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Microdose Study of Melphalan, Bortezomib and Dexamethasone

NCT ID: NCT02109861

Last Updated: 2015-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Melphalan

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

Group Type EXPERIMENTAL

Melphalan

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Bortezomib

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

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

Interventions

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Melphalan

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

Bortezomib

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

Dexamethasone

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

Other Intervention Names

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Alkeran® Velcade® Dexaven®)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henrik Gregersen

OTHER

Sponsor Role lead

Responsible Party

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Henrik Gregersen

Consultant haematologist, MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Henrik Gregersen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital, Department of Haematology, 9000 Aalborg, Denmark

Locations

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Department of Haematology, Aalborg University Hospital

Aalborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2011-003791-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

KFE2011.06

Identifier Type: -

Identifier Source: org_study_id