Prognostic Study of Markers of Angiogenesis and Coagulability in Patients With Monoclonal Gammopathy (PACMoG)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01543100
First received: August 23, 2011
Last updated: January 3, 2014
Last verified: January 2014

August 23, 2011
January 3, 2014
November 2010
January 2014   (final data collection date for primary outcome measure)
  • Blood levels of CEC and its progenitors [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Blood levels of CEC and its progenitors
  • Blood levels of soluble parameters of angiogenesis and of coagulability [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Blood levels of soluble parameters of angiogenesis and of coagulability
  • Blood levels of microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak). [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Blood levels of microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak).
Same as current
Complete list of historical versions of study NCT01543100 on ClinicalTrials.gov Archive Site
  • Bone marrow levels of endothelial cells and its progenitors [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Bone marrow levels of endothelial cells and its progenitors
  • Bone Marrow levels of soluble parameters of angiogenesis and of coagulability [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Bone Marrow levels of soluble parameters of angiogenesis and of coagulability
  • Bone Marrow levels of microparticles versus classical indicators of tumoral growth of monoclonal gamopathies (beta2-mcicroglobulin and Ig peak). [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Bone Marrow levels of microparticles versus classical indicators of tumoral growth of monoclonal gamopathies (beta2-mcicroglobulin and Ig peak).
Same as current
Not Provided
Not Provided
 
Prognostic Study of Markers of Angiogenesis and Coagulability in Patients With Monoclonal Gammopathy
Prognostic Study of Markers of Angiogenesis and Coagulability in Patients With Monoclonal Gammopathy

Blood circulating endothelial cells (CEC) and microparticles (MPs) are described in the literature to be associated with vascular failures and dysfunction that reflect neo-angiogenesis and risk of thrombosis, respectively. There a few number of CEC in healthy patients although they significantly increase in several cancers including myeloma. However, no study explored to date a correlation of CEC and/or circulating endothelial progenitors (CEP) and MPs with the tumoral growth of monoclonal gammopathy. On the other hand, there is no study measuring the CEC and CEP directly in the bone marrow. The investigators aim is to evaluate these 2 original features in patients with monoclonal gammopathy: monoclonal gammopathy of undetermined signification (MGUS) and myeloma. This is a preliminary multicentric study.

Principal objective : Research of a correlation of blood CEC and MPs with the tumoral volume and the clinico-biological staging of monoclonal gammopathies.

Secondary objectives : Research of a correlation of bone marrow endothelial cells and MPs, both measured by flow cytometry, with the tumoral volume and the clinico-biological staging of monoclonal gammopathies.

Principal analyses : Blood levels of CEC and its progenitors, soluble parameters of angiogenesis and of coagulability, and microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak).

Secondary analyses : Bone marrow levels of endothelial cells and its progenitors, soluble parameters of angiogenesis and of coagulability, and microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak).

Methodology : PACMoG is an interventional, prospective and multicentric pilot study. Biologic parameters will be determined at the diagnosis of monoclonal gammopathy. Results will be compared to the monoclonal gammopathy international staging and the clinical follow-up.

Procedures : Specific tests of the study will be realized from :

  • Blood samples: 2 EDTA tubes and 1 tube without anticoagulant per included patient.
  • Bone marrow: 3 ml collected during of myelogram punction made for the diagnosis.

In all cases, no additional sampling will be performed.

Specific analyses :

- Specific biological assays in blood and bone marrow will be:

  • Endothelial and progenitor cells levels
  • Number and cellular origin of MPSs
  • Levels of phospholipid-dependant coagulability
  • Soluble parameters of angiogenesis (VEGF, soluble CD146, endostatin)
  • Soluble parameters of coagulability (Levels of thrombomodulin, tissue factor and D-Dimer)
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Monoclonal Gammopathy
  • Monoclonal Gammopathy of Undetermined Signification
  • Myeloma
Other: blood and bone marrow samples

Specific tests of the study will be realized from :

  • Blood samples: 2 EDTA tubes and 1 tube without anticoagulant per included patient.
  • Bone marrow: 3 ml collected during of myelogram punction made for the diagnosis.

In all cases, no additional sampling will be performed.

Experimental: monoclonal gamopathy

Patients with monoclonal gammopathy either MGUS or myeloma at diagnosis or more than 3 months after a first myeloma treatment with chemotherapy and/or antiangiogenic drugs.

  • Patient's age ≥18 yo,
  • Patients having signed the specific consent of the study.
Intervention: Other: blood and bone marrow samples
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with monoclonal gammopathy either MGUS or myeloma at diagnosis or more than 3 months after a first myeloma treatment with chemotherapy and/or antiangiogenic drugs.
  • Patient's age ≥ 18 years old,
  • Patients having signed the specific consent of the study.

Exclusion Criteria:

  • Treatment with chemotherapy and/or antiangiogenic drugs at the inclusion
  • Age < 18 years old
  • No specific consent of the study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01543100
LOC/10-02 - PACMoG, 2010-A00378-31, B100413-10, 10/16-758
No
Rennes University Hospital
Rennes University Hospital
Not Provided
Principal Investigator: Benoît GUILLET, MD Rennes University Hospital
Rennes University Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP