Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Phase 0 study, Microdose study, Micro array, Gene expression profiling
Brief summary
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.
Interventions
DRUGMelphalan
A microdose of 2 mg/m2 iv Melphalan (1% of standard dose) is given two hours prior to planned standard dose Melphalan
DRUGBortezomib
A microdose of 0.013 mg/m2 iv Bortezomib (1% of standard dose) is given two hours prior to planned standard dose Bortezomib
DRUGDexamethasone
A microdose of 0.4 mg iv Dexamethasone (1% of standard dose) is given two hours prior to planned standard dose of Dexamethasone
Sponsors
Henrik Gregersen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in gene expression at 15, 30, 60, 120 minutes upon microdose drug exposure. | Prior to microdose and 15, 30, 60 and 120 minutes post-microdose | The primary outcome measure is determination of differential and significantly expressed genes across time successive samples from each individual patient. The analysis will be based on global gene expression profiling and differentially expressed genes will be identified using pairwise comparisons of samples means by two sample t-tests and corrections for multiple testing. |
Countries
Denmark
Outcome results
None listed