Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma

NCT00503763 | Withdrawn Phase 2

• 1 other identifier: PSMMSS-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to evaluate the effect of statin administration on the course of progressive Smoldering Multiple Myeloma.

Conditions

Smoldering Multiple Myeloma

Keywords

Smoldering multiple myeloma; Simvastatin; Paraprotein

Outcome Measures

Primary Outcomes (1)

• Paraprotein level

  18 months

Interventions

Simvastatin DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Meir Medical Center: lead

MeSH Terms

Conditions

Smoldering Multiple Myeloma

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Michael Lishner, MD

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2007
• First Posted: July 19, 2007
• Study Start: September 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: April 16, 2015

Record last verified: 2007-07