Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments melphalan, bortezomib, dexamethasone
Phase phase 0
Target proteasome
Sponsor Henrik Gregersen
Start date January 2014
End date December 2015
Trial size 6 participants
Trial identifier NCT02109861, 2011-003791-37, KFE2011.06

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification bio-availability study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
A microdose of 2 mg/m2 iv Melphalan (1% of standard dose) is given two hours prior to planned standard dose Melphalan
melphalan Alkeran®
A microdose of 2 mg/m2 iv Melphalan (1% of standard dose) is given two hours prior to planned standard dose Melphalan
(Experimental)
A microdose of 0.013 mg/m2 iv Bortezomib (1% of standard dose) is given two hours prior to planned standard dose Bortezomib
bortezomib Velcade®
A microdose of 0.013 mg/m2 iv Bortezomib (1% of standard dose) is given two hours prior to planned standard dose Bortezomib
(Experimental)
A microdose of 0.4 mg iv Dexamethasone (1% of standard dose) is given two hours prior to planned standard dose of Dexamethasone
dexamethasone Dexaven®)
A microdose of 0.4 mg iv Dexamethasone (1% of standard dose) is given two hours prior to planned standard dose of Dexamethasone

Primary Outcomes

Measure
Change from baseline in gene expression at 15, 30, 60, 120 minutes upon microdose drug exposure.
time frame: Prior to microdose and 15, 30, 60 and 120 minutes post-microdose

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase 0 Microdose Study to Evaluate the Effect of Melphalan, Bortezomib and Dexamethasone on Cellular Gene-expression in Patients With Multiple Myeloma
Principal investigator Henrik Gregersen, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Aalborg Universitetshospital.