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

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.

Study Overview

• Status: Completed
• Conditions: Myeloma; Monoclonal Gammopathy; Monoclonal Gammopathy of Undetermined Signification
• Intervention / Treatment: Other: blood and bone marrow samples

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bretagne
    • Rennes, Bretagne, France, 35033
      • Rennes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood levels of CEC and its progenitors	Blood levels of CEC and its progenitors	Day 1
Blood levels of soluble parameters of angiogenesis and of coagulability	Blood levels of soluble parameters of angiogenesis and of coagulability	Day 1
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone marrow levels of endothelial cells and its progenitors	Bone marrow levels of endothelial cells and its progenitors	Day 1
Bone Marrow levels of soluble parameters of angiogenesis and of coagulability	Bone Marrow levels of soluble parameters of angiogenesis and of coagulability	Day 1
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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Benoît GUILLET, MD, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: August 23, 2011
• First Submitted That Met QC Criteria: March 1, 2012
• First Posted (Estimate): March 2, 2012

Study Record Updates

• Last Update Posted (Estimate): January 6, 2014
• Last Update Submitted That Met QC Criteria: January 3, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: MGUS
• Additional Relevant MeSH Terms: Immune System Diseases; Immunoproliferative Disorders; Hematologic Diseases; Blood Protein Disorders; Hypergammaglobulinemia; Paraproteinemias; Monoclonal Gammopathy of Undetermined Significance
• 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)