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

NCT ID: NCT01543100

Last Updated: 2014-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-01-31

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.

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)

Conditions

Monoclonal Gammopathy; Monoclonal Gammopathy of Undetermined Signification; Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

blood and bone marrow samples

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benoît GUILLET, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

Rennes University Hospital

Rennes, Brittany Region, France

Countries

France

Other Identifiers

2010-A00378-31

Identifier Type: OTHER

Identifier Source: secondary_id

B100413-10

Identifier Type: OTHER

Identifier Source: secondary_id

10/16-758

Identifier Type: OTHER

Identifier Source: secondary_id

LOC/10-02 - PACMoG

Identifier Type: -

Identifier Source: org_study_id