search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


High dose simvastatin combined with standard chemotherapy in patients with refractory Multiple Myeloma: a phase II study.


- candidate number2602
- NTR NumberNTR988
- ISRCTNISRCTN85384018
- Date ISRCTN created27-jun-2007
- date ISRCTN requested11-jun-2007
- Date Registered NTR24-mei-2007
- Secondary IDs04/239 
- Public TitleHigh dose simvastatin combined with standard chemotherapy in patients with refractory Multiple Myeloma: a phase II study.
- Scientific TitleHigh dose simvastatin combined with standard chemotherapy in patients with refractory Multiple Myeloma: a phase II study.
- ACRONYMHigh dose simvastatin combined with standard chemotherapy in patients with refractory Multiple Myeloma: a phase II study
- hypothesisSimvastatin (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) studiedMultiple myeloma (Kahler's disease)
- Inclusion criteria1. Multiple myeloma patients;
2. At least two cycles of chemotherapy with adriamycin and dexamethasone;
3. age < 75 y.
- Exclusion criteria1. Inadequate hepatic and renal function.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 3-mei-2005
- planned closingdate14-sep-2006
- Target number of participants12
- InterventionsTreatment 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 outcomeThe 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 outcomeWe 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.
- TimepointsN/A
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIES E. Spek, van der
- CONTACT for SCIENTIFIC QUERIESDhr. 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 summaryIn 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)
- RECORD24-mei-2007 - 27-okt-2010


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl