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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR988 |
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Date of registration:
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24/05/2007 |
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Primary sponsor: |
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Public title:
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High dose simvastatin combined with standard chemotherapy in patients with refractory Multiple Myeloma: a phase II study.
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Scientific title:
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High dose simvastatin combined with standard chemotherapy in patients with refractory Multiple Myeloma: a phase II study. - High dose simvastatin combined with standard chemotherapy in patients with refractory Multiple Myeloma: a phase II study |
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Date of first enrolment:
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3/5/2005 |
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Target sample size:
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12 |
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Recruitment status: |
other |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=988 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: [default]; Control: Not applicable; Group: [default]; Type: [default]
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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E.
Spek, van der |
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Address:
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University Medical Center Utrecht
Dept of Hematology
P.O.Box 85500, Heidelberglaan 100
3508 AB
Utrecht
The Netherlands |
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Telephone:
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+31-30-2507655 |
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Email:
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e.vanderspek@umcutrecht.nl |
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Affiliation:
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Name:
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H.M.
Lokhorst |
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Address:
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University Medical Center Utrecht (UMCU),
Department of Hematology (B02.226),
P.O. Box 85500
3508 GA
Utrecht
The Netherlands |
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Telephone:
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+31 (0)88 7557230 |
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Email:
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h.lokhorst@umcutrecht.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Multiple myeloma (Kahler's disease)
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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04/239
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ISRCTN85384018
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Source(s) of Monetary Support
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Dutch Cancer Society, International myeloma foundation
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