multiple myeloma
Conditions
Interventions
Treatment of relapsed/ refractory multiple myeloma patients with high dose statins, combined with chemotherapy. We treat multiple myeloma patients with 15 mg/kg simvastatin Day 0-7 followed by VAD day
Sponsors
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.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Multiple myeloma patients; 2. At least two cycles of chemotherapy with adriamycin and dexamethasone; 3. age < 75 y.
Exclusion criteria
Exclusion criteria: 1. Inadequate hepatic and renal function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactE. Spek, van der
University Medical Center Utrecht Dept of Hematology P.O.Box 85500
Outcome results
None listed