No registrations found.
ID
Source
Brief title
Health condition
multiple myeloma
Sponsors and support
International myeloma foundation
Intervention
Outcome measures
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.
Background 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.
Study objective
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.
Study design
N/A
Intervention
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.
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
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
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL962 |
| NTR-old | NTR988 |
| Other | : 04/239 |
| ISRCTN | ISRCTN85384018 |