Comparison of Pharmacokinetics and Pharmacodynamics of Subcutaneous Versus Intravenous Administration of Bortezomib in Patients With Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00291538|
Recruitment Status : Completed
First Posted : February 14, 2006
Last Update Posted : February 4, 2009
In this open-label randomised phase I trial, bortezomib will be administrated to 2 groups of 10 patients with MM who have inclusion criteria use the extended 2nd line indication, either intravenously (group 1 = 10 patients) or subcutaneously (group 2 = 10 patients). The schedule of administration of bortezomib will be the following : 1.3 mg per square meter of body-surface area twice weekly for 2 weeks, followed by 1 week without treatment, for up to eight cycles, either IV (group 1) or SC (group 2).
The primary objective is to characterize the pharmacokinetics of the 2 routes of administration.
The secondary objectives are to characterize the pharmacodynamics (20S proteasome inhibition in whole blood), toxicity, including cardiac safety, and efficacy of the 2 routes of administration.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: bortezomib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Pharmacokinetics and Pharmacodynamics of Subcutaneous Versus Intravenous Administration of Bortezomib in Patients With Multiple Myeloma|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||October 2008|
- characterize the pharmacokinetics of the 2 routes of administration.
- characterize the pharmacodynamics (20S proteasome inhibition in whole blood),
- toxicity, including cardiac safety,
- efficacy of the 2 routes of administration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291538
|Lille, France, 59000|
|Nancy, France, 54000|
|Nantes, France, 44093|
|Principal Investigator:||Jean-Luc HAROUSSEAU, MD||Nantes UH|