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Microdose Study of Melphalan, Bortezomib and Dexamethasone (Phase-0-MM)

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Melphalan
Bortezomib
Dexamethasone
Sponsored by
Henrik Gregersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Multiple Myeloma focused on measuring Multiple Myeloma, Phase 0 study, Microdose study, Micro array, Gene expression profiling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Haematology, Aalborg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Melphalan

Bortezomib

Dexamethasone

Arm Description

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

A microdose of 0.013 mg/m2 iv Bortezomib (1% of standard dose) is given two hours prior to planned standard dose Bortezomib

A microdose of 0.4 mg iv Dexamethasone (1% of standard dose) is given two hours prior to planned standard dose of Dexamethasone

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 15, 2014
Last Updated
December 4, 2015
Sponsor
Henrik Gregersen
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1. Study Identification

Unique Protocol Identification Number
NCT02109861
Brief Title
Microdose Study of Melphalan, Bortezomib and Dexamethasone
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Henrik Gregersen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Phase 0 study, Microdose study, Micro array, Gene expression profiling

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melphalan
Arm Type
Experimental
Arm Description
A microdose of 2 mg/m2 iv Melphalan (1% of standard dose) is given two hours prior to planned standard dose Melphalan
Arm Title
Bortezomib
Arm Type
Experimental
Arm Description
A microdose of 0.013 mg/m2 iv Bortezomib (1% of standard dose) is given two hours prior to planned standard dose Bortezomib
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
A microdose of 0.4 mg iv Dexamethasone (1% of standard dose) is given two hours prior to planned standard dose of Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Melphalan
Other Intervention Name(s)
Alkeran®
Intervention Description
A microdose of 2 mg/m2 iv Melphalan (1% of standard dose) is given two hours prior to planned standard dose Melphalan
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade®
Intervention Description
A microdose of 0.013 mg/m2 iv Bortezomib (1% of standard dose) is given two hours prior to planned standard dose Bortezomib
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Dexaven®)
Intervention Description
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 Measure Information:
Title
Change from baseline in gene expression at 15, 30, 60, 120 minutes upon microdose drug exposure.
Description
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.
Time Frame
Prior to microdose and 15, 30, 60 and 120 minutes post-microdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Gregersen, MD, PhD
Organizational Affiliation
Aalborg University Hospital, Department of Haematology, 9000 Aalborg, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Haematology, Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Microdose Study of Melphalan, Bortezomib and Dexamethasone

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