Microdose Study of Melphalan, Bortezomib and Dexamethasone

Multiple Myeloma Clinical Trial

— Phase-0-MM  

Official title:

Phase 0 Microdose Study to Evaluate the Effect of Melphalan, Bortezomib and Dexamethasone on Cellular Gene-expression in Patients With Multiple Myeloma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02109861
• Other study ID #: KFE2011.06
• Secondary ID: 2011-003791-37
• Status: Active, not recruiting
• Phase: Early Phase 1
• First received: January 15, 2014
• Last updated: December 4, 2015
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Melphalan
A microdose of 2 mg/m2 iv Melphalan (1% of standard dose) is given two hours prior to planned standard dose Melphalan
• 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
A microdose of 0.4 mg iv Dexamethasone (1% of standard dose) is given two hours prior to planned standard dose of Dexamethasone

Locations

Country	Name	City	State
Denmark	Department of Haematology, Aalborg University Hospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Henrik Gregersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in gene expression at 15, 30, 60, 120 minutes upon microdose drug exposure.	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.	Prior to microdose and 15, 30, 60 and 120 minutes post-microdose