Microdose Study of Melphalan, Bortezomib and Dexamethasone

Early Phase 1

• Conditions: Multiple Myeloma
• Interventions: Drug: Melphalan; Drug: Bortezomib; Drug: Dexamethasone

• Registration Number: NCT02109861
• Lead Sponsor: Henrik Gregersen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-10
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-04
• Last Update Posted: 2015-12-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Melphalan	Melphalan	A microdose of 2 mg/m2 iv Melphalan (1% of standard dose) is given two hours prior to planned standard dose Melphalan
Bortezomib	Bortezomib	A microdose of 0.013 mg/m2 iv Bortezomib (1% of standard dose) is given two hours prior to planned standard dose Bortezomib
Dexamethasone	Dexamethasone	A microdose of 0.4 mg iv Dexamethasone (1% of standard dose) is given two hours prior to planned standard dose of Dexamethasone

Primary Outcome Measures

Name	Time	Method
Change from baseline in gene expression at 15, 30, 60, 120 minutes upon microdose drug exposure.	Prior to microdose and 15, 30, 60 and 120 minutes post-microdose	The primary outcome measure is determination of differential and significantly expressed genes across time successive samples from each individual patient. The analysis will be based on global gene expression profiling and differentially expressed genes will be identified using pairwise comparisons of samples means by two sample t-tests and corrections for multiple testing.

Trial Locations

Locations (1)

Department of Haematology, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark