Trial Information

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

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)