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.
ID
Bron
Verkorte titel
Aandoening
multiple myeloma
Ondersteuning
International myeloma foundation
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Publiek
Dept of Hematology
P.O.Box 85500
E. Spek, van der
Heidelberglaan 100
Utrecht 3508 AB
The Netherlands
+31-30-2507655
e.vanderspek@umcutrecht.nl
Wetenschappelijk
Dept of Hematology
P.O.Box 85500
E. Spek, van der
Heidelberglaan 100
Utrecht 3508 AB
The Netherlands
+31-30-2507655
e.vanderspek@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Multiple myeloma patients;
2. At least two cycles of chemotherapy with adriamycin and dexamethasone;
3. age < 75 y.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Inadequate hepatic and renal function.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL962 |
| NTR-old | NTR988 |
| Ander register | : 04/239 |
| ISRCTN | ISRCTN85384018 |