| - candidate number | 2602 |
| - NTR Number | NTR988 |
| - ISRCTN | ISRCTN85384018 |
| - Date ISRCTN created | 27-jun-2007 |
| - date ISRCTN requested | 11-jun-2007 |
| - Date Registered NTR | 24-mei-2007 |
| - Secondary IDs | 04/239 |
| - Public Title | High dose simvastatin combined with standard chemotherapy in patients with refractory Multiple Myeloma: a phase II study. |
| - Scientific Title | High dose simvastatin combined with standard chemotherapy in patients with refractory Multiple Myeloma: a phase II study. |
| - ACRONYM | High dose simvastatin combined with standard chemotherapy in patients with refractory Multiple Myeloma: a phase II study |
| - hypothesis | Simvastatin (an HMG-CoA reductase inhibitor) induces apoptosis in vitro and sensitizes the myeloma cell to chemotherapy. This is the first clinical trial to test if in vivo there is the same sensitization in relapse or refractory multiple myeloma. |
| - Healt Condition(s) or Problem(s) studied | Multiple myeloma (Kahler's disease) |
| - Inclusion criteria | 1. Multiple myeloma patients; 2. At least two cycles of chemotherapy with adriamycin and dexamethasone; 3. age < 75 y. |
| - Exclusion criteria | 1. Inadequate hepatic and renal function. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | no |
| - group | [default] |
| - Type | [default] |
| - Studytype | intervention |
| - planned startdate | 3-mei-2005 |
| - planned closingdate | 14-sep-2006 |
| - Target number of participants | 12 |
| - 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 7-11 (Vincristin, adriamycin, dexamethasone)chemotherapy in a scheme as used in HOVON trials (eg HOVON 65). On day 29 a new cycle is started. Patients are treated with 3 cycles. An additional cycle can be given in case of response (MR, PR ,CR). In case of progressive disease during treatment, the therapy is ended. |
| - Primary outcome | 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 | 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. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped |
| - CONTACT FOR PUBLIC QUERIES | E. Spek, van der |
| - CONTACT for SCIENTIFIC QUERIES | Dhr. Prof. Dr. H.M. Lokhorst |
| - Sponsor/Initiator | University Medical Center Utrecht (UMCU), Department of Hematology |
| - Funding (Source(s) of Monetary or Material Support) | Dutch Cancer Society, International myeloma foundation |
| - Publications | |
| - Brief summary | In a prospective fase II study, we evaluated the combination of high dose simvastatin and VAD chemotherapy in patients with refractory or relapsed multiple myeloma. Although treatment was feasible with mild side effects, we found that after treatment of 12 patients, only 1 patient achieved a partial response. According to our predefined criteria this was insufficient to continue the study. |
| - Main changes (audit trail) | |
| - RECORD | 24-mei-2007 - 27-okt-2010 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl