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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003791-37 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melphalan | Experimental | A microdose of 2 mg/m2 iv Melphalan (1% of standard dose) is given two hours prior to planned standard dose Melphalan |
|
| Bortezomib | Experimental | A microdose of 0.013 mg/m2 iv Bortezomib (1% of standard dose) is given two hours prior to planned standard dose Bortezomib |
|
| Dexamethasone | Experimental | A microdose of 0.4 mg iv Dexamethasone (1% of standard dose) is given two hours prior to planned standard dose of Dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melphalan | Drug | A microdose of 2 mg/m2 iv Melphalan (1% of standard dose) is given two hours prior to planned standard dose Melphalan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in gene expression at 15, 30, 60, 120 minutes upon microdose drug exposure. | 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. | Prior to microdose and 15, 30, 60 and 120 minutes post-microdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henrik Gregersen, MD, PhD | Aalborg University Hospital, Department of Haematology, 9000 Aalborg, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Haematology, Aalborg University Hospital | Aalborg | 9000 | Denmark |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 2, 2017 | |
| Reset | Feb 1, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 2, 2017 | Feb 1, 2018 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D008558 | Melphalan |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
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| Bortezomib | Drug | A microdose of 0.013 mg/m2 iv Bortezomib (1% of standard dose) is given two hours prior to planned standard dose Bortezomib |
|
|
| Dexamethasone | Drug | A microdose of 0.4 mg iv Dexamethasone (1% of standard dose) is given two hours prior to planned standard dose of Dexamethasone |
|
|
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |