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

Myeloma Clinical Trial

— PACMoG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543100
• Other study ID #: LOC/10-02 - PACMoG
• Secondary ID: 2010-A00378-31B1
• Status: Completed
• Phase: N/A
• First received: August 23, 2011
• Last updated: January 3, 2014
• Start date: November 2010
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Monoclonal Gammopathy
• Monoclonal Gammopathy of Undetermined Significance
• Monoclonal Gammopathy of Undetermined Signification
• Myeloma
• Paraproteinemias

Intervention

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.

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood levels of CEC and its progenitors	Blood levels of CEC and its progenitors	Day 1	No
Primary	Blood levels of soluble parameters of angiogenesis and of coagulability	Blood levels of soluble parameters of angiogenesis and of coagulability	Day 1	No
Primary	Blood levels of microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak).	Blood levels of microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak).	Day 1	No
Secondary	Bone marrow levels of endothelial cells and its progenitors	Bone marrow levels of endothelial cells and its progenitors	Day 1	No
Secondary	Bone Marrow levels of soluble parameters of angiogenesis and of coagulability	Bone Marrow levels of soluble parameters of angiogenesis and of coagulability	Day 1	No
Secondary	Bone Marrow levels of microparticles versus classical indicators of tumoral growth of monoclonal gamopathies (beta2-mcicroglobulin and Ig peak).	Bone Marrow levels of microparticles versus classical indicators of tumoral growth of monoclonal gamopathies (beta2-mcicroglobulin and Ig peak).	Day 1	No