no results.
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?
Paraprotein level (time frame: 18 months). 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 16 Apr 2015.