High dose simvastatin combined with standard chemotherapy in patients with refractory Multiple Myeloma: a phase II study
ISRCTN | ISRCTN85384018 |
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DOI | https://doi.org/10.1186/ISRCTN85384018 |
Secondary identifying numbers | 04/239, NL962 (NTR988) |
- Submission date
- 27/06/2007
- Registration date
- 27/06/2007
- Last edited
- 27/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr E. van der Spek
Scientific
Scientific
University Medical Centre Utrecht
Department of Hematology
P.O. Box 85500
Utrecht
3508 AB
Netherlands
Phone | +31 (0)30 250 7655 |
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e.vanderspek@umcutrecht.nl |
Study information
Study design | Prospective phase II feasibility study |
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Primary study design | Interventional |
Secondary study design | Single-centre |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | High dose simvastatin combined with standard chemotherapy in patients with refractory Multiple Myeloma: a phase II study |
Study objectives | Simvastatin (an Hydroxymethylglutaryl-coenzyme A [HMG-CoA] reductase inhibitor) induces apoptosis in vitro and sensitises the myeloma cell to chemotherapy. This is the first clinical trial to test if in vivo there is the same sensitisation in relapse or refractory multiple myeloma. |
Ethics approval(s) | Received from the METC Medisch Ethische Toetsingscommissie on the 3rd May 2005 (ref: 04/239-E). |
Health condition(s) or problem(s) studied | Multiple myeloma |
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 (e.g., HOVON 65; ISRCTN64455289). On day 29 a new cycle is started. Patients are treated with three 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. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase II |
Drug / device / biological / vaccine name(s) | Simvastatin, chemotherapy (vincristin, adriamycin, dexamethasone) |
Primary outcome measure | The primary endpoint is response as defined by the European Group for Blood and Marrow Transplantation (EBMT) criteria. This group of extensively pre-treated patients are multi-resistant and we defined - based in literature - a response of 10 - 30% as reasonable. The primary endpoint (response) is measured during and after the trial by measurement of the M-protein measured in serum (an excellent tumour marker in multiple myeloma). After every cycle of 29 days M-protein will be measured. The M-protein will then be measured monthly until disease progression. |
Secondary outcome measures | 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. The secondary outcome of this trial is to confirm the feasibility as shown in the previous phase I trial. |
Overall study start date | 03/05/2005 |
Completion date | 14/09/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Not Specified |
Target number of participants | 12 |
Total final enrolment | 12 |
Key inclusion criteria | 1. Multiple myeloma patients 2. At least two cycles of chemotherapy with adriamycin and dexamethasone 3. Aged less than 75 years |
Key exclusion criteria | 1. Inadequate hepatic and renal function |
Date of first enrolment | 03/05/2005 |
Date of final enrolment | 14/09/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht
Utrecht
3508 AB
Netherlands
3508 AB
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Haematology
P.O. Box 85500
Utrecht
3508 GA
Netherlands
Website | http://www.umcutrecht.nl/zorg/ |
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https://ror.org/04pp8hn57 |
Funders
Funder type
Research organisation
Dutch Cancer Society (The Netherlands)
No information available
International Myeloma Foundation (USA)
Government organisation / Trusts, charities, foundations (both public and private)
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Myeloma, Intl. Myeloma Foundation, IMF
- Location
- United States of America
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Protocol article | Protocol | 01/12/2006 | Yes | No | |
Results article | 01/12/2007 | 27/10/2021 | Yes | No |
Editorial Notes
27/10/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.