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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
History of Changes
  Purpose

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.


Condition Intervention
Monoclonal Gammopathy
Monoclonal Gammopathy of Undetermined Signification
Myeloma
 Other: blood and bone marrow samples

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Prognostic Study of Markers of Angiogenesis and Coagulability in Patients With Monoclonal Gammopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).
Enrollment: 60
Study Start Date: November 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.

Detailed Description:

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)
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543100

Locations
France
Rennes University Hospital
Rennes, Bretagne, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Benoît GUILLET, MD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01543100     History of Changes
Other Study ID Numbers: LOC/10-02 - PACMoG, 2010-A00378-31, B100413-10, 10/16-758
Study First Received: August 23, 2011
Last Updated: January 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Rennes University Hospital:
MGUS

Additional relevant MeSH terms:
Monoclonal Gammopathy of Undetermined Significance
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
 Hypergammaglobulinemia
Immune System Diseases
Immunoproliferative Disorders

ClinicalTrials.gov processed this record on March 01, 2015