Back to resultsEfficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma (PSMMSS)
Primary Purpose
Smoldering Multiple Myeloma
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Smoldering Multiple Myeloma focused on measuring Smoldering multiple myeloma, Simvastatin, Paraprotein
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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
Sites / Locations
Outcomes
Primary Outcome Measures
Paraprotein level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00503763
Brief Title
Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma
Acronym
PSMMSS
Official Title
Open -Label Phase IIa Trial of the Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Withdrawn
Why Stopped
We found out that there is another study on the same issue
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2009 (Anticipated)
Study Completion Date
March 2009 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoldering Multiple Myeloma
Keywords
Smoldering multiple myeloma, Simvastatin, Paraprotein
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Primary Outcome Measure Information:
Title
Paraprotein level
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Lishner, MD
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma
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