High dose simvastatin combined with standard chemotherapy in patients with refractory Multiple Myeloma: a phase II study.
Suspended
- Conditions
- multiple myeloma
- Registration Number
- NL-OMON20029
- Lead Sponsor
- The study is conducted on the department of hematology in het University Medical Center Utrecht. The study is approved by the Medical Ethical Board of this same hospital.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
1. Multiple myeloma patients;
2. At least two cycles of chemotherapy with adriamycin and dexamethasone;
Exclusion Criteria
1. Inadequate hepatic and renal function.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is response as defined by the EBMT criteria. This group of extensively pre-treated patients are multiresistent and we defined -based in literature- a respose of 10- 30% as reasonable.
- Secondary Outcome Measures
Name Time Method We recently performed a phase I study to define the maximum tolerated dose (MTD) and dose-limiting toxicity(DLT) (published in Haematologica 2006; 91:542-545) of high dose simvastatin, combined with VAD. Secondary outcome is to confirm the faesibility as shown in this phase I trial.<br>