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

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ClinicalTrials.gov Identifier: NCT02109861
Recruitment Status : Unknown
Verified December 2015 by Henrik Gregersen, Aalborg University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 10, 2014
Last Update Posted : December 8, 2015
Sponsor:
Information provided by (Responsible Party):
Henrik Gregersen, Aalborg University Hospital

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Melphalan Drug: Bortezomib Drug: Dexamethasone Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : January 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: Melphalan
A microdose of 2 mg/m2 iv Melphalan (1% of standard dose) is given two hours prior to planned standard dose Melphalan
Drug: Melphalan
A microdose of 2 mg/m2 iv Melphalan (1% of standard dose) is given two hours prior to planned standard dose Melphalan
Other Name: Alkeran®

Experimental: Bortezomib
A microdose of 0.013 mg/m2 iv Bortezomib (1% of standard dose) is given two hours prior to planned standard dose Bortezomib
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
Other Name: Velcade®

Experimental: Dexamethasone
A microdose of 0.4 mg iv Dexamethasone (1% of standard dose) is given two hours prior to planned standard dose of Dexamethasone
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
Other Name: Dexaven®)




Primary Outcome Measures :
  1. 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 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109861


Locations
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Denmark
Department of Haematology, Aalborg University Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
Henrik Gregersen
Investigators
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Principal Investigator: Henrik Gregersen, MD, PhD Aalborg University Hospital, Department of Haematology, 9000 Aalborg, Denmark
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Responsible Party: Henrik Gregersen, Consultant haematologist, MD, PhD, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT02109861    
Other Study ID Numbers: KFE2011.06
2011-003791-37 ( EudraCT Number )
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015
Keywords provided by Henrik Gregersen, Aalborg University Hospital:
Multiple Myeloma
Phase 0 study
Microdose study
Micro array
Gene expression profiling
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Bortezomib
Melphalan
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents