Multiple Myelomatosis (MM). MedDRA version: 14.1 Level: LLT Classification code 10028569 Term: Myelomatosis multiple System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Alkeran 50mg Injection
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: MELPHALAN
CAS Number: 148-82-3
Other descriptive name: L-Phenylalanine Mustard
C
Sponsors
Department of Haematology, Aalborg University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Any patient who, • is set start a planned treatment for Multiple Myelomatosis (Newly diagnosed as well as relaps and refractory disease) with one of the following chemotherapy regimens: Highdose Alkeran (includes melphalan), or VEL-DEX/Velcade therapy alone (includes Bortezomib), or VEL-DEX/Dexaven therapy alone (Includes Dexaven). • is 18 years or older. • can understand and have the will to sign the informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 21 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 21
Exclusion criteria
Exclusion criteria: Any patient who, • have their planned treatment cancelled immediately prior to the experiment. • have received treatment with biphosphonates in the week prior to the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify the specific genes that is up- or downregulated in patiaents who receive a microdose of either Melphalan (Alkeran), Bortezomib (Velcade) or Dexamethasone (Dexaven).;Secondary Objective: Identify specific mechanisms of action and pathways for each individual drug, based on the genes found to be up- or down regulated during the experiment. Further, in the future, to combine results from this study with tecniques and use of biomarkers, in development of methods that can be used to predict the individual patient response to therapy.;Primary end point(s): To identify the specific genes that is up- or downregulated in patiaents who receive a microdose of either Melphalan (Alkeran), Bortezomib (Velcade) or Dexamethasone (Dexaven).;Timepoint(s) of evaluation of this end point: Before 01.12.2015 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Identify specific mechanisms of action and pathways for each individual drug, based on the genes found to be up- or down regulated during the experiment. Further, in the future, to combine results from this study with tecniques and use of biomarkers, in development of methods that can be used to predict the individual patient response to therapy. ;Timepoint(s) of evaluation of this end point: Before 01.12.2015 | — |
Countries
Denmark
Contacts
Public ContactClinical Research Unit
Henrik Gregersen, Department of Haematology, Aalborg University Hospital
Outcome results
None listed