Overview

Microdose Study of Melphalan, Bortezomib and Dexamethasone

Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Henrik Gregersen
Treatments:
BB 1101
Bortezomib
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Melphalan
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