Microdose Study of Melphalan, Bortezomib and Dexamethasone
This trial is active, not recruiting.
|Treatments||melphalan, bortezomib, dexamethasone|
|Start date||January 2014|
|End date||December 2015|
|Trial size||6 participants|
|Trial identifier||NCT02109861, 2011-003791-37, KFE2011.06|
The purpose of the study is to identify specific genes that are up- or downregulated in multiple myeloma patients who receive a microdose of either Melphalan (Alkeran®), Bortezomib (Velcade®) or Dexamethasone (Dexaven®). The study treatment constitutes 1% of the planned standard myeloma treatment and will be given two hours prior to standard treatment. Blood samples are taken at baseline, 15, 30, 60 and 120 minutes for microarray analysis.
|Endpoint classification||bio-availability study|
|Intervention model||single group assignment|
|Primary purpose||basic science|
Change from baseline in gene expression at 15, 30, 60, 120 minutes upon microdose drug exposure.
time frame: Prior to microdose and 15, 30, 60 and 120 minutes post-microdose
Male or female participants at least 18 years old.
Inclusion Criteria: - Planned treatment for Multiple Myeloma (newly diagnosed as well as relapse and refractory disease) with one of the following chemotherapy regimens: 1) Highdose melphalan, 2) Bortezomib or 3) Dexamethasone - 18 years or older. - Understand and have the will to sign the informed consent. Exclusion Criteria: - Prior treatment with the study drug - Received treatment with biphosphonates in the week prior to study treatment
|Official title||Phase 0 Microdose Study to Evaluate the Effect of Melphalan, Bortezomib and Dexamethasone on Cellular Gene-expression in Patients With Multiple Myeloma|
|Principal investigator||Henrik Gregersen, MD, PhD|
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