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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Monoclonal Gammopathy; Monoclonal Gammopathy of Undetermined Signification; Myeloma	Other: blood and bone marrow samples	Not Applicable

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)

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Basic Science
Official Title:	Prognostic Study of Markers of Angiogenesis and Coagulability in Patients With Monoclonal Gammopathy
Study Start Date :	November 2010
Actual Primary Completion Date :	January 2014
Actual Study Completion Date :	January 2014

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Blood levels of CEC and its progenitors [ Time Frame: Day 1 ]
   Blood levels of CEC and its progenitors
2. Blood levels of soluble parameters of angiogenesis and of coagulability [ Time Frame: Day 1 ]
   Blood levels of soluble parameters of angiogenesis and of coagulability
3. Blood levels of microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak). [ Time Frame: Day 1 ]
   Blood levels of microparticles versus classical indicators of tumoral growth of monoclonal gammopathies (beta2-microglobulin and Ig peak).

Secondary Outcome Measures :

1. Bone marrow levels of endothelial cells and its progenitors [ Time Frame: Day 1 ]
   Bone marrow levels of endothelial cells and its progenitors
2. Bone Marrow levels of soluble parameters of angiogenesis and of coagulability [ Time Frame: Day 1 ]
   Bone Marrow levels of soluble parameters of angiogenesis and of coagulability
3. Bone Marrow levels of microparticles versus classical indicators of tumoral growth of monoclonal gamopathies (beta2-mcicroglobulin and Ig peak). [ Time Frame: Day 1 ]
   Bone Marrow levels of microparticles versus classical indicators of tumoral growth of monoclonal gamopathies (beta2-mcicroglobulin and Ig peak).

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Rennes University Hospital
ClinicalTrials.gov Identifier:	NCT01543100 History of Changes
Other Study ID Numbers:	LOC/10-02 - PACMoG; 2010-A00378-31 ( Other Identifier: ID RCB ); B100413-10 ( Other Identifier: AFSSAPS ); 10/16-758 ( Other Identifier: CPP Rennes )
First Posted:	March 2, 2012
Last Update Posted:	January 6, 2014
Last Verified:	January 2014

Keywords provided by Rennes University Hospital:

MGUS

Additional relevant MeSH terms:

Paraproteinemias; Monoclonal Gammopathy of Undetermined Significance; Blood Protein Disorders; Hematologic Diseases	Immunoproliferative Disorders; Immune System Diseases; Hypergammaglobulinemia