drugset / Trial / NCT02109861

Microdose Study of Melphalan, Bortezomib and Dexamethasone

NCT02109861

Phase 0 Unknown 6 enrolled Henrik Gregersen
Non-randomizedSingle-groupOpen-labelBasic science

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.

Timeline

Start
2014-01
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 0.013 mg/m2 Intravenous
Subject Dexamethasone Small molecule 0.4 mg Intravenous
Subject Melphalan Small molecule 2 mg/m2 Intravenous

Indications