Microdose Study of Melphalan, Bortezomib and Dexamethasone
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Multiple Myeloma, Phase 0 study, Microdose study, Micro array, Gene expression profiling
Study Type
Interventional
Study Phase
Phase 0
Study Design
Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Intervention
Name: Melphalan Type: Drug
Name: Bortezomib Type: Drug
Name: Dexamethasone Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Department of Haematology, Aalborg University Hospital
Aalborg, Denmark
Status: Recruiting
Start Date
January 2014
Completion Date
December 2015
Sponsors
Henrik Gregersen
Source
Aalborg Universitetshospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page